LifeMine Therapeutics Inc., a clinical-stage biopharmaceutical company pioneering Top-Down Drug Discovery™, which leverages digital genomic search technology from fungi to source next-generation precision medicines, today announced $263 million in financing to accelerate the clinical development of the company’s lead program, LIFE-001, and advance its pipeline of novel transplantation and immunology therapies.
LIFE-001 is a structurally and mechanistically novel calcineurin activation inhibitor (CNai) delivered as a long-acting injectable and designed de novo to avoid the immunophilin-dependent organ damage common to all legacy calcineurin inhibitors (CNis) such as cyclosporin, voclosporin and tacrolimus. In LifeMine’s ongoing Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) study in more than 120 adult participants, LIFE-001 has demonstrated a substantially improved profile compared to legacy CNis, including no clinically meaningful renal, metabolic or cardiovascular safety signals observed to date.
“More than 1.6 million people worldwide are living with a transplanted organ, yet physicians continue to rely on calcineurin inhibitors that have remained largely unchanged for more than three decades despite their well-recognized toxicities,” said Gregory Verdine, Ph.D., Co-founder, President and Chief Executive Officer of LifeMine. “As the first proof point of our discovery engine, LIFE-001 is designed to overcome the limitations of legacy calcineurin inhibitors through the direct inhibition of calcineurin activation without relying on intermediary immunophilin proteins. We believe this novel approach has the potential to redefine the standard of care by delivering the proven efficacy of calcineurin inhibition for the prevention of organ transplant rejection while dramatically improving safety, tolerability and dosing convenience for patients. With this financing and the support of an outstanding syndicate of investors, we are well positioned to rapidly advance LIFE-001 through the next phase of clinical development.”
“Calcineurin inhibition remains the gold standard for preventing organ rejection, but today’s therapies come with substantial toxicities that can compromise long-term patient outcomes because transplant recipients typically remain on these medicines for life,” said Andrew Cameron, M.D., Surgeon-in-Chief of Johns Hopkins Hospital. “A next-generation calcineurin activation inhibitor capable of maintaining efficacy while significantly reducing multiorgan toxicity would represent one of the most meaningful advances in transplantation in decades. The emerging clinical profile of LIFE-001 is very encouraging, and its novel mechanism of action and long-acting formulation have the potential to meaningfully advance the field.”
LifeMine has completed an oversubscribed $188 million Series E financing led by Milky Way Investments with participation from new investors including Bezos Expeditions, Gates Frontier, and RA Capital Management, alongside continued support from existing investors including GV (Google Ventures), LoLa Capital Partners, GlaxoSmithKline (GSK), Invus and ARCH Venture Partners. The Series E round builds on the company’s previously completed $75 million Series D round with existing investors plus LoLa Capital Partners, bringing total new capital raised to $263 million. Proceeds will support the continued clinical development of LIFE-001, including LifeMine’s planned Phase 2 kidney transplant study and Phase 1b islet cell transplant study.
“LIFE-001 exemplifies the power of LifeMine’s approach, which harnesses evolutionary biology to identify medicines with fundamentally new mechanisms of action,” said Rick Klausner, M.D., Co-founder and Chairman of the Board of LifeMine and Managing Partner of Milky Way Investments. “By targeting calcineurin activation through a novel mechanism, LIFE-001 has the potential to overcome limitations that have defined this therapeutic class for decades. LIFE-001 provides the first clinical validation of a platform capable of producing an entirely new generation of differentiated medicines, and I am excited for the company’s next chapter of growth.”
LifeMine also continues to expand its executive leadership team, including the recent appointment of Yves Zinggeler as Chief Commercial Officer. Mr. Zinggeler joins LifeMine from Vertex, where he served as Vice President and General Manager of the U.S. Cystic Fibrosis Business Unit. He brings more than two decades of global commercial leadership experience, including leadership of 14 product launches and more than a dozen label expansions. Additional recent team appointments in transplant clinical development and translational medicine further strengthen LifeMine’s expertise as it prepares to advance LIFE-001 into multiple clinical studies and toward potential commercialization.
“The opportunity to help bring a potentially practice-changing therapy to transplant patients is what attracted me to LifeMine,” said Mr. Zinggeler. “Transplantation represents a significant global commercial opportunity with a longstanding unmet need, yet meaningful innovation in immunosuppressive therapy has been limited for decades. LIFE-001 has the potential to become an important new treatment option for transplant patients around the world, and I’m excited to help prepare the company for that opportunity.”
About LIFE-001
LIFE-001 is a structurally and mechanistically novel, organ-sparing, immunophilin-independent calcineurin activation inhibitor (CNai) delivered as a long-acting injectable being developed for the prevention of organ transplant rejection. Unlike currently available calcineurin inhibitors such as cyclosporin, voclosporin, and tacrolimus, LIFE-001 does not depend on intermediary immunophilin chaperone proteins and directly targets and binds calcineurin to keep it inactive and prevent T-cell activation and proliferation. LIFE-001 has demonstrated compelling efficacy in preclinical models and has shown unequivocally improved safety over legacy calcineurin inhibitors. LIFE-001 is currently being evaluated in a first-in-human Phase 1 clinical trial.
About LifeMine Therapeutics
LifeMine Therapeutics is a clinical-stage biopharmaceutical company pioneering Top-Down Drug Discovery™, which leverages evolutionary insights from fungi to unearth next-generation precision medicines. LifeMine’s data-immersive platform integrates the latest advancements in human genetics and genomics, bioinformatics, machine learning and synthetic biology. LifeMine’s lead program, LIFE-001, is a structurally and mechanistically novel calcineurin activation inhibitor (CNai) being developed for the prevention of organ transplant rejection. Headquartered in Watertown, Mass., LifeMine has raised $558 million from leading life science investors. For additional information, please visit www.lifeminetx.com.
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