SBIR-STTR Award

United Biomedical, Inc. (UBI) has developed an alternative approach to injectable LHRH agonists and other androgen-ablation therapies for the treatment of prostate cancer through the development of an anti-LHRH immune response. The LHRH synthetic peptide vaccine comprises the LHRH decapeptide covalently linked to helper T cell epitopes and to an additional peptide that provides specific immune adjuvanting activities. This molecular conformation produces a potent B cell response and anti- LHRH antibodies in sufficiently high titer to neutralize circulating LHRH and thereby suppress androgen production. Studies in rodents have demonstrated that the LHRH peptide vaccine can rouse a specific immune response that inhibits androgen-dependent tumor growth in the host by blocking synthesis of testosterone. The goal is to evaluate the efficacy and safety of the LHRH peptide vaccine prepared in several adjuvant formulations to induce antibody responses capable of blocking the LHRH functions and to effect castrate levels of testosterone in adult male baboons. If successful, these preclinical studies will provide supporting data for an IND application and the testing of the LHRH peptide vaccine formulation as an alternative hormonal ablative therapy for prostate cancer. PROPOSED COMMERCIAL APPLICATIONS: The LHRH synthetic peptide vaccine is an immunotherapy for the treatment of androgen-responsive, advanced prostate cancer. This vaccine is predicted to be effective because its mode of action is analogous to the LHRH agonist androgen-ablation therapies currently used to treat prostate cancer as well as other hormone-responsive benign conditions and tumors (e.g., endometriosis, leiomyoma). Commercial advantages of the LHRH vaccine therapy over agonists include improved patient compliance and less costly treatment option.

United Biomedical, Inc, (UBI) has developed an alternative approach to injectable LHRH agonists and other androgen-ablation therapies for the treatment of prostate cancer through development of an anti-LHRH immune response. The LHRH synthetic peptide vaccine comprises the LHRH decapeptide covalently linked to helper T cell epitopes and to an additional peptide that provides specific immune adjuvanting activities. This molecular conformation produces a potent B cell response and anti- LHRH antibodies in sufficiently high titer to neutralize circulating LHRH and thereby suppress androgen production. Studies in rodents have demonstrated that the LHRH peptide vaccine can rouse a specific immune response that inhibits and androgen-dependent tumor growth in the host by blocking synthesis of testosterone. The goal is to evaluate the efficacy and safety of the LHRH peptide vaccine prepared in several adjuvant formulations to induce antibody adult male baboons. If successful, these preclinical studies will provide supporting data for an IND application and the testing of the LHRH peptide vaccine formulation as an alternative hormonal ablative therapy for prostate cancer. PROPOSED COMMERCIAL APPLICATIONS: The LHRH synthetic peptide vaccine is an immunotherapy for the treatment of androgen-responsive, advanced prostate cancer. This vaccine is predicted to be effective because its mode of action is analogous to the LHRH agonist-androgen-ablation therapies currently used to treat prostate cancer as well as other hormone-responsive benign conditions and tumors (e.g., endometriosis, leiomyoma). Commercial advantages of the LHRH vaccine therapy over agonists include improved patient compliance and less costly treatment option.

Thesaurus Terms:
gonadotropin releasing factor, human therapy evaluation, neoplasm /cancer immunotherapy, neoplasm /cancer vaccine, prostate neoplasm, synthetic peptide, synthetic vaccine, vaccine development clinical trial phase I, dosage forms, hormone metabolism, testosterone baboon, clinical research, human subject, male, patient oriented research, peptide chemical synthesis