slow_feet
4 años hace
SI as of 2/12/21
Report Date Total Shares Sold Short
2/12/2021 2,390,000 shares
1/29/2021 1,130,000 shares
1/15/2021 1,240,000 shares
12/31/2020 1,920,000 shares
12/15/2020 1,920,000 shares
11/30/2020 470,000 shares
11/15/2020 444,200 shares
10/30/2020 644,100 shares
slow_feet
4 años hace
Quellis Biosciences, Inc.
Management
Jonathan Violin, Ph.D. – Founder and President
Jonathan joined Quellis shortly after its incorporation to lead its launch and growth. He is a partner at Viridian LLC, a biotech incubator that builds virtual drug discovery companies to pursue product-focused drug discovery hypotheses. Prior to joining Viridian, Jonathan co-founded and helped lead Trevena Inc. from discovery research through clinical development and NDA submission, including multiple rounds of venture and public financing. While there, he held a series of roles including leadership of discovery biology, investor relations, corporate strategy, and scientific affairs. He has helped identify and progress four novel molecules into clinical development, including one program granted Breakthrough Therapy Designation by the FDA. He also has experience in alliance management, business development, and regulatory interactions including team lead and moderator for a new chemical entity FDA Advisory Committee. Jonathan has co-authored over 45 peer-reviewed publications. He holds a Ph.D. from the Department of Pharmacology at the University of California, San Diego, an M.B.A. from the Fuqua School of Business, and a B.S. in Chemical Pharmacology from Duke University.
Vahe Bedian, Ph.D. – Founder and Chief Scientific Officer
Vahe joined Quellis at its inception and is responsible for research and discovery. He is a partner at Viridian LLC, a biotech incubator that builds virtual drug discovery companies to pursue product-focused drug discovery hypotheses. Vahe previously served for 10 years at AstraZeneca focused on antibody therapeutics and immuno-oncology, most recently as Director, Search and Evaluation, Global Product and Portfolio Strategy. His other roles at AstraZeneca included site lead for a biologics discovery group, helping to oversee oncology and technology portfolios, and supporting the AstraZeneca-MedImmune integration. Prior to this, Vahe spent 8 years at Pfizer where he helped established the company’s biologics strategy across therapeutic areas and led discovery efforts for clinical development teams responsible for four INDs and a Phase 3 program. Vahe has authored more than 40 publications. He holds a Ph.D. in Biophysics from SUNY Buffalo and a M.S. and B.S. in Physics from the American University of Beirut.
About
Focused on Designing Meaningful Medicines
Quellis was founded to deliver best-in-class therapies to patients suffering serious rare diseases – and underserved by current treatment options. The Company is based in Boston, and is led by partners from the biotech incubator Viridian LLC in collaboration with team at biotech accelerator Xontogeny LLC, and with funding from the Perceptive Xontogeny Venture Fund. The Quellis team has deep experience in mAb discovery and development, company creation, and private and public biotech investment. Our shared goal is to create meaningful medicines for every disease we target.
The lead Quellis program targets a life-threatening and burdensome rare disease. Approved medications leave substantial unmet needs for these patients; Quellis is pursuing a product-focused hypothesis to discover a new molecule with best-in-class performance. The Company is currently optimizing several new monoclonal antibodies (mAbs) leveraging a validated mechanism of action. We are engineering these mAbs to include features intended to deliver greater value and improve patients’ lives. As part of these efforts, the Company plans to incorporate Xencor, Inc.’s Xtend™ Fc technology, for which the Company holds a target-exclusive license from Xencor. Xtend is a clinically proven antibody technology that provides for improved antibody half-life and thereby reduces the size and frequency of doses that patients require compared to a standard antibody drug candidate.
Board of Directors
Chris Garabedian, Chairman
Chris Garabedian founded Xontogeny in June of 2016 to support multiple promising technologies from early development through clinical proof of concept. In 2017, Chris joined Perceptive Advisors to develop their Venture Fund strategy and launched the Perceptive Xontogeny Venture Fund in 2018 to support early stage companies seeded and incubated at Xontogeny and other ventures.
Chris has a broad base of experience and a track record of success over his decades long experience in the biopharma industry. Chris served as the President and CEO of Sarepta Therapeutics from 2011 to 2015, overseeing the turnaround of a company that is now a commercial stage leader in the genetic technology space after leading the development of the company’s Duchenne Muscular Dystrophy program. Prior to Sarepta, Chris led Corporate Strategy for Celgene from 2007 to 2010. Prior to Celgene, Chris served in a number of global commercial and corporate development leadership roles at Gilead from 1997 to 2005.
Chris serves on a number of Boards of life sciences companies and speaks at industry conferences on a wide range of important issues. Chris is also on the Board of Directors of MassBio and serves as a Senior Advisor for the Boston Consulting Group.
Fred Callori
Fred joined Xontogeny in September 2017 as SVP, Corporate Development. Fred’s responsibilities include due diligence, deal structuring and negotiation, company formation, and the operational oversight and management of Xontogeny’s seed investments. He provides corporate governance, transactional and strategic advice to Xontogeny’s portfolio of companies and serves on several portfolio company Boards. In 2018, Fred joined the Perceptive Xontogeny Venture Fund to support fund investments, including continued investments in companies seeded and incubated at Xontogeny.
Prior to joining Xontogeny, Fred was a Partner in the Life Science and Emerging Companies practices of Choate, Hall & Stewart LLP, a Boston law firm ranked among the most active firms worldwide for private equity and venture capital deals. During his 20-year tenure at Choate, Fred developed deep expertise in the formation, structure, financing and overall corporate development of early stage and emerging life science companies, including representing leading venture capital and institutional investment firms focused on investing in the sector.
Fred holds a JD from Boston University School of Law and a BA in Economics from Binghamton University.
Jonathan Violin, Ph.D.
Jonathan joined Quellis shortly after its incorporation to lead its launch and growth. He is a partner at Viridian LLC, a biotech incubator that builds virtual drug discovery companies to pursue product-focused drug discovery hypotheses. Prior to joining Viridian, Jonathan co-founded and helped lead Trevena Inc. from discovery research through clinical development and NDA submission, including multiple rounds of venture and public financing. While there, he held a series of roles including leadership of discovery biology, investor relations, corporate strategy, and scientific affairs. He has helped identify and progress four novel molecules in to clinical development, including one program granted Breakthrough Therapy Designation by the FDA. He also has experience in alliance management, business development, and regulatory interactions including team lead and moderator for a new chemical entity FDA Advisory Committee. Jonathan has co-authored over 45 peer-reviewed publications. He holds a Ph.D. from the Department of Pharmacology at the University of California, San Diego, an M.B.A. from the Fuqua School of Business, and a B.S. in Chemical Pharmacology from Duke University.
12/10/19: Quellis Biosciences Inc. Announces $17 Million Series A Financing
http://web.archive.org/web/20201201021841/https://quellisbio.com/
nole92
5 años hace
Edasalonexent (formerly CAT-1004) is an oral and small molecule experimental therapy being developed by Catabasis Pharmaceuticals to treat all forms of Duchenne muscular dystrophy (DMD).
How edasalonexent works
DMD is one of the most common types of muscular dystrophy. It primarily affects boys and leads to the progressive loss of muscle fibers. The condition is caused by a mutation that results in a lack of dystrophin protein production. This protein provides structure to muscle fibers and protects them against injury. Without dystrophin, muscle fibers get damaged at each contraction.
A signaling pathway called the NF-kappa B pathway is activated in DMD patients from infancy. This pathway is responsible for muscle fiber breakdown, and the failure to repair muscle injuries that are seen in DMD patients.
Edasalonexent inhibits NF-kappa B, blocking the pathway. Through this mechanism, it is thought that edasalonexent may be able to preserve muscle function in DMD patients.
Edasalonexent in clinical trials
A combined Phase 1/2 clinical trial (NCT02439216) called MoveDMD evaluated the safety, efficacy, and pharmacokinetics (how the treatment moves in the body) of edasalonexent in children with a genetically confirmed diagnosis of DMD. A total of 31 boys, ages 4 to 8, were enrolled.
Edasalonexent preserved muscle function and substantially slowed DMD disease progression through 60 weeks of treatment compared to placebo. Consistent improvements in all assessments of muscle function were observed after more than a year of treatment. Edasalonexent was well-tolerated with no safety signals observed in the trial.
A Phase 3 clinical trial to further test edasalonexent is now underway. This 52-week trial, PolarisDMD (NCT03703882), is a multi-center trial with test sites in the U.S., Canada, Asia, and Australia.
PolarisDMD aimed to recruit 125 boys, ages 4 to 7, who have not been treated with corticosteroids for at least six months. The study actually exceeded this recruitment target due to high demand and enrolled 130 participants and is no longer enrolling. Patients were randomized, 2:1, to receive either edasalonexent (100 mg/kg capsule) or placebo daily. Patients will have clinical visits every three months, and the study’s primary goal is to measure the change in North Star Ambulatory Assessment scores at one year. This includes tests that measure the time it takes the children to stand, the four-stair climb test, and the 10-meter walk/run test. The boys’ muscle strength and growth, as well as their heart and bone health, will also be assessed. No muscle biopsies or magnetic resonance imaging (MRI) will be required for this study. The trial is expected to conclude in June 2020.
After 12 months, patients will be invited to continue receiving edasalonexent, or begin treatment, in an open-label extension study, GalaxyDMD (NCT03917719). The study is open to patients involved in the MoveDMD or PolarisDMD trials or DMD-affected siblings of boys enrolled in those trials. GalaxyDMD will follow the participants for up to 104 weeks (2 years) and is expected to complete in June of 2020.
Other information
The U.S. Food and Drug Administration (FDA) granted edasalonexent orphan drug, rare pediatric disease, and fast track designations. The European Commission (EC) also granted the treatment orphan medicinal product designation for the treatment of DMD.
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