Prilenia Therapeutics Development Ltd.

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.  Lonza nabs new CEO after snapping up Roche site Lonza From one Swiss CDMO to another. That’s the course Wolfgang Wienand is taking, with summer plans to jump from his role at Siegfried’s helm over to lead Lonza.  Lonza’s interim CEO Albert Baehny, who stepped up from his chair position in October after Pierre-Alain Ruffieux abruptly left, is set to retire from the CDMO giant after a transition period. The interim leader is expected to cede his chair title to Heineken Chair Jean-Marc Huët at Lonza’s annual shareholder meeting this May. Newly tapped Wienand will join Lonza after serving as Siegfried’s CEO for five years. He joined the CDMO in 2010 and held a variety of leadership roles before taking up the top spot, including chief scientific officer, head of global R&D and chief strategy officer.  The CEO announcement follows years of leadership turnover at Lonza and comes a few weeks after the CDMO unveiled a $1.2 billion acquisition of a large biologics manufacturing facility in California from Roche’s Genentech. Fierce Pharma  Amgen R&D leader jumps to Acadia Acadia Pharmaceuticals After leading R&D at Horizon Therapeutics, and then Amgen after Horizon’s $27.8 billion acquisition, Elizabeth H. Z. Thompson, Ph.D., is heading over to neuroscience-focused Acadia Pharmaceuticals.  Thompson is taking on the role of EVP and head of R&D at Acadia, which touts the only FDA-approved drug to treat hallucinations and delusions tied to Parkinson’s disease psychosis as well as the only FDA-approved drug for treating Rett syndrome. Thompson will focus on Acardia’s clinical-stage programs, which include a candidate for a genetic disorder called Prader-Willi syndrome and an Alzheimer’s disease psychosis program. Thompson joins from Amgen, where she was EVP of rare disease R&D after the October acquisition of Horizon, where Thompson led R&D activities. Years ago, from 2003 to 2014, Thompson had started her biopharma career at Amgen before going on to hold roles across AbbVie, Raptor and InterMune. Release  3 C-suite leaders depart I-Mab I-Mab I-Mab’s chief business officer Weimin Tang, chief communications officer Gigi Qi Feng and chief legal officer Richard Cheng Li have all chosen to exit the oncology biotech. The departures aren’t due to any disagreement with the company, according to a Securities and Exchange Commission filing, with all three leaders leaving to pursue other opportunities.  Lan Kang, a director of I-Mab’s board, has also resigned, citing personal reasons. Of late, the company has taken steps toward becoming a U.S.-focused biotech, beginning the process of divesting its China operations in February. I-Mab did not return Fierce Biotech’s request for comment as of the time of publication. Release  > Julie Clauss is joining Odyssey Therapeutics’ adventure as chief operating officer, the company announced this week. Joining her is Christopher Butler, who was named SVP and head of chemistry. Release  > Mosaic is painting an updated R&D future with two new hires. The biotech has named Malavi Madireddi, Ph.D., as SVP of drug discovery and Scott Glaser, Ph.D., as SVP of biologics discovery. Release  > Margaret Garin, M.D., has been named VP of clinical development at Trevi Therapeutics after working on the clinical development team at now-GSK-owned Bellus Health. Former Bellus CEO Roberto Bellini took to LinkedIn last month to advocate for his former employees following layoffs at the bought biotech. Release  > NewAmsterdam Pharma has appointed Juliette Audet to serve as the company’s chief business officer. Audet was most recently a partner at life sciences VC Forbion, where she helped build NewAmsterdam Pharma. “She was very instrumental in our founding—she and I worked together on the first financing, the series A, and has been very involved in the strategy for the company formation,” NewAmsterdam CEO Michael Davidson, M.D., told Fierce Biotech this week. “So it's exciting to see her with her talent and experience actually join the leadership team now.” Release > Zura Bio has tapped Robert Lisicki to replace founding CEO Someit Sidhu, M.D., who will stay on as a non-independent board director. Lisicki most recently worked a brief six-month stint as CEO of InCarda Therapeutics. Release  > After overseeing regulatory development at Samsung Bioepis, Luke Oh, Ph.D., is set to join NeoImmuneTech as CEO. Oh worked at the FDA prior to his executive position at Samsung. Release  > Ratio Therapeutics has called on Bill Cupelo to be chief business officer after he led the sales team at Invicro. The company also announced that D. Scott Holbrook would join its board of directors. Release  > Dutch biotech Prilenia Therapeutics has hired Jina Swartz, M.D., Ph.D., as its chief medical officer. She previously held the same role at fellow neurodegenerative-focused company, Exciva. Release  > CDMO KBI Biopharma is bringing aboard Peter Carbone as chief quality officer. He joins from the Center for Breakthrough Medicines, another CDMO where he was chief operating officer. Fierce Pharma > Former CEO of Seeker Biologics, Rand Sutherland, M.D., has been named the new CEO of Upstream Bio. The company also brought on Mike Gray as CFO and COO in addition to Lisa Fiering as SVP of people and culture. Release > Addex CEO Tim Dyer will lead a new spinout company, Neurosterix, according to an announcement this week. He has been at Addex for more than 20 years. Release > Ex-Heron Therapeutics CMO Chris Storgard, M.D., has been named chief medical officer of ADARx. Before that, he was the CMO of Fate Therapeutics. Release > Merck & Co. has a new head of human resources, naming Betty Larson for the job, according to an emailed press release. She most recently was chief people officer at GE HealthCare.  > It’s difficult to fully understand the human impact of biopharma layoffs, but Fierce Biotech calculated at least 2,398 people laid off from the 25 companies reporting numbers of employees affected for 2024’s first quarter. In total, 58 layoff rounds were recorded for the industry from January through March. Fierce Biotech

-- Expansion of leadership team aligned with planned first global regulatory submission for approval for pridopidine for Huntington’s disease and preparation for commercialization -- NAARDEN, Netherlands & WALTHAM, Mass.--(BUSINESS WIRE)-- Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, today announced the appointment of Dr. Jina Swartz, M.D. Ph.D., as its first Chief Medical Officer (CMO). In this role, Jina will lead all clinical development and medical affairs activities at Prilenia. This press release features multimedia. View the full release here: Jina Swartz, M.D. Ph.D., Chief Medical Officer at Prilenia (Photo: Business Wire) Jina has more than 30 years’ experience in both academic neurology practice and in global drug development at leading pharmaceutical companies and joins Prilenia from Exciva, a neurodegeneration-focused biotech, where she was Chief Medical Officer. Previously, Jina served as Therapeutic Area Head of Neuroscience in Global Clinical Drug Development at Merck and Co. Renowned within both research and industry circles, Jina is active in several important neurology and neurodegeneration associations including the European Brain Council and the European Federation of Neurological Associations. She also was recently elected to the Fellowship of the Academy of Medical Sciences for her expertise in neurodegenerative disorders and neuropsychiatric drug development. “Jina joins Prilenia during an important phase of the Company’s growth. We recently announced plans to submit pridopidine for regulatory review in Europe for Huntington’s disease (HD) and to commence a pivotal, global Phase 3 study in amyotrophic lateral sclerosis (ALS). Jina, in our newly created CMO role, will be a key leader as we advance these important initiatives,” said Dr. Michael R. Hayden, CEO of Prilenia. “Jina’s deep expertise as a thought leader, clinician treating neurodegenerative diseases and leader in global drug development is perfectly matched to our goal of changing the therapeutic landscape in HD and ALS.” “This is such an exciting time to be joining Prilenia and to help advance the Company’s mission to develop new therapeutic options for people living with neurodegenerative diseases like HD and ALS,” said Jina Swartz, M.D. Ph.D., Chief Medical Officer of Prilenia. “We have a remarkable opportunity, with pridopidine, to positively impact the lives of those living with these devastating diseases where progression has proven difficult to slow thus far. I believe that Prilenia is on the cusp of changing that paradigm.” Jina completed her Doctorate at the University of Cambridge, where her thesis focused on the exploration of molecular mechanisms of neurodegeneration in Huntington's disease and trinucleotide disorders. About Pridopidine Pridopidine (45 mg twice daily) is an oral, highly selective and potent investigational S1R agonist that has exhibited a safety and tolerability pro to placebo in clinical studies to date. The safety dataset includes approximately 1,700 patients who have been on pridopidine for up to seven years. The S1R protein is highly expressed in the brain and spinal cord, where it regulates several key processes that are commonly impaired in various neurodegenerative diseases. Activation of the S1R by pridopidine stimulates multiple cellular protective pathways including enhancing autophagy, axonal transport, mitochondrial energy production and respiration, and restores calcium homeostasis. These effects are essential to neuronal function and survival, and lead to neuroprotective effects. Prilenia holds Orphan Drug designation for pridopidine in HD and ALS in the U.S. and EU. In addition, pridopidine has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of HD. About Prilenia Prilenia is a clinical stage biotechnology company founded in 2018 focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders. The initial focus of the company has been on HD and ALS. Prilenia is backed by a group of well-respected investors including: Forbion, Morningside, Sands Capital, SV Health Investors, Sectoral Asset Management, Talisman, Amplitude Ventures and the ALS Investment Fund. The Company is based in the Netherlands, Israel and Massachusetts in the U.S. For more information, visit and follow us on LinkedIn and Twitter. ©2024 Prilenia Therapeutics B.V. For a copy of this release, visit Prilenia’s website at .

NAARDEN, Netherlands & WALTHAM, Mass.--( BUSINESS WIRE )-- Prilenia Therapeutics B.V. , a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, announced its plan to submit a Marketing Authorization Application (MAA) for pridopidine for the treatment of Huntington’s disease (HD) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This decision follows positive pre-submission meetings with regulatory authorities in the European Union. Submission is planned for mid-2024. “Pridopidine demonstrates consistent treatment benefits across independent measures that are important to patients and families. These measures include day-to-day function, cognition, motor and clinical progression in people living with HD. The benefits are clearly evident in those with HD who are not taking anti-dopaminergic medications (ADM),” said Dr. Michael R. Hayden, CEO of Prilenia. “We appreciate the constructive discussions with European regulators regarding our data for pridopidine. This provides a pathway to potential approval of a therapy for HD, a rare neurodegenerative disease with a predictable decline, and no currently approved treatments that address progression. We are now finalizing our MAA submission for mid-2024 and preparing to make pridopidine commercially available for patients in Europe, if approved.” ADMs include neuroleptics (also known as antipsychotics) and VMAT2 inhibitor (anti-chorea) drugs. Prilenia intends to discuss with the U.S. Food and Drug Administration (FDA) a potential path forward for pridopidine as a possible treatment for those living with HD in the United States. The Company will also consider global regulatory submissions for additional countries and regions following the regulatory review process in Europe. In addition to the progress in HD, Prilenia announced in January 2024 that it had completed discussions with global regulatory agencies regarding the next stage of development of pridopidine for amyotrophic lateral sclerosis (ALS) and is planning for a single pivotal Phase 3 study. About Pridopidine Pridopidine (45 mg twice daily) is an oral, highly selective and potent investigational S1R agonist that has exhibited a safety and tolerability profile similar to placebo in clinical studies to date. The safety dataset includes approximately 1,700 patients who have been on pridopidine for up to seven years. The S1R protein is highly expressed in the brain and spinal cord, where it regulates several key processes that are commonly impaired in various neurodegenerative diseases. Activation of the S1R by pridopidine stimulates multiple cellular protective pathways including enhancing autophagy, axonal transport, mitochondrial energy production and respiration, and restores calcium homeostasis. These effects are essential to neuronal function and survival, and lead to neuroprotective effects. Prilenia holds Orphan Drug designation for pridopidine in HD and ALS in the U.S. and EU. In addition, pridopidine has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of HD. About Huntington’s disease Huntington’s disease (HD) is a rare inherited (genetic) neurodegenerative disorder caused by a mutation in the huntingtin gene. Each child of a parent with HD has a 50 percent chance of developing the disease. HD causes neurons in the brain to degenerate and lose their ability to communicate with each other, resulting in functional, motor, cognitive and behavioral symptoms. HD affects about 100,000 people around the world with an additional 300,000 people at risk of developing HD. It is usually diagnosed between the ages of 30 and 50, although HD can also occur at any age including children and young adults (known as juvenile onset HD or JHD). The disease progresses slowly over 15 to 20 years, with patients slowly losing their ability to work, communicate, manage day to day life and take care of themselves. Currently, there is no treatment to address the progression of HD. About PROOF-HD PROOF-HD, a Phase 3, randomized, double-blind, placebo-controlled study, evaluated the safety and efficacy of pridopidine (45 mg twice daily for 65-78 weeks), in individuals with HD ( NCT04556656 ). The study enrolled 499 individuals and was conducted in the U.S., Canada, Austria, Czech Republic, France, Germany, Italy, the Netherlands, Poland, Spain and the United Kingdom. Pridopidine (45 mg bid) has shown consistent and sustained benefit on multiple, independent, clinically meaningful measures in HD participants not taking ADMs. These benefits were seen across multiple clinical endpoints that matter to people with HD and their families (function, cognition, motor, global disease progression and quality of life). In pre-specified analyses, there were improvements compared to placebo across progression, motor, cognition and HD QoL (as measured by TFC, cUHDRS, SWR, Q-Motor, HDQoL). These treatment benefits were sustained for up to 78 weeks at all time points. There was also unprecedented improvement from baseline for a minimum of 1 year in cUHDRS, cognition and motor function (Q-Motor). These PROOF-HD results are further supported by an independent integrated efficacy analysis from a 4 placebo-controlled, double-blind studies of pridopidine in HD which showed significance for cUHDRS, TFC and Q-Motor in patients off ADMs. In clinical studies to date, pridopidine’s safety and tolerability profile was comparable to placebo. The PROOF-HD study was conducted in collaboration with the Huntington Study Group (HSG) , a world leader in clinical research for HD and valued collaborator for Prilenia. About Prilenia Prilenia is a clinical stage biotechnology company founded in 2018 focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders. The initial focus of the company has been on HD and ALS. Prilenia is backed by a group of well-respected investors including: Forbion, Morningside, Sands Capital, SV Health Investors, Sectoral Asset Management, Talisman, Amplitude Ventures and the ALS Investment Fund. The Company is based in the Netherlands, Israel and Massachusetts in the U.S. For more information, visit www.prilenia.com and follow us on LinkedIn and Twitter . © 2024 Prilenia Therapeutics B.V. For a copy of this release, visit Prilenia’s website at www.prilenia.com .