Valor Biotherapeutics, a joint venture between ImmunGene, Inc and Caliber Biotherapeutics, LLC, and The Leukemia & Lymphoma Society (LLS) recently announced that the FDA has approved a new investigational drug (IND) application for Valor’s lead drug candidate, IGN002.
The approved IND allows Valor to initiate a phase 1 clinical trial of IGN002 in patients with a diagnosis of non-Hodgkin lymphoma (NHL).
Through its Therapy Acceleration Program (TAP), a planned initiative to collaborate with companies in the biotechnology industry and speed the development of novel drugs, Caliber Biotherapeutics, LLC has committed about $6 million to co-sponsor the pre-clinical development, manufacturing, and Phase 1 IGN002 clinical trial.
“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 consists of an anti-CD20 monoclonal antibody attached to IFN through a stable peptide linker system. CD20 is a membrane receptor expressed on Non-Hodgkin lymphoma and other B cell driven haematological malignancies.
Results from pre-clinical studies of IGN002, showed that IGN002 has a remarkable efficacy in treating rituximab resistant tumor models. These preclinical data demonstrate that IGN002 effectively targets and locally acts on CD20- positive tumors.
Non-Hodgkin lymphomas (NHLs) are a diverse group of blood cancers that include any kind of lymphoma except Hodgkin’s lymphomas. Different types of NHL can vary significantly in their severity, from slow growing to very aggressive types. NHL is a cancer of the lymph tissue, which can be found in the lymph nodes, spleen, and other organs of the immune system. White blood cells are found in lymph tissue and help prevent infections. Most lymphomas start in a type of white blood cell called the B lymphocyte, or B cell. In the United States, indolent subtypes of NHL make up about 30 percent of the approximately 585,000 people living with or in remission from NHL.
“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.”
