CAMBRIDGE, MA, USA I April 08, 2025 I LifeMine Therapeutics Inc., a clinical-stage biopharmaceutical company pioneering Top-Down Drug DiscoveryTM, which leverages digital genomic search technology from fungi to source next-generation precision medicines, today announced the first participant has been dosed in a first-in-human Phase 1 clinical trial evaluating LIFE-001 for safety, tolerability, drug exposure and effectiveness of T cell suppression in the blood, as a prelude to treatment of multiple immune-mediated disorders and organ transplant rejection. LIFE-001 is a structurally and mechanistically novel calcineurin inhibitor, designed de novo to avoid the immunophilin-dependent organ damage common to all legacy calcineurin inhibitors (CNis). In preclinical studies, LIFE-001 has demonstrated radically improved safety compared to legacy CNis, improved convenience of drug administration, and compelling efficacy in validated animal models of ulcerative colitis and Crohn’s disease.
“Owing to the unrivalled breadth and depth of efficacy in calcineurin inhibition as a proven mode of immune suppression across over 30 distinct indications, and with LIFE-001 now having overcome the deficiencies of legacy CNis, this fundamentally reinvented, immunophilin-independent drug has the potential to become the go-to universal immunosuppressant with applicability across dozens of indications, and with significant advantages over other classes of immunosuppressants, including recently emergent biologics,” said Gregory Verdine, Ph.D., Co-founder, President and Chief Executive Officer of LifeMine. “LifeMine’s transition into a clinical-stage company marks a significant achievement for our team and underscores the power of our genomic discovery engine to bring sophisticated medicines to patients in urgent need of breakthrough disease intervention.”
“CNis have been a primary treatment for organ and tissue transplantation, as well as multiple immune-mediated disorders, for many years,” said Simon Cooper, MBBS, Chief Medical Officer at LifeMine. “Despite their broad utility, off-tissue toxicity and narrow therapeutic index have limited the use of legacy CNis and represent a key unmet need for both physicians and patients. We have designed LIFE-001 to replace all legacy CNis with a potential best-in-class new drug having improved safety and tolerability, predictability of drug exposure with a long-acting injectable formulation, and greatly improved convenience and freedom from burdensome blood monitoring and concomitant therapy to counter side-effects. We look forward to executing on our first clinical study and advancing LIFE-001 as rapidly as possible.”
The Phase 1, first-in-human, clinical study is designed to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LIFE-001. The Phase 1a single ascending dose (SAD) / multiple ascending dose (MAD) portion aims to enroll approximately 100 adult participants. The Phase 1b portion aims to evaluate the preliminary efficacy of LIFE-001 across multiple immune-mediated disease cohorts, including ulcerative colitis.
LifeMine, supported by a committed syndicate of top-tier investors, has secured funding for the entire Phase 1a study, and is currently bringing in additional capital to power efficacy studies and provide additional investment catalysts in 2026 and beyond.
About LIFE-001
LIFE-001 is a precision-engineered, controlled-release, organ-sparing, immunophilin-independent calcineurin inhibitor (CNi) being developed for multiple immune-mediated disease indications and organ transplant rejection. With a previously unprecedented structure and mechanism of action, LIFE-001 has the potential to become a field-dominating universal T cell immunosuppressant with applicability across multiple indications and significant advantages over legacy CNis and most if not all other classes of immunosuppressants. LIFE-001 has demonstrated compelling efficacy in preclinical models of ulcerative colitis and Crohn’s disease, 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 DiscoveryTM, 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 novel, precision-engineered, long-acting calcineurin inhibitor being developed for multiple immunologic disorders and organ transplant rejection. Headquartered in Cambridge, Mass., LifeMine has raised more than $320 million from leading life science investors. For additional information, please visit www.lifeminetx.com.
SOURCE: LifeMine Therapeutics
Post Views: 1,170
CAMBRIDGE, MA, USA I April 08, 2025 I LifeMine Therapeutics Inc., a clinical-stage biopharmaceutical company pioneering Top-Down Drug DiscoveryTM, which leverages digital genomic search technology from fungi to source next-generation precision medicines, today announced the first participant has been dosed in a first-in-human Phase 1 clinical trial evaluating LIFE-001 for safety, tolerability, drug exposure and effectiveness of T cell suppression in the blood, as a prelude to treatment of multiple immune-mediated disorders and organ transplant rejection. LIFE-001 is a structurally and mechanistically novel calcineurin inhibitor, designed de novo to avoid the immunophilin-dependent organ damage common to all legacy calcineurin inhibitors (CNis). In preclinical studies, LIFE-001 has demonstrated radically improved safety compared to legacy CNis, improved convenience of drug administration, and compelling efficacy in validated animal models of ulcerative colitis and Crohn’s disease.
“Owing to the unrivalled breadth and depth of efficacy in calcineurin inhibition as a proven mode of immune suppression across over 30 distinct indications, and with LIFE-001 now having overcome the deficiencies of legacy CNis, this fundamentally reinvented, immunophilin-independent drug has the potential to become the go-to universal immunosuppressant with applicability across dozens of indications, and with significant advantages over other classes of immunosuppressants, including recently emergent biologics,” said Gregory Verdine, Ph.D., Co-founder, President and Chief Executive Officer of LifeMine. “LifeMine’s transition into a clinical-stage company marks a significant achievement for our team and underscores the power of our genomic discovery engine to bring sophisticated medicines to patients in urgent need of breakthrough disease intervention.”
“CNis have been a primary treatment for organ and tissue transplantation, as well as multiple immune-mediated disorders, for many years,” said Simon Cooper, MBBS, Chief Medical Officer at LifeMine. “Despite their broad utility, off-tissue toxicity and narrow therapeutic index have limited the use of legacy CNis and represent a key unmet need for both physicians and patients. We have designed LIFE-001 to replace all legacy CNis with a potential best-in-class new drug having improved safety and tolerability, predictability of drug exposure with a long-acting injectable formulation, and greatly improved convenience and freedom from burdensome blood monitoring and concomitant therapy to counter side-effects. We look forward to executing on our first clinical study and advancing LIFE-001 as rapidly as possible.”
The Phase 1, first-in-human, clinical study is designed to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LIFE-001. The Phase 1a single ascending dose (SAD) / multiple ascending dose (MAD) portion aims to enroll approximately 100 adult participants. The Phase 1b portion aims to evaluate the preliminary efficacy of LIFE-001 across multiple immune-mediated disease cohorts, including ulcerative colitis.
LifeMine, supported by a committed syndicate of top-tier investors, has secured funding for the entire Phase 1a study, and is currently bringing in additional capital to power efficacy studies and provide additional investment catalysts in 2026 and beyond.
About LIFE-001
LIFE-001 is a precision-engineered, controlled-release, organ-sparing, immunophilin-independent calcineurin inhibitor (CNi) being developed for multiple immune-mediated disease indications and organ transplant rejection. With a previously unprecedented structure and mechanism of action, LIFE-001 has the potential to become a field-dominating universal T cell immunosuppressant with applicability across multiple indications and significant advantages over legacy CNis and most if not all other classes of immunosuppressants. LIFE-001 has demonstrated compelling efficacy in preclinical models of ulcerative colitis and Crohn’s disease, 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 DiscoveryTM, 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 novel, precision-engineered, long-acting calcineurin inhibitor being developed for multiple immunologic disorders and organ transplant rejection. Headquartered in Cambridge, Mass., LifeMine has raised more than $320 million from leading life science investors. For additional information, please visit www.lifeminetx.com.
SOURCE: LifeMine Therapeutics
Post Views: 1,170
