AVROBIO, Inc. Announces FDA Clearance of Investigational New Drug Application for AVR-RD-01 Gene Therapy for the Treatment of Fabry Disease; The plato(TM) platform represents a significant advance towards a commercial-stage gene therapy solution designed to treat thousands of patients; AVROBIO to incorporate U.S. clinical sites into its ongoing global FAB-201 Phase 2 clinical trial in Fabry disease
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 29, 2019–AVROBIO, Inc. (NASDAQ: AVRO) (the “Company”), a Phase 2 clinical-stage gene therapy company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for AVR-RD-01, its gene therapy candidate for the treatment of Fabry disease. The Company now expects to move forward on two key initiatives in its Fabry clinical program: the incorporation of AVROBIO‘s plato(TM) platform into its FAB-201 Phase 2 trial, and the dosing of patients at clinical sites in the U.S. The plato platform consists of a state-of-the-art four-plasmid vector system, automation of a closed cell manufacturing process and a conditioning regimen that utilizes therapeutic drug monitoring (TDM).
“We are very pleased that FAB-201 remains on track to expand into sites in the U.S in the second half of 2019,” said Geoff MacKay , President and CEO of AVROBIO. “Importantly, we believe this U.S. FDA clearance represents a major milestone as we transition to plato, our optimized commercial-scale platform for our anticipated future worldwide commercialization activities. We have now achieved initial regulatory clearances for clinical trials in Australia, Canada and the U.S. which incorporate our plato platform.”
Clinical data presented at WORLDSymposium in February 2019 continued to support the potential of AVR-RD-01 as a gene therapy for Fabry disease. A total of 7 patients have been dosed with AVR-RD-01 across the investigator-sponsored Phase 1 clinical study and FAB-201, the Phase 2 clinical trial of AVR-RD-01 in Fabry disease, which is currently underway in Australia. The Company plans to provide additional preliminary clinical data from these trials this summer.
“Mytaxi” to be renamed “Free Now” and offer more services
26 April 2019 | Hamburg News
Rebranding in summer – rental cars with driver and e-scooter to complement taxi business
The Hamburg-based mytaxi app is to be renamed Free Now from summer 2019, a press release said Thursday (April 25, 2019). Mytaxi is already part of Free Now, the taxi-hailing joint venture launched by BMW and Daimler in February. Europe’s leading taxi app seeks to position itself as a mobility service provider with a broader offer and will include e-scooters in the app pending national approval. A rental car offer with driver can also be booked on the app after the brand change in Germany.
E-scooters to complement mobility mix
E-scooters are gaining popularity all over Europe and are likely to be registered in Germany soon, according to the German Ministry of Transport. Alexander Mönch, CEO of mytaxi Germany, said: “I am firmly convinced that e-scooters will very quickly become an important part of urban mobility after their nationwide approval. The company already operates its Hive scooters in five European capitals. We will integrate this offer into Free Now.” In mid April, Hive launched a pilot project on the DESY research centre in Hamburg-Bahrenfeld.
Fixed-price entry into rental car and taxi sharing
Free Now also plans to launch its own fleet of rental cars in association with taxi entrepreneurs. The entry into the rental car business is a strategic step for mytaxi. Mönch noted: “As a company with European roots, we do not want to leave the market to competitors from other continents. We continue to argue in favour of merging taxi and rental cars in a reformed joint trade with the same rules and fair competitive conditions.” At the same time, the modernisation of the taxi industry is crucial to staying competitive. Mytaxi’s taxi sharing service has been available at a fixed price since April 2019. In future, the taximeter will be replaced by a binding, electronic, price-fixing system.
Urban mobility “Made in Hamburg”
Founded in June 2009 in Hamburg, mytaxi now has 14 million passengers and more than 100,000 registered drivers making it Europe’s leading taxi app. The company employs over 700 people in 100 cities across nine European countries.
Stealth BioTherapeutics Completes Enrollment of Pivotal Study in Primary Mitochondrial Myopathy
BOSTON, April 25, 2019 /PRNewswire/ – Stealth BioTherapeutics (NASDAQ: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced completion of enrollment for MMPOWER-3 (SPIMM-301), with top-line data expected by year end. MMPOWER-3 is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of daily subcutaneous injections of elamipretide in patients with primary mitochondrial myopathy (PMM) followed by an open-label treatment extension.
“The debilitating fatigue and muscle weakness due to primary mitochondrial myopathy often has a negative impact on the quality of life of affected patients,” said Dr. Michio Hirano, professor of neurology at Columbia University Medical Center in New York, who enrolled the most patients across the 28 sites involved in the trial. “I am encouraged by the data demonstrated with elamipretide in prior trials and was pleased to be able to offer our patients the opportunity to participate in this trial.”
Approximately 40,000 individuals in the U.S. have been diagnosed with PMM, a rare primary mitochondrial disease. There are currently no therapies approved by the U.S. Food and Drug Administration (FDA) for the treatment of PMM.
“We are grateful to the scientific, advocacy and patient communities, as well as the FDA, for partnering with us in our efforts to reach this important milestone, which we hope will pave the way toward providing potentially transformative therapy for affected individuals,” said Stealth Chief Executive Officer Reenie McCarthy. “We are particularly encouraged by the strong patient interest, which enabled us to exceed our enrollment goal.”
The MMPOWER-3 study exceeded its expected enrollment with 218 patients out of a targeted 202 patients. The primary endpoints of the six-month, parallel-design study are change in distance walked (meters) as measured by the six-minute walk test, and change in the Total Fatigue score on the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA), a patient-reported outcome measure. Secondary endpoints include safety and tolerability, as well as patient- and clinician-reported outcomes. Patients completing the double-blind portion of the study (Part 1) are eligible to continue into an open-label extension (Part 2); 80 of the 85 patients who have completed Part 1 so far are participating in Part 2.
In December 2015, the FDA granted Fast Track designation for elamipretide for the treatment of PMM. In October 2017, the FDA Office of Orphan Products Development granted Orphan Drug Designation for elamipretide for this indication.
Stealth BioTherapeutics Announces Positive Results for Elamipretide in Barth Syndrome Open-Label Extension Trial
Design and results from TAZPOWER and the TAZPOWER open-label extension were presented as late-breaking abstracts at the 2019 MDA Clinical & Scientific Conference
BOSTON, April 16, 2019 /PRNewswire/ – Stealth BioTherapeutics (NASDAQ: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced positive results from the open-label extension of the Phase 2/3 TAZPOWER study of elamipretide, an investigational drug, in patients with genetically confirmed Barth syndrome. Barth syndrome is an ultra-rare mitochondrial disease in which reduced levels of the mitochondrial phospholipid cardiolipin are associated with skeletal muscle weakness, debilitating fatigue, cardiac abnormalities, recurrent infections, delayed growth and reduced life expectancy. The TAZPOWER open-label results, presented at the 2019 MDA Clinical & Scientific Conference, demonstrated potential for elamipretide to improve the relative levels of normal to abnormal cardiolipin which are diagnostic for the disease, as well as measures of exercise performance and patient-reported outcomes.
“These Phase 2/3 results support previous pre-clinical findings suggesting that elamipretide may help improve cardiolipin levels,” said Dr. Hilary Vernon, TAZPOWER trial investigator, Associate Professor of Pediatrics at the McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine and Director, Barth Syndrome Clinic at Kennedy Krieger Institute, Baltimore, MD. “Based on the correlation of the cardiolipin ratio with disease severity, these changes in the cardiolipin ratio data may suggest that elamipretide has the potential to modify the course of disease in Barth syndrome rather than merely addressing the symptoms.”
TAZPOWER was a Phase 2/3 crossover study of elamipretide in 12 patients with Barth syndrome followed by an open-label extension in which 10 of the 12 patients participated. Although statistical significance was not achieved in the intent-to-treat population during the blinded, placebo-controlled portion of the study, a pre-specified analysis of subjects with relatively higher levels of normal cardiolipin showed improvement on several endpoints.
Today’s presentation of the open-label extension data, demonstrating improvements in various endpoints irrespective of baseline cardiolipin levels, suggests that a longer duration of elamipretide therapy is particularly important for patients with lower baseline levels of normal cardiolipin. Overall, a significant (almost 40%) decrease in the average ratio of abnormal to normal cardiolipin was observed from the start of the study to week 12 of the open-label extension.
Additionally, significantly increased exercise performance in the Six Minute Walk Test (6MWT) was observed both in patients with relatively more normal cardiolipin as well as in those with relatively less normal cardiolipin. Reductions in fatigue, measured through the BarTH Syndrome Symptom Assessment (BTHS-SA) tool, a novel patient-reported outcome assessment measure, were also observed, with greater improvements observed with longer duration of elamipretide treatment. Improvements were also seen across additional secondary and exploratory endpoints including functional assessments and patient-reported outcomes.
Patients reported improvements in various symptoms, including fatigue/energy levels (90% of patients reported improvement), stamina/endurance (90%), muscle strength (80%) and appetite (70%). In addition, most patients reported improvement in daily life activities (90%), physical activities (90%) and quality of life (80%).
“Our patient community is in dire need of a therapy that addresses the complex, multi-system challenges that occur in Barth syndrome,” said Emily Milligan, Barth Syndrome Foundation Executive Director. “The positive findings presented today that elamipretide may improve fatigue and overall quality of life for people living with this devastating disease are encouraging that a potential therapy could finally be on the horizon.”
In the placebo-controlled and open-label extension portions of the study, most adverse events were mild to moderate in severity. The most commonly reported adverse events included injection site reactions.
“We are encouraged by these signals that elamipretide may benefit individuals affected by the severe cardiolipin deficiency characteristic of Barth syndrome, which we believe to be one of the most challenging mitochondrial diseases for elamipretide due to reduced opportunity for elamipretide to engage with its target, cardiolipin,” said Reenie McCarthy, Chief Executive Officer of Stealth BioTherapeutics. “These findings, which align with the improvements in activities of daily living reported by TAZPOWER subjects in our patient and caregiver perception of change video protocols, will inform our upcoming discussions on a regulatory path forward.”
The U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations for elamipretide for the treatment of Barth syndrome. Last summer, the Barth Syndrome Foundation (BSF) hosted a patient-focused drug development meeting with the FDA, from which the organization published a Voice of the Patient Report. The BSF recently shared the report with the FDA during a Professional Affairs and Stakeholder Engagement meeting.
First ICA Maxi Store in Sweden, One of 84 Grocery Locations, Launches Sale of Onsite-Grown Produce
Freight Farms customer ICA Maxi Högskolan now offers customers leafy greens grown onsite just steps from in-store shelves
BOSTON, April 10, 2019 /PRNewswire/ — Freight Farms is pleased to announce the launch of ICA Maxi Högskolan’s own line of produce grown onsite for shoppers. Located in Halmstad Sweden, Freight Farms customer ICA Maxi Högskolan is one of ICA Gruppen’s 1,300 grocery stores in the country. This month, the store began harvesting a range of hydroponically-grown greens for shoppers from Freight Farms’ flagship container farm, the Leafy Green Machine.
“We’re excited to be the first ICA Maxi store to implement an onsite farm,” said Rikard Hillarp, owner ICA Maxi Högskolan. “By growing crops just steps from our shelves, we’re able to offer our customers what are truly the freshest greens possible.”
Freight Farms’ containerized farming technology allows ICA Maxi Högskolan to create and maintain the optimal growing conditions to harvest produce year-round using less than 5 gallons of water per day. Beyond the store’s initial offering of butterhead lettuce, spinach, and herbs, the farm’s integrated IoT data platform, farmhand, will also allow the store to grow non-native crops otherwise unavailable in the region, regardless of seasonal limitations in Sweden’s Nordic climate.
“Freight Farms’ technology is especially helpful in Sweden, where our short growing seasons can limit crop availability throughout the year and increase our reliance on imported produce,” added Hillarp. “We’re now able to shorten the distance food travels to get to our customers from 2,000 kilometers to just 30 meters.”
By removing the miles between the food source and consumers, produce maintains nutrient density and stays fresh for far longer, significantly reducing food waste for both retailers and consumers.
On March 29, ICA Maxi Högskolan kicked off its launch with a Harvest Festival for customers, selling produce and offering free samples of the newly-harvested greens and a Q&A with store employees Max Rydberg and Douglas Klang, now the newest onsite farmers.
“Our team innovated the technology to empower individuals and businesses all over the world to decentralize the food system in meaningful ways specific to their local community or environment,” said Freight Farms CEO Brad McNamara. “We’re thrilled to work with industry leaders like Rikard Hillarp and retailers like ICA Maxi, who together have the forward-thinking vision and reach to disrupt the grocery industry internationally.”
Cognoa Licenses Innovative Digital Therapeutic Technology; Technology will be productized into readily accessible digital applications and incorporated into Cognoa’s precision health platform
PALO ALTO, Calif., April 10, 2019 (GLOBE NEWSWIRE) – Cognoa, a company at the forefront of digital behavioral health for children, today announces it has exclusively licensed technology from the Stanford University School of Medicine to accelerate development and worldwide commercialization of a novel digital therapeutic for children with autism spectrum disorder (ASD). Underscoring the need for earlier access to personalized therapies, Cognoa has already received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its first digital therapeutic device using the technology.
Cognoa‘s ASD digital therapeutic uses the licensed technology to target the core deficit of social-emotional reciprocity in autism. Social-emotional reciprocity is the ability to recognize, interpret and respond to social cues such as facial expressions and emotional states. Study results from a randomized clinical trial, recently published by peer-reviewed medical journal, JAMA Pediatrics, showed children who used the technology on Google Glass tested better for socialization, play and coping skills than those who only received standard of care behavioral therapy for ASD. Cognoa is actively working to further develop and productize the technology for increased accessibility on more broadly available digital platforms.
“Digital therapeutics can extend a therapist’s reach into the home, complementing in-person therapies for improved life-long outcomes,” said Brent Vaughan, CEO and co-founder of Cognoa, Inc. “We know that many families are facing obstacles to get their children the help they need. This technology accelerates our goal to empower parents with access to evidence-based solutions so they can more directly impact the progress of their children.”
Today, most children in the U.S. who receive an autism diagnosis, and subsequent treatments, do so after the age when interventions have the greatest opportunity to impact the life of the child. Cognoa will integrate the licensed technology into its precision health platform for the earlier diagnosis and treatment of pediatric behavioral health conditions. By uniquely combining artificial intelligence machine learning diagnostics and therapeutics within the same platform, Cognoa is working to create a new standard in behavioral healthcare so that children receive an earlier diagnosis and more effective therapies for the greatest potential impact on their lives.
Amylyx Pharmaceuticals Announces First Patients Dosed in PEGASUS Phase 2 Trial of AMX0035 in Alzheimer’s Disease and Expansion of the Trial
CAMBRIDGE, Massachusetts, April 3 – Amylyx Pharmaceuticals, Inc., in collaboration with the Alzheimer’s Association, the Alzheimer’s Drug Discovery Foundation (ADDF) and the Cure Alzheimer’s Fund, today announced the dosing of its first patients in a recently expanded Phase 2 clinical trial (PEGASUS) to assess AMX0035 in individuals with Alzheimer’s disease. AMX0035 is Amylyx‘s proprietary two-drug combination therapy in development to prevent nerve cell death and degeneration.
“The urgent need for a new approach to Alzheimer’s is clearer now than ever. As this is one of the first major combination therapy clinical trials for Alzheimer’s Disease, we’re optimistic about AMX0035′s potential to slow disease progression in individuals through its novel mechanisms of action,” said Steven E. Arnold, M.D., Translational Neurology Head of the Interdisciplinary Brain Center at Massachusetts General Hospital and Harvard Medical School and the study’s principal investigator.
Alzheimer’s is a complex disease that likely has multiple, interrelated causes. A growing number of experts believe combination therapy-with multiple therapeutics-will be required to effectively treat it.
“Although targeting the classic pathologies of Alzheimer’s disease, beta-amyloid and tau, has proven challenging in clinical trials, this research has awarded us with a wealth of knowledge in our understanding of the disease,” said Rudolph Tanzi, Ph.D., of Massachusetts General Hospital, chair of the Cure Alzheimer’s Fund Research Leadership Group and chair of the Amylyx SAB. “Cure Alzheimer’s Fund is proud to take initiative and provide additional funding to expand Amylyx‘s trial to support the development of novel approaches that patients need,” Dr. Tanzi added.
With additional funding from the Cure’s Alzheimer’s Fund, the PEGASUS trial has doubled its planned enrollment to 100 participants, with 20 patients enrolled and dosed to date. The trial was first supported in 2017 through the Alzheimer’s Combination Therapy Opportunities (ACTO) program, a joint research funding initiative created by the Alzheimer’s Association and the ADDF to support clinical trials combining multiple treatment approaches.
“There have been trials targeting amyloid, and there have been trials targeting tau, but this is the first trial to target two novel mechanisms in tandem,” said Howard Fillit, M.D., the ADDF’s founding executive director and chief science officer. “The ADDF was one of the earliest supporters of innovative targets for Alzheimer’s, and we believe combination therapies are a critical next step in finding effective treatments for the disease.”
“The rationale for combination therapies has already been demonstrated in diseases like HIV/AIDS, cancer and heart disease. We believe this type of approach will also work for Alzheimer’s and other dementias and are encouraged by the launch of this combination therapy trial,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association’s chief science officer. “The Alzheimer’s Association is honored to be at the forefront of the mission to keep expanding the research pipeline for therapies that attack this complex disease from a variety of angles.”
PEGASUS is a 3:2 randomized, double-blind, multi-center, placebo-controlled study evaluating the safety, tolerability and activity of AMX0035 in patients with late mild cognitive impairment or early dementia due to Alzheimer’s disease over 24 weeks. The biomarker-focused trial design will assist in demonstrating the effects of AMX0035 and its potential in treating Alzheimer’s disease. Study results are expected in 2020.
“We believe AMX0035 has potential across multiple neurodegenerative diseases. We’re moving quickly to determine the synergistic efficacy of these two therapies and deeply value the support from the Alzheimer’s Drug Discovery Foundation (ADDF), the Alzheimer’s Association and the Cure Alzheimer’s Fund to expand this unique trial,” said Kent Leslie, Amylyx‘s chief scientific officer.
CollegeVine Secures $24 Million In Series B Funding To Continue Its Disruption Of The College Guidance Industry With Affordable And Effective Solutions
CAMBRIDGE, Mass., April 1, 2019 (PR Newswire)
Today, CollegeVine, the leading provider of affordable, data-driven high school guidance and college admissions advising, announced it has secured $24 million in Series B funding from Maywood Street Investments (Maywood”), Fidelity Investments (“Fidelity”), Morningside Technology Ventures (“Morningside”), and University Ventures (“UV”). Using over a million data points to power and propel their technology, CollegeVine has helped over 10,000 students navigate the path into college, making it the largest marketplace for college advisory services in the country.
“The pricing in the college advising industry can get outrageous. Our mission is to bring data tools to families and drive down costs to expand access,” said Jon Carson, the CEO of CollegeVine. “We plan to use the Series B investment to expand our data science and engineering teams and to support our ability to bring affordable services to families making one of the most consequential decisions in their lifetime.”
CollegeVine‘s mission is to address the increasingly significant college guidance gap in U.S. public high schools, where the average student typically receives 38 minutes of guidance over four years even as they confront a high degree of information asymmetry in college selection. Approximately ninety-one percent of its customers are public school students and packages start at less than one-thousand dollars. CollegeVine provides them the tools to not only navigate the high school to college journey and but also recommends the highest ROI schools to minimize debt and improve career outcomes.
“We felt CollegeVine was affordable and offered the best value for the investment,” said Christine Sloss, the mother of a CollegeVine student. “They helped us negotiate the offer from my son’s first choice school, and got us a significant boost in aid. CollegeVine was a gift for our family. The amazing advice and emotional support they gave us was worth every penny and more.”
“CollegeVine is leading the way in creating an affordable, data-driven approach to decision making for students hoping to get into college,” said Daniel Pianko, University Ventures Managing Director.
Amylyx Completes Patient Recruitment for Phase 2 Study Testing AMX0035 for ALS
Amylyx has completed patient recruitment for the Phase 2 clinical trial CENTAUR, which addresses the safety and effectiveness of AMX0035 as an oral treatment for amyotrophic lateral sclerosis (ALS).
In 2017, Amylyx launched the CENTAUR study (NCT03127514) at several centers across the U.S. with plans to enroll 132 individuals diagnosed with sporadic or familial ALS. Now, the required number of patients has been reached, completing the recruitment phase.
Given the urgency for patients with ALS, were encouraged to reach this milestone, Justin Klee, president and co-founder of Amylyx told ALS News Today.
AMX0035 is an oral combination therapy made of two small molecules, tauroursodeoxycholic acid (TUDCA) and sodium phenylbutyrate (PB).
The medication was designed to reduce nerve cell death by blocking key cellular pathways implied in cellular stress and death.
In preliminary studies, AMX0035 reduced those signals at two important cell compartments, the mitochondria and the endoplasmic reticulum, both of which are strongly implicated in the death of nerve cells.
Preclinical testing in animal models of ALS, Alzheimers disease, and mitochondrial diseases showed that AMX0035 can effectively inhibit nerve cell death and neurotoxic inflammation.
Each of the agents that make up AMX0035, PB or TUDCA, have demonstrated strong effectiveness in several preclinical models of ALS.
But more recent studies suggest that combining both can improve effectiveness compared with single therapy.
In addition, TUDCA or PB alone have given signs of being safe and well-tolerated in clinical studies with ALS patients.
In 2017, AMX0035 was granted orphan drug status by the U.S. Food and Drug Administration (FDA) as a potential medicine for ALS.
In the CENTAUR trial, patients are randomized to receive either twice-daily oral doses of AMX0035 or a placebo for 24 weeks.
The trials primary goals are to see if therapy with AMX0035 is safe and well-tolerated and able to delay the loss of capacities during the treatment period.
The later will be measured by the ALSFRS-R scale, a doctor-reported instrument for monitoring disability progression in ALS.
Other efficacy measures will be the treatments impact in muscle strength, respiratory function, and biomarkers of ALS, including markers of neuronal death and neuroinflammation.
At the end of the 24-week trial period, patients who wish may move to an open-label extension study and continue to receive treatment.
The study is a collaboration between Amylyx, ALS Finding a Cure Foundation, ALS Association, Northeast ALS Consortium, Massachusetts General Hospital Neurology Clinical Research Institute and the Leandro P. Rizzuto Foundation.
This collaborative effort to assess the impact of AMX0035 on disease progression involves a committed team of individuals who share a strong personal connection to ALS, Sabrina Paganoni, MD, PhD, from Healey Center for ALS at Massachusetts General Hospital and the studys principal investigator said.
We thank the CENTAUR study participants and their families, site investigators and staff who are devoted to pushing ahead with us on this mission. Its exciting to be fully underway as we continue to study AMX0035, she added.
Thousands of people suffer from this disease, so were working as quickly as possible to evaluate AMX0035 as a treatment for ALS, said Joshua Cohen, Amylyxs CEO and co-founder. 2019 Global Data Point.
Engineers Making Waves in Aquaculture
The human race is staring down a crisis like nothing it has ever faced before. As the population around the world continues to grow, humanity is faced with increasingly short supplies of food.
The United Nations estimates that 815 million out of the 7.6 billion people in the world, or 10 percent, suffered from chronic undernourishment in 2016. While global food production needs to substantially increase to meet this ever-growing demand, we are also running out of places to produce this food. The Earth has already lost a third of its arable land, and climate change will only continue this trend.
The answer to these challenges is being found not on land, but under water. Aquaculture, or fish farming, has become viewed as an inexpensive, efficient way to feed the world. Fish varieties grow quickly to maturity, are very lean, and offer other health benefits, including those from Omega-3 fatty oils. At the same time, properly managed production facilities can limit the farms’ impact on the environment.
Seafood is, in many ways, an ideal food source. It’s healthy, plentiful, and sustainable. And the market knows it. The industry was worth roughly $176 billion in 2017 and is on track to reach $219 billion by 2022. That’s a five percent compounded annual growth rate.
Given this soaring demand, engineers in many fields are currently working to ensure that aquaculture as an industry is as clean and efficient as possible. This includes remote sensing technology, targeted feed additives, and recirculating water systems that can be built and function on dry land.
For example, Prospective Research, a startup out of Massachusetts, is leveraging bacteria to create naturally occurring replacements for antibiotics and other pharmaceuticals used in aquaculture. They’re doing this by modulating individual bacteria using signaling molecules that can trick the bacteria into turning on its natural biotics, or defense mechanisms.
“Maybe in 10 years this technology will be used in humans and maybe in five years in cattle and poultry to replace antibiotic growth promoters,” said Dakota Hamill, founder and CEO. “But we focused on aquaculture because it was fast growing and is faced with a very large challenge, which is how do you control disease in a population of animals in which governments have completely banned the use of antibiotics?”
The company’s solution has been to create what it calls “stim keys,” which are in effect chemical listeners that mimic what bacteria and fungi use to communicate in the soil to detect competitors or threats. In response to that signal, they’ll turn on their biodefense weapons, which are antibiotic, antifungal, and antiparasitic.
As many as 70 percent of the drugs we know today come directly from these bacterial sources, which have been evolving these tools for billions of years. Researchers can access the blueprints to as many as 40 different secondary metabolites just from the bacteria that’s found at the bottom of the ocean or in the soil.
An Hour of Light and Sound a Day Might Keep Alzheimer’s at Bay
Playing a flashing white light and a trilling sound reversed signs of Alzheimer’s in mice. Researchers are now trying it in humans
By Angus Chen
Scientific American March 14, 2019
There is no cure for Alzheimer’s disease. Although a few drugs manage temporarily certain cognitive symptoms of the illness, none can stop or meaningfully slow its progression. “We really don’t have much to offer people,” says Shannon Macauley, a neuroscientist at Wake Forest School of Medicine. Virtually all new treatments have failed in clinical trials. But new research is looking beyond drugs to see what relief might come from a simple LED light and a speaker.
Bathing patients in flashing light and pulsing sounds both tuned to a frequency of 40 hertz might reverse key signs of Alzheimer’s in the brain, according to a paper published in Cell on Thursday. “I think it’s an absolutely fascinating paper to be honest,” says Macauley, who was not involved in this work. “It’s a very provocative idea. It’s noninvasive and easy and low cost, potentially, so if it were to come to fruition in humans—that’s fabulous.”
Still, all this is a big if, Macauley acknowledges. The work was done in mice with genetic alterations that doomed them to develop key symptoms and pathology of Alzheimer’s disease. One batch of mice formed neurofibrillary tangles inside their neurons—dysfunctional knots of a protein called tau that can lead to the cell’s death. Another batch of the mice developed amyloid beta plaques—sticky heaps of protein
that dam the flow of communication between neurons. All the mice also had a third hallmark of the disease—irregular brain activity in the gamma range of brain waves that oscillate between 30 and 100 times a second.
In 2015 neuroscientist Li-Huei Tsai, director at The Picower Institute for Learning and Memory at Massachusetts Institute of Technology, was working on an experiment to manipulate that brain activity by flashing a white light at these mice. Like light strobes, our brains flicker. Brain waves are generated when large groups of neurons oscillate on and off together. Neurons encode our thoughts and actions and
senses in this rhythmic electrical flutter. So when Tsai tuned her light to flash 40 times a second, or 40 hertz, and flickered it at the mice, their brains flickered back— generating gamma waves at a corresponding 40 hertz. Then, something unexpected happened.
When Tsai dissected the mice brains afterward, the amount of amyloid plaques and tau tangles in the mice that saw the light had plummeted. “It was the most remarkable thing,” Tsai says. “The light flicker stimulation triggers a tremendous microglia response. These are the brain’s immune cells that clear cell debris and toxic waste including amyloid. They’re impaired in Alzheimer’s disease, but [the light] seems to restore their abilities.”
This clearing-out process only happened in the visual cortex where the brain processes light information. To get these effects to penetrate deeper into the brain, she added a clicking sound like a dolphin’s chirrup that also had a 40-hertz frequency. When the mice sat in a room with both the flashing light and the droning sound for an hour day, seven days in a row, amyloid plaques and tau tangles began
falling in not just the audio and visual cortices but the prefrontal cortex and the hippocampus as well. “This was one of the big jumps in the new paper,” Macauley says. “These are the learning and memory centers of the brain. And there was about a 40 or 50 percent decrease in amyloid and tau levels. It’s an absolutely impressive feat.”
That showed when Tsai put the mice through a set of cognitive tests. In one, where the mice were given a familiar and an unfamiliar object to explore, mice that didn’t get the treatment acted as though they’d never seen the familiar object. “That shows some memory problems,” Tsai says. Mice that saw the light and heard the sound spent about two thirds of the time that untreated mice did examining the familiar
object. “It was unbelievable,” Tsai says. “This is the first time we’ve seen that this noninvasive stimulation can improve cognitive function. It’s not a drug or an antibody or anything, it’s just light and sound.”
One possible explanation for this is brains with Alzheimer’s have irregular, often hyperactive, neurons, says Jorge Palop, a neurologist at the University of California, San Francisco, who did not work on the study. By providing the brains with a steady and regular beat, the repeating light and sound might work as a kind of metronome for brain activity. “This could be like resetting the mice every day and correcting some
of this abnormal activity that they have,” he says. “Then downstream of that are all these beneficial effects.”
All of this is still at the level of speculation. Researchers simply do not know why these brain waves, specifically ones rising from light and sound stimulation at 40 hertz and no other frequencies, can lead to a reversal of Alzheimer’s disease symptoms. “That’s a mystery,” says Terrence Town, a neuroscientist, at the University of Southern California who was not involved with the work. It’s also not clear if these
beneficial effects would appear or if 40 hertz is the “magic” frequency in humans, he says.
Tsai is already working on answering those questions. In human studies underway at Cognito Therapeutics, a start-up she founded with her colleague Ed Boyden, she says light and sound seem to increase gamma waves in healthy participants without negative side effects. “Nobody gets sick or even complains about it,” Tsai says. “But to see a [therapeutic] effect in humans, you’ll have to wait a long time. If this approach
has an impact, the experiment could easily take five years to have some conclusive answer.”
Flashing Lights and Sounds Improve Memory and Learning Skills in Mice
Researchers hope the techniques can be applied to help people with Alzheimerʼs.
By Pam Belluck
The New York Times March 14, 2019
Could people’s eyes and ears help fix the damage Alzheimer’s disease does to the brain? Just by looking at flashing light and listening to flickering sound?
A new study led by a prominent M.I.T. neuroscientist offers tantalizing promise. It found that when mice engineered to exhibit Alzheimer’s-like qualities were exposed to strobe lights and clicking sounds, important brain functions improved and toxic levels of Alzheimer’s-related
What’s more, the rapid-fire soundtrack appeared to make mice better at cognitive and memory skills, like navigating mazes and recognizing objects.
Of course, mice are not people. And many drugs that have helped Alzheimer’s-engineered mice haven’t done much for people with Alzheimer’s, which affects 44 million people worldwide, including 5.5 million Americans. Also, because the technique didn’t have long-lasting effects — results faded about a week after the sensory stimulation was stopped — any therapy developed from the research might have to be repeated regularly.
Still, seeing that a noninvasive daily dose of light and sound could have such significant effects in mice give some experts reason for optimism.
“It’s exciting, I think,” said Dr. Lennart Mucke, director of the Gladstone Institute of Neurological Disease, who was not involved in the study. “Reading the paper made me quite enthusiastic about seeing this move forward into some well-crafted clinical trials.”
The experiments were led by Li-Huei Tsai, director of MIT’s Picower Institute for Learning and Memory. She and her colleagues showed that light and sound delivered to mice at a certain frequency — 40 hertz or 40 flashes or clicks per second — appears to synchronize the rhythm of the brain’s gamma waves, which is disrupted in patients with Alzheimer’s. Gamma waves are among several types of electrical brain waves believed to be involved in concentration, sleep, perception and movement.
Somehow — neither Dr. Tsai nor outside experts are quite sure how — 40 hertz produces a gamma-wave oscillation that appears to increase activation of cells called microglia, which perform trash-clearing and immune-regulating functions. The microglia became more efficient at
chewing up the amyloid protein that forms toxic plaques in Alzheimer’s.
Another Alzheimer’s-related protein, tau, which forms tangles, also decreased. And in the sound experiments, brain blood vessels also worked better, further helping clear harmful proteins. Especially striking was that these effects occurred in brain areas active in memory formation, planning and decision-making, and that the mice became better at learning and remembering.
“The effects on cognitive function are pretty big,” said Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, which funds some of Dr. Tsai’s work. He said the results of the study, published Thursday in the journal Cell, are “definitely something that I don’t think anybody could have predicted.”
Enhancing or regulating electrical brain activity through techniques like surgically implanted electrodes is used to treat some other conditions, like Parkinson’s and obsessive-compulsive disorder. And previous research has shown that the activity of gamma waves, the highest frequency waves ranging from 25 to 140 hertz, decreases in the brains of patients with Alzheimer’s.
Intrigued, Dr. Tsai began experimenting with light, and in 2016, she and colleagues showed, after trying different frequencies, that light flickering at 40 hertz, beamed at mice an hour daily for a week, decreased amyloid and tau and revved up microglia in the brain’s visual cortex.
Aiming to reach other brain areas, she tried sound, settling on clicks because “your brain seems to be able to perceive clicks more than a tone,” she said.
Her team found that 40 hertz clicks, broadcast from speakers over mouse enclosures, produced the same brain changes in the auditory cortex and the nearby hippocampus, an area active in forming memories that is damaged early in Alzheimer’s. The mice also performed better at maze navigating and recognizing objects they had seen before.
Light and sound combined magnified the brain effects and extended them to the prefrontal cortex, a key area for planning and executing tasks.
“It’s stunning that the intervention had beneficial effects on so many different aspects of Alzheimer-like pathology,” said Dr. Mucke, who is also a professor of neurology and neuroscience at University of California San Francisco. “On the other hand, it shouldn’t be surprising that the brain is influenced by outside stimuli because what it was designed for was to adapt to a changing environment.”
The results also dovetail with findings by Dr. Mucke and his colleagues, who have genetically altered brain cells called interneurons, which he likened to conductors of the brain’s orchestra. The altered interneurons enhanced gamma rhythm activity, generating cognitive improvement in mice. “When there isn’t proper brain rhythm, there is disharmony and everyone is sort of playing when they want to, a little like the tuning up of an orchestra,” he said.
His colleagues are also developing a drug that would have similar effects. So there might be several ways to enhance gamma rhythms, he said.
Because the brain changes subsided somewhat after a week without the light or sound treatment, experts said it’s likely that people would need such stimulation consistently, essentially a sensory version of a daily pill to control a chronic condition.
Dr. Tsai’s team has tested light and sound on healthy people, using a four-by-three-foot light panel and high-quality stereo speakers, “so the sound is more tolerable to humans, because it’s not melody, it’s clicks,” she said. Electroencephalogram measurements show the desired gamma-wave effect, she said, and “nobody complains about any discomfort or headache or anything.”
They will soon start testing on people with mild Alzheimer’s. Dr. Tsai and a co-author, Edward Boyden, co-director of the M.I.T. Center for Neurobiological Engineering, have also co-founded a company, Cognito Therapeutics, which is testing a goggles-like light-and-sound device on Alzheimer’s patients, she said. Dr. Tsai said the company is not involved in her team’s academic research, which was funded by several foundations and the National Institutes of Health.
Experts cautioned that people should wait for clinical trial results and shouldn’t suddenly start illuminating their homes with disco strobes or pipe clicking sounds through their earbuds. Still, said Dr. Koroshetz, sensory treatment is likely to be safe for most people.
“Can’t think of any harm that can come out of this one,” he said. And because Alzheimer’s is so devastating, he added: “I think people would participate in studies, even if they require flashing lights for an hour and listening to a very quick drummer.”
Desora Launches Cinder Countertop Smart Grill to Help Consumers Cook Food Perfectly and Effortlessly
Officially available for purchase, Desora reintroduces the crowdfunded countertop grill featuring next-gen technology
CAMBRIDGE, Mass., March 12, 2019 /PRNewswire/ – Desora, the leading food and grilling technology company, announced today the launch of Cinder, the world’s first countertop grill with 1° Precision that cooks like magic. Now available for purchase online in the United States, Cinder Grill, powered by Desora, combines waterless sous vide cooking with the searing capabilities of an outdoor grill to create restaurant-worthy meals without ever overcooking food again.
Cinder Grill offers exact temperature control by simply selecting a temperature for the food or by pairing Cinder with its mobile app. The app automatically reads the thickness of food and, through “Temp-Sense,” its proprietary algorithm, determines the temperature. It then cooks to that temperature and alerts via mobile when completed, holding food perfectly until users are ready to eat.
“We are so pleased to announce retail availability for Cinder Grill,” said Michel Maalouly, Co-Founder and CEO of Desora. “Cinder Grill, along with our other Desora grilling products, provides effortless precision grilling for which home cooks don’t need extensive culinary backgrounds – incredible food is now accessible to all.”
Acquired in November 2018, Cinder launches as part of Desora’s family of cooking and grilling products, including the iKamand, a smart grill controller, and ProJoe, the high-caliber grill powered by Desora.
Cinder Grill is now available for purchase at www.cindergrill.com for $429.00.
All consumers who ordered Cinder Grill through the previous crowdfunding campaign will be contacted and their order will be fulfilled.
Liquidia’s LIQ861 Meets Primary Endpoint in Pivotal Phase 3 INSPIRE Study in Patients with Pulmonary Arterial Hypertension
- LIQ861 was well-tolerated in PAH patients at two months of treatment
- INSPIRE enrollment complete, including PK sub-study
- Anticipate submitting NDA for LIQ861 to the FDA in late 2019
RESEARCH TRIANGLE PARK, N.C., March 11, 2019 (GLOBE NEWSWIRE) – Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology, today announced top-line results of its pivotal Phase 3 INSPIRE study in patients with pulmonary arterial hypertension (“PAH”) treated with LIQ861, the first inhaled dry powder formulation of treprostinil. Initial analysis indicates the study has met its primary endpoint of safety and tolerability of LIQ861 at the two-month timepoint.
Nicholas Hill, MD, Chief Pulmonary, Critical Care & Sleep Division and Professor of Medicine at Tufts University School of Medicine and INSPIRE Principal Investigator, stated: “The top-line analysis of LIQ861 from the INSPIRE study is highly encouraging for physicians and patients. LIQ861 was safely titrated to therapeutic levels across a wide range of inhaled doses and was very well tolerated. This means that we are moving closer to having an inhaled therapy available for PAH that is much more convenient than previous ones. Most patients tolerated relatively high doses of treprostinil, raising the possibility that the PRINT technology, by virtue of its ability to make microscopic particles of uniform size, could improve distribution of drug to the lung, enhancing therapeutic effect.”
LIQ861 was observed to be well-tolerated in 109 patients, with 101 patients (93%) completing at least two months of treatment. During the two-month period, LIQ861 was evaluated at doses up to 150 mcg capsule strength with no study-drug related serious adverse events observed. Reported treatment-emergent adverse events (“TEAEs”) were mostly mild to moderate in nature. The most common TEAEs reported with LIQ861 in ≥4% of PAH patients were cough (33%), headache (18%), throat irritation (14%), dizziness (10%), diarrhea (8%), oropharyngeal pain (6%), nausea (6%) dyspnea (6%), flushing (6%) and chest discomfort (5%). These observations are consistent with the safety data at the two-week timepoint reported on January 7, 2019. Of the TEAEs observed, most were reported during the first two weeks of initial exposure and occurred in patients previously naïve to prostacyclin-based therapy in which LIQ861 was added to oral therapy.
Neal Fowler, Chief Executive Officer of Liquidia, commented: “We are extremely grateful to the patients participating in the clinical trial and for the effort and speed with which our investigators completed enrollment. We believe the commitment to this study signals an increasing need for safe, more convenient inhaled treatment options. We are preparing the new drug application submission, while collecting additional longitudinal data on the benefits from LIQ861.”
In addition to meeting the primary endpoint, the one-directional crossover sub-study to compare bioavailability and pharmacokinetics of treprostinil as the patients transition from Tyvaso to LIQ861 has been fully enrolled. Liquidia expects to report its pharmacokinetics results in the second quarter of 2019 and plans to provide more detailed clinical results through scientific disclosures at upcoming congresses and in peer-reviewed publications.
LIQ861 is an inhaled dry powder formulation of treprostinil designed using Liquidia’s PRINT technology to enhance deep-lung delivery using a convenient, palm-sized, disposable dry powder inhaler (“DPI”) for the treatment of PAH. Liquidia believes LIQ861 can overcome the limitations of current inhaled therapies and has the potential to maximize the therapeutic benefits of treprostinil in treating PAH by safely delivering higher doses into the lungs.
About INSPIRE Clinical Trial
Liquidia’s pivotal open-label Phase 3 clinical trial, known as INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, is designed to evaluate patients who have either been under stable treatment with nebulizer-delivered treprostinil for at least three months and are transitioned to LIQ861 under the protocol or patients who have been on stable treatment with no more than two non-prostacyclin oral PAH therapies for at least three months and have their treatment regimen supplemented with LIQ861 under the protocol. The primary objective of the INSPIRE study is to evaluate the long-term safety and tolerability of LIQ861. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03399604.
MyTaxi hailed a success; 400 CAB DRIVERS SIGN UP TO APP IN ITS FIRST YEAR IN CITY
by Phoebe Ram, Nottingham Post
A taxi booking app has celebrated its first year of business in Nottingham, and cabbies have managed to rack up some impressive mileage.
MyTaxi was founded in 2009 and launched in Nottingham on March 1, 2018. Since then, the drivers who have signed up to the company have collectively travelled over 430,000 miles – a distance equivalent to driving 17 times around the earth.
Nottingham was the first location for MyTaxi to launch the app outside of London, and is the most successful city in terms of business growth, after the capital.
The company now has almost 400 licensed taxi drivers in Nottingham, with over 41,000 passengers using the service, which is similar to Uber.
The launch last year, in partnership with Nottingham City Council, has helped provide the city with skilled and knowledgeable drivers and a guarantee of safe, reliable, convenient and cost-effective travel for residents.
The business now has a central role in Nottingham’s transport system.
David Savage, general manager at MyTaxi, said: “We’re really pleased with how well the business is doing in Nottingham. It’s great to see the results after a year in the city, with almost 400 drivers now signed up to the app. We’ve really enjoyed working with the local council on this partnership and getting to know some of the drivers in the city who are using the app. Drivers using mytaxi in the city see, on average, four extra jobs per day, or almost 30 per week, so the app really is benefiting them. Passengers are also enjoying using the app to get them around safely.”
Kaleem Ashraf, a taxi driver from Nottingham, added: “Using the MyTaxi app has really improved my work life and I haven’t looked back. It has enabled me to become more flexible with my jobs and has given me extra work when I need it.”
Amer Alam, another taxi driver from Nottingham, said: “I recommend MyTaxi to all of my friends who are cabbies. The app gives you so many more extra jobs a week.”
Portfolio holder for community protection, Councillor Toby Neal, said: “We were very pleased to partner with MyTaxi a year ago to help improve the experience for passengers using hackney cabs in Nottingham, the first city outside London to do so.
“Taxis are an important part of the transport options available in Nottingham and MyTaxi is one part of a wider drive to raise the quality of local hackney services, with cleaner, modern vehicles being added all the time, and drivers being held to higher standards.
“It’s brilliant, and no great surprise, that people have taken to the app in such large numbers in Nottingham.
“With other apps becoming a popular way of booking taxis, it makes complete sense to have something similar for hackneys so it’s as easy and appealing as possible.”
CollegeVine Closes 2018 as the Largest Marketplace for College Advisory Services in the U.S.
Company Marks Milestone of Helping Over 10,000 Students Navigate the High School to College Journey
CAMBRIDGE, Mass., Feb. 26, 2019 /PRNewswire/ — Today, CollegeVine, the leading provider of data-driven high school guidance and college admissions advising, announced a major milestone reached in 2018, making it the largest marketplace for college advisory services in the country. The company has now helped over 10,000 students navigate the path into the college and has over a million data points to power and propel their technology forward in 2019.
“CollegeVine is addressing the increasingly significant college guidance gap in U.S. public high schools where the average student typically receives 38 minutes of guidance over four years,” said Jon Carson, CollegeVine CEO. “That alarming statistic, coupled with the fact that this is the one of the biggest financial decisions most families make, allows CollegeVine to provide students with the tools to navigate the high school to college journey. In addition, the technology we released in 2018 also helps them determine schools with the best return on investment for each families’ unique needs.”
This year, counselors in CollegeVine’s ecosystem used technology powered by more than a million data points from past students, resulting in:
- Unparalleled admissions results: 74% of CollegeVine were students accepted to one or more of their top three reach schools. Additionally, CollegeVine students experienced a 3x higher likelihood of getting accepted to a top school relative to their peers.
- Increased Early Action/Early Decision Acceptance: CollegeVine EA/ED acceptance rate was 3.5 times higher than the market rate for top 15 schools; and 2.5 times higher than the top 30 schools.
- A record amount of scholarship funding for clients for a second straight year: CollegeVine clients received an average scholarship award of roughly $83,000 during the 2017-2018 admissions season — an increase of $15,000 year over year.
- Recognition as leaders in the college admissions space: Data and insights recognized in top-tier media including Business Insider, CBS, Forbes, Fox News and NBC.
- The launch of CollegeVine Applications™ Platform: CollegeVine released its end-to-end college advising platform including data-driven school list generation, deadline management, and predictive career ROI tools.
- Expansion of HQ staff and management team: Added 35 new employees at its Cambridge headquarters and strengthened the management team by adding Scott Powers as Chief Financial Officer and Rob Merklinger as Senior Vice President of Enrollment.
- Record customer satisfaction: 91% of families’ say they are “extremely satisfied” with CollegeVine’s admissions services; 89% are “extremely satisfied” with their re-launched SAT advising platform.
“Getting help from CollegeVine to get us organized and know what we needed to have before we applied was essential,” said Bety Gegundez, the mother of a CollegeVine student.
“If we approached it on our own, we probably would have missed two or three schools we never would have thought about,” Christopher Arnold, the father of a CollegeVine student.
“In 2019, the growth in our counseling ecosystem will fuel more data insights, higher quality counseling, and improved student outcomes,” said Carson. “Simultaneously we will be expanding our offerings to younger students with the launch of some free tools to get families started in the right direction in this process, as early as possible.”
CollegeVine is a technology platform that enables high school families to navigate the college admissions process using data. With software powered by millions of past student data points, CollegeVine intelligently analyzes colleges based on students’ odds of acceptance and recommends the highest ROI schools to minimize debt and improve career outcomes. Families can also choose to receive personalized guidance from an ecosystem of hundreds of expert admissions consultants recruited from the nation’s top universities. Consultants use CollegeVine’s guidance technology to triple their clients’ odds of acceptance and increase their average scholarship awards by $25,000. With a data-driven model that enables affordable, high quality advising to families, CollegeVine has helped over 10,000 students navigate the path to college. For more information, visit www.collegevine.com.
How Freight Farms Plans To Grow Sales (And More Veggies) With Its Next-Gen Farm In A Box
Robin D. Schatz, Contributor
February 26, 2019 www.forbes.com
Almost a decade ago, the cofounders of Boston-based Freight Farms pioneered the idea of outfitting used shipping containers with everything a farmer needs to grow greens and herbs in a pesticide-free, climate-controlled environment without soil. These hydroponic vertical farms, which grow plants in nutrient-enriched water, are turnkey operations that enable a farmer to get up and running in a matter of days. And the whole thing takes up just 320 square feet.
Cofounders Jon Friedman and Brad McNamara formed their company in 2010, raised their first funds on Kickstarter in 2011 and introduced their Leafy Green Machine a year later. Freight Farms has since raised about $12 million from VC firms. To date, it has sold more than 250 of those shipping-container farms, which use off-the shelf parts and their own proprietary software, in more than 15 countries.
After about four years of working with that model and pushing it as far as we could go, we realized we needed to make a more quantum leap, said Friedman, who is chief operating officer.
Freight Farms says its new LED lighting system produces higher yields and heavier plants
Today Freight Farms will announce its next-gen product, called the Greenery. Instead of using recycled shipping containers, the units are built from the ground up for Freight Farms with all new components. Growing racks can now be configured to accommodate bigger plants, such as tomatoes. Lighting has improved too. Its energy-efficient LED arrays, with three times the power of the old ones, result in heavier plants and greater yields, according to the company.
Water and energy usage are also more efficient than the old design. The farm’s new climate-control system condenses and recycles ambient moisture. The company said it offers 70% more growing space, among other features. Its IoT-connected sensors continuously send the farmer data on temperature, lighting, moisture content, CO2 levels and other environmental variables to allow them to monitor and adjust conditions remotely from a smart phone.
I first wrote about Freight Farms in December 2015, when revenue was about $3 million and the company had about 50 customers. Granted, the business is still small, but it s growing steadily and adapting, much as plants do, to a changing environment. The company declined to disclose its revenue this time around, citing intense industry competition. Indeed, a quick Google search shows they aren’t alone anymore in the shipping-container farm business. Competitors include the CropBox and Growtainer. Customers might also opt for other types of vertical, hydroponic systems that don’t use a shipping container.
In 2015, Leafy Green Machines had a base price of $76,000. The new Greenery costs $104,000.
Some of the most enthusiastic customers of the freight-container farms are big corporations, who see it as an extension of health and wellness programs or social action initiatives. You can find a Leafy Green Machine on the Google campus in Mountain View, Calif., where it’s used to grow greens and edible flowers. In Detroit, Ford Motor Company Fund, the automaker’s philanthropic arm, also has a freight farm, that it’s operating in partnership with a nonprofit to help supply its community kitchen with fresh produce and provide job training. Everlane, the clothing company, uses its shipping-container farms in Vietnam to provide food for its workers.
Academic institutions find freight farming particularly appealing, said McNamara, who is CEO. We’re seeing more and more of the education segment who want onsite local high quality produce and want to connect students and employees to where their food is coming from.
The University of Georgia has just ordered two Greenery farms to help supply their dining halls with local greens more efficiently and sustainably while educating students about where their food comes from, the school told me in an e-mail.
Of course, not every university or corporation wants to actually do the work of farming, the cofounders realized. So, in late 2018, they launched Grown by Freight Farms, where customers sign up for a service contract. We provide them with a farm and a farmer, said McNamara, who is CEO.
Small farmers are also an important market for Freight Farms. In Guam, a farmer uses his Leafy Green Machine to supply Wendy’s with lettuce. In North Carolina, Heather David and John Peters, who sell pasture-raised meat to chefs from their WhyNot Farms with two locations in North Carolina and a new one in Tennessee, are among the first in line for a Greenery. They expect to receive delivery in May.
We were looking to diversify our business in a way that would be less labor intensive, and we wanted something that would weigh less than cows or pigs, said Davis. We re middle-aged and felt it would be more sustainable for us to be raising vegetables.
Davis, president and chief investment officer at Nuveen Private Markets in Charlotte, N.C., moonlights as her husband’s farmhand on weekends and she happens to have a local vertical, hydroponic farming operation in her portfolio. There were plenty of options for Davis to consider for their own hydroponic system, which they hope to power mostly with solar energy.
What appealed to me about Freight Farms is that they are very focused on the sustainability aspect and conservation of water, she said. It s in a compact unit, and they just drop it on your site.
Davis also liked the fact that the company provides intensive farmer support and education.
It s not clear to me yet the extent of what we ll be able to grow in this, she said. I’ll grow what anybody will buy as long as it’s not a total pain in the neck and I can make a profit.
Apnimed Listed a New Clinical Trial of AD036 in Obstructive Sleep Apnea
Contify Life Science News
Feb. 19 – Apnimed has listed an interventional clinical trial, Phase 2, for placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of three dose levels of AD036 in adults with obstructive sleep apnea. The trial’s principal investigators are Mark Gotfried, MD, Paul E Wylie, MD, Daniel Norman, MD, Helene Emsellem, MD, James P Maynard, MD and James Andry, MD.
The trial for a sample of 140 participants from USA is currently open for recruiting.
The study is being conducted for the following purpose:
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.
The full document can be viewed at https://clinicaltrials.gov/ct2/show/NCT03845023?recrs=abdfm&type;=Intr&cntry;=US&phase;=0123&sfpd;_s=02%2F19%2F2019&sfpd;_e=02%2F19%2F2019&rank;=10.
Stealth BioTherapeutics Announces Pricing of Initial Public Offering
BOSTON – February 14, 2019 – Stealth BioTherapeutics (Stealth), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the pricing of its initial public offering of 6,500,000 American Depositary Shares (“ADSs”), each representing 12 ordinary shares of Stealth, at an initial public offering price of $12.00 per ADS. The total gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Stealth, are expected to be $78.0 million.
In addition, Stealth has granted the underwriters a 30-day option to purchase up to an additional 975,000 ADSs on the same terms and conditions.
The offering is expected to close on February 20, 2019, subject to satisfaction of customary closing conditions.
Stealth’s ADSs have been approved for listing on The Nasdaq Global Market and are expected to begin trading on February 15, 2019 under the ticker symbol “MITO.”
Jefferies LLC, Evercore Group L.L.C. and BMO Capital Markets Corp. are acting as joint book-running managers for the offering. Nomura Securities International, Inc. is acting as the lead manager for the offering.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on February 14, 2019. Copies of the registration statement can be accessed by visiting the SEC’s website at www.sec.gov. The offering is being made only by means of a prospectus. When available, copies of the final prospectus may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at email@example.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055 or by telephone at (888) 474-0200 or by email at firstname.lastname@example.org; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by e-mail at email@example.com.
CellCentric launches clinical programme in blood cancers led by Prof Andy Davies
CellCentric is initiating a clinical study of CCS1477, a first-in-class p300/CBP inhibitor, in haematological malignancies. CCS1477 is already in Phase I studies for late stage prostate cancer. The clinical programme is being extended to include acute myeloid leukaemia (AML), multiple myeloma (MM) and non-Hodgkin lymphoma (NHL) following new pre-clinical data showing profound anti-tumour effects of CCS1477 in models of these haematological malignancies. The Chief Investigator for the new Phase I/II clinical study will be Prof Andy Davies of University Hospital Southampton. The trial is expected to open for recruitment in Q2 2019.
CCS1477 is a novel, highly potent and specific inhibitor of the common bromodomain of two critical cancer regulatory proteins, p300 and CBP. The drug is formulated as a capsule to be taken orally. Inhibiting p300/CBP in blood cancers affects the IRF4-Myc pathway and can have a significant impact on tumour growth in pre-clinical models. CellCentric is now transitioning the product into haematological cancer clinical trials.
Andy Davies is Professor of Haematological Oncology and Consultant in Medical Oncology within The Faculty of Medicine at the University of Southampton. He has specific interests in the clinical course of malignant lymphoma, the investigation of novel therapeutic approaches and biomarker identification. He has extensive experience in early phase trials, including leading several first in man lymphoma studies. He is Chair of the UK National Cancer Research Institute High Grade Lymphoma Study Group and Director of Cancer Research UK/National Institute of Health Southampton Experimental Cancer Medicine Centre.
CCS1477 is currently enrolling patients in a Phase I/II clinical trial for late stage prostate cancer, with Prof Johann de Bono of the Royal Marsden Hospital, as the Chief Investigator. The drug is positioned to be used after or in combination with second generation anti-hormonal drugs such as abiraterone, enzalutamide and apalutamide. The mode of action of CCS1477 addresses the primary resistance mechanisms to these current agents, whether inherent or acquired.
Dr Nigel Brooks, CellCentric’s Director of Translational Research, commented: “At CellCentric and with our network of scientific collaborators, we have generated new and compelling pre-clinical data showing profound anti-tumour effects of CCS1477 in models of AML, MM and NHL. We are excited to now translate these findings into the clinic. We look forward to working with Prof Andy Davies and other clinical experts as we develop this novel approach for the benefit of patients with haematological cancers.”
The clinical need and potential market for a new agent for late blood cancers remains significant. Particularly in late stage relapsed refractory multiple myeloma the market could be in the tens of thousands of patients to treat each year.
CellCentric will be presenting CCS1477 in the ‘New Drugs on the Horizon’ session at AACR in Atlanta, on the 31st March 2019.
Cognoa scores FDA breakthrough designations
by Liz Hollis, Staff Writer, BioWorld MedTech
Palo Alto, Calif.-based Cognoa Inc. received breakthrough device designations from the U.S. FDA for its digital diagnostic and digital therapeutic devices for autism. Cognoa’s digital precision health platform weds machine learning and predictive analytics to parental inputs and diagnostic data and responses to therapeutics to create more personalized care. The single platform aims to help clinicians to come to accurate diagnostic and therapeutic decisions faster and modify treatments.
About 1 in 59 children has been identified with autism spectrum disorder, according to estimates from CDC’s Autism and Developmental Disabilities Monitoring Network. The company noted that the average age of autism spectrum disorder diagnosis has remained unchanged for more than 15 years, standing at more than 4 years of age.
“We believe [artificial intelligence]-based precision health can empower parents and their pediatricians to act on early concerns that are highly predictive of developmental delays, like autism, with potentially life-changing results for children and their families,” Brent Vaughan, CEO and co-founder of Cognoa, explained. “We are thankful that the FDA recognizes the critical need for innovative solutions to help address these challenges. We look forward to working closely with them to further our clinical studies and support our development.”
The company said its diagnostic device is intended to help health care professionals provide a diagnosis of autism spectrum disorder in children between the ages of 18 months and 72 months who are at risk for developmental delays. That is important because a diagnosis often comes later, after the window of brain plasticity that is crucial to maximizing treatment outcomes.
With its therapeutic device, the company will aim to help boost socialization and responsiveness of children with autism spectrum disorder. The device will be intended for use outside the clinician’s office to supplement existing therapies, giving patients timely and convenient access to care, with the potential of reducing wait times.
“Cognoa’s diagnostic device is unique in that we expect it to be the first medical device intended for use by pediatricians and primary care physicians to enable a diagnosis up to two-and-a-half years sooner than the current standard of care,” Vaughan told BioWorld MedTech. “The Cognoa device is also unique in that it engages both the parent and their child’s trusted doctor to enable earlier diagnosis and treatment.”
The company is hoping for a quick turnaround with the FDA. “We are focused on our product development and continue to work with the FDA to gain regulatory clearance. We expect to make substantial progress towards the goal of FDA clearance in 2019,” Vaughan said.
In terms of other offerings, he noted that the company provides the Cognoa Child Development app via partnerships with employers, payers and applied behavior analysis therapy centers.
Last fall, Baltimore-based Learn Behavioral, a network of providers serving children with autism and other special needs, reported a partnership with the company that aims to improve the timeliness of care. The company’s solution will be deployed in nine regions within the Learn network. Just last month, the company said Cambia Health Solutions Inc., of Portland, Ore., would incorporate its evidence-based platform within its subsidiary health plans.
Feedback for the development app, which, so far, has been used by more than 250,000 families, has been positive. Vaughan said parents like that it can help them obtain answers sooner, allowing for earlier diagnosis and treatment. “Regardless of whether their child’s development is on track or not, parents have reported feeling empowered with our evidenced-based activities to support their child’s unique developmental progress. We have also received strong support and enthusiasm from clinicians wanting to participate in our clinical studies,” he added.
When asked about the potential for going to other markets, Vaughan said the U.S. is the main focus right now, but the company will evaluate expansion. Also, the company is looking to go beyond its first therapeutic area of autism. “We intend to develop further devices based on our precision health platform for ADHD and other behavioral health indications. We are committed to generating and sharing clinical data and trials and submitting further results to peer-reviewed medical journals,” Vaughan said.
Another company trying to help identify those with autism spectrum disorder early is Madison, Wis.-based Neuropointdx, a division of Stemina Biomarker Discovery. Last fall, the company, which focuses on metabolomics, unveiled the Npdx AA test. That test identifies metabolic subtypes associated with the condition. (See BioWorld MedTech, Nov. 2, 2018.) The test, provided through Neuropointdx’s CLIA-certified laboratory, may be used to screen children as young as 18 months.
Heuresis Announces Its Rebrand to Viken Detection
Viken Detection Committed to Leveraging Emerging Technology to Address Urgent Homeland Security and Public Safety Threats
NEWTON, Mass.–(BUSINESS WIRE)–Heuresis, pioneer of handheld x-ray imaging and analytical devices, today announced it is rebranding the company as Viken Detection (effective February 11). The brand name, Viken, and tagline, “One Sense Ahead,” reflect the vision of the company, led by CEO Jim Ryan and CTO Dr. Peter Rothschild, to significantly increase the use of cutting-edge technologies to address urgent homeland security and public safety challenges.
Viken Detection is already the recognized leader in handheld imaging used by law enforcement to uncover contraband such as opioids, cash and explosives hidden in vehicles, cargo containers, boats, buildings and other concealed areas. Viken Detection is also revolutionizing lead paint detection with its Pb200i, a handheld analyzer that can identify the hazard at much lower levels than currently being tested. In addition to the advanced physics, all Viken’s ergonomic handheld devices are Android-based, and include smartphone technologies such as a camera, GPS, WiFi, third-party app integration and other functionality.
“There are many areas of homeland security and public safety that can be addressed with new technology advances,” said Ryan. “Our focus is to quickly get this technology into the hands of professionals who need it to protect the public. Now our brand name reflects that vision and mission.”
“VIKEN” is derived from “sixth sense” through the blending of concepts “VI” the roman numeral for six and “KEN” meaning knowledge or range of sight. Along with its new tagline, “One Sense Ahead”, the brand VIKEN is intended to signify the company’s focus on detecting public threats with breakthrough technology.
Viken Detection recently announced a 5-year IDIQ contract award, valued up to $29 million, with U.S. Customs and Border Protection for the HBI-120 (Viken’s handheld x-ray imaging device) to help thwart drug-trafficking across the border. Viken also announced contracts with the U.S. Department of State and the World Customs Organization for wide international deployment of the handheld device.
The new website can be found by visiting vikendetection.com.