OncBioMune’s investigational cancer vaccine ProscaVax reduced tumor growth in 70% of prostate cancer patients included in a Phase 1a study. The immunotherapy candidate consists of a combination of the PSA protein (a hallmark of prostate cancer) with the cytokines — molecules produced by immune cells — interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). The clinical trial (NCT02058680) is evaluating the safety and efficacy of ProscaVax in patients with recurrent prostate cancer and increasing prostate specific antigen (PSA) levels, who either have not been treated by or are not responsive to hormonal therapy.
Twenty patients received six intradermal injections of ProscaVax at weeks 1, 2, 3,7, 11, and 15 of treatment. The latest data show that ProscaVax increased PSA Doubling Time (PSADT) in 14 of 20 patients, or 70%. PSADT is the time needed to double the blood level of PSA and a key tool in assessing biochemical and clinical progression. This result indicates reduced tumor growth at a minimum of 31 weeks after the start of ProscaVax treatment. Also at 31 weeks of treatment, 15 of 18 patients showed increased immunity to PSA. Four of the 20 patients who completed ProscaVax therapy exhibited disease progression at 31 weeks. Three of the four did not show increased PSADT. Of note, one patient withdrew from the trial after 19 weeks without disease progression.
The findings add to previously reported positive safety data. Results at 19 weeks of treatment showed that ProscaVax stopped disease progression in 80% of patients. Slowing the PSA elevation, thus increasing PSADT in patients with relapsed and advanced prostate cancer, has been increasingly shown to improve disease prognoses. The company plans to enroll a total of 48 participants in this Phase 1a/1b study and anticipates its completion by December, 2018.
As described in recent website blogs, utilizing one’s immune system to combat cancer (immunotherapy) is at the cutting edge of prostate cancer research and cancer research in general. I am personally familiar with an on-going National Cancer Institute (NCI) clinical trial combining the prostate cancer vaccine Prostvac and the checkpoint inhibitor antibody Opdivo® (nivolumab), currently approved by the FDA for the treatment of non-small cell lung cancer. On October 12th, it was reported that the National Institutes of Health (NIH), the nation’s medical research agency announced a partnership with eleven leading biopharmaceutical companies to accelerate the development of new cancer immunotherapy strategies. This Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million is part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer.
NIH, the nation’s medical research agency, includes 27 Institutes and Centers of which the National Cancer Institute (NCI) is the largest. NIH is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.
New immunotherapies have resulted in dramatic responses in certain cancer cases. They have also been the focus of intense investment by biopharmaceutical companies seeking to provide new options for patients who do not respond to other cancer therapies, but they don’t work for all patients. Development and standardization of biomarkers to understand how immunotherapies work in some patients, and predict their response to treatment, are urgently needed for these therapies to provide benefit to the maximum number of people.
The biopharmaceutical companies are expected to contribute $55 million over the five years while NIH will contribute $160 million. For more information and for the companies involved, see the following link. For more information about NIH and its programs, visit www.nih.gov