The Leukemia & Lymphoma Society (LLS) and Valor Biotherapeutics, LLC, a joint venture between ImmunGene, Inc. and Caliber Biotherapeutics, focused on the clinical development and commercialization of next generation monoclonal antibody-based cancer therapeutics, have announced the US Food and Drug Administration has approved Valor’s investigational new drug (IND) application for its flagship investigational product, IGN002. This marks significant progress in Valor’s goal to launch a Phase I clinical trial in patients diagnosed with non-Hodgkin lymphoma (NHL).
IGN002 is a fusion molecule between an anti-CD20 antibody and interferon alpha, two clinically validated anti-cancer drugs, and is designed to deliver therapeutically effective doses of interferon alpha to CD20-expressing lymphoma cells, exerting direct suppression of tumor cell growth and engaging multiple anti-tumor immunologic effector mechanisms, leading to substantially improved efficacy while avoiding the systemic toxicity seen with free interferon.
The LLS, through its Therapy Acceleration Program (TAP) that aims to form strategic partnerships with biotechnology companies accelerating development activities, had previously pledged $6 million to help fund IGN002’s preclinical development, manufacturing, and upcoming Phase I clinical trial. For the past 2 years, Valor, ImmunGene, and LLS have been working closely together to bring the drug’s preclinical activities and IND filing to completion.
“Valor is excited to announce this milestone in the development of IGN002 and we anticipate starting the Phase 1 clinical study later this year,” said Sanjay D. Khare, Ph.D., a founding board member of Valor Biotherapeutics and president and CEO of ImmunGene. “We are grateful for the technical and financial support of The Leukemia & Lymphoma Society and look forward to continuing our partnership as we work together to advance the IGN002 program.”
“Non-Hodgkin lymphoma, whether indolent or aggressive, continues to be a disease requiring more effective, less toxic therapies and this project shows great promise in helping to meet that critical unmet need,” said LLS President and Chief Executive Officer Louis J. DeGennaro, Ph.D. “We are pleased to see another example of The Leukemia & Lymphoma Society’s commitment to bridging the gap between academic discovery and drug development. LLS helped accelerate the antibody-fusion technology underlying the IGN002 program by providing early funding of an academic grant.”