Affamed Therapeutics (Us), Inc.

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.   Scorpion’s CEO, CMO out the door Scorpion Therapeutics It’s a new year and change is afoot at Scorpion Therapeutics, with both former CEO Axel Hoos, M.D., Ph.D., and CMO Michael Streit, M.D., hitting the exits.  Industry veteran Hoos has led the oncology company since July 2021, when he left GSK for Scorpion. At the time, Hoos had taken the reins from interim CEO Adam Friedman, M.D., Ph.D., who will now take back the top title, this time without the temporary designation. Friedman is part of Scorpion’s founding team and most recently served as the biotech’s president of corporate strategy and business development.    The Boston biotech is also replacing Streit, who was the first to fill the company’s chief medical officer position. Streit joined in 2022 from Sanofi, where he had most recently served as vice president and senior project head.  Now, Mark Chao, M.D., Ph.D., will take over as CMO. He joins Scorpion from TenSixteen Bio, where he served as co-founder and CEO.  But the changes don’t stop there. Scorpion has also promoted Erica Jackson, Ph.D., to chief discovery officer. She previously served as the company’s executive vice president of biology. Fierce Biotech  CRISPR hunts for new CMO  CRISPR Therapeutics CRISPR Therapeutics Chief Medical Officer Phuong Khanh Morrow, M.D., is resigning—a decision that was announced six days after the company secured FDA approval for its Vertex-partnered gene therapy Casgevy. The biotech has already kicked off the search for a new CMO, a spokesperson told Fierce Biotech. “CRISPR Therapeutics has a seasoned leadership team with extensive experience managing clinical development for CRISPR’s programs and is well positioned to successfully manage the transition,” a spokesperson said via email. Morrow, who has been with the company since May 2022, will officially depart Jan. 26. Her resignation was not the result of any disagreement with the gene-editing company, according to CRISPR Tx. Before joining the Swiss-American biotech, Morrow spent more than 10 years in various leadership roles at Amgen. Fierce Biotech  Long-time Evotec CEO steps down Evotec Evotec’s CEO Werner Lanthaler has resigned from his role before his expected end of term, which was set for March 2026, citing personal reasons.  Lanthaler, who has led the German biotech since 2009, will serve as a strategic advisor to Evotec’s board, which has launched a search for a permanent CEO.  Until a successor is chosen, board member Mario Polywka will take on the role of interim CEO. Ploywka had served as Evotec’s chief operating officer from 2006 to 2018. Release  > LianBio CEO Yizhe Wang, Ph.D., is headed for the exits in pursuit of new opportunities. Chief Investment Officer Adam Stone will be the interim chief while the search for a permanent replacement begins. Release > Ex-Biogen CEO Michel Vounatsos has joined the board of Quris-AI. Former Merck regional president Yossi Ben Amram was also named president of the company. Release > Vicore Pharma has hired Bertil Lindmark, Ph.D., M.D., to serve as chief medical officer, taking the reins from Rohit Batta. Lindmark joins from Galecto, where he also held the CMO role, and has previous experience as AstraZeneca’s global vice president of clinical development for respiratory and inflammation. Release > Applied Therapeutics has named Constantine Chinoporos as its new chief operating officer and chief business officer. He’s been a strategic advisor for Apollo Therapeutics since February 2023 after past c-suite roles at other biotechs. Disclosure > Innate Pharma CEO Mondher Mahjoubi has resigned to pursue a new gig at a larger pharmaceutical company, the European biotech announced. Chairman and co-founder Hervé Brailly will be the interim leader while the search for a replacement gets underway. Release > SpliceBio will bring on Aniz Girach, M.D., as chief medical officer. Girach was previously CMO of fellow gene editing biotech ProQR until March 2023. Release > New year, new gig for Nathan Dowden, who’s been promoted at Entrada from chief operating officer to president and COO. He’s been with the company since 2019 after working at Rubius. Release > Relmada CMO Cedric O’Gorman, M.D., is leaving the company after one year. He previously was the chief medical officer at Alpha Cognition. Release > After Zevra’s recent acquisition of Acer, Adrian Quartel, M.D., will become the new chief medical officer. He was the CMO of Acer and was the chief medical officer of Adamis before that. Release > ARIAD Pharmaceuticals founder Harvey Berger, M.D., has been hired as the new CEO of Kojin Therapeutics. Kojin is backed by the likes of Leaps By Bayer and AbbVie’s venture arm. Release > Included in Radionetics Oncology’s latest financing announcement was news that the biotech has brought on Paul Grayson as CEO. He was most recently president and CEO of fellow oncology company Tentarix Biotherapeutics. Release  > Mineralys Therapeutics has tapped Minji Kim, Ph.D., to serve as chief business officer. Before Mineralys, she held the same role at Affamed Therapeutics and has past experience at Jounce Therapeutics, Curis and Hoffmann-La Roche. Release > ProMIS Neurosciences is bringing on Neil Warma as interim CEO to replace Gail Farfel, Ph.D. Warma has been a director on the company’s board since 2022. Release > Brii is bringing aboard former HemoShear CSO Brian Alvin Johns, Ph.D., for the same role. Before HemoShear, he was VP of discovery at Viiv and GSK. Release > Heike Keilhack, Ph.D., is joining ROME Therapeutics as chief scientific officer. She previously was CSO and oversaw R&D of two now-clinical-stage PARP inhibitors at Ribon Therapeutics. Release > Diagnostics vet Brian Kim is the new CEO of genomics company Mission Bio, the company announced. He previously was CEO of Fortis Life Science and held other leadership roles at Biosearch Technologies and PerkinElmer. Release > SV Health Investors has appointed Nikola Trbovic as managing partner and Jamil Beg as partner. The two will help steer the firm’s biotech portfolio, which includes companies like Bicycle and Nimbus. Release > CymaBay Therapeutics and former Chief Commercial Officer Lewis Stuart mutually agreed that Stuart would leave the company on Dec. 29. CymaBay’s VP Liver Franchise Lead Ben Kozub will assume leadership of commercial organization. Release > Alaunos Therapeutics has tapped Dale Curtis Hogue, Jr., to serve as director of the immuno-oncology company. Hogue most recently founded Dune Lake Capital and previously worked as a senior analyst at Discovery Capital Management. Release > Viatris has chosen Philippe Martin to lead the company’s research and development as chief R&D officer. Martin has clocked in past experience at Celgene and Schering-Plough (acquired by Merck). Release > Noriyuki Kasahara, M.D., Ph.D., is moving from 4DMT’s board to its C-suite, being named chief scientific officer. Kasahara is a brain surgeon who previously worked at UCSF. Release > Scribe Therapeutics’ next chief scientific officer and head of research and development will be Aarif Khakoo, M.D., who joins the CRISPR genetic medicines company from Calico Life Sciences. Also joining the biotech is Maria Mirotsou, Ph.D., as vice president of discovery biology. Release > Eterna Therapeutics has picked Sanjeev Luther as its next CEO, as of Jan. 1. He succeeds Matt Angel, Ph.D. Luther has spent the past 30 years at various roles across biopharma, most recently as CEO at Cornerstone Pharmaceuticals. Release > Henrik Luessen is the new chief business officer for German biotech Eleva, which has a moss-based platform that develops complex proteins for treatment of diseases. Release > Ashvattha Therapeutics has named Mehdi Paborji, Ph.D., as senior vice president of technical operations to oversee CMC and manufacturing for the biotech’s nanomedicines. Release  > Deka Biosciences has tapped Stanley Frankel, M.D., to serve as senior clinical advisor, interim chief medical officer and scientific advisory board member. The hematologist-oncologist joins Deka with past experience as SVP, global drug development for cell therapy for BMS following the 2019 acquisition of Celgene. Release > HERVOLUTION Therapeutics has chosen J. Robert Coleman, Ph.D., to lead the biotech as CEO. Before joining HERVOLUTION, Coleman co-founded Codagenix and served as the company’s CEO for 12 years. Release > ImPact Biotech has appointed clinical radiologist Eyal Morag, M.D., to be the company’s chief medical officer. Morag joins from Microbot Medical, where he was also CMO, and currently serves in scientific and medical advisory roles at Aidoc Medical, Vortex Imaging and HighRad. Release

RADNOR, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced the appointment of Minji Kim, Ph.D. as Chief Business Officer. Adam Levy will remain in his role as Chief Financial Officer. “With our expanding operations, we have decided to split the functions of Chief Financial Officer and Chief Business Officer into two roles, and we are excited to have Minji join our team. She brings a solid track record of generating value for multiple companies by identifying and executing strategic opportunities,” stated Jon Congleton, Chief Executive Officer of Mineralys. “We are pleased to start 2024 with our full executive team in place as we execute against our late-stage clinical development of lorundrostat for the treatment of aldosterone dependent conditions such as hypertension and chronic kidney disease.” “With several clinical milestones for lorundrostat expected over the next 12-18 months, I am excited to join Mineralys. Given the current trajectory of the ongoing pivotal clinical development program, lorundrostat has great potential to address unmet needs in patients suffering from diseases driven by abnormally elevated aldosterone,” stated Dr. Kim. Dr. Kim brings more than two decades of experience in business development, strategic leadership, and scientific research. During her career, she has worked with biotech companies in the U.S. and overseas across broad therapeutic and technical areas. Prior to joining Mineralys, she held the role of Chief Business Officer at Affamed Therapeutics and General Manager at Affamed Digital, and brought multiple products into their pipeline. Before Affamed, Dr. Kim was Head of Business Development and Alliance Management at Jounce Therapeutics. She led the execution of pharma partnerships and over $200 million in non-dilutive funding for the company. Prior to Jounce, she held the role of Vice President of Corporate and Business Development at Curis, Inc. During her tenure at Curis, she led strategic transactions that had a fundamental impact on the future sustainability of the company, tripling the value of the company and pivoting its R&D direction. Previously, Dr. Kim served on the Global Oncology Business Development and Licensing group at Hoffmann-La Roche. She began her career as an instructor in neurology at Harvard Medical School. Currently, Dr. Kim is an independent board member of SK Biopharmaceuticals, a global commercial-stage life science company. She obtained her Ph.D. from Seoul National University in South Korea and her MBA from Yale School of Management. About LorundrostatLorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled and resistant hypertension and CKD. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects. About Mineralys TherapeuticsMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD and other diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and CKD. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter. Forward-Looking StatementsMineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that the Advance-HTN and the planned Phase 3 clinical trial of lorundrostat may serve as pivotal trials in any submission of a new drug application (NDA) to the United States Food and Drug Administration (FDA); the Company’s ability to evaluate lorundrostat as a potential treatment for CKD or uncontrolled hypertension; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com

SHANGHAI, April 17, 2023 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders, today announced that China's National Medical Products Administration (NMPA) has approved AffaMed's Clinical Trial Application (CTA) to initiate a Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery. In addition, AffaMed is pleased to announce that DEXTENZA has recently been approved in Macau, China for the treatment of ocular itching associated with allergic conjunctivitis. In October 2020, AffaMed Therapeutics entered into a licensing agreement with Ocular Therapeutix (NASDAQ: OCUL) for the development and commercialization of DEXTENZA in Greater China, South Korea, and certain ASEAN markets. DEXTENZA is approved in the U.S. and Macau for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. Following this CTA approval, AffaMed will soon initiate the proposed registrational study in China. Dr.Dayao Zhao, CEO of AffaMed commented: "We are encouraged by the Chinese regulator's efficiency in approving our application for this novel therapy based on the proposed Phase 3 study design and the totality of the existing registrational trial data previously submitted by our partner Ocular Therapeutix to the U.S. FDA. We are ready to start the Phase 3 trial, and we are looking forward to completing the development of DEXTENZA so that we can bring this novel and differentiated treatment option to patients in China as soon as possible." AffaMed is developing DEXTENZA to become the first sustained-release intracanalicular insert in China delivering a preservative-free dose of dexamethasone for up to 30 days with a single administration. DEXTENZA offers patients significant benefit in the form of assured compliance, and convenience relative to current treatments requiring multiple administrations of eyedrops per day. In January 2022, AffaMed initiated a Real World Study in Boao, Hainan, evaluating the safety and efficacy of DEXTENZA (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain post-cataract surgery. The purpose of the study is to support and accelerate the registration application for DEXTENZA, and AffaMed anticipates sharing top-line data from this study in Q4 2023. About AffaMed Therapeutics AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets include: OTX-TKI (axitinib intravitreal implant), currently in Phase 1 clinical trials for the treatment of wet AMD and diabetic retinopathy; OTX-TIC (travoprost intracameral implant), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease, both of which have completed Phase 2 clinical trials. About DEXTENZA DEXTENZA is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal. Please see full Prescribing and Safety Information at . SOURCE AffaMed Therapeutics Ltd.