Yesterday, BioSante Pharmaceuticals, Inc. announced that it has licensed its Pancreas Cancer Vaccine and Prostate Cancer Vaccine to Aduro BioTech, a clinical-stage immunotherapy company, for use in combination with Aduro’s proprietary vaccine platform based on Listeria monocytogenes (Lm). BioSante will receive milestone and royalty payments after commercialization of combination cancer vaccines using BioSante’s cancer vaccine technology; Aduro also has an option to additional BioSante Cancer Vaccine indications, all for use in combination with its proprietary vaccine platform.
CRS-207 is Aduro’s lead Lm-based therapeutic and has been engineered to express the tumor-associated antigen mesothelin. CRS-207 was evaluated in a Phase I trial in 17 end-stage patients with cancers known to express mesothelin, including: mesothelioma, non-small-cell lung, ovarian and pancreatic. Analysis after the completion of the trial revealed a mesothelin-specific T cell response in multiple patients and despite an expected survival of three-five months for all subjects, six out of 17 subjects lived 15 months or longer.
BioSante cancer vaccines are based on human cancer cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine. BioSante has a portfolio of cancer vaccines, including Pancreas Cancer Vaccine and Prostate Cancer Vaccine. The Pancreas Cancer Vaccine has been evaluated in more than 120 patients and shown to be well tolerated and able to induce mesothelin-specific T cell responses.
Based on the synergy in preclinical animal models, Drs. Elizabeth Jaffee and Dung Le of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins included three pancreatic cancer patients, in the CRS-207 Phase 1 clinical trial who had previously received the BioSante Pancreas Cancer Vaccine, as part of separate clinical trials. All three late-stage patients who received sequential therapy lived 15 months or longer.
Drs. Jaffee and Le have been instrumental in collaborating with Aduro to design the Phase II trial, which is expected to initiate in the fourth quarter of 2011 and enroll a total of 90 late-stage pancreatic cancer patients. In addition, Dr. Jaffee is one of the original inventors of the BioSante Cancer Vaccines and has many years of experience developing the vaccines.
“We hope that this license agreement will be the first of many that can result in bringing improved cancer treatments to patients and increased value to our stockholders,” said Stephen M. Simes, president and CEO of BioSante. “In addition to BioSante’s Pancreas and Prostate cancer vaccines, our cancer vaccine portfolio extends into breast, colorectal, leukemia, melanoma and multiple myeloma vaccines,” Simes continued.