BOSTON– Corventum, Inc., a biotechnology company developing novel medicines to make existing cancer treatments safer and more effective, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CVT-130, a first-in-class small molecule designed to prevent anthracycline-related cardiotoxicity. The company plans to initiate a first-in-human Phase 1 clinical trial in the second quarter of 2026.
CVT-130 is a metabolic modulator developed to protect against chemotherapy-induced cardiac injury and to address other diseases involving mitochondrial dysfunction. The therapy is intended to prevent heart damage caused by anthracyclines while preserving the drugs’ potent anti-cancer activity, potentially allowing patients to safely receive additional treatment cycles in cases of recurrent disease.
“Anthracyclines have saved countless lives, yet the use of these highly effective chemotherapies is limited by cumulative heart damage that can appear months or years after treatment,” said Randall Peterson, Ph.D., Corventum co-founder, CVT-130 co-inventor, and Dean of the University of Utah College of Pharmacy. “CVT-130 was designed to protect cardiac cells from damage caused by anthracyclines, potentially allowing more patients to benefit from these widely used cancer treatments and enabling retreatment in recurrent disease.”
“Our preclinical data show that CVT-130 prevents cardiac injury while maintaining full anti-tumor potency, a balance that no therapy has achieved to date,” said Aarti Asnani, M.D., Corventum co-founder, CVT-130 co-inventor, and Chair of the Cardio-Oncology Committee of the American Heart Association. “With FDA clearance of the IND, we can now advance CVT-130 to the clinic and take the next step toward delivering a therapy that could benefit millions of patients worldwide who depend on anthracyclines for cancer treatment.”
The planned Phase 1 randomized, placebo-controlled study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CVT-130 in healthy volunteers, along with cardiac and mitochondrial biomarkers. Results from this study will help determine the optimal dose for a subsequent Phase 2 clinical trial in cancer patients. Corventum collaborated closely with the FDA on the study design to align it with the intended dosing strategy for Phase 2.
Anthracyclines such as doxorubicin, epirubicin, and daunorubicin are used in more than two million patients each year and remain among the most effective cancer treatments available. However, their use is limited by dose-dependent cardiac damage that can lead to heart failure and prevent retreatment in recurrent cases.
CVT-130’s preclinical data demonstrate robust cardioprotection with no loss of anthracycline efficacy. The compound modulates mitochondrial and metabolic pathways to prevent cardiac injury and preserve mitochondrial function. Its room-temperature stable formulation allows for rapid injection prior to chemotherapy, offering a promising approach to reducing heart-related complications from anthracycline use.
