Paroxysmal Nocturnal Hemoglobinuria Treatment Receives Fast Track Designation
RDR Staff; Published Online: Tuesday, Dec 20, 2016
Apellis Pharmaceuticals announced that their orphan drug APL-2, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) received Fast Track Designation by the FDA.
APL-2 is designed for patients who experience hemolysis and require RBC transfusions even while taking eculizumab.
APL-2 currently in two Phase Ib clinical trials. One trial assessing doses APL-2 administered by daily subcutaneous injection (SC) in patients with PNH who have not received the standard of care in the past, and the other is assessing doses of APL-2 as an add on with standard care.
APL-2 doses of 180mg and 270mg significantly reduced hemolytic activity as early as eight days after the start of dosing, and this inhibition was maintained through the dosing period.
APL-2 is a synthetic cyclic peptide conjugated to a polyethylene glycol (PEG) polymer that binds specifically to C3 and C3b, effectively blocking all three pathways of complement activation (classical, lectin, and alternative) with a particularly high potency against the alternative pathway.
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare disorder in which red blood cells break apart prematurely. It is an acquired hematopoietic stem cell disorder.
Some hematopoietic stem cells in individuals with PNH are defective and consequently produce defective blood cells. These defective red blood cells of PNH are extremely susceptible to premature destruction by a particular part of a person’s own immune system called the complement system.
About Fast Track Designation
The FDA’s Fast Track program is designed to facilitate and expedite development and review of new drugs. Through the Fast Track program, a product may be eligible for priority review at the time of BLA and may be eligible to submit sections of the BLA on a rolling basis as data become available.
APL-2 doses of 180mg and 270mg significantly reduced hemolytic activity as early as eight days after the start of dosing, and this inhibition was maintained through the dosing period.
Green Biologics Begins Customer Shipments at First Commercial Plant
Little Falls, MN, facility produces 100 percent bio-based n-butanol and acetone
Ashland, Virginia USA and Abingdon, Oxfordshire U.K. (December 13, 2016) – Green Biologics, Ltd., a UK industrial biotechnology and renewable specialty chemicals company, announced today the start of commercial shipments of bio-based n-butanol and acetone from its manufacturing facility in Little Falls, Minnesota.
Over the past year, Green Biologics has built a robust pipeline of domestic and export customers combined with multiple partnerships to bring its products to downstream markets. These include distribution agreements with Acme Hardesty, Nexeo Solutions, and Caldic as well as a strategic partnership with HOC Industries, a custom blender, packager and distributor of consumer and government products. The company is collaborating with other industry leaders in a range of specialty markets and applications where performance and sustainability drive value.
“The start of our first commercial facility is a critical milestone in building our position within the industry as a global renewable speciality chemicals company,” said Sean Sutcliffe,Chief Executive of Green Biologics. “We’re very proud to announce the start of shipments to key customers in highvalue markets and look forward to working with existing and new collaborators to bring a wide range of sustainable, environmentally-friendly products to shelves.”
Offered as a high-performance, high purity, fully-sustainable alternative to conventional petrochemical-based commodities, Green Biologics’ speciality chemicalsaim to drive value in customer applications and downstream markets ranging from specialty coatings, pharmaceuticals, cosmetics, personal care and consumer products. Both butanol and acetone products carry the brand name BioPure™ and have receivedUSDA BioPreferred® status. As a member of the American Chemistry Council (ACC), Green Biologics’ commercial facility is actively working towards meeting Responsible Care® standards.
Cognito Therapeutics Launched with Exclusive License to Promising Alzheimer’s Research from The Massachusetts Institute of Technology
Boston, Mass. and San Francisco, Calif. — December 7, 2016 – Cognito Therapeutics announced today that the company has secured an exclusive worldwide license to the intellectual property developed from scientific discoveries by Li-Huei Tsai, Ph.D., and Ed Boyden, Ph.D., professors in the Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology (MIT). The company was launched earlier this year with Series A financing from Morningside Venture.
The scientific discoveries are featured in the December 8th issue of Nature. Working with mouse models of Alzheimer’s disease, the team of scientists showed that by using a unique and totally non-invasive method of stimulation, they were able to restore gamma oscillation in the brains of the mice, which in turn activated the microglia cells to remove beta amyloid plaques in the brains. These plaques are characteristic of the brains of Alzheimer’s disease patients, which are also deficient in gamma oscillation.
“These results have opened up new doors to our understanding of Alzheimer’s,” said Prof. Tsai, Picower Professor of Neuroscience at MIT and co-founder of Cognito Therapeutics. “By demonstrating the underlying importance of these brain wave signatures, we have potentially uncovered a key to solving this disease in humans.”
Tsai and Boyden co-founded Cognito Therapeutics to translate their findings into a treatment for Alzheimer’s patients. The company has filed an extensive portfolio of patents covering the applications of this novel approach to treating a variety of neurological disorders.
“This is truly breakthrough science,” said Gerald Chan, ScD, founder of Morningside and board member of Cognito Therapeutics. “It has the potential of being a game changer in our struggle to find an effective treatment for Alzheimer’s disease. The social impact of such a treatment, if successful, would be enormous, as dementia is becoming the leading medical problem of an aging population.”
Cognito Therapeutics is based in Cambridge, Massachusetts, and at the San Francisco incubator TheraNova, a medical device developer with expertise in accelerating time-to-market for innovative medical technologies.
“A device-based approach to Alzheimer’s is novel,” said Daniel Burnett, M.D., chief technology officer of Cognito Therapeutics and founder of TheraNova. “We are excited to be working with Morningside, which has shown an unwavering commitment to bringing this technology all the way into the clinic.”
ENYO Pharma receives a €2.5 million grant from EU under the Horizon2020/SME Instrument Phase 2 programme for its project MIMESIS
• MIMESIS will accelerate and enable large scale development of ENYO Pharma’s novel discovery approach aimed at identifying new preclinical assets against infectious diseases and cancer from innovative drug discovery starting points inspired by viruses.
Lyon, December 5, 2016 – ENYO Pharma, a biopharmaceutical company currently focused on developing treatments for viral infections, today announced that it has received a grant of €2.5 million in response to its application to the highly competitive SME Instrument Phase 2 funding programme (6% success rate).
The SME Instrument is part of Horizon 2020, the EU framework programme dedicated to innovation and research managed by the European Commission. It belongs to the pillar “Industrial Leadership” of H2020 and aims to support high growth and highly innovative SMEs with global ambitions.
ENYO Pharma’s MIMESIS project applied for the June 2016 cut-off under the topic “Dedicated support to biotechnology SMEs closing the gap from lab to market”. MIMESIS has been selected by an independent jury of four experts recognised for their scientific and business expertise. The company will receive 2.5 M€ corresponding to the financing of 70% of the total project budget (€3.6 million).
After a feasibility Phase that generated ENYO’s internal drug development programme on an autophagy target, MIMESIS will be expanded to an industrialised scale to accelerate the discovery of new therapeutic targets and innovative new chemical entities against infectious diseases and cancer.
Dr Eric Meldrum, ENYO Pharma’s Chief Scientific Officer commented, “We are very honoured to receive the recognition from the Horizon 2020 jury in what was a highly competitive process. MIMESIS represents a real paradigm shift in the development of new innovative drugs for pathologies where the medical need is immense. This financing will enable us to screen our library of original peptides and small molecules on hundreds of intracellular human targets previously untapped by the pharmaceutical industry.”
For this project ENYO Pharma has designed a proprietary library of 10’000 small molecules to modulate host cell biology and also capable of disrupting protein:protein interactions (PPIs) between pathogens and the host. This library of developable chemical templates will be screened in phenotypic assays for inhibitors of the replication cycle of several viruses (Influenza, RSV, HRV, Zika) and a mycobacterium (TB). As this library is designed to modulate host cell biology, it will also be screened for inducers of Immunogenic Cell Death (ICD) in tumors. With €3.6 million over 24 months, most promising chemistries will be the starting point for numerous hit to lead optimisation programmes funded within the EU grant. Those optimisation efforts focused on novel intracellular targets will generate valuable Intellectual Property. Upon completion of MIMESIS, ENYO Pharma will further optimise its best chemical series either internally or in collaboration with other pharmaceutical companies up to clinical proof of concept.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement n° 739086- MIMESIS
Apellis Reports Positive Interim Results from Phase Ib Clinical Trials of APL-2 in PNH
C3 inhibitor reduces hemolysis in patients with PNH, is generally well tolerated
LOUISVILLE, Ky., December 2, 2016 – Apellis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on inhibition of the complement system, today will present positive interim results from two ongoing Phase Ib open-label, dose-escalation clinical trials of APL-2, a complement C3 inhibitor, in paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare, acquired, potentially lifethreatening disease characterized by complement-mediated hemolytic anemia.
Interim results suggest that APL-2 reduces hemolysis in patients with PNH who receive daily subcutaneous injections of APL-2 as monotherapy or as an add-on to the standard of care, eculizumab. With APL-2 (270 mg) as monotherapy, three out of three (3/3) PNH patients achieved a reduction in lactate dehydrogenase (LDH) levels to below the standard for control in PNH (500 U/L). With APL-2 (270 mg) as add-on to eculizumab, six out of six (6/6) previously transfusion-dependent PNH patients did not require transfusions during the study and five out of six (5/6) PNH patients achieved hemoglobin levels within the normal range for healthy individuals.
All 15 PNH patients who have been dosed across the two trials to date have completed at least one month of dosing, with five having received more than three months of dosing. Based on preliminary assessment, APL-2 is generally well tolerated.
“Establishing that systemic inhibition of C3 is feasible with daily subcutaneous injections of APL-2 in patients with PNH is a significant achievement that validates C3 as a target in the complement pathway,” said Cedric Francois, M.D., Ph.D., chief executive officer of Apellis. “APL-2’s unique ability to target C3 and block all three pathways of the complement system is indicative of its potential to be an effective treatment for multiple complement-driven diseases. We are encouraged by the preliminary results APL-2 has demonstrated, as well as the favorable safety data observed thus far in the Phase Ib trials and our previous studies in healthy volunteers. All patients in the Phase Ib trials will have completed three months of dosing in January 2017.”
Apellis will present the Phase Ib interim results today at the International PNH Interest Group (IPIG) Annual Scientific Assembly and will present the poster “APL-2, a Complement C3 Inhibitor for the Potential Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH): Phase I Data from Two Completed Studies in Healthy Volunteers” tomorrow at the American Society of Hematology (ASH) Annual Meeting.
Why High School Students Should Seek Out Peer Mentors for College Applications
Find out how CollegeVine’s near peer mentors can help high school students successfully apply for college.
DEC 2, 2016 2:59PM EST — When Ling Ritter applied early decision one of her top college choices, she had doubts about her ability to get in, but her guidance counselor told her she had a strong enough profile that the school would either accept or defer her, but not deny. So, when she received a rejection from that school, she was flummoxed. Ling, now 19, went back to that counselor who, this time, told her the rejection was an “indicator of [her] competitiveness,” and that she should remove any other “reach” schools she was planning to apply to. She didn’t listen. Instead, she added a few “safe” schools, and applied to her “reach” options as well — and was accepted to 13 out of 17, including Princeton University, where she’s currently a sophomore politics major.
Ling’s college application process was rocky, perhaps in part because her main source of guidance was an adult counselor who was also responsible for helping out all of her classmates. After all, according to CollegeVine, the average public school student receives only 38 minutes with her school’s guidance department over the course of four years. But, Ling is determined to make it better for other high schoolers. She now works as a “Near-Peer Mentor” with CollegeVine, which pairs high schoolers with college students who not only still have the application process fresh in their minds, but also can lend insight on actual, current college life. As part of her one-on-one relationships with her mentees, Ling (who went through training with CollegeVine for the job) helps with their school selections, applications, and essays, managing deadlines and timelines, and more.
And she’s not alone. CollegeVine’s college mentors attend schools around the country, and represent more than 20 different majors, extracurriculars, and individual experiences. We caught up with Ling to find out even more about the program — and why it’s awesome for both the mentors and the mentees.
Teen Vogue: How do you think having a near-peer mentor would have changed your college application experience?
Ling Ritter: Near-peer mentors help make college applications less of a guessing game. There is no silver bullet, no magic formula. However, after joining the CollegeVine team and going through their consultant training program, I now understand that there are ways mentors can help students authentically maximize their strengths in order to stand out in the applicant pool.
TV: What do you wish a college student would have or could have told you during that process?
LR: One piece of advice high school seniors frequently hear during the application process is, “Just be yourself.” I want to double down on that. You don’t need to be anyone else to succeed — you need to know that you are enough. But I also want to expand on this idea: Be yourself and understand who you are. Colleges are looking for individuals who demonstrate that they have been thinking about the intersections of their different identities, extracurricular interests, and academic pursuits, and that they are exploring how they can apply their unique perspectives to the world around them. An application is a very condensed representation of you, so seek out ways to add complexity and color.
TV: As a mentor, what kind of advice do you give? What aspects of your college experience do you share?
LR: Although [we follow a] curriculum, I will share anything about my college experience that my student wishes to know. CollegeVine’s pairing process is very specific, so I have thus far always been paired with a student who either is really interested in Princeton or has many shared passions in common with me (or both). This often leads to all sorts of great conversations [and questions, like], “Should I submit an arts supplement?” [or] “How do I begin to navigate the myriad career paths that stem from my interests?”
TV: Do you have any moments from your mentoring experiences with high school students that especially stand out to you?
LR: My favorite thing to hear from a student is, “Oh! I didn’t think I could do that.” Many students come in believing that college applications have to be weighty, and serious, and formal. While it’s important to demonstrate diligence, it’s equally important to convey personality. The times in which I was able to help students discover new and creative ways of expressing themselves, or showcasing quirky hobb[ies] that [don’t] fit within the confines of a traditional resume are definitely special moments for me.
TV: What’s the best part about being a near-peer mentor?
LR: Getting to know my students has been incredible. They are all such kind hearted, multifaceted, and spirited individuals. I am rooting for them in their college searches, and I know that, when spring comes around, the tables will turn, and they will be the ones choosing college[s] that fill them with pride and excitement for the future.
TV: How does mentoring high school students affect your current college life and path?
LR: Mentoring gives my college life a sense of purpose. Being raised by immigrant grandparents instilled in me the importance of not only being thankful for the resources available to me, but also using those resources to help future generations obtain the same opportunities. CollegeVine gives me a platform to do so on a very personal level.
TV: What about your confidence and outlook as a student and a person?
LR: Working with CollegeVine has given me insight into some of the potential reasons…behind my own admittance to Princeton. This, coupled with hard work paying off in the classroom, has really helped me prove to myself that I belong here.
TV: If you could give one piece of advice to students beginning the college application process, what would it be?
LR: The weight of a hundred rejections is still less than that of refusing to try and always wondering if things could be different. Rub some dirt on it and get back to being awesome.
MicuRx Initiates Phase 1 Clinical Trial in U.S. for Novel Antibiotic Agent MRX-4
HAYWARD, Calif. and SHANGHAI, China – November 30, 2016 – MicuRx Pharmaceuticals, Inc. today announced the start of a Phase 1 clinical trial of a new antimicrobial agent, MRX-4, for the treatment of infections caused by Gram-positive bacteria including methicillin-resistant S. aureus (MRSA) and vancomycin-resistant Enterococci (VRE). MRX-4 is a prodrug form of the oral antibiotic MRX-1, presently in Phase 3 clinical trials in China for the treatment of complicated skin infections.
This comprehensive Phase 1 trial, now enrolling patients at a single center in the United States, will evaluate safety, tolerability, pharmacokinetics and bioavailability of the oral formulation of MRX-4. The study will enroll 122 healthy subjects in nine single- and four multiple-ascending dose cohorts. Concurrently, the safety, tolerability, and pharmacokinetics of the intravenous formulation of MRX-4 will be evaluated in 60 healthy subjects of five single- and four multiple-ascending dose cohorts, along with an oral to IV crossover study.
“We anticipate that success in this Phase 1 trial would enable a rapid transition into advanced clinical studies in the U.S. for this new means of efficient delivery of our antibiotic systemically,” stated Zhengyu Yuan, Ph.D., president and CEO of MicuRx.
MRX-1 is a next-generation oxazolidinone agent that has shown notably improved hematopoietic safety compared to first-generation antibiotics, such as linezolid, while maintaining excellent efficacy characteristics for this class. The prodrug form of MRX-1, named MRX-4, serves to expand its utility into both intravenous and enhanced oral applications.
Green Biologics Receives USDA Certification
Renewable Specialty Chemicals Company Receives Certification Under USDA BioPreferred® Program
Ashland, Virginia and Abingdon, Oxfordshire U.K. (November 29, 2016) – Green Biologics, Inc., the U.S. subsidiary of Green Biologics Ltd., a U.K. industrial biotechnology and renewable chemicals company, announced today that its high purity bio-based n-butanol and acetone have received official certification under the USDA BioPreferred® program. The products are now certified as 100 percent bio-based and are marketed under the BioPure™ brand.
“Having our n-butanol and acetone named as USDA Certified BioBased Products is yet another milestone that we can point to when demonstrating the value and differentiation of our products from conventional petrochemical-based commodities,” said David Anderson, Global Vice President of Marketing for Green Biologics.
Stealth BioTherapeutics Announces Positive Phase 2 Clinical Trial Findings for Patients Undergoing Renal Angioplasty
Data support company’s cardiorenal program, including three ongoing heart failure trials
Single elamipretide infusion improves kidney microvasculature and function after renal artery angioplasty
BOSTON – November 18, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today presented results from the EVOLVE trial, which demonstrated that a single dose of elamipretide prior to renal artery angioplasty and stenting procedures improved kidney function and blood flow for three months post-procedure. The data were presented as a late-breaking poster at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago.
“Patients undergoing renal angioplasty and stenting, intended to open up kidney arteries blocked by atherosclerosis, often fail to regain normal kidney function due to tissue damage during the procedure, possibly due to the sudden replenishment of oxygen to starved tissues,” said Dr. Stephen Textor, the principal investigator for the trial. “The study results validate our preclinical findings and our underlying hypothesis that elamipretide may help prevent acute kidney injury by preserving mitochondrial function in cells and ultimately improve measures of kidney function in these patients.”
SKSpruce Technologies Finalist WBA Awards
San Jose, CA, November 15, 2016—SKSpruce Technologies, an emerging Silicon Valley leader in carrier-class Wi-Fi, is a finalist for the Wireless Broadband Alliance (WBA) “Best Next Gen Wi-Fi Network Infrastructure” award, recognizing and celebrating excellence in
The WBA recently announced the shortlist for its annual WBA Industry Awards 2016, taking place at the Wireless Global Congress, November 16-17 in San Jose, California. The finalist entry recognizes SKSpruce’s Wi-Fi solution used in the largest integrated Wi-Fi/cellular system in the world, deployed in Japan by SoftBank, a leading global carrier with more than 100 million subscribers. The SoftBank Mobile Wi-Fi system has 460,000 access points throughout the country seamlessly integrated into their 4G LTE network providing transparent uninterrupted handover between 4G LTE and Wi-Fi, delivering a superior user experience. SoftBank Mobile’s entire Wi-Fi network is controlled by the SKSpruce SKG10000 gateway, and its integration to the core mobile network is provided by SKSpruce.
Stealth BioTherapeutics Initiates Phase 1 Study of Elamipretide in Dry Age-Related Macular Degeneration
Top-line data from study evaluating elamipretide in patients with dry age-related macular degeneration expected mid-year 2017
BOSTON – November 14, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of ReCLAIM, a Phase 1 study evaluating elamipretide in intermediate age-related macular degeneration (AMD). Top-line data are expected mid-year 2017.
“There are currently no FDA-approved treatment options for dry AMD, so we are eager to better understand the effect that elamipretide may have in treating these roughly 13 million patients,” said Dr. Scott Cousins, the trial investigator, and Professor of Ophthalmology and Director of the Duke University Center for Macular Diseases. “Mitochondrial dysfunction that stems from various environmental toxins may be an important causative factor in dry AMD, and in laboratory models, elamipretide appears to prevent mitochondrial dysfunction in the retinal pigment epithelium.”
ReCLAIM is an open-label study to evaluate the safety and tolerability of 12 weeks’ treatment with daily subcutaneous injections of elamipretide in patients, age 55 and above who have at least one eye with intermediate AMD, and have either: a) high-risk protein deposits (drusen) on the retina without any geographic atrophy (GA), a characteristic of advanced AMD which can result in the loss of photoreceptor cells or b) GA with an unaffected central fovea (noncentral GA). The study’s primary endpoints are safety and tolerability, and the secondary endpoints are changes from baseline in physical/ophthalmic examinations and feasibility of subcutaneous injections in this patient population.
“ReCLAIM will build upon our ongoing ophthalmic program to help us better understand the potential of elamipretide to treat back of the eye diseases as well as the effects of the treatment to slow the aging process in eye tissue,” said Stealth Chief Executive Officer Reenie McCarthy. “We look forward to evaluating initial results of this study mid-year 2017.”
DNAtrix Licenses Myxoma Virus for New Immunotherapy Platform
Houston, TX – November 8, 2016 – DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, announced it has entered into an exclusive license agreement with the University of Florida, Gainesville to develop a novel oncolytic virus platform. The platform is based on myxoma virus, a poxvirus that has been shown to have beneficial features for treating cancers.
A major advantage of the myxoma virus is its ability to attach to T lymphocytes and other white blood cells, which are then delivered to the patient to trigger tumor cell killing and antitumor immunity. Myxoma virus can be armed with multiple immune stimulatory genes, a feature shared by other large DNA virus such as herpes simplex and adenovirus.
“The myxoma virus has unique properties for attacking cancer,” said CEO Frank Tufaro, Ph.D. “We think this technology platform provides a new modality for delivery of a potent oncolytic virus to tumors by co-administering it along with T cells. We look forward to testing this “Trojan horse” strategy in the clinic.”
“The myxoma virus is a novel oncolytic candidate that does not infect normal human cells but has a unique ability to identify the damaged signaling pathways found in the majority of human cancers; thus, resulting in productive infections in the patient’s cancer cells,” stated Grant McFadden, Ph.D., Professor in the Department of Molecular Genetics & Microbiology at the University of Florida, College of Medicine.
Stealth BioTherapeutics Announces Acceptance of Late-Breaking Clinical Trial Poster at American Society of Nephrology Kidney Week 2016
Late-breaking poster presents data from elamipretide clinical trial in chronic kidney disease patients at risk of acute kidney injury
BOSTON – November 7, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced that the abstract, “Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) during Stent Revascularization in Patients with Atherosclerotic Renal Artery Stenosis” has been accepted as a late-breaking clinical trial poster at the American Society of Nephrology (ASN) Kidney Week 2016 taking place in Chicago, November 15-20, 2016.
“The EVOLVE trial underscores our commitment to our cardiorenal program,” said Stealth’s Chief Executive Officer Reenie McCarthy. “We are pleased to present the details of these results both in the context of our three ongoing Phase 2 heart failure studies, as well as to inform our approach to other diseases of aging in which mitochondrial dysfunction is a contributing factor.”
EVOLVE was a double-blind, placebo-controlled study that evaluated 14 patients ages 40 to 80 with chronic kidney disease (CKD) at risk of acute kidney injury (AKI). The primary endpoint was change in kidney function, and the secondary endpoint was a change in renal blood flow and cortical perfusion.
CollegeVine Secures $3.1 Million In Series A Funding
CAMBRIDGE, Mass., Nov. 2, 2016 /PRNewswire/ – CollegeVine, the fast-growing EdTech startup specializing in high school mentoring for college applications, has closed a $3.1 million Series A funding round led by Morningside Technology Ventures (“Morningside”) with participation by New York-based University Ventures.
Morningside is a private equity and venture capital firm. Gerald Chan, its co-founder, has joined CollegeVine’s Board of Directors. University Ventures is a specialty venture capital fund that exclusively focuses on promising ideas in the higher education space.
The announcement was made today by Jon Carson, the CEO of CollegeVine.
CollegeVine was started by two Harvard University students and one University of Chicago student working out of the Harvard iLab. The company uses a near peer model of matching talented college students with high schoolers to help them with the college application process. CollegeVine’s services quickly earned a reputation for its outstanding college admissions results. Two years ago, the company employed 20 college students as consultants; today it employs almost 300.
“There is a huge unmet need for high school students to get proper guidance and mentoring in their planning for college and their application for admission. The fast growth of CollegeVine’s business validates that its services are exactly what high school students are looking for. Optimizing the college application process is beneficial both to the applicants and to the universities,” said Chan.
“With the backing of Morningside and support from University Ventures, we are now positioned to grow the company to meet consumer demand. We plan to use the Series A investment to build out our technology platform and product suite, grow the team, and accelerate our growth,” said Carson. “We are pleased to have Gerald join our Board as he has been a valued partner and mentor over several ventures. I am honored, to be working with him on another new and exciting EdTech venture.”
Morningside was the primary backer of FamilyEducation Network where Carson was both the founder and CEO. FamilyEducation Network became the largest K-12 online network when it was acquired by Pearson Plc for $175 million in 2000.
CollegeVine has recently strengthened its management team with the addition of former Zipcar executive Doug Williams as chief technical advisor and Harvard Business School professor Deepak Malhotra as a member of the board of directors.
DNAtrix Announces First Patients Treated in Phase 2 Trial with DNX-2401 and KEYTRUDA
Houston, TX – November 1, 2016 – DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, announced that the first patients have been treated in a multicenter Phase 2 trial investigating its oncolytic adenovirus, DNX-2401, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with recurrent glioblastoma.
The CAPTIVE trial is evaluating the potential effect of DNX-2401 and KEYTRUDA in patients with recurrent glioblastoma, a disease for which there is neither a cure nor adequate treatment. Leading medical centers in the United States and Canada are participating.
DNX-2401 is a potent conditionally replicative oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response.
KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. This activity enhances the T cell response and leads to effective tumor destruction. KEYTRUDA is currently approved in the United States for advanced melanoma, metastatic non-small cell lung cancer (NSCLC), and advanced head and neck squamous cell cancer (HNSCC).
“Glioblastoma is a difficult disease to treat with conventional therapies,” said Frank Tufaro, Ph.D., Chief Executive Officer of DNAtrix. “Based on remarkable preclinical data, we anticipate that the addition of KEYTRUDA to DNX-2401 therapy will provide even more benefit to patients with recurrent disease.”
Myanmar HTI Project Formally Launched
October, 2016 – SKSpruce Technologies formally launched the Myanmar Carrier-grade Wi-Fi project. A dedicated project team led by Henry Wu (VP of Product, SE & Product Marketing) was set up to ensure the smooth implementation of this project. The project marks the inaugural collaboration between SKSpruce and Myanmar HTI. Aimed at providing excellent data communication services and comprehensively improving user experience, the project will deploy the world-class carrier-grade Wi-Fi solution of SKSpruce in major areas of Yangon. During this project, over ten thousand APs will be deployed in 22 towns (10 towns in phase I) of Yangon to provide Wi-Fi services to 6 million Yangon citizens, in order to improve the data communication capacity of Yangon public areas, and to bring great economic profits and social benefits to Myanmar.
Myanmar HTI project is SKSpruce’s largest project in Southeast Asia this year. Meanwhile, it indicates that SKSpruce is making a significant move to expand Southeast Asian market. SKSpruce is attracting an increasing number of international clients with its continuous product innovation, solution optimization, and technology development.
Stealth BioTherapeutics Initiates Phase 2 Study of Elamipretide in Patients Hospitalized with Congestive Heart Failure
Top-line results anticipated in second half of 2017
BOSTON – October 25, 2016 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction associated with common diseases of aging and genetic mitochondrial diseases, today announced the initiation of IDDEA-HF, a Phase 2 study evaluating elamipretide in patients hospitalized due to congestive heart failure. Heart failure causes more than two million hospitalizations in the U.S. and Europe each year.
“In heart failure, mitochondrial dysfunction may not only be a causative factor, but may also contribute to the progression of the disease and the associated fluid build-up that causes congestion, due to muscle weakness from a lack of energy production,” said Stealth Vice President of Clinical Development Jim Carr. “In line with our findings in elderly patients enrolled in the trial, we hope to demonstrate the ability of elamipretide to increase energy production to help the heart muscle work better, subsequently relieving congestion in the body.”
IDDEA-HF is a randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of daily treatment with elamipretide in patients who have been hospitalized with congestive heart failure. Up to 300 patients will be randomized within 72 hours of presentation to receive 20 mg daily elamipretide or placebo intravenously for up to seven days. The primary endpoint is change in NT-proBNP, a cardiac biomarker reflecting the level of congestion. Secondary endpoints include change in clinical status and safety and tolerability.
“IDDEA-HF is a key step in our development of therapies for common diseases of aging. These patients have failed current therapies, experiencing an episode of acute decompensation, which highlights the intense need for new options within the heart failure treatment paradigm where we believe elamipretide can have a significant impact,” said Stealth Chief Executive Officer, Reenie McCarthy. “The data from this study, together with our other ongoing trials in heart failure, will help inform our projected Phase 3 heart failure program as well as our approach to other common diseases of aging for which elamipretide may have therapeutic potential.”
ENVISIA THERAPEUTICS RELEASES ENV515 (travoprost XR) PHASE 2 DATA SHOWING NINE-MONTH DURATION OF ACTION AFTER A SINGLE DOSE IN PATIENTS WITH GLAUCOMA
Results Provide Encouraging Outlook for Extended Treatment of Glaucoma Patients
RESEARCH TRIANGLE PARK, NC – OCTOBER 17, 2016 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.
“ENV515 continues to show great potential with a favorable safety profile and a sustained, clinically meaningful reduction in IOP over the initial nine months,” said Benjamin Yerxa, President of Envisia. “We plan to initiate enrollment in a new cohort of this phase 2 trial by year-end, which will enable us to evaluate the high dosage form of ENV515 that has been formulated with the goal of achieving efficacy comparable to TRAVATAN Z® with a duration greater than 9 months.”
New app helps workers track child development, identify autism early
As employers struggle with retention rates across the board, healthcare technology company Cognoa is trying to keep a specific population employed: parents of children with developmental disorders.
The Palo Alto-based company recently launched Cognoa for Employers, a mobile app that screens children as young as 18 months for developmental disorders, to assist with early detection and cut down on future healthcare costs and missed workdays. The app would be included in a benefits package for parents to assess how their young children are reaching developmental benchmarks and screens for autism, speech delays and ADHD.
With one in six children in the United States diagnosed with a developmental disorder, according to the Centers for Disease Control and Prevention, the impact affects parents who work full-time.
“There is a greater pressure on one of the parents to leave the workforce and stay home with the child,” says Cognoa CEO Brent Vaughan. “The key benefit is it allows valuable employees to be happy and focused at work.”
The company built the parent-facing app to encourage early detection and intervention; the average age of an autism diagnosis is age 4, according to nonprofit Autism Speaks. An earlier diagnosis, says Vaughan, could be “the difference between attending special or normal schools” and could create a “lifelong change for a family.”
“We hear from parents constantly who are unable to keep a job,” says Wendy Fournier, president of the National Autism Association. “Many get frequent calls to pick up their kids from school, or have lots of medical appointments and need to take time off. It’s difficult for a lot of us to be dependable employees because caring for a child with autism can be volatile: Some days are fine, some are disastrous.”
Cognoa’s machine learning-based platform, which has been running for two years and has data from more than 140,000 children screened by the app, attempts to minimize the number of doctor’s visits that could leave an employee to take time off, says Vaughan.
Parents are asked to fill out a questionnaire that details their child’s play habits, eye contact, stomach and sleep problems, sensitivity to noise, and body and verbal language. They are also able to record videos of their children for a home-based, parent-selected evaluation, which is then compared to other videos and information in the system. The data is kept password protected and has rigorous data encryption that meet or exceed HIPAA compliance, Vaughan says.
“In the detailed assessments, parents receive descriptions of specific behavioral areas where their child is meeting developmental milestones, as well as areas that correspond with any elevated risk for delay,” he says. “The assessment reports also include the links to the videos the parent provided of the child’s actual behavior that corresponds with the assessment. We have found that both parents and clinicians find it valuable to see the videos of the child’s natural behavior at home.”
Vaughan says the app’s main competitor is standard care. However, not all pediatricians screen for developmental disorders, which is where the app bridges the gap in care for parents who might not be able to pay the co-pay or bring their child to the doctor’s office.