Inotrem Secures Strategic Licensing Agreement for a Companion Diagnostics Test in Septic Shock
PARIS, January 21, 2020 (BUSINESS WIRE) — Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway with potential applications for acute and chronic inflammatory syndromes, announced today that it has entered a worldwide licensing agreement with Roche Diagnostics for the commercialization of a mechanism-based companion diagnostic test using a soluble plasma protein (sTREM-1).
This agreement consolidates existing ties between Roche Diagnostics and Inotrem who are jointly developing since 2017 an in vitro assay for measurement of sTREM-1 in plasma samples of septic shock patients. Measurement of sTREM-1 in blood provides a valuable indicator for the severity and outcome prediction of septic shock patients.
One of the main issues with septic shock is the heterogeneity of the patient population. The companion diagnostic test will allow a stratification of patients to identify those who are more likely to respond to Inotrem’s treatment. Septic shock is the ultimate complication of sepsis. The incidence of septic shock continuously raises, and mortality remains elevated (35%) in developed countries. There is currently no specific mechanism-based therapy approved for this indication besides antibiotics and symptomatic treatment. Inotrem’s therapeutic solution has the potential to become the first targeted treatment for septic shock.
“We are delighted to extend our partnership with Inotrem to make the sTREM-1 test, which we are co-developing at Roche, available for patients globally. Through the development and commercialization of this novel companion diagnostic test we are committed to delivering a solution that enables much needed, better decisions for sepsis patients”, said Ann Costello, Global Head Centralised and Point of Care Solutions, Roche Diagnostics.
“Roche Diagnostics’ licensing agreement is an important milestone for us: it is a strong endorsement of Inotrem’s innovative approach targeting the TREM-1 pathway, and it allows us to further focus on our core mission: the development of a nangibotide-based septic shock treatment” added Dr. Jean-Jacques Garaud, CEO of Inotrem.
Inotrem has recently initiated its Phase IIb study in septic shock patients (ASTONISH trial) and enrolled its first patient. The study aims at demonstrating efficacy of its lead compound, nangibotide, and bring a clinically relevant proof of clinical activity in septic shock patients. This study also intends to confirm the value of soluble TREM-1 as a potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment.
PhoreMost Enters Multi-Project Drug Discovery Collaboration With Otsuka Pharmaceutical
CAMBRIDGE, England, January 21, 2020 (BUSINESS WIRE) –PhoreMost Limited, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, today announced it has entered into a multi-project collaboration with Otsuka Pharmaceutical Co., the world-leading pharmaceutical company dedicated to the research and development of highly-innovative drugs and diagnostics. Financial details of the agreement are not disclosed.
PhoreMost will deploy its in-house expertise and next-generation phenotypic screening platform, SITESEEKER®, towards disease relevant pathways nominated by Otsuka. Novel targets identified will be further validated and characterised by Otsuka as part of its internal development pipeline, with an initial focus on gene therapy applications of identified targets.
PhoreMost’s SITESEEKER platform exploits protein shape diversity to find functionally active peptides, significantly enhancing the power of phenotypic screening and translation into therapeutic modalities. Based on proprietary protein interference, or ‘PROTEINi®’, technology PhoreMost uses SITESEEKER to probe the entire proteome in a live cell environment for novel druggable targets linked to any chosen disease. This enables the systematic discovery of functionally active peptides which are directly linked to useful therapeutic applications.
Dr Chris Torrance, CEO of PhoreMost, said: “This collaboration with Otsuka is further recognition of the power of the SITESEEKER approach to drive the identification of novel, druggable targets. We are particularly excited to be exploring not only small molecule therapeutics but also gene therapy applications of our platform.”
Alyce Named Leader in the G2 Winter 2020 Account-Based Execution Software Grid Report
BOSTON, MA, January 15, 2020 (BUSINESS WIRE) – Alyce, the AI-powered gifting platform that’s redefining sales and marketing outreach, today announced its position in the Leader quadrant in G2’s Winter 2020 Grid Report for Account-Based Execution. Leaders are determined by their high levels of customer satisfaction and likeliness to recommend ratings from real users on G2, the world’s leading business solutions review website. As part of this Winter 2020 report, Alyce also scored highest in G2′s Relationship Index for the Account-Based Execution category (with a score of 9.59 out of 10), which is measured based on ease of doing business, likely to recommend, and quality of customer support.
Alyce also scored highest in the same Account-Based Execution category (9.21 out of 10) in G2′s Usability Index, ranking companies based on ease of administration, ease of use, and meeting other key requirements.
“Enterprise companies are turning to Alyce to transform their approach to growing their business, looking to create personal experiences and authentic connections that resonate with buyers and customers,” said Sean MacPherson, Head of Customer Success. “Alyce’s commitment to creating lasting and sustained relationships with our customers and helping them see success is resonating with the market and we are thrilled by G2’s recognition as a category leader. This is truly a testament to the dedication, spirit, and strength of our customer success team.”
“Rankings on G2 reports are based on data provided to us by real users of the products,” said Michael Fauscette, Chief Research Officer at G2. “Technology buyers use the ranking on G2 to find the best software products based on the real-world voice of the user, accelerating their digital transformation projects and gaining competitive advantage.”
Alyce has received more than 125 G2 Crowd reviews. Review highlights include:
- “Alyce is the best door opener – companies that I’ve been working for months, not responding whatsoever, finally answering me because it’s a unique AND personal way to reach someone.” ~Allison F.
- “Creative and personalized way to engage prospects. Alyce’s is a great way to engage with prospects on a personal level. The AI will recommend gifts to send to prospects based on a variety of factors – all of which increase your chance of getting a response from them. Giving the option to exchange gifts or donate the value of the gift to charity is also an awesome aspect of Alyce – I am really a big fan of the charity donation.” ~William R.
Since its inception, Alyce has been focused on creating real personal experiences that help businesses grow with the only platform that gives sales, marketing, and customer teams the ability to create individual personal gifts at scale. Fully focusing on the recipient and customers’ interests, rather than sending everyone the same generic item, Alyce bridges the physical and digital marketing worlds to help companies create breakthrough connections engaging people on their own terms. Providing the power of choice, recipients can select the personal gift recommended, pick something else from the Alyce gift marketplace, or even choose to donate the value of a gift to a charity of their interest.
“We’ve had a huge year at Alyce with 1,200% growth, closing out the year with some of the largest enterprise brands, including 6Sense, Bandwidth, Citrix, Dialpad and ServiceNow selecting our platform, and more importantly, investing in our unique personal experience business approach to help them scale and grow more effectively,” said Greg Segall, founder, and CEO of Alyce. “And now being recognized by G2 is an amazing milestone honor and testament to our focus on making our customers incredibly successful, with them accomplishing tremendous ROI – leading to greater expansion, adoption, and utilization of the Alyce platform throughout their organizations.”
Evonetix and Imec develop MEMS IC to scale up production of gene synthesis system
By David Manners
January 15, 2020 | ElectronicsWeekly.com — Evonetix’s technology controls the synthesis of DNA at many thousands of independently controlled reaction sites or ‘pixels’ on the chip’s surface in a highly parallel fashion.
Following synthesis, strands are assembled on-chip into double-strand DNA in a process that identifies and removes errors, enabling accuracy, scale and speed that is several orders of magnitude better than conventional approaches.
Under the terms of the collaboration, Imec will work with Evonetix to scale up manufacturing of the MEMS technology on 8-inch silicon wafers, enabling Evonetix to supply customers in volume.
Imec is able to leverage its experience in manufacturing silicon for life sciences applications to transfer the novel Evonetix process to their foundries and to manage further expansion in volume.
“Evonetix has developed an innovative approach that integrates physics and biology to enable the production of high-fidelity long DNA in a highly parallel fashion,” says Imec’s Peter Peumans.
Freight Farms goes to school
The shipping containers are used for growing food — and for teaching vital lessons
By Andrea Pyenson
January 15, 2020 | The Boston Globe
Inside the big white shipping container parked behind a classroom building on the campus of the Rivers School in Weston, it smells like a verdant field on a warm spring day, with a degree of humidity that is completely at odds with the cold, dry air outside. A variety of lettuces, herbs, and a smattering of other vegetables grow on vertical towers in adjustable rows. The sixth-grade students who maintain the school’s Freight Farm cycle through in groups of four to reap the bounty of work they started at the beginning of the 2019-2020 academic year. The first harvest day was in late October.
“They all love to come in here,” says Emily Poland, who teaches eighth-grade science and is the farm director at this independent school for grades 6 through 12. The Freight Farm and related projects are built into the sixth-grade curriculum, incorporating humanities, social justice, and science, among other subjects. Students spend time there once a week planting, cleaning, and harvesting. Farming is a club activity for the school’s high school students, who can go in during their free time.
Based in Boston, Freight Farms manufactures technologically advanced hydroponic farming systems. In 320-square-foot, climate-controlled shipping containers, users can grow up to 13,000 plants at a time, vertically, without soil. The company was founded in 2010 by Brad McNamara and Jon Friedman. Several area schools, among them Rivers, Boston Latin School, and Worcester State University, are using the farms to grow food for their own communities, for their neighbors, and as educational tools.
For Poland, managing the farm was a natural extension of her teaching. “I like to create curriculum. I care about food. I like to be outside,” she says. One of the sixth-graders’ annual activities, which combines academics with community service, is cooking a meal for the Natick Open Door at St. Paul’s Episcopal Church. These are hosted every week and attended primarily by seniors. Poland explains that planning the meal incorporates math skills because the students have to scale recipes to feed up to 45 people. And naturally they use their own greens in the salads.
The students run a farmers market in the spring. And this year they are maintaining a (very micro) CSA, which one parent won in an auction. The school’s chef, Michael Clancy, also gets involved, using the students’ produce in the dining room, and helping them cook with what they grow — so far this year they have made pesto and herb vinaigrette. “Their pride is really amazing,” he says.
Boston Latin, a public exam school for grades seven through 12, acquired its farm in 2013 after students in the Youth Climate Action Network won the $75,000 prize in the Global Green Schools Makeover Competition. Farming is a student-run after-school activity here, under the guidance of eighth-grade history and civics teacher Cate Arnold, whose evident affection for her students appears to be reciprocal.
Though roughly 70 students have signed up as student farmers, there is a smaller core group that farms regularly, with an even smaller leadership team that is trained by Freight Farms. At the beginning of each academic year the leaders meet to plan what they will grow, who will work to train new students, and organize schedules. They keep track of chores on a whiteboard in the farm.
Addy Krom, a junior, notes of the farm, “You can come in, it’s a whole different environment. All the stress from school [goes] away.” Adds sophomore Azalea Thompson, “This makes locally grown food more accessible to the city.” The students give the food they grow to faculty members, bring some home, and are working to create a CSA. With Arnold’s help they are also trying to reestablish a more consistent connection to a food pantry in Jamaica Plain, where a former Boston Latin parent, recently deceased, used to deliver their greens.
At Worcester State, Mark Murphy, associate director of dining services, oversees the Freight Farm, which sits outside of Sheehan Hall, the school’s newest dormitory and site of its main cafeteria. Rich Perna, former director of dining, made the decision to purchase the farm five years ago, says Murphy, “to bring hyperlocal produce to the campus.”
Murphy has been responsible for the farm for the last two years. An employee of Chartwells, which has the contract for all of the school’s food services, he grows almost all of the greens for the cafeteria, as well as for alumni catering events, and the salad bar in the food court in the building next door. “I’m learning from trial and error,” he says.
At full capacity, Murphy explains, the farm produces about two acres’ worth of crops. He is constantly looking for different varieties of lettuce that will appeal to the students and is currently “trying to figure out a gourmet mix.” In addition to three varieties of lettuce, he grows kale, rainbow Swiss chard, parsley, and basil. He coordinates with the cafeteria’s cooks, telling them what he is growing so they can plan menus to incorporate the farm’s production.
Though WSU students are not currently working in the farm Murphy says he promotes the fact that most of the greens in the cafeteria are grown right outside the door. And, he says, “We’re trying to get the word out to get students involved.”
Through a partnership with the Worcester Public Schools and its program that helps young adults with differences transition from school to the workforce Murphy has three part-time helper/trainees. Once a week three students, who have completed high school with a certificate, come (often with a job coach from the program) to seed, plant, harvest, and clean. Murphy is in the process of hiring one of the students, who has aged out of the program. She “has a lot of passion for the farm,” he says.
“I never thought we’d be growing food inside a container,” Murphy says. “I think it may become a necessity someday.”
BPS and 2020 On-site Launch ‘Vision for Boston’ Pilot Program
BOSTON, MA, January 13, 2020 — The Boston Public Schools (BPS), 2020 On-site and eyewear brand Warby Parker have partnered to launch “Vision for Boston,” a pilot program offering BPS students free, comprehensive eye examinations and corrective eyewear.
The program brings the eye doctor to students in their schools. 2020 On-site licensed optometrists and specialists will visit 13 BPS schools over 20 days beginning January 6. All students in participating schools are eligible to receive free eye exams, and any form of health insurance will be accepted. Students without health insurance will not be asked to pay. Any student found to need eyeglasses can choose a pair at no cost.
“The Boston Public Schools is committed to providing our students with the resources they need to thrive academically and throughout their lives,” said BPS Superintendent Brenda Cassellius. “A healthy body means a healthy mind, and this all hands on deck community support will allow our young people to become more engaged in their education, further preparing them for success.”
2020 On-site, a leading provider of on-site vision care for businesses and schools, founded in Boston, previously partnered with individual BPS schools beginning in 2015. In recent years, 2020 On-site has visited over 30 schools in the Boston area. Other organizations, such as the New England College of Optometry (NECO), Boston Medical Center, and Prevent Blindness have also partnered with BPS Health Services to assist with state-mandated vision screenings for many years. BPS Health Services met with these organizations to combine and expand efforts, with the goal of creating a district-wide vision initiative.
“It’s fantastic that we’re kicking off 2020 by making sure our students’ vision needs are being met inside their own schools,” said Boston School Committee Chairperson Michael Loconto. “I am grateful to 2020 On-site and all the partner organizations that help us to provide essential vision screenings and optometry services for students, easing the financial burden on our families.”
There are several mandated health screenings for students required by state law. All BPS students in grades K0-5, 7, and 10 must receive a vision screening in school. Students are screened by BPS nurses and health paraprofessionals. In addition, NECO students and instructors also visit schools to assist with screenings. All students who do not pass their vision screenings are flagged as requiring a full eye examination.
Families were asked to complete consent forms to permit students to participate in the pilot program. 2020 On-site will provide students in grades 4-12 a complete, comprehensive eye exam. Any student found to need corrective eyewear will have the opportunity to choose a pair at no cost. Students in grades K0-3 can also choose eyeglasses, for no cost, if the school has a copy of a recent prescription, written within the last year.
Through the pilot program, Warby Parker will provide free prescription eyeglasses to students that need them. The company has designed a line of glasses specifically for students that are part of this program and Warby Parker’s Pupils Project initiative.
“Warby Parker opened its first store in Boston nearly seven years ago. We’ve loved being part of the city’s rich, historic community and look forward to making an impact on its students by providing access to free glasses through this public-private partnership,” says co-founder and co-CEO Neil Blumenthal.
Vision exams will take place both inside schools and onboard 2020 On-site’s mobile vision center, an eye clinic on-the-go. 2020 On-site optometrists and vision specialists will conduct pre-testing, including capturing a high-definition image of the retina and an eye pressure test for glaucoma detection, before students receive a comprehensive eye exam using fully-digital, top-of-the-line equipment.
“So much of learning is visual. While we know that long-term educational performance is closely linked to a child’s ability to see clearly in class, many students lack access to routine eye exams,” said Alexis McLaughlin, CEO of 2020 On-site. “2020 On-site is incredibly proud to once again partner with Boston Public Schools to bring free eye exams and glasses to students who need them. Expanding access to vision care for all is central to 2020 On-site’s mission, and we can’t think of a better place to channel our passion than in our own community.”
Thirteen BPS schools are participating in the pilot. Schools were recommended by Boston Public Schools Health Services Department due to their high need of vision support, while school administration and school nurses advocated for their school communities to participate. The participating schools are: Blackstone Elementary, BTU Pilot K-8, Conley Elementary, Curley K-8, East Boston High, Henderson Upper, Hernandez K-8, Irving Middle, JFK Elementary, King K-8, McCormack Middle, Sumner Elementary and Umana Academy.
Apellis Pharmaceuticals Announces Closing of Public Offering of Common Stock and Full Exercise of Option to Purchase Additional Shares
WALTHAM Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company pioneering targeted C3 therapies, today announced the closing of its previously announced underwritten public offering of common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,425,000 shares at the public offering price of $37.00 per share. The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by Apellis to 10,925,000 shares and increased the amount of gross proceeds, before deducting underwriting discounts and commissions and expenses payable by Apellis, to approximately $404.2 million.
Citigroup, J.P. Morgan and Evercore ISI acted as joint book-running managers for the offering. Cantor Fitzgerald & Co. and Baird acted as lead managers for the offering.
Meissa Vaccines Receives U.S. FDA Fast Track Designation for Respiratory Syncytial Virus Vaccine, MV-012-968
SOUTH SAN FRANCISCO, Calif., Jan. 10, 2020 (BUSINESS WIRE) — Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent viral respiratory infections, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. The FDA’s Fast Track program expedites the development and review of drugs and biologic agents demonstrating potential to fill an unmet medical need in the treatment or prevention of serious conditions.
With Fast Track Designation, Meissa is eligible for early and frequent interactions with FDA reviewers to discuss all aspects of the clinical development plan for MV-012-968, ensuring that the appropriate data are collected to support an application for vaccine licensure. The frequency of communication granted by Fast Track Designation assures that questions and issues are resolved quickly, often leading to earlier approval and access by patients.
Additionally, Fast Track Designation may allow Meissa to submit data for the MV-012-968 Biologics License Application (BLA) before the full application is complete (“Rolling Review”) and receive BLA review under an expedited time frame (“Priority Review”), if relevant criteria are met. A Phase 1 clinical trial evaluating the safety and immunogenicity of MV-012-968 is presently recruiting healthy adult volunteers.
“Fast Track Designation of MV-012-968 accelerates our ability to develop a much-needed RSV vaccine,” said Martin Moore, Ph.D., cofounder and CEO of Meissa. “A safe and effective RSV vaccine is a significant global health priority, and if we are successful, we can save thousands of lives and help millions of patients around the world.”
RSV is the most common cause of acute lower respiratory tract infections in young children and infects nearly all children by two years of age. The virus is responsible for more than 30 million acute lower respiratory infections and nearly 60,000 deaths per year among children under five worldwide.
Elysium Health™ Announces Clinical Trial to Study Correlations Between Epigenetic Aging and Nicotinamide Adenine Dinucleotide (NAD+) Levels in Healthy Adults
NEW YORK, Jan. 9, 2020 (PRNewswire) – Elysium Health, Inc.™, a life sciences company developing clinically validated health products based on advancements in scientific research, today announced the initiation of a clinical trial at Duke Clinical Research Institute to study correlations between biological age and circulating NAD+ levels in healthy adults, in addition to other clinical biomarkers that have been implicated in aging. As opposed to marking calendar years, biological age is the average age an individual’s body is expected to function and is a powerful measure of overall health and wellness. Biological age will be calculated using Elysium Health’s next-generation epigenetic platform, Algorithmic Platform for Epigenetic Examination (APEX), which the company developed to support the 2019 launch of its at-home epigenetic test Index.
Published biological age applications such as DNAm PhenoAge typically look at hundreds of sites on the genome. To ensure greater accuracy at the individual level, Elysium Health head of bioinformatics and Yale School of Medicine professor Dr. Morgan Levine led the development of a proprietary measure that examines global methylation patterns across more than 100,000 sites in collaboration with Elysium Health bioinformatics director Dr. Tina Hu-Seliger. A key consideration for developing the methodology that underlies APEX and Index was the need to refine the technology to address the inherent variability of earlier epigenetic age predictors. Later this year, Elysium Health intends to publish the data that supports its methodology, and which demonstrates that Index is a better predictor of biological age than earlier measures.
As an essential coenzyme involved in hundreds of metabolic processes, NAD+ is critical to cellular metabolism; and its reduced form, NADH, is required for mitochondrial metabolism and the resulting synthesis of ATP for cellular energy creation. NAD+ is also utilized by sirtuins, often referred to as the “guardians of the genome.” NAD+ levels have been shown to decline with age in humans in circulating blood as well as skin and brain tissue. Although the underlying causes for deteriorating NAD+ levels have not yet been fully determined, understanding correlations between epigenetic aging and NAD+ levels may help elucidate the benefits of maintaining NAD+ levels with age.
“Over the past decade, epigenetic tests have evolved to measure biological age with an increasing level of accuracy,” said Elysium Health chief scientist and director of the Glenn Center for Biology of Aging Research at MIT Dr. Leonard Guarente. “Having studied aging for more than 30 years, it’s my belief that the field is at a tipping point. The newfound ability to measure biological age allows us to study whether interventions can have an impact, thus unlocking the potential to realize the benefits of aging research in our lifetime.”
This study is intended to further the understanding of the links between NAD+ levels and other markers of biological age. In the study, NAD+ levels in whole blood, interleukins, inflammatory cytokines, growth factors, omega-3 polyunsaturated fatty acids, and patterns in DNA methylation will be measured and compared in age-matched individuals to determine whether NAD+ levels are associated with biological age.
One hundred and seventy healthy adults ages 25–80 will be enrolled in the study, which is scheduled to complete in May 2020. More information can be found on www.clinicaltrials.gov under the identifier NCT04220658.
Allysta Pharmaceuticals, Inc. Doses First Patient with ALY688 Ophthalmic Solution in Phase 1/2a Dry Eye Study
SAN MATEO, CA, January 8, 2020 (ACCESSWIRE) — Allysta Pharmaceuticals, Inc. (Allysta) today announced dosing of the first patient in its Phase 1/2a trial (ALY688-201) of ALY688 Ophthalmic Solution for the treatment of dry eye disease. Dry eye is a very common condition affecting millions of people in the US and causes eye symptoms (e.g., burning, foreign body sensation, pain) which can limit daily activities such as computer use, reading and driving. In advanced cases, significant inflammation and even scarring of the eye surface can occur.
ALY688 is a novel peptide agonist that binds to and activates adiponectin receptors which are widely distributed on the ocular surface. Following receptor binding, it acts to reduce inflammation and promote healing of injured cells lining the ocular surface. In animal models of dry eye disease, this resulted in significant improvement in corneal damage, tear integrity, and tear volume associated with reductions in inflammatory cells and cytokines in the eye.
“This marks a significant milestone for Allysta, as we now progress from a preclinical into a clinical stage company. We look forward to completing this trial by mid-year and reporting data in the second half of 2020,” said Henry Hsu, M.D., Chief Executive Officer and President of Allysta.
Cognoa Wins 2019 Fierce Innovation Life Science Award
Palo Alto, Calif., Dec. 18, 2019 (GLOBE NEWSWIRE) – Cognoa, a company at the forefront of pediatric behavioral health, has won the Fierce Innovation Life Science Award for Technology Innovation. Cognoa’s digital therapeutics will advance the standard of care by giving every child the opportunity to receive treatments earlier when they can have the greatest impact.
Currently, diagnosis and treatment of behavioral conditions relies on a limited and decreasing number of specialists, resulting in delayed access to treatments and potential long-term ramifications. Cognoa is developing what is expected to be the first diagnostic for autism spectrum disorder (ASD) that enables pediatricians and primary care physicians to diagnose ASD so that children can receive earlier treatment. Cognoa has launched a pivotal trial of its ASD diagnostic and intends to submit the results as basis of its premarket submission to the FDA in 2020. The company will receive priority review by the FDA for the diagnostic and for its first digital therapeutic for children with autism, both of which have received FDA Breakthrough designation.
“All of us at Cognoa are proud of this prestigious recognition of our mission and work to improve lifelong outcomes with earlier diagnosis and treatment,” said Brent Vaughan, CEO and co-founder of Cognoa. “In 2020, we will be taking important steps forward for both children and pediatricians as we anticipate bringing our first prescription digital medicine to market and advancing our prescription digital therapeutic for autism. In order to fundamentally change the standard of care and make the benefits of early intervention available to every child, we must empower the trusted family pediatricians who are the first line of care and know the child best.”
Cognoa’s solutions will provide a continuum of care from identifying at-risk children to empowering early diagnosis and treatment of behavioral health conditions. By targeting the critical, early neurodevelopmental windows, Cognoa’s digital therapeutics promote neuromodulation of specific brain networks, improving functional connectivity to create lifelong gains.
With its commercialization partner EVERSANA, Cognoa will enable its digital medicines to be prescribed, dispensed and reimbursed through the same healthcare infrastructure utilized by payers and providers for other medicines, so that these solutions can be available to every pediatrician and child.
“It’s an incredibly exciting time for pediatric behavioral healthcare. Earlier this week, the American Academy of Pediatrics (AAP) updated, for the first time in over a decade, its guidelines for the identification, evaluation and management of children with autism,” explains Dr. Colleen Kraft, the 2018 Past President of the AAP and Professor of Pediatrics, Keck School of Medicine at the University of Southern California. “The guidelines emphasize the importance of early diagnosis and treatment and support pediatricians’ potential to diagnose autism consistent with DSM-V criteria. I’m confident that Cognoa will play a critical role in pediatricians’ ability to facilitate earlier treatments with its clinically validated, practical products.”
Amylyx Pharmaceuticals Announces AMX0035 Demonstrated Statistically Significant Treatment Benefit for People with ALS in the CENTAUR Trial
CAMBRIDGE, Mass., December 17, 2019–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, and the Sean M. Healey & AMG Center for ALS at Mass General today announced that AMX0035 demonstrated a significant treatment benefit for people with ALS in the CENTAUR study. In the study, participants taking AMX0035 had a statistically significant slowing of ALS disease progression as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) compared to placebo (p<0.05), the primary outcome of the trial.
Detailed results from CENTAUR will be submitted for peer-reviewed publication and presentation at a future medical congress.
“Today marks a significant step forward in the fight to develop new treatments for ALS,” said Dr. Sabrina Paganoni, M.D., Ph.D., principal investigator of the CENTAUR study, investigator at the Healey Center for ALS at Mass General and Assistant Professor of PM&R at Harvard Medical School and Spaulding Rehabilitation Hospital. “The study results highlight AMX0035 as a potentially beneficial new treatment for people with ALS, and the design and execution of the CENTAUR trial are a testament to true collaboration across the many stakeholders in this fight. Thank you to everyone who made this possible, and I look forward to presenting the full study results in the coming months.”
“We are honored and humbled to have reached this milestone after working nearly seven years on the development of AMX0035,” said Joshua Cohen, CEO, Chairman, and Co-Founder of Amylyx. “Thank you to each and every participant, family, physician, nurse, coordinator, vendor, and advisor who has and continues to work with us to better the lives of people with ALS.”
“With these results, Amylyx now has a responsibility to move ahead as efficiently as possible, as people living with ALS don’t have time to wait,” said Justin Klee, President and Co-Founder of Amylyx. “We will work closely with the FDA and the ALS community, including the wonderful Northeast ALS Consortium leadership and member sites that conducted the CENTAUR trial, to decide next steps and will continue to keep everyone informed.”
Participants in CENTAUR were given the option after the trial to enroll in an open-label extension study to receive treatment with AMX0035. Nearly 90 percent of participants who completed CENTAUR elected to enroll in the extension study. Interim data from the ongoing extension study will be presented in 2020.
In addition, the company will provide an update on regulatory plans and further details on expanded access plans in early 2020.
“ALS Finding a Cure is proud to have catalyzed and supported the CENTAUR study, and I am encouraged by what the results mean for people living with ALS. Our team at the Mass General Neurological Clinical Research Institute is proud of this collaboration with Amylyx and our colleagues in the Northeast ALS Consortium on this important study,” commented Dr. Merit Cudkowicz, Chief Medical Officer from ALS Finding a Cure®, Director of the Healey Center for ALS, Chief of Neurology at Mass General, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. “We look forward to advancing this research and what it might mean for those living with ALS.”
Dr. Neil Thakur, executive vice president for mission strategy at The ALS Association, added, “We are proud to have supported AMX0035 and Amylyx from an early stage and are very excited about what AMX0035 may accomplish for people with ALS. This company and study team have focused on the patient perspective during the design and conduct of this study and we are happy to work with and innovate together with them. We are excited to continue to collaborate on this therapy in the future.”
Dr. Rudolph Tanzi, Ph.D., Kennedy Professor of Neurology, Massachusetts General Hospital, chair of the Cure Alzheimer’s Fund Research Leadership Group and chair of the Amylyx SAB, shared, “The positive results from the CENTAUR ALS study demonstrate that the novel mechanism of AMX0035 may represent a new treatment approach for not only ALS, but for Alzheimer’s disease. I am very excited about the demonstrated benefit of AMX0035 in people with ALS, and look forward to the results from the ongoing PEGASUS trial for people with Alzheimer’s disease.”
ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The progressive neurodegeneration in ALS eventually leads to the death of motor neurons and loss of the ability of the brain to initiate and control muscle movement. With muscle action progressively affected, patients in the later stages of the disease may become paralyzed and unable to breathe normally.
ALS Drug Works in Study, Researchers Say
by Jonathan D. Rockoff
December 17, 2019 | Wall Street Journal
An experimental drug slowed the paralyzing march of amyotrophic lateral sclerosis, or Lou Gehrig’s disease, in a clinical trial, according to researchers who say the results are a fresh sign that recent insights into the condition may soon bring new medicines.
The drug’s maker, closely held Amylyx Pharmaceuticals Inc., is releasing only the barest outlines of the mid-stage trial for now, as researchers continue to analyze the results. The drug slowed the rate of ALS’s progression in patients as measured by a widely used scale, said the researchers and the company’s founders.
“We’re just another step closer to hopefully stopping this illness,” said Merit Cudkowicz, who heads the Healey Center for ALS at Massachusetts General Hospital in Boston and helped design and coordinate the study.
If the drug is ultimately approved, it would add a much-needed weapon to a relatively limited arsenal of ALS treatments and cap an improbable drug-discovery effort by former Brown University students who began the project in a dorm room.
More than 16,000 Americans have ALS, which kills off the nerve cells that control muscle movements. As these motor neurons die, patients lose the ability to eat, speak, move and breathe. Within three to five years of symptoms, most patients die.
Only two drugs have been approved to treat the underlying cause of the disease, and neither provides a cure.
About 20 drugs are in clinical testing, doctors and scientists say, after research furnished new insights in recent years about the roots and course of the disease and thereby provided drug researchers promising targets for experimental medicines.
At least five medicines are now in the late stages of development, Dr. Cudkowicz said. Among them is an agent from Biogen Inc. attacking a genetic mutation that plays a role in the inherited form of the disease.
ALS doctors said they are intrigued by Amylyx’s drug, but would need to wait for the full results from the study before they could say whether its drug might make a difference for patients.
Raymond Roos, director of the ALS treatment center at the University of Chicago Medical Center, said he can’t be certain of the real-world benefit from Amylyx’s medicine without seeing how much it slowed ALS’s progression and the drug’s impact on specific functions, especially breathing.
And the trial, which studied patients for six months, wasn’t long enough to answer the key question whether the drug would prolong the lives of ALS patients, said Dr. Roos, who wasn’t involved in the study.
Sabrina Paganoni, an assistant professor at Harvard Medical School who led the study, said researchers were still reviewing all the results from the trial, and planned to publish them in a medical journal and present them at a medical meeting early next year.
“Most trials fail to see a positive result,” Dr. Paganoni said in an interview, making the top-line findings of Amylyx’s study “really incredible.”
Amylyx’s drug, a powder that has been going by the designation AMX0035, combines two separate medicines. Each strikes a different line of attack that ALS takes to destroy the motor neurons in patients.
Justin Klee, Amylyx president and co-founder, said the company’s drug appears to have a bigger impact on the disease’s progression than giving each of its components individually. The synergistic effect, he said, suggests ALS treatment might require a cocktail of drugs.
Mr. Klee said the company will reach out to the U.S. Food and Drug Administration about holding a meeting to discuss whether the trial results would be enough to seek the drug’s approval.
In the trial, AMX0035 was tested in patients who were diagnosed within 18 months of symptoms appearing and had developed problems like trouble speaking, difficulty walking and arm weakness.
The 137 subjects in the trial took either AMX0035 or a placebo for six months in addition to any other ALS drugs they were taking.
Then researchers, following a standardized questionnaire widely used by doctors and scientists, asked the subjects to rate their ability to do things like dress, feed themselves and write on a five-point scale.
“I believe my ALS slowed down somewhat during the trial,” said Kristina Golji, 34, from Grafton, Mass., who was diagnosed in March 2017.
Ms. Golji said her ability to talk had been gradually declining before the trial, but steadied while in the study. After it ended, she lost fine motor skills and had more trouble walking and swallowing until she began taking the drug again under an extension of the study.
The experimental drug was well tolerated by study subjects and safe, said Dr. Paganoni, the trial’s principal investigator.
The idea for the drug came to Amylyx Chief Executive Josh Cohen, he said, while he was a Brown University junior in 2012 and 2013 majoring in biomedical engineering and reading scientific papers on how neurons die.
Mr. Cohen told Mr. Klee, whom he had first met playing club tennis in college. Mr. Klee, a neuroscience major, spent the following night reading up on his friend’s idea.
“We did what most people in our generation do” when trying to learn about a topic, Mr. Klee said. “We went to the Internet. We Googled it.”
The research shed light on some molecular routes that neurodegeneration follows, which Mr. Cohen said sparked his interest in combining drugs that attacked two important pathways. The problem was, each drug alone hadn’t worked in studies.
Unfamiliar with both drug research and the industry, Messrs. Cohen and Klee sounded out experts, including Dr. Cudkowicz, to learn how to test their hypothesis in a laboratory, start a company and conduct testing in patients.
Their project took off after the pair scraped together $6,000 from personal savings and family donations to pay contract researchers in Finland, who found their combination drug worked in a petri dish.
Mr. Cohen took all his courses during his final year of college on Thursdays so he could devote the rest of the week to Amylyx.
Mr. Klee, who had moved to Cambridge, Mass., after graduating, took odd jobs coaching swimming, working as a research technician and participating in medical-research studies to earn money for the fledgling startup then based in his apartment.
The company, based in Cambridge, had three employees last March and seven today, but plans to add 100 employees next year.
Meissa Vaccines Receives FDA Clearance of IND Application for a Phase 1 Clinical Trial of MV-012-968 for Respiratory Syncytial Virus
SOUTH SAN FRANCISCO, Calif, December 5, 2019 – Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent viral respiratory infections, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to proceed with a U.S. clinical trial of MV-012-968, an investigational vaccine for respiratory syncytial virus (RSV). The company plans to initiate a Phase 1 clinical trial in adults early in 2020 to assess tolerability and immunogenicity of MV-012-968.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms, but RSV infections can be serious, especially for infants and older adults. In children younger than one year of age, RSV is the most common cause of bronchiolitis and pneumonia. In children under five, RSV causes more than 30 million new acute lower respiratory infections, resulting in more than three million hospital admissions from serious infections around the world.
“FDA clearance of this IND for a live attenuated RSV vaccine is a significant milestone in the global mission to prevent RSV in at-risk populations,” said Martin Moore, Ph.D., cofounder and CEO of Meissa. “We look forward to beginning our clinical studies to develop a safe and effective RSV vaccine for infants and the elderly.”
Meissa’s technology platform leverages synthetic biology and genetic engineering for the rational design of vaccines that solve suboptimal immune responses, vaccine stability, and manufacturing. Meissa’s proprietary technologies of reverse genetics and human codon deoptimization allow for rapid generation of live attenuated vaccine candidates that may be safer yet more immunogenic than the natural pathogens.
DNAtrix Presents Positive Results from the Phase 2 CAPTIVE/KEYNOTE-192 Study of DNX-2401 in Combination with Pembrolizumab for Glioblastoma at the 2019 SNO Annual Meeting
HOUSTON, Texas, Nov. 24, 2019 (PRNewswire) – DNAtrix, a leader in the development of oncolytic viruses for cancer therapy, today presented updated safety and efficacy data from the fully-enrolled Phase 2 CAPTIVE / KEYNOTE-192 study of DNX-2401 (tasadenoturev), DNAtrix’s oncolytic adenovirus, followed by pembrolizumab for patients with recurrent glioblastoma. The data demonstrate that the therapy elicits durable clinical activity and has a favorable safety profile. These results are being presented at the Society for Neuro-Oncology (SNO) Annual Meeting held from November 22-24, 2019 in Phoenix, Arizona.
A total of 48 patients with recurrent glioblastoma were treated at 15 participating clinical sites with the regimen of DNX-2401, followed by pembrolizumab. The majority of patients experienced clinical benefit following treatment, including durable complete and partial responses. Interim median overall survival for patients is currently 12.3 months. In addition, the interim safety analysis demonstrates that the therapy has a positive benefit-risk profile, there were no unanticipated adverse events and patients remained on pembrolizumab for a median of 5.5 months with a maximum of 34 cycles.
“The data hold great promise for patients afflicted with glioblastoma, the most common form of adult brain cancer. Glioblastoma is a disease associated with near uniform fatality. The results are striking in this context,” said Clark Chen, MD, PhD, Professor, Lyle French Chair in Neurosurgery and Department Head at the University of Minnesota, presenting author for the CAPTIVE / KEYNOTE-192 study. “The results suggest that the combination of DNX-2401 and pembrolizumab has the potential to revolutionize the care of glioblastoma patients. I look forward to the rigorous studies aimed to validate the efficacy of DNX-2401.”
“These interim data from our CAPTIVE trial are a significant milestone for us in the development of DNX-2401 as an innovative treatment for glioblastoma,” said Frank Tufaro, PhD, CEO of DNAtrix. “Importantly, these data suggest that DNX-2401 has a superior clinical benefit and safety profile compared to currently approved chemotherapy for recurrent glioblastoma, and we are particularly pleased that, together with pembrolizumab, DNX-2401 elicited a number of robust and durable antitumor responses.”
Inotrem Announces Enrollment of First Patient in its Phase IIb ASTONISH Trial for Nangibotide in the Treatment of Septic Shock
PARIS, France, November 21, 2019 – Inotrem S.A., a biotechnology company specializing in immunotherapy for acute inflammatory syndromes, through its knowledge of the TREM-1 pathway biology, announced today it has initiated its Phase IIb ASTONISH trial to evaluate nangibotide in the treatment of septic shock and has enrolled the first patient in the trial.
Nangibotide is a TREM-1 inhibitor peptide with the potential to restore appropriate inflammatory response, vascular function, and improve post septic shock survival. Septic shock is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific therapy approved for this indication besides antibiotics and supportive treatment. Inotrem’s therapeutic solution has the potential to become the first mechanism-based treatment for septic shock. Nangibotide in septic shock has been granted the fast track status in September 2019 by the FDA and the PRIME status in 2017 by the EMA.
The Phase IIb ASTONISH study aims to demonstrate the efficacy of nangibotide and bring a medically relevant proof of clinical activity in septic shock patients. In addition, this global multicentric study intends to validate a personalized medicine approach using soluble TREM-1 as potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment. The study will be conducted in 48 clinical sites across 5 European countries and the United States and will enroll a total number of 450 patients.
Jean-Jacques Garaud, CEO of Inotrem, said: “The ASTONISH trial is a Phase III enabling trial and we expect that it will generate important insights about nangibotide’s clinical activity and our personalized medicine approach in septic shock. We are enthusiastic about this study and Inotrem’s capacity to bring a first in class product in an area with major unmet medical need and to patients who today have no access to any approved treatment”.
With nangibotide, Inotrem has developed a novel approach of immunomodulation targeting the TREM-1 pathway which has the potential to address, beyond septic shock, several others acute inflammatory syndromes for which there is a major and today unsatisfied therapeutic need. Based on its its extensive knowledge of the TREM-1 pathway biology, Inotrem has aso launched a new program to expand its TREM-1 franchise into chronic inflammatory diseases.
‘A Clever Bit of Chemistry’: NuCana CEO Speaks on Company’s Biliary Tract Cancer Drug
November 19, 2019 | BioSpace.com — Hugh Griffith, founder and chief executive officer of NuCana, has been excited about what he called a “clever bit of chemistry.” And that excitement was finally revealed days ago when the U.S. Food and Drug Administration cleared the path for a Phase III study of a potential new biliary tract cancer treatment.
The FDA provided NuCana with clearance for its Investigational New Drug Application for Acelarin, what Griffith described as a transformation of Eli Lilly’s old drug Gemzar. In the Phase III trial, Acelarin will be studied in combination with cisplatin for patients with previously untreated locally advanced or metastatic biliary tract cancer. If successful, Griffith told BioSpace in an exclusive interview that Acelarin will break the glass ceiling as the first FDA-approved treatment for biliary tract cancer.
“No drug has been approved for this cancer but there are more than 40,000 people with this disease. The standard of care is two chemotherapy drugs and that manages to buy patients on average a year of survival,” Griffith said.
He is hoping that Acelarin will change that. He said the drug, internally called NUC-1031, has the potential to significantly improve the survival outcomes of patients with advanced biliary tract cancer. In a Phase Ib study, the company saw an approximate doubling of the response rate with Acelarin plus cisplatin compared to previously reported data for gemcitabine plus cisplatin.
“Our goal is to establish Acelarin in combination with cisplatin as the global standard of care for the first-line treatment of patients with advanced biliary tract cancer,” he said.
Looking at the oncology landscape, Griffith said it’s exciting to be part of an “era of biology and understanding cancer cells” that leads to new treatments being developed for cancer patients. Griffith said it’s important to realize that chemotherapy will still be the cornerstone of cancer treatment but added that the advent of IO drugs are significantly improving outcomes in many patients. Their belief is that chemo will always be important but cannot always be relied upon to hit certain targets and sometimes comes with its own toxicity concerns.
“Chemo is the workhorse of the treatment, but what we’ve got here (meaning Acelarin) is an approach than can make this less efficacious and less safe medicine more efficacious and more safe,” he said.
With the Phase III trial, the primary endpoints will be overall survival and objective response rate. NuCana believes that a statistically significant improvement in ORR at either of the first two planned interim analyses supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a New Drug Application for Acelarin.
There are other companies going after biliary tract cancer but, as of yet, none have been successful. Most recently, Singapore’s ASLAN Pharmaceuticals revealed its biliary tract cancer drug failed to meet the primary endpoints of progression-free survival and overall response rate. Other companies developing therapies for biliary tract cancer include Agios Pharmaceuticals, Imbrium Therapeutics, Ability Pharmaceuticals and Puma Biotechnology.
In addition to the biliary tract study, Acelarin is currently being evaluated a Phase II study for patients with ovarian cancer and a Phase III study for patients with pancreatic cancer. In addition to the biliary tract cancer drug, Griffith said he is also excited about the company’s second ProTide NUC-3373. Griffith said they are making strides in the administration of this intravenous medication, which is a transformation of the colorectal cancer drug 5FU. The standard drug has to be given intravenously over the course of two days and Griffith said it’s “deeply flawed” because the body breaks much of it down before it gets to the target, which can cause some toxicity issues. However, by applying their chemistry to this product, Griffith said they are seeing big advantages. Not only can it be administered in only a few hours, they’re not seeing the toxicities.
F2G Receives US FDA Breakthrough Therapy Designation for Olorofim
MANCHESTER, England and VIENNA, November 11, 2019 (PRNewswire) — F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.
Olorofim is currently being investigated in an open-label single-arm Phase 2b study (ClinicalTrials.gov Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents. Olorofim has been well tolerated across more than 10 years of patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA as part of the Breakthrough Therapy designation submission.
Breakthrough Therapy designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Breakthrough Therapy designation conveys all the features of fast track designation, more intensive FDA guidance on an efficient drug development program, an organisational commitment by FDA to involve senior managers, and eligibility for rolling review and priority review.
Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said:
“The granting of FDA Breakthrough Therapy designation is a truly transformational step for our company and will support our goal of rapidly developing this novel treatment for patients suffering from serious and life-threatening fungal infections. Olorofim acts via a novel and differentiated mechanism to traditional antifungals, and preliminary data have indicated that it is efficacious in tackling life-threatening invasive fungal infections that cannot be managed with currently approved agents.
“Our Phase 2b programme is on track with over 40 patients recruited in Europe, Australia and the US. We look forward to working closely with the FDA to accelerate development of this therapy for patients having limited or no approved treatment options for an invasive mold infection.”
Professor Sharon Chen, Westmead Hospital Sydney and Principal Investigator for the Phase 2b study said:
“This news is very exciting for clinicians caring for patients with these very serious, and devastating mold infections. We have had limited treatment options for many years and now the news about olorofim brings realistic hope that we can cure these previously treatment–refractory infections.”
TransThera Biosciences Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma
NANJING, China, Nov. 7, 2019 (PRNewswire) – TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.
Dr. Frank Wu, Founder and CEO of TransThera, commented: “Cholangiocarcinoma lacks effective therapies and remains a huge unmet medical need around the world. TT-00420 has demonstrated great potential in multiple experiments. We believe that today’s orphan drug designation will help accelerate the development of this potential product in the clinical trials and bring meaningful benefit to cholangiocarcinoma patients. We are very excited about this news, which expands the horizon of our lead product in development. In addition to triple negative breast cancer, cholangiocarcinoma is identified by our scientists to be second indication for TT-00420.”
TT-00420 is in global Phase I trial both in the US and China. Dose expansion Phase Ib/II trials in cholangiocarcinoma and triple negative breast cancer are planned to start in 2020.
Viken Unveils the Osprey Integrated Checkpoint SolutionTM for High Throughput Passenger & Commercial Vehicle Scanning at US Border Crossings
BURLINGTON, Mass., November 7, 2019 — (BUSINESS WIRE)–Viken Detection, pioneer of handheld x-ray imaging and analytical devices, today announced an award to install four Osprey-UVXTM under vehicle x-ray inspection systems at select U.S. Customs and Border Protection (CBP) land points of entry. The Osprey-UVX, in conjunction with Viken’s widely deployed handheld imagers, provides U.S. CBP and other security agencies with a comprehensive, practical, affordable and safe non-intrusive inspection (NII) solution for high-throughput vehicle scanning at border, critical infrastructure and other security and military checkpoints.
“Together, Viken’s HBI-120 and Osprey-UVX represent a powerful combination in the fight against drug and human trafficking, and terrorism that targets critical infrastructure,” said Viken CEO, Jim Ryan. “Instead of solely relying on camera-based systems or canine teams, law enforcement and security professionals can actually ‘see through’ an entire vehicle in under a minute to safely make fast and accurate threat assessments.”
The Osprey-UVX is a fixed “in-the-ground” system that provides real-time undercarriage and lower vehicle imaging for security officers. Passengers can safely stay in the vehicle while under vehicle images are created using Viken’s X-ray imaging technology. Both a passenger and commercial versions are available, and mobile configurations are in the works. Viken is also launching its Osprey-EVXTM portal with demonstrations in the first half of 2020. The Osprey-EVX is a complementary solution to already installed Osprey-UVX units and is specifically targeted for locations with the highest traffic.
With nearly 1,000 units deployed, the HBI-120 is currently in use by law enforcement agencies around the country and with CBP at the southern U.S. border. The HBI-120 is responsible for significant seizures of cash, drugs and weapons concealed in vehicles. The addition of the Broadwing-LAD (large-area detector) accessory provides for wider and deeper (and thus faster) scanning, without an increase in x-ray intensity.
Viken Detection is the market leader in handheld x-ray imaging and in handheld lead detection, helping officials in each of these areas keep the public safe. Viken manufactured the first ever handheld device capable of imaging vehicles for drug interdiction.
For more information, please visit us at www.VikenDetection.com
Elysium Health™ Announces Head of Bioinformatics and the Launch of INDEX by Elysium Health
NEW YORK, Nov. 4, 2019 (PRNewswire) – Elysium Health, Inc.,TM a life sciences company developing clinically validated health products based on aging research, today announced the launch of INDEX by Elysium Health, an at-home test that enables customers to measure their cumulative rate of aging and their biological age. The company also announced the addition of Yale School of Medicine professor and aging researcher Morgan Levine, Ph.D., who joined as head of bioinformatics to lead the development of Index using the latest generation of an epigenetic biomarker called DNAm PhenoAge. Unlike earlier epigenetic clocks, which were developed to support population-level research, the Elysium Health team worked with Levine to further improve the testing methodology to make its application accurate and informative at the individual level. Since its founding, Elysium Health has been best known for the company’s cellular health supplement Basis. Index marks the beginning of an expansion of the brand’s product portfolio to include aging tests as well as interventions that target fundamental processes of aging.
“Scientists in the field of aging research have long explored two fundamental questions: Can aging itself be measured, and can we slow, stop, or reverse the processes associated with aging?” said Elysium Health CEO Eric Marcotulli. “With aging as the single greatest risk factor for all major chronic conditions—and a force that affects everyone even before birth—these questions are focused on supporting our collective ability to not only improve lifespan but, more importantly, healthspan. With the launch of Index, we hope to continue the scientific exploration of these two questions by extending the conversation to the consumer market and allowing everyone to benefit from the ability to determine their cumulative rate of aging and, with it, to see if lifestyle and other changes can impact how they age in the future.”
Levine helped to identify specific DNA methylation sites along the epigenome that are highly correlated with nine clinical chemistry biomarkers of biological age and chronological age in the NHANES study. Since the development of the first epigenetic clock in 2011, the methodology has been further refined and validated in multiple large-scale data sets across diverse populations and tissues. A challenge to developing Index—and a key differentiator—was ensuring its accuracy and repeatability at the individual level. While the published applications of the biological age measure typically look at hundreds of sites on the genome, with the custom Elysium chip, Index examines global patterns across more than 100,000 sites, which solves for issues related to technical replicates—an incredibly important consideration for making this technology available to consumers and researchers.
“Historically, chronological age has served as the best estimation of health and aging. However, not all individuals age at the same rate—based on genetics, demographics, and lifestyle factors—and therefore, people of the same chronological age don’t necessarily share the same current health status or future outlook,” said Levine. “Index provides a better picture of where an individual is in his/her aging process, which is why I’m excited to make this aging measure and the technology that supports it directly available to consumers. It shows incredible promise when it comes to monitoring overall health and wellness and there is potential for even more diverse applications in the future. In clinical research, tools like this also enable faster evaluation of intervention efficacy, avoiding the need for decades of follow-up. It may also inform basic and population research, by shedding light on factors that alter the pace of aging and facilitating the identification of therapeutic targets to slow the process. For people in their everyday lives, while there are no guarantees, understanding one’s cumulative rate of aging and the factors that are reflected on the epigenome may help them prioritize behaviors and lifestyle choices to proactively optimize their health and wellness today and in the future.”
While the technology required for epigenome and genome mapping has historically made comprehensive testing cost prohibitive, with help from Illumina— a global leader in DNA sequencing and array-based technologies —Elysium Health has developed the custom Elysium chip to make the initial release of Index as accessible as possible. Elysium Health is committed to continuing to innovate the testing technology to make the powerful health measure of biological age available to everyone.
During the first month of the product’s initial limited release, Index will be available for purchase to existing Basis subscribers. New Elysium Health customers will have the option to purchase Basis semi-annual or annual subscriptions to become eligible to purchase Index in advance of the full public release in 2020. In addition to early access, Basis subscribers also have the benefit of preferred pricing during the limited release period.
PhoreMost and Sentinel Oncology Expand Collaboration to Jointly Accelerate Novel Glioma Therapeutic Through Preclinical Development
CAMBRIDGE, England, November 4, 2019 (BUSINESS WIRE)–PhoreMost Limited, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, and Sentinel Oncology, today announce an expansion of their collaboration to accelerate the progression of SOL686, a novel allosteric Polo-like kinase 1 (PLK1) inhibitor through preclinical development and IND enabling studies for the treatment of Glioma.
Mitotic PLKs are widely recognised as playing crucial roles in disease causing pathways, including K-Ras mutant cancers. Traditional approaches to drugging PLK enzymes have focused on targeting their active site; however this tactic has been hindered by toxicity-associated adverse events. Sentinel Oncology’s allosteric PLK1 inhibitor takes the novel approach of targeting the Polo-box domain (PBD) of the PLKs, thereby aiming to mitigate adverse events seen by active site inhibitors.
The programme has demonstrated a promising combination of specific drug-like properties, mode of action and target validation data obtained so far. Originating from the laboratory of Prof Ashok Venkitaraman at the University of Cambridge, PhoreMost subsequently developed the lead chemical series. Sentinel Oncology then optimised drug-like properties for the series and guided therapeutic positioning. Both PhoreMost and Sentinel Oncology received funding from Innovate UK for the drug discovery programme.
Dr Chris Torrance, CEO of PhoreMost, said: “We are delighted to deepen our long-standing association with Sentinel Oncology, and excited to be progressing this drug discovery programme towards the clinic. This lead compound exemplifies the value of PhoreMost’s strategy to use functional protein-protein interactions to drive the development of novel therapies, and to capitalise on its SITESEEKER® platform to change the model of drug discovery through innovation, strategic partnerships and collaboration.”
Robert Boyle, CEO of Sentinel Oncology, commented: “We are very excited about the prospects for this programme, and to be collaborating with PhoreMost to advance our allosteric PLK1 inhibitor. The programme adds to our NeuroOncology pipeline, has started formal preclinical studies and is well positioned to enter clinical development as a glioma treatment by 2021.”