Cellevolve Bio, 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.  Longtime BioMarin CEO hands baton off to Genentech chief BioMarin In pharma executive leadership terms, 18 years is an eternity. For comparison, that’s longer than the entire tenure of Robert Bradway at Amgen, who himself is a pharmaceutical staple.  But such was the length of Jean-Jacques Bienaimé’s tenure at the helm of BioMarin. Still, all good things must come to an end, and Bienaimé is hanging it up. The rare disease drug developer is not looking far for a replacement. Taking over will be Genentech CEO Alexander Hardy, from a company headquartered just a few miles south of BioMarin’s Marin County campus. BioMarin says the announcement followed a “multi-year succession planning process.” Hardy takes over a company that in the years since Bienaimé’s appointment has grown to about 3,000 employees and three commercial products. BioMarin recently reported $581.3 million in third-quarter earnings, a 15% increase compared to the same period a year ago.  Genentech will, for now, stick with interim CEO Ashley Magargee, who leads the U.S. commercial portfolio. She’s been temporarily guiding the company since Hardy’s “recent sabbatical.” Fierce Pharma  J&J’s cancer R&D chief to retire  Johnson & Johnson J&J’s oncology R&D team is transitioning from the leadership of Peter Lebowitz, M.D., Ph.D., to Yusri Elsayed, M.D., Ph.D., effective Jan. 1, 2024. The healthcare giant said Lebowitz will retire after a “remarkable career” that included overseeing a group that delivered 14 novel medicines.  He oversaw work on therapies such as small molecules, advanced biologics, cell therapies, vaccine platforms, translational research, diagnostics and immuno-oncology therapies. Lebowitz’s efforts also helped J&J secure dozens of deals in key indications.  Elsayed, meanwhile, will rise from his role as vice president and head of the hematologic malignancies group at J&J. He has worked at the company for more than 18 years. Prior to J&J, he briefly worked at Bristol Myers Squibb. Release Viridian taps ex-Magenta CFO for chief executive job  Viridian Therapeutics  Magenta Therapeutics had a tough go of it after the death of a patient in a clinical trial halted the study and ultimately spurred the closure of the entire company. Now, one executive of the company has found a new landing spot.  Stephen Mahoney, Magenta’s former chief financial and operating officer, has been named the CEO of Viridian Therapeutics and a member of the board. Before Magenta, Mahoney was the president and chief operating officer of Kiniksa Pharmaceuticals and led commercial work for Synageva Biopharma Corp.  Mahoney’s hiring comes after previous CEO Scott Myers officially departed on the company Oct. 29. In addition to Mahoney’s arrival, the company unveiled a couple of new FcRn inhibitors and announced a $185 million private placement. Release > Dren Bio has tapped Amit Mehta, Ph.D., to serve as the company’s chief operating officer and chief business officer. Mehta joins after an 18-year run at Roche’s Genentech, where he was most recently VP and head of business development. Release > Vir Biotechnology has chosen Jennifer Towne, Ph.D., to serve as EVP and chief scientific officer starting Nov. 6. Towne joins Vir from Johnson & Johnson’s Janssen pharmaceutical arm, where she most recently held the role of SVP, immunology discovery and external innovation. Release > Third Harmonic Bio’s chief scientific officer Adrian Ray, Ph.D., has transitioned to the role of scientific adviser, while Chief Financial Officer Robert Ho is set to exit the company Nov. 10. The inflammatory-disease-focused biotech has initiated a search for their successors. Release > Amarin has appointed Jonathan Provoost to serve as EVP, chief legal and compliance officer starting Nov. 15. He most recently served as Tris Pharma’s VP, general counsel and chief compliance officer and has past experience at Mallinckrodt Pharmaceuticals' Ikaria, Kos Pharmaceuticals and Bristol Myers Squibb. Release > Lexicon is bringing on Matthew Cullen to serve as VP of value and access as well as Lisa DeFrancesco to serve as head of investor relations and corporate strategy. Before Lexicon, Cullen was VP of value, access and policy at Apellis Pharmaceuticals, while DeFrancesco most recently served as SVP of investor relations and corporate affairs for Amarin Pharma. Release > Medicenna Therapeutics is reducing its U.S. presence with Chief Financial Officer Jeff Caravella and Chief Business Officer Brent Meadows departing the company. Medicenna will now seek a CFO who is familiar with the Toronto Stock Exchange. Fierce Biotech > RS BioTherapeutics has promoted Michelle Shuffett, M.D., to serve as chief medical officer. Shuffett joined the company in May as SVP of medical and scientific affairs and has previous experience at Boehringer Ingelheim. Release > Sangamo Therapeutics is laying off 162 employees—equivalent to 40% of its U.S. workforce. As part of the restructuring, Chief Operating Officer D. Mark McClung and Chief Scientific Officer Jason Fontenot, Ph.D., will both be heading for the exit. Fierce Biotech > Cell therapy biotech cTRL Therapeutics has chosen Derrell Porter, M.D., to helm the company. Porter most recently served as founder and CEO of Cellevolve Bio and has held past roles at Atara Bio, Gilead Sciences, AbbVie, Amgen and McKinsey & Company. Release > Ocuphire Pharma is welcoming George Magrath, M.D., aboard as CEO. Magrath most recently led Lexitas Pharmaceutical Services through its acquisition by QHP Capital. Release > Storm Therapeutics has selected Marguerite Hutchinson to serve as the biotech’s chief business officer. Hutchinson was previously the chief operating officer and general counsel fo Daiichi Sankyo’s Plexxikon. Release > Myriad Genetics has chosen Sam Raha as chief operating officer, effective Dec. 11. Raha has previously served as Agilent’s president of diagnostics and genomics group and Illumina’s VP of global marketing. Release > Gate Bioscience has exited stealth with $60 million in hand and a roster of leaders onboard, including: Jordi Mata-Fink, Ph.D., co-founder and CEO; Pat Sharp, Ph.D., scientific co-founder and VP of discovery science; Raman Talwar, co-founder and chief technology officer; and Brian Cathers, Ph.D., chief scientific officer. Release > Seattle-based ProfoundBio is adding a couple of key hires to its executive team, naming Erin Lavelle as chief operating officer and chief financial officer and Kevin Hambly as chief business officer. Lori Kunkel, M.D., has also been tapped to lead the company's scientific advisory board. Release > 4DMT has called on Alan Cohen, M.D., to be the therapeutic head of the pulmonary division. One of his most recent roles was as SVP and chief medical officer of gene editing biotech Metagenomi. Release > RNA biotech Senisca is swapping executive positions, with former Chief Operating Officer Sarah Cole, Ph.D., now taking on the role of CEO, while former CEO Kirsty Semple assumes the role of COO. Semple served as launch CEO since January 2020, while Cole joined Senisca in March 2023. Release > Endeavor BioMedicines has elected Paul Frohna, M.D., Ph.D., to serve as its chief medical officer. Frohna joins from ImCheck Therapeutics, where he was CMO and head of R&D, and has held past roles at Bioniz Therapeutics, Receptos, ProFibrix, Fibrogen and Roche’s Genentech. Release > Cognito Therapeutics has chosen Christian Howell as chief commercial officer. Howell joins the neurotech company from Aetion’s medical device and diagnostic group, where he was SVP and general manager. Release > Spatial multi-omics developer Stellaromics has appointed Todd Dickinson as president and CEO. Dickinson previously held technical and commercial executive roles at Illumina and Bionano Genomics and most recently served as CEO of Cantata Bio. Fierce Medtech

CHARLOTTESVILLE, Va. and CARMEL, Ind., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer’s disease (AD), today announced Derrell Porter, M.D., has joined its Board of Directors. “We are thrilled to welcome Dr. Porter to our Board of Directors at a time when we’re rapidly advancing clinical development of ACU193,” said Daniel O’Connell, President and Chief Executive Officer of Acumen Pharmaceuticals. “Dr. Porter brings significant expertise in drug development and commercialization to the Board as we develop a novel and potentially disease-modifying treatment for Alzheimer’s disease. His deep experience in diseases that benefit from personalized treatments and combination therapies will be invaluable to Acumen.” Dr. Porter said: “This is an exciting time for drug development in Alzheimer’s disease, and I am drawn to Acumen’s pioneering science and the therapeutic promise of ACU193. I look forward to contributing my experience bringing meaningful treatments to market as Acumen works to deliver therapies that can substantially impact those affected by this devastating disease.” Dr. Porter is a physician-entrepreneur with more than 20 years of experience in drug development. He is currently the Founder and CEO of Cellevolve, a development and commercialization cell therapy biotech focused on neglected diseases, and previously served in commercial and corporate development roles at Atara Bio, Gilead, AbbVie and Amgen. He is also a Board Member at Passage Bio, a genetics medicine company developing therapeutics for disorders of the central nervous system; Portal Innovations, LLC, a venture development engine which delivers seed capital, specialized equipment, lab space, and management expertise to early-stage biotech companies; and an Advisory Committee Member at the University of Pennsylvania School of Medicine. Dr. Porter started his career at McKinsey & Company. He earned his M.D. from the Perelman School of Medicine and MBA from the Wharton School at the University of Pennsylvania, and his B.S. in Neuroscience from the University of California, Los Angeles. About ACU193 ACU193 is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble AβOs, which Acumen believes are the most toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, ACU193 aims to directly address what a growing body of evidence indicates is a primary underlying cause of the neurodegenerative process in AD. ACU193 has been granted Fast Track designation for the treatment of early Alzheimer’s disease by the U.S. Food and Drug Administration. About Acumen Pharmaceuticals, Inc. Acumen, headquartered in Charlottesville, VA, with clinical operations based in Carmel, IN, is a clinical stage biopharmaceutical company developing a novel disease-modifying approach to treat Alzheimer’s disease. Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are primary triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, ACU193, a humanized monoclonal antibody that selectively targets toxic soluble AβOs in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients. For more information, visit www.acumenpharm.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include the those concerning the therapeutic potential of Acumen’s product candidate, ACU193. These statements are based upon the current beliefs and expectations of Acumen management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of the COVID-19 pandemic, geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and future filings with the SEC, including Acumen’s Quarterly Report on Form 10-Q for the quarter ended and September 30, 2022. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise. Investors:Alex Braunabraun@acumenpharm.com Media:AcumenPR@westwicke.com

SAN FRANCISCO, Oct. 25, 2022 /PRNewswire/ -- Cellevolve Bio, Inc. ("the Company" or "Cellevolve"), a clinical stage development and commercialization platform company focused on cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CE-VST01-JC, a JC Virus Specific T Cell Therapy (JC-VST) that is being studied for the treatment of progressive multifocal leukoencephalopathy (PML). CE-VST01-JC also received FDA orphan drug designation. "We are thrilled to have received IND clearance to begin our Phase 2 clinical study," said Derrell Porter, M.D., Founder and CEO, Cellevolve. "This is a significant milestone for both Cellevolve and the PML community: ASCEND-JC will be the largest ever cell therapy study conducted in PML, and this is Cellevolve's first IND approval and a powerful proof point for our business model of partnering with innovators around the world to bring cell therapies through late stage development and into commercialization." PML is a demyelinating disease of the central nervous system (CNS) caused by JCV and occurs in immunocompromised patients. PML is rapidly progressive, debilitating, and often fatal. There are no FDA or EMA approved treatments for this condition, which affects ~ 4,000 individuals in the US and Europe annually. 1,2 The safety and efficacy of CE-VST01-JC will be evaluated in ASCEND-JC, a global, multi-center, randomized, double-blind, placebo-controlled Phase 2 study that will enroll up to 60 patients across the US, Canada, and EU. The first patient enrolled is anticipated in the first half of 2023. References NORD (2021). Progressive Multifocal Leukoencephalopathy. Retrieved from https://rarediseases.org/rare-diseases/progressive-multifocal-leukoencephalopathy/. Accessed on September 10, 2022. Cortese I, Reich DS, Nath A. Progressive multifocal leukoencephalopathy and the spectrum of JC virus- related disease. Nat Rev Neurol. 2021a;17(1):37-51. Doi:10.1038/s41582-020-00427- y. About CEVST01-JC Cellevolve's lead product, CE-VST01-JC, is in clinical development as an allogeneic, off-the-shelf, JC-specific T-cell therapy (JC-VST) targeting JC polyoma virus (JCV) in patients that develop progressive multifocal leukoencephalopathy. CE-VST01-JC will be evaluated in ASCEND-JC, a global, multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial in patients with PML due to JCV. The study is designed to evaluate whether CE-VST01-JC will slow and ultimately halt neurological progression in patients with PML compared with placebo as evaluated by a modified Rankin Score (mRS). About Cellevolve Cellevolve Bio is a development and commercialization company focused on cell therapies. The Company's mission is to partner with innovators to translate early stage clinical therapies into commercially available treatments for neglected diseases, including pediatric and rare diseases, which can have a major impact if they are advanced into clinical development and beyond. Founded by leaders with extensive experience developing and launching therapeutics, Cellevolve understands that the development and commercialization of cell therapies requires unique and specialized capabilities. The Company is addressing this need with it's partnering, development approach and integrated Cellution™ platform that translates breakthrough science into powerful new therapies for patients.