HER2/NEU MULTI-EPITOPE VACCINE: Kaumaya’s laboratory has developed a multivalent cancer vaccine at The Ohio State University, which targets HER-2/neu. He identified unique sequences on HER-2/neu protein that result in immune response to their vaccine. The vaccine consists of specific HER-2/neu epitopes and incorporates a state-of-the-art activator of specific immune B cells to generate anti-tumor antibodies against HER-2/neu in cancer patients. This vaccine, which completed an FDA and NCI sponsored phase I clinical trials in advanced cancer patients was conducted to evaluate the safety and tolerability. The vaccine was well tolerated, and no significant adverse events were reported.
Phase I Active Immunotherapy Trial with Chimeric and Multi-epitope Based Peptide Vaccines Targeting HER-2 Oncoprotein and nor-MDP Adjuvant in Patients with Metastatic and/or Recurrent Solid Tumors
FROM BENCH TO CLINIC: An NCI funded (CA84356), OSU Cancer IRB approved (2001C0108) and FDA approved (BB-IND-9803) Phase 1 clinical trial with a “first” generation combination of two HER-2 Chimeric B-cell MVF 316-339 epitopes and MVF 628-647 (38-40) emulsified with nor-MDP as adjuvant and ISA 720 vehicle was recently successfully completed at the James Cancer Hospital. The goals of the trial were to determine the safety, toxicity and MTD of the vaccine. 24 patients receiving three immunizations of the HER-2 peptide vaccines were assessable for disease response. The vaccine was well-tolerated and the MTD was identified as the highest dose level (1.5 mg) peptide. The results demonstrate that tumor antigen-specific B-cell immune responses (IgG1) can be elicited in 50% of cancer patients; that is, tolerance can be reversed, without the induction of serious adverse events or autoimmune disorders. 4 patients classified with stable disease (SD) had adrenal, colon, ovarian and squamous cell carcinomas, the 2 patients with a partial response (PR) had endometrial and ovarian cancer and eleven patients had progressive disease (PD). Several patients received 6 months booster immunization and one patient received an additional 2 year booster.
