On November 13, 2012 ImmunGene, Inc. (ImmunGene) and Caliber Biotherapeutics, LLC (Caliber) reported the launch of Valor Biotherapeutics, LLC (Valor), a joint venture focused on the clinical development and commercialization of monoclonal antibody-interferon (mAb-IFN) fusion protein therapeutics targeting certain cancers (Press release, Valor Biotherapeutics, NOV 13, 2013, Caliber and ImmunGene Launch Valor Biotherapeutics, a Joint Venture to Develop Antibody-Interferon Fusion Therapeutics to Treat Cancers [SID:1234513256]). The mAb-IFN fusion protein technology was invented in Professor Sherie Morrison’s laboratory at the University of California, Los Angeles and licensed exclusively to ImmunGene. This technology is being used to enable the precise targeting of tumor cells with monoclonal antibodies and their destruction by interferon.

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Valor will combine the assets and resources of Caliber with ImmunGene’s technologies, know-how, and intellectual property (IP). ImmunGene will grant Valor exclusive licenses to its IP for three mAb-IFN fusion product candidates currently in various stages of preclinical development. Caliber will commit sufficient funds to enable Valor to reach certain development milestones for these compounds in the treatment of non-Hodgkin’s lymphoma, multiple myeloma, and breast cancer.

Valor will be led by Rahul Singhvi, Sc.D., Managing Director of Caliber Biotherapeutics, LLC and former President and CEO of Novavax, Inc. Dr. Singhvi will be joined on the Valor board of directors by David Shanahan, a serial entrepreneur, philanthropist and a Caliber founder. Mr. Shanahan is also the founder and President of Gradalis, Inc., a cancer immunotherapy company, and President of the Mary Crowley Cancer Research Center. Dr. Sanjay Khare, CEO of ImmunGene, and Dr. Michael Gresser, Chair of ImmunGene’s scientific advisory board, will also join the Valor board.

Dr. Singhvi commented, "The creation of Valor Biotherapeutics further marks the evolution of Caliber from a technology company into a drug development company with a highly promising pipeline. We intend to leverage our complementary resources to develop these product candidates and welcome the opportunity to work with the highly accomplished ImmunGene team to accomplish our goals."

"We are impressed with the promise of ImmunGene’s mAb-IFN fusion technology in addressing many unmet needs in cancer," said Mr. Shanahan. "We are thrilled to support the development of this technology through our joint venture and demonstrate the potential benefits this technology can bring to cancer patients."

"This joint venture will allow us to accelerate the development of ImmunGene’s antibody interferon fusion drug candidates into human proof-of-concept studies in cancer patients." said Sanjay D. Khare, Ph.D., CEO of ImmunGene. "We believe our technology has the potential to improve the treatment of certain cancers and that Caliber’s unique experience in cancer research will help us realize the clinical and commercial potential of our pipeline through this promising joint venture."

About Monoclonal Antibody – Interferon (mAb-IFN) Fusion Proteins

mAb-IFN fusion proteins are a new class of biotherapeutics that are produced by fusing antibodies to tumor cell-killing cytokines (e.g. IFN). These fusion proteins offer potential advantages because several important properties can be built into a single, genetically engineered molecule. They are thought to kill tumor cells mainly by stimulating apoptosis, in an ADCC (antibody-dependent cell-mediated cytotoxicity)-independent manner. Consequently, these molecules have the potential to be efficacious in patients with defective ADCC mechanisms. In addition, they have the potential to be cytotoxic to tumor cells with low density of targeted surface antigens. The fusion proteins retain the properties of conventional, non-fused antibody therapeutics in stimulating ADCC and complement-dependent cytotoxicity (CDC) functions. Such mAb-IFN fusion proteins have demonstrated superior efficacy and safety in preclinical studies, validating the therapeutic potential of this technology.