Cancer Vaccines
Cancer vaccines are an increasingly exciting option for cancer treatment, especially after the FDA approval of Provenge for the treatment of prostate cancer in April 2010. BioSante Pharmaceuticals Inc. owns exclusive development and commercial rights in a pipeline of BioSante Immunotherapies (cancer vaccines). Biosante cancer vaccines use cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immunostimulant. The cells then are irradiated to prevent further cell division; however the cells remain metabolically active.
Currently, Biosante Cancer Vaccines are in various Phase I and Phase II cancer clinical trials and may represent the widest portfolio (cancer types) of cancer vaccines in development. Studies are conducted primarily at Johns Hopkins Cancer Center and are sponsored/funded by The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, various philanthropies, foundations and the National Cancer Institute. BioSante has entered various licenses including with Aduro BioTech and the Hussman Foundation for development and commercialization of certain of the vaccines (see Partners & Licenses).
»BioSante Cancer Vaccine Presentation Video
Cancer Types Being Studied:- Pancreatic Cancer
- Leukemia
- Chronic Myeloid Leukemia (CML)
- Acute Myeloid Leukemia (AML)
- Multiple Myeloma
- Breast Cancer
- Prostate Cancer
- Colorectal
- Melanoma
Development / Regulatory Status
Chronic Myeloid Leukemia (CML) — Results of a Phase II clinical trial
Of 19 patients treated with BioSante CML, 7 had complete remission.
- Gleevec was taken for at least one year (range 13-53 months) pre-vaccine and then Biosante CML was administered while the patients remained on a stable dose of Gleevec.
- 19 patients enrolled (median of 72 months of follow-up)
- 13 patients (8 of whom had increasing disease burden before vaccination): the number of remaining cancer cells declined
- 12 patients reached their lowest levels of residual cancer cells to date following vaccination
- 7 patients had complete remission
"We want to get rid of every last cancer cell in the body, and using cancer vaccines may be a good way to mop up residual disease," said lead investigator Hyam Levitsky, M.D., professor of oncology, medicine and urology at the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland.
Acute Myeloid Leukemia (AML) — Results of Phase II
Patients treated with BioSante had both a relapse-free survival and overall survival rate improvement of approximately 30% compared with the non-BioSante-treated subjects.
- BioSante AML was accompanied by immunotherapy-primed lymphocytes after autologous stem cell transplantation.
- 54 subjects enrolled
- 28 (52%) received a pre-transplantation BioSante AML dose
- 46 (85%) subjects achieved complete remission during the treatment period. Of these patients, the 3-year relapse-free survival (RFS) rate was:
- 47.4% in non-BioSante treated patients
- 61.8% in the BioSante-treated group
- Overall survival (OS) rate in all subjects was 57.4%
- Overall survival (OS) rate was 73.4% in the BioSante-treated group
- In summary, patients treated with BioSante had both a relapse-free survival and overall survival rate improvement of approximately 30% compared with the non-BioSante-treated subjects.
Pancreatic Cancer — Results of Phase II
Phase II clinical study that showed BioSante's Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. A new multicenter clinical study is planned to begin this year.
In the study, titled, "A Lethally Irradiated Allogeneic GM-CSF-Secreting Tumor Vaccine for Pancreatic Adenocarcinoma: A Phase II Trial of Safety, Efficacy, and Immune Activation," published in the February 2011 issue of Annals of Surgery, the primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses. The median disease-free survival of patients was 17.3 months (95% CI, 14.6–22.8) with median survival of 24.8 months (95% CI, 21.2–31.6). The administration of immunotherapy was well tolerated. In addition, the postimmunotherapy induction of mesothelin-specific T cells in patients correlates with disease-free survival. The investigators concluded that "an immunotherapy approach integrated with chemoradiation is safe and effective for resected pancreas cancer."
The 60 patient Phase II study was conducted by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland. The research was funded by the National Institutes of Health and other foundations. BioSante's Pancreas Cancer Vaccine is made from allogeneic pancreatic cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth.
BioSante Orphan Drug Designation
BioSante has received FDA Orphan Drug designation for:- Pancreas vaccine to treat pancreatic cancer
- AML vaccine to treat acute myeloid leukemia
- CML vaccine to treat chronic myeloid leukemia
- Melanoma vaccine to treat melanoma
- The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States or,
- If the drug is a vaccine, the persons to whom the drug will be administered in the United States are fewer than 200,000 per year
- Tax credits
- Seven years of marketing exclusivity
- Products approval submissions not subject to a prescription drug user fee
- Products approved not subject to discounting under new healthcare law
- Orphan Drug grants available
