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news.The US Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for Valor Biotherapeutics' lead product candidate, IGN002, a new class of biotherapeutics.
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IGN002 is genetically engineered by fusing an antibody with interferon, a protein that plays a major role in regulating the immune system.
The approved IND will allow Valor, a joint venture between ImmunGene and Caliber Biotherapeutics, to begin a Phase I clinical trial of IGN002 in patients with non-Hodgkin lymphoma (NHL).
The Leukemia & Lymphoma Society (LLS) has partnered with Valor and committed $6m to advance this therapy into a Phase I trial.
LLS president and chief executive officer Louis DeGennaro said: "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.
"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."
Over the past two years Valor, ImmunGene and LLS staff have collaborated to complete the pre-clinical development and manufacturing of IGN002 for the IND filing.