Vaccine Guidance System

Therapeutic cancer vaccines represent a novel drug class, enabled by the recent FDA approval of Dendreon's prostate cancer vaccine Provenge® (sipuleucel-T) and a highly favorable safety and tolerability profile. However, efficacy reported to date for Provenge and other cancer vaccines has been generally modest, i.e. 4-8 months prolonged overall survival, in the absence of tumor shrinkage or delay in short term disease progression.

DeCIDe™ dendritic cell vaccines contain a CID Signaling Domain for the tightly regulated membrane protein CD40, which acts as the master control switch for dendritic cell activation, and thus is the gateway to enhanced immune system function. 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.

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. Preclinical development work demonstrates potent in vivo antitumor efficacy, including eradication of solid tumors, with no toxicity or auto-immunity. An ongoing Phase I/II trial of the autologous DeCIDe™ vaccine BPX-101 is designed to demonstrate clinical proof of principle by measuring immunological, biochemical and radiological responses in patients treated with BPX-101 followed by AP1903.

DeCIDe™ is a platform technology since it can be paired with a pan-cancer antigen like PSMA as in BPX-101, or with a disease-specific antigen for other cancers or infectious diseases, such as HIV. While BPX-101 is a patient-specific product, we are actively pursuing strategies to deliver the DeCIDe™ genetic construct to dendritic cells in vivo, thereby enabling off-the-shelf DeCIDe™ vaccines.

Advances in antigen selection, vaccine delivery, and adjuvant therapy may synergize with DeCIDe™, leading to more effective and ultimately potentially curative vaccine therapy in the future.