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Bellicum Pharmaceuticals, Inc.

Drug Names(s): BP-GMAX-CD1

Description: BPX-101 is an autologous vaccine for the treatment of patients with metastatic castrate resistant prostate cancer (mCRPC), with potential expansion into earlier stages of the disease and other cancers that express the Prostate Specific Membrane Antigen (PSMA).

BPX-101 is comprised of matured, prostate cancer antigen-expressing dendritic cells derived from monocytes collected from the patient in a leukapheresis procedure, and modified so that they can be activated by a proprietary drug, AP1903. BPX-101 is administered intradermally, followed 24 hours later by a two hour infusion of AP1903. This one day delay gives the cells time to migrate to the patient’s lymph nodes, where they are activated by AP1903.

BPX-101 is a DeCIDe vaccine. DeCIDe dendritic cell vaccines contain a CID Signaling Domain for the membrane protein CD40. DeCIDe technology significantly increases the effectiveness of cancer vaccines by bypassing critical check points in the patient's immune system, most notably negative feedback mediated through CD40’s natural upstream control pathways. The vaccine is activated by turning on CD40 signaling at the right time and in the right place - after the DeCIDe dendritic cells reach the lymph node - by administering AP1903 24 hours after vaccination. This leads to a potent and durable antigen-specific T cell immune response.

AP1903 is a lipid permeable, synthetic organic compound consisting of two identical ligands joined by a chemical linker. Each ligand binds with high affinity to a CID Binding Domain based on the naturally occurring protein FKBP. AP1903 thus cross-links two CID Binding Domains, bringing the CID Signaling Domains together in the correct protein-protein interaction to trigger the protein's natural downstream signal.

AP1903 is used exclusively in conjunction with a CID therapy, so BioMedTracker does not maintain a separate drug entry for it.

Deal Structure: In October 2008, Bellicum entered into a non-exclusive, royalty-bearing licensing agreement with ARIAD Pharmaceuticals for ARIAD's ARGENT cell-signaling regulation technology, on which BPX-101 is based. ARIAD will have an equity stake in Bellicum and will receive additional payments. Bellicum also may be granted exclusive licenses in certain product applications based on its achievement of development, regulatory and commercial milestones.

Partners: ARIAD Pharmaceuticals, Inc.

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