Shanghai Green Valley Pharmaceutical Co., Ltd.

The Biotechnology Innovation Organization, Passage Bio and Palisade Bio saw leadership shakeups at the top, while Maze Therapeutics, Cerecin and more appointed new chief medical officers. Biotechnology Innovation Organization Michelle McMurray Heath stepped down from her role as president and chief executive officer of BIO. She will now serve as an adviser to the executive committee, offering guidance on key BIO initiatives. During her short tenure as CEO, McMurry-Heath reorganized the leadership structure of the trade group to provide what was expected to be “long-term stability for the organization.” However, reports have suggested that stability has not been achieved. Rachel King, co-founder and former CEO of GlycoMimetics, Inc. has stepped in to serve as interim CEO. BIO will search for a full-time CEO. In addition to her role at GlycoMimetis, King served as a senior vice president at Novartis. Before that, she was CEO of Genetic Therapy, Inc. Passage Bio William Chou will assume the role of chief executive officer of Philadelphia-based Passage Bio. He replaces Edgar B. Cale, who has served as interim CEO. Cale will continue his role as general counsel and corporate secretary. Chou most recently served as CEO of Aruvant Sciences, a gene therapy company. Before Aruvant, he held multiple leadership roles at Novartis, including vice president, global disease lead for the company's Cell and Gene Therapy unit. Before Novartis, Chou worked at the Boston Consulting Group. Palisade Bio Thomas Hallam ceased his duties as CEO of Palisade on Oct. 10. JD Finley, the company’s current chief financial officer, has stepped in to serve as interim CEO. Prior to joining Palisade, Finley was president, CFO and CEO of PointAcross, Inc., a software company. Prior to that, he co-founded Proteus Capital Partners, Inc. New Chief Medical Officers Maze Therapeutics Harold Bernstein, M.D., Ph.D., has been appointed president, head of research and development and chief medical officer. Bernstein joins Maze from BioMarin, where he served as senior vice president, CMO and head of global clinical development. Prior to BioMarin, he was head of translational medicine and vice president of global medicines development and medical affairs at Vertex. Before that, he held roles at Merck, including head of early development for cardiometabolic diseases. Additionally, Eric Green, M.D., Ph.D., who has served as Maze’s senior vice president, research and translational sciences, has been promoted to chief scientific officer. Previously, Green was an entrepreneur-in-residence at Third Rock Ventures. Cerecin, Inc. Marc Cantillon, M.D. was named CMO of neurotherapeutics company Cerecin. Prior to Cerecin, Cantillon was CMO of Reviva Pharmaceuticals. Before that, he was CMO of Green Valley Pharmaceuticals. He has also held leadership roles at AstraZeneca, Impax Labs and Kyowa Kirin. Cantillon was also the founding executive medical director of the Coalition for Major Diseases at the Critical Path Institute, a public-private partnership. Walden Biosciences Peter Guest Linde, M.D. was named the first CMO of Walden Biosciences. Most recently, Linde was CMO of Morphic Therapeutic, Inc. Prior to that, he was vice president of medical research at Acceleron Pharma, Inc. Before that, Linde was project lead of clinical asset development at AbbVie. Before that, he was senior director of clinical development at FibroGen, Inc. In addition, Linde was founder, director and president of Triaxis Medical Devices, Inc. He started his corporate career at Johnson & Johnson, Inc., where he was the director of clinical research. Canary Medical Patrick Verta, M.D., was appointed CMO. He previously served as vice president of medical affairs, clinical science and biometrics at Edwards Lifesciences. Prior to his role at Edwards, Verta served as the company’s vice president of medical affairs and heart failure in the corporate development and strategy group. Previously, he served as CMO for start-up companies Sunshine Heart and Neomend. Before that, he served in various roles of increasing responsibility at Abbott Vascular and Guidant. Vor Bio Longtime industry executive Eyal C. Attar, M.D., was named CMO of Vor Bio. Attar most recently served as senior vice president and CMO for Aprea Therapeutics. Before Aprea, he held multiple positions in clinical development at Agios Pharmaceuticals, including senior medical director and IDH hematology medical lead. Attar was previously an attending hematologist/oncologist at Massachusetts General Hospital. Maternova, Inc. Luna M. Mehrain, M.D., was tapped as CMO of Rhode Island-based Maternova. Mehrain previously held positions with Médecins Sans Frontières, Merlin, DAI, Population Services International and the International Planned Parenthood Federation.

A Phase III study of a seaweed-derived Alzheimer’s drug, conditionally approved in China in November 2019, has been halted, five trial sites have confirmed to Endpoints News. Shanghai-based Green Valley Pharmaceuticals’ oligomannate, or GV-971, was in a late-stage Alzheimer’s study dubbed “Green Memory,” but the trial was halted due to supply chain issues, according to four of the sites. One site said it was not supply chain-related. Eric Reiman, a former scientific advisor to Green Valley, said he was informed the trial was discontinued “due to unexpected financial challenges related to the COVID-19 Pandemic in China.” “Based on the information that was shared with us, the advisors were not aware of any treatment-related safety issues,” Reiman said in an email to Endpoints. He is also executive director of Banner Alzheimer’s Institute, which is listed as one of the study’s trial sites on clinicaltrials.gov. The trial was halted at one site in early April, another about two weeks ago and others “several” and “a couple” weeks ago. One trial site said they received a calendar invite from the company for tomorrow. “Shanghai is not in a happy place,” one of the trial sites said, citing the Covid-19 lockdowns currently taking place in the city. Endpoints has reached out to multiple phone numbers and emails associated with Green Valley and will update accordingly. At the time of its IND clearance in April 2020, Green Valley said it would work with IQVIA on the trial. A spokesperson for the CRO told Endpoints in an emailed statement: “It’s our corporate policy to defer all study questions to the respective study sponsors.” The news comes after CMO Samuel Agus left his post last month, according to his LinkedIn profile. The study kicked off in October 2020 and had expected to enroll 2,046 patients with mild to moderate Alzheimer’s. At the time of the IND clearance news, Green Valley said it planned to wrap up the trial in 2024 and submit an NDA by 2025. In January, the biotech said the trial was now slated for completion by 2025 and that it had screened 949 patients and had 292 randomized, thus far. At that time, 154 clinical centers in 10 countries and regions had been activated. Green Valley has described the drug as: “Being the world’s first AD drug that targets the gut-brain axis, GV-971 reduces peripheral and central inflammation by reconditioning the gut microbiota and inhibiting the abnormal balance of gut microbiota-derived metabolites.” China’s regulators conditionally approved the drug in November 2019, sending shockwaves into the Alzheimer’s drug development world as there hadn’t been a new medicine for the memory-robbing disease in nearly two decades. But experts were “cautiously optimistic” following the nod. Related:Alzheimer's breakthrough? Not so fast — experts poke holes in data underlying China's surprise approval “The other scientific advisors and I were excited about the chance to help the company design a rigorous global Phase 3 clinical trial. We were interested in the drug’s potentially novel mechanism of action, the initial basic science and clinical trial findings from China, the chance to clarify the drug’s efficacy, and potential implications for the role of the microbiome in the development and treatment of Alzheimer’s disease,” Reiman told Endpoints. The drug was included in China’s national reimbursement drug list late last year, Green Valley said in December 2021, reducing the monthly medication cost from RMB 3,580 ($531) to RMB 1,184 ($175). The FDA also cleared an IND for a Phase II study of the drug in patients with early-stage Parkinson’s, Green Valley said in January. That trial is expected to include 300 patients at 30 centers in North America and Asia-Pacific over the course of a 36-week study. The news comes as Biogen and Eisai said Monday that they completed the submission for their second Alzheimer’s treatment, dubbed lecanemab, and as Eli Lilly works on its application for its drug donanemab. Green Valley was founded in 1997 and employs 1,500 people, according to the company’s website.