BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced it has licensed its Pancreas Cancer Vaccine and Prostate Cancer Vaccine to Aduro BioTech, a clinical-stage immunotherapy company, solely 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 Aduro’s proprietary vaccine platform. “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. Aduro plans to initiate a Phase II trial in the fourth quarter of 2011 with approximately 90 late-stage pancreatic cancer patients, using a novel sequential vaccine regimen of BioSante’s Pancreas Cancer Vaccine and CRS-207. 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: 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.
Sequential administration of BioSante Pancreas Cancer Vaccine followed by CRS-207 was first shown by Aduro to be synergistic in mouse models, demonstrating enhanced tumor-specific T cell and anti-tumor responses. Because BioSante Pancreas Cancer Vaccine and CRS-207 target the tumor-associated antigen mesothelin, the sequential administration is a heterologous prime-boost regimen. Lm is known to be especially effective in this regimen.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. “The synergy from the sequential administration of BioSante’s Pancreas Cancer Vaccine and CRS-207 has the potential to significantly extend and improve the lives of a patient population where progress has historically been measured by extra weeks of survival,” said Stephen Isaacs, chairman and chief executive officer of Aduro BioTech. “This partnership may very well represent the future of immunotherapy in which combination therapy becomes the standard.” About Aduro BioTech Aduro BioTech is a clinical-stage immunotherapy company with a platform technology for therapeutic and prophylactic vaccines for cancer and infectious diseases. The platform of attenuated and targeted vaccines based on Listeria monocytogenes has been in development for nine years and has been validated by 20 major publications and more than $20 million in federal and private grant and contract funding. The company’s lead therapeutic, CRS-207, is in clinical development for the treatment of mesothelin-expressing tumors, including pancreatic and non-small-cell lung cancer, and has completed Phase 1. About BioSante Pharmaceuticals, Inc. BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante’s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA has been filed with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com. Forward-Looking Statements To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.