Valor Biotherapeutics, LLC, (Valor) and The Leukemia & Lymphoma Society (LLS) announced that the US Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for Valor's lead product candidate, IGN002. The approved IND is a key step in allowing Valor—a joint venture between ImmunGene and Caliber Biotherapeutics—to begin a phase 1 clinical study of IGN002 in patients with non-Hodgkin lymphoma (NHL).

Through its Therapy Acceleration Program (TAP), a strategic initiative to partner with biotechnology companies and speed the development of new therapies, LLS previously committed approximately $6 million to co-fund the pre-clinical development, manufacturing, and a phase 1 clinical study of IGN002. Valor, ImmunGene, and LLS staff have collaborated over the past two years to complete the pre-clinical development and manufacturing of IGN002 for the IND filing.

"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."

IGN002 is a new class of biotherapeutics genetically engineered by fusing an antibody with interferon, a protein that plays a critical role in regulating the immune system. Together, they form a potent agent that is designed to be safer and less toxic while maximizing its targeted anti-tumor effects. IGN002 has the potential to improve treatment outcomes for indolent non-Hodgkin lymphoma (NHL) patients, for whom there are currently few effective therapies. NHL is a diverse group of blood cancers that impact the lymphatic system, part of the body's immune system. In the US, indolent subtypes of NHL make up about 30 per cent of the approximately 585,000 people living with or in remission from NHL. IGN002 was created under the support of a research grant by LLS.

"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."

IGN002, a fusion molecule of anti-CD20 antibody and interferon alpha, two clinically validated anti-cancer drugs, is designed to deliver therapeutically effective doses of interferon alpha to CD20-expressing lymphoma cells to exert direct suppression of tumor cell growth and engage multiple anti-tumor immunologic effector mechanisms, leading to substantially improved efficacy while avoiding the systemic toxicity seen with free interferon.

The Leukemia & Lymphoma Society (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Valor Biotherapeutics, a joint venture between ImmunGene, Inc. and Caliber Biotherapeutics, is focused on the clinical development and commercialization of the next generation of monoclonal antibody-based therapeutics to treat cancer.

ImmunGene is a privately held biotechnology company focused on the development of proprietary antibody-cytokine fusion technology and monoclonal antibody-based therapies to treat cancer, autoimmune disorders, and other diseases.