HepaRegeniX GmbH

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.

Funds to support Phase Ib clinical trial of HRX-215 in the US and an international multicenter Phase IIa clinical trial in liver regeneration Elias Papatheodorou moves from Chair of the Board to CEO of HepaRegeniX Dr. Linda Greenbaum joins HepaRegeniX as CMO TUEBINGEN, Germany, July 10, 2024 (GLOBE NEWSWIRE) -- HepaRegeniX GmbH, a clinical stage company developing a novel regenerative therapy for the treatment of acute and chronic liver diseases, today announced the closing of a Series C round led by Vesalius Biocapital IV with participation of existing investors Novo Holdings, Boehringer Ingelheim Venture Fund (BIVF), and High-Tech Gründerfonds (HTGF). The new funds of €15 million will be used to advance the clinical development of the Company’s clinical candidate HRX-215. As part of the financing, Fabienne Roussel, Partner at Vesalius Biocapital, joins the Non-Executive Board of Directors. Elias Papatheodorou will become Chief Executive Officer, moving from Chair of the Board. Elias Papatheodorou, Chair of the Board, said “We are thrilled to secure this significant financing, which underscores the confidence our investors have in our science and our capabilities to bring effective treatments to patients suffering from liver diseases. 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.” HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4). Inhibition of MKK4 unlocks the regenerative capacity of hepatocytes and can strongly boost liver regeneration in patients. This is highly relevant for patients with liver metastases or primary liver tumors, as resection of the tumors is the only curative therapeutic approach. Liver regeneration is also key in liver transplant and especially in enabling left liver lobe living donor transplant. This strategy could significantly reduce waiting list for liver transplant candidates. Promising preclinical data have confirmed HRX-215’s capacity for liver regeneration, and HepaRegeniX has successfully completed a Phase I trial. These results have been published in the prestigious journal Cell. “Vesalius Biocapital is excited to support HepaRegeniX as it progresses into the next phase of clinical development for HRX-215. There is an immense need for a treatment that can induce liver regeneration in patients suffering from liver damage, liver tumors, as well as in transplant settings. HRX-215 has potential to help these patients and make a meaningful impact on their lives. I look forward to working with HepaRegeniX’ excellent leadership team to advance this promising treatment candidate,” commented Fabienne Roussel, Partner at Vesalius Biocapital IV. Importantly, to take HepaRegeniX through the next stages of clinical development and value creation, Dr. Linda Greenbaum is joining HepaRegeniX as Chief Medical Officer (CMO). She brings extensive expertise and experience in clinical development and translational medicine. She recently served as Executive Director, Translational Medicine at Novartis in the US. Before joining Novartis, she held the position of Director of Clinical Development at Janssen R&D and served on the faculty of Thomas Jefferson University and University of Pennsylvania where she led a research laboratory investigating liver regeneration and fibrosis. Dr. Greenbaum holds an MD from the Columbia University Vagelos College of Physicians and Surgeons. “I am honored to join HepaRegeniX at such a critical juncture in its development,” added Dr. Linda Greenbaum, Chief Medical Officer of HepaRegeniX. “MKK4 is a key regulator of liver regeneration, and MKK4 inhibition has been shown to induce liver regeneration after a partial hepatectomy. 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 tumors, and other patient groups affected by liver failure. I look forward to working with the talented team at HepaRegeniX to advance the clinical development of HRX-215 through Phase II trials and beyond, with the ultimate goal of improving outcomes for patients with liver diseases worldwide." Elias Papatheodorou concluded “It is a pleasure to welcome Dr. Linda Greenbaum to our leadership team. With her extensive knowledge and expertise, she will guide the future clinical development of HRX-215. With our new funding and the extension to our experienced leadership team, we hope to bring a much-need therapy to patients suffering from liver diseases.” 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), Novo Holdings A/S, Coparion, High-Tech Gründerfonds (HTGF) and Ascenion GmbH.

Clinical and pre-clinical data generated from collaborations between the Tuebingen University Hospital, researchers from the Mayo Clinic in Rochester (USA) and HepaRegeniXHRX-215 proved to be safe and well tolerated in healthy volunteers, pre-clinical data showed increased regeneration of liver cellsHRX-215 to be further developed to usher in a new era in oncological liver surgery and liver transplantation TUEBINGEN, Germany, March 14, 2024 (GLOBE NEWSWIRE) -- HepaRegeniX GmbH, a clinical stage company developing novel regenerative therapies for the treatment of acute and chronic liver diseases, today published clinical and preclinical results on its first-in-class MKK4 inhibitor HRX-215 in the prestigious journal Cell. The manuscript, available online here (DOI: 10.1016/j.cell.2024.02.023), describes strongly enhanced liver regeneration and prevention of liver failure by HRX-215 in preclinical model systems and a first-in-human trial showing safety and tolerability. HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4). “The positive results in terms of safety and tolerability confirm our intention to soon offer a drug that has the potential to revolutionize the treatment of severe liver diseases. The data pave the way for further Phase II studies evaluating the efficacy of HRX-215 in humans,” emphasizes Dr. Wolfgang Albrecht, COO of HepaRegeniX. In patients with liver metastases from colorectal cancer, which affect about 1 million people per year worldwide, or with primary liver tumors, complete resection of the liver tumors is the only curative therapeutic approach. However, when the remaining liver volume would be below a certain threshold, patients are at high risk of developing post-hepatectomy liver failure (PHLF), an often lethal complication limiting the surgical treatment of liver cancers. HRX-215 holds promise to make more extensive liver resections possible by safely preventing PHLF. “HRX-215 would not only be an urgently needed treatment option in the surgical removal of liver tumors, but would also be able to help overcome the major problem of organ shortage in the field of liver transplantation,” Prof. Lars Zender, Medical Director at the University Hospital Tuebingen points out the possible applications. Living donor transplants from the smaller left part of a healthy donor's liver would be a solution, as removal poses little health risk for healthy donors. However, this part of the liver is often too small to take over the function of the liver that was removed from the recipient. “Due to the rapid enhancement of liver regeneration mediated by HRX-215, we assume that HRX-215 treatment would enable the safe transplantation of small left liver lobes in normal size adults,” Prof. Zender continues. Before HRX-215 was tested in healthy volunteers in a Phase I study, it was thoroughly investigated in animal models. In particular, Tuebingen collaborated with Prof. Dr. Scott L. Nyberg at the Mayo Clinic in Rochester (USA), an internationally renowned expert in the field of transplantation and regenerative medicine. His team was able to show that treatment with HRX-215 can boost liver regeneration after partial liver removal (hepatectomy) while intact livers are not affected by the drug candidate. Further, HRX-215 was also able to protect hepatocytes from cell death in a model for acute liver injury. In the consecutive first in human trial, conducted by HepaRegeniX, HRX-215 was well tolerated at all doses with no drug-related adverse events being observed. “We are very excited about the results from this collaborative effort that have now resulted in a publication in Cell. I would like to congratulate the three teams for even making the cover of this leading scientific journal. MKK4 inhibition has proven to be an ideal mechanism of action for inducing liver regeneration because it depends on the activation of stress pathways and has an excellent safety profile even after long-term treatment without the risk of tumorigenesis. Our successfully completed Phase I trial further underlines the enormous potential this drug candidate has for treating acute and chronic liver damage in patients,” concludes Elias Papatheodorou, Chairman of HepaRegeniX’ Board of Directors. For further information please contact:HepaRegeniX GmbHDr. Wolfgang AlbrechtManaging Director, COOinfo@heparegenix.com For media inquiries:MC Services AGKatja Arnold, Dr. Cora Kaiser, Dr. Regina Lutz+49 89 210 228-0UK: Shaun BrownM: +44 7867 515 918heparegenix@mc-services.eu About HepaRegeniX GmbH – www.heparegenix.com 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 the Boehringer Ingelheim Venture Fund (BIVF), Novo Holdings A/S, Coparion, High-Tech Gruenderfonds and Ascenion GmbH.