Theralink Technologies Inc (THER)

[BooDog]

A45 Preliminary results of a Phase 1 clinical trial of a PSA, IL-2, GM-CSF containing prostate
cancer vaccine in PSA defined biochemical recurrent prostate cancer patients. Jonathan Head,
Oncbiomune Pharmaceuticals, Baton Rouge, LA, United States.


Poster Session A
Monday, October 2
5:30-7:30 p.m. Back Bay Exhibit Hall

http://www.aacr.org/Documents/TII17_PosterA.pdf

Abstract:
Preliminary results of a Phase 1a clinical trial of a PSA, IL-2, GM-CSF containing prostate cancer vaccine in PSA defined biochemical recurrent prostate cancer patients

Jonathan F. Head, Gregory A. Daniels, Michelle McKinney, Weg Ongkeko, Kyoko Sakamoto, Jessica Wang-Rodriguez

Immunotherapy for cancer has had two main approaches that have led to clinical applications. The first is stimulating immune responses to tumor cells with cytokines or cellular immunotherapy and the second is blocking tumor immune evasion and the associated inhibition of T-cell activation with antibodies to the CTLA-4 receptor, PD-1 receptor or PD-L1. We have taken a different approach and have developed therapeutic cancer vaccines that are a combination of tumor antigens (proteins overexpressed by tumors) with biological adjuvants (the cytokines IL-2 and GM-CSF). This study is a Phase 1a/1b clinical trial of a PSA/IL-2/GM-CSF vaccine in recurrent prostate cancer in hormone-naïve and hormone-independent patients. Major inclusion criteria include adenocarcinoma of the prostate, rising serum PSA and no measurable disease. Phase 1a examines the rate of dose limiting adverse events (DLAEs) in an initial course of 6 vaccinations (“induction vaccination”). The patients will receive intradermal injections of the PSA/IL-2/GM-CSF vaccine at weeks 1, 2, 3, 7, 11 and 15. Enrollment of the twenty patients in the Phase 1a has been completed. To date, 14 patients in the Phase 1a portion of the trial have received all 6 vaccines. Twelve of the 15 patients who have received vaccines have increased immune responses to PSA in a lymphocyte blastogenesis assay by week 19. After 6 vaccines, 9 of 14 patients had an increase in the doubling time of their serum PSA, suggesting a slowing of the progression of the cancer. Median follow up after the first vaccine is 33 months. None of the patients vaccinated in the Phase 1a portion have had a DLAE.

Head, J.F., Daniels, G.A., McKinney, M., Ongkeko, W., Sakamoto, K., and Wang-Rodriguez, J.: Preliminary Results of a Phase 1 Clinical Trial of a PSA, IL-2, GM-CSF Containing Prostate Cancer Vaccine in PSA Defined Biochemical Recurrent Prostate Cancer Patients. AACR Special Conference on Tumor Immunology and Immunotherapy Poster A45, 2017.