BioSante Pharmaceuticals signed an exclusive, worldwide license of its melanoma vaccine to the John P. Hussman Foundation. Under the agreement, the foundation has committed up to approximately $11 million in clinical development funding that will allow for the vaccine’s first clinical trial.
BioSante received $100,000 on signing the license and is eligible for up to $39 million in milestone payments, plus royalties on sales. Also, BioSante will receive between 15% and 33% of any sublicense payments received by the Hussman foundation, depending on the timing of any sublicense by the foundation to a corporate sublicensee.
“The foundation intends to move rapidly into human clinical trials,” states Stephen M. Simes, BioSante’s president & CEO. “Assuming a successful outcome of the first Phase I clinical trial, the foundation will fund a Phase II clinical trial with the objective of obtaining further clinical evidence, and engaging a corporate sponsor for Phase III clinical trials.”
BioSante expects to begin the first Phase I trial within the next several months. The clinical trial protocol is being finalized, and a quantity of vaccine has been produced for the trial.
The company was granted orphan drug designation in the treatment of stage IIb to IV melanoma by the FDA in January.The designation is BioSante's fourth for its pipeline of cancer vaccines, which includes vaccines for pancreatic cancer, acute myeloid leukemia, and chronic myeloid leukemia. The firm is also developing a vaccine for breast cancer.