MKK4

Elias Papatheodorou moves from Chair of Board to CEO and Managing Director of HepaRegeniX Preparations for upcoming clinical trials in the USA are ongoing Tuebingen (Germany), October 22, 2024 – HepaRegeniX GmbH, a clinical stage company developing a novel regenerative therapy for the treatment of acute and chronic liver diseases, today announced the appointment of Dr. Martin Bonde as its new Chair of the Board of Directors, effective immediately. His appointment follows the recent €15 million Series C financing round, which supports the further clinical development, through Phase II clinical trials of HepaRegeniX’ innovative approach to liver regeneration. Dr. Martin Bonde succeeds Elias Papatheodorou, who is now CEO and Managing Director of HepaRegeniX after serving two and a half years as Chair. Dr. Bonde brings a wealth of international experience in the biotech sector and currently serves as the CEO of Akylox Therapeutics ApS and Chairman of the Board at Asgard Therapeutics AB. Previously, he held leadership positions in various biotech companies such as Inthera Bioscience AG, Vaccibody AS (now operating as Nykode Therapeutics AS), Epitherapeutics Aps (acquired by Gilead Sciences, Inc.), NatImmune A/S (acquired by Azanta A/S), Combio A/S (acquired by Arpida AG), Torsana Biosensor (acquired by Celtor Bioscience, Inc.), and Osteometer Biotech (now part of Nordic Bioscience A/S). Further, he is an entrepreneur-in-residence at BiOrigin, the advisory unit of Seed Investments – Novo Holdings A/S, and also serves on the board of the life science incubator BioInnovation Institute (BII) and on the board of digital pathology company Visiopharm A/S. Martin Bonde holds a Ph.D. in Chemistry from the Technical University of Denmark, along with a Diploma in Business Administration from Copenhagen Business School. “We are excited to welcome Martin Bonde to HepaRegeniX at this pivotal time for the company,” said Elias Papatheodorou, CEO of HepaRegeniX. “Martin brings over two decades of leadership experience in the biotech sector, with a proven track record in driving innovation and strategic partnerships. His expertise in advancing drug candidates through clinical development will be instrumental as we progress HRX-215 through Phase II trials. With his guidance, we are confident in advancing our mission to restore liver function and prevent liver failure, addressing the urgent needs of patients worldwide.” Dr. Martin Bonde, Chair of the Board of Directors, commented: “I am thrilled to join HepaRegeniX as Chair of the Board, especially after the recent successful financing that will enable the next stages of clinical development. With its advanced approach to liver regeneration, HepaRegeniX has the potential to make a significant impact on the lives of patients who are affected by liver failure and other liver diseases. I look forward to supporting the company through its next stages of clinical and business development.” HepaRegeniX is developing HRX-215, a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4). This new mechanism of action has shown great potential for inducing liver regeneration in preclinical experiments, and a Phase I trial has been successfully completed with results published in the journal Cell. A Phase Ib study in the US as well as an international Phase IIa study are planned. — For further information please contact: HepaRegeniX GmbH Elias Papatheodorou CEO info@heparegenix.com For media inquiries: MC Services AG Katja Arnold, Dr. Regina Lutz +49 89 210 228-0 UK: Shaun Brown M: +44 7867 515 918 heparegenix@mc-services.eu About HepaRegeniX GmbH Since 2017, HepaRegeniX has successfully discovered and developed several drug candidates for the treatment of acute and chronic liver diseases based on a novel proprietary molecular target Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4). The first MKK4 inhibitor HRX-215 recently completed Phase 1 clinical testing. MKK4 is a key regulator of liver regeneration and suppression of MKK4 unlocks the regenerative capacity of hepatocytes even in severely diseased livers. This new and unique therapeutic concept was discovered by Prof. Lars Zender and his research group at the University Hospital Tuebingen, Germany. Investors in HepaRegeniX include Vesalius Biocapital IV, the Boehringer Ingelheim Venture Fund (BIVF), Seed Investments – Novo Holdings A/S, Coparion, High-Tech Gründerfonds and Ascenion GmbH.

NEW YORK, Aug. 27, 2024 /PRNewswire/ -- ProJenX, Inc., a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the formation of its Clinical Advisory Board (ClAB). The ClAB, which includes internationally renowned experts in clinical trial strategy and design for ALS and related neurodegenerative diseases, will provide strategic guidance for the clinical development of ProJenX's lead therapeutic candidate, prosetin—a novel, brain-penetrant, MAP4 kinase (MAP4K) inhibitor—and additional pipeline programs. Prosetin is being evaluated in Study PRO-101, a hybrid Phase 1 clinical trial designed to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and participants with ALS. Parts A and B of the study, which assessed single and multiple ascending doses of prosetin in healthy volunteers, are complete, and positive safety, tolerability, and pharmacokinetic data from 48 healthy volunteers supports continued exploration of prosetin in ALS participants. The inaugural ClAB Chair is Angela Genge, MD, FRCP(C), eMBA (McGill University), who is joined by members Jinsy Andrews, MD, MSc (Columbia University), Leonard van den Berg, MD, PhD (UMC Utrecht), and Merit Cudkowicz, MD, MSc (Massachusetts General Hospital). Dr. Genge, Director of the ALS Global Centre of Excellence at the Montreal Neurological Institute and Professor of Neurology at McGill University, said, "Improved clinical outcomes for ALS patients will only be achieved through stewarding novel, scientifically rational investigational therapies supported by compelling and thorough preclinical data into the ALS clinical trial pipeline. Prosetin has been developed specifically for ALS and demonstrates robust neuroprotection in diverse ALS patient-derived stem cell models of the disease, and I am excited to guide Study PRO-101 as Chair of the ProJenX Clinical Advisory Board, as well as Principal Investigator of one of the trial study sites." Erin Fleming, Co-Founder and Chief Operating Officer at ProJenX, said, "As we initiate the first-ever clinical study of prosetin in people living with ALS, we are thrilled to convene a world-class Clinical Advisory Board, which will bring unrivaled experience and knowledge across ALS drug development and data-driven clinical trial design to the prosetin development program. With our advisors' leadership, ProJenX is poised to translate decades of scientific discovery to people with ALS." ProJenX's ClAB member biographies can be viewed here. About ProJenX ProJenX is a clinical-stage biotechnology company developing novel, brain-penetrant, targeted therapies to address neurodegenerative diseases, with an initial focus on ALS. ProJenX was created out of a long-term research collaboration between Project ALS and researchers at Columbia University to rapidly develop and commercialize its lead therapy candidate, prosetin, for people living with ALS. At the heart of ProJenX's approach is an innovative, patient-specific, cell-based drug discovery platform that can be leveraged for research and drug development for ALS and other debilitating brain diseases. For more information, visit projenx.com. About Prosetin Prosetin is a potent, oral, brain-penetrant, mitogen-activated protein kinase (MAP4K) inhibitor targeting endoplasmic reticulum (ER) stress. ER stress is a common feature across sporadic and familial forms of ALS, and MAP4Ks emerged as the critical regulators of ER stress-mediated motor neuron loss in a patient-specific, cell-based discovery platform developed by researchers at Columbia University. ProJenX is currently conducting a three-part Phase 1 clinical trial, PRO-101, investigating prosetin in healthy individuals and people living with ALS. Prosetin is an investigational new drug and has not been approved by the FDA. SOURCE ProJenX

HepaRegeniX said Wednesday it has successfully closed a €15 million ($16.2 million) series C round to advance a new therapy designed to jumpstart the liver's regenerative powers. The financing was led by Vesalius Biocapital IV with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund, and High-Tech Gründerfonds.HRX-215 is a small molecule inhibitor of MKK4, designed to unlock the regenerative capacity of hepatocytes and boost liver regeneration in patients. According to HepaRegeniX, the therapy holds promise for people with liver metastases, primary liver tumours, and those undergoing liver transplantation."With the new funds, HepaRegeniX will advance with its clinical plans for a Phase Ib study in the US and an international Phase IIa study to enhance liver recovery and prevent liver failure," commented Elias Papatheodorou, who transitions from chair of the board to CEO.The company also announced the appointment of Linda Greenbaum as chief medical officer. "MKK4 is a key regulator of liver regeneration, and MKK4 inhibition has been shown to induce liver regeneration after a partial hepatectomy," she said. "With this mode of action, HRX-215 has an immense potential to improve outcomes for patients who are currently not able to undergo potentially curative surgical resections due to liver tumours."The funding comes on the heels of promising preclinical data and a Phase I trial. In a paper published in the journal Cell earlier this year, researchers said "we are convinced that the observed antisteatotic and antifibrotic activity provides a very good basis for further testing of HRX215 in chronic liver disease.""We envision that HRX215 harbours the potential to push the boundaries of oncological liver surgery," they said, adding "perioperative HRX215 treatment holds the promise to safely prevent PHLF [post-hepatectomy liver failure] after liver resections and will make more extensive resections possible, thus allowing a potential curative perspective for more patients with colorectal cancer liver metastases and also for patients suffering from primary liver carcinomas."HepaRegeniX raised a €9 million series A and €11 million series B in 2017 and 2020, respectively.