We are a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in early 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
The Company has developed a therapeutic cancer vaccine for prostate cancer patients using similar techniques developed for breast cancer patients. It is tested and laboratory proven and could become the standard of care for prostate cancer treatment. The Company incorporates scientifically proven and clinically validated treatments for cancer. We utilize patented technology developed and or acquired by OncBioMune. The intellectual property consists of multiple technologies combined with laboratory and clinical procedures that provide new insight into the treatment of cancer. The Company’s proprietary technology provides the necessary tools for the successful treatment of patient’s with a therapeutic vaccine. It is marketable and would be very profitable upon FDA approval.
The Company has data from a phase 1/2 clinical trial of their therapeutic prostate cancer vaccine. Patients with prostate cancer confirmed by biopsy and with an elevated PSA received the vaccine. We enrolled 12 patients in this study. All patients received their initial course of six vaccinations containing prostate specific antigen and biological adjuvant. Serum PSA concentrations were determined before initiating vaccination and 3-4 weeks after the 6th vaccination. Two-thirds of the prostate cancer patients’ PSAs decreased after vaccination. During the trial the prostate cancer patients received no other concurrent therapy (surgery, hormone, radiation, radioactive seeds, chemotherapy), and have additionally received three further vaccinations alternated with low dose IL-2 for the 6 months following the initial vaccinations. The Company developed the protocol for the vaccination of prostate cancer patients using techniques developed for vaccination of breast cancer patients. We are currently in a Phase 1 clinical trial at UCSD Medical School under an IND from the FDA with funding from the US Navy Cancer Vaccine Program. If proven effective clinically, it could become the standard of care for prostate cancer.
----------------------------- Breast cancers and other epithelial malignancies are antigenic and elicit lymphocyte responses in the autologous host, and patients that express good host immunity to their tumor have better survival. Adequate host immunity is an independent prognostic indicator and those with poor immunity have shorter disease free intervals and shorter overall survival. The Company’s novel approach defines the tumor specific immune status of patients both pre and post immunotherapy that uses autologous tumor antigens to immunize patients. We have the ability to discriminate patients who are immunologically unreactive to tumor antigens and may be generally lymphocyte depressed from those who are tumor antigen reactive and lymphocyte competent. Thus those patients who are unreactive and in need of immunostimulation qualify for vaccination with specific tumor antigen .
We developed our vaccine in 1993 and then immediately began vaccinating patients with depressed immunity. We obtained the first patent on a breast cancer vaccine in the U.S.A. in 1994, and were the first to use the cytokines GM-CSF and IL-2 as biological adjuvants. Appropriate patients are vaccinated in the adjuvant setting and patients with advanced disease are treated with a combined chemo-immunotherapy protocol. Some of these patients have had dramatic responses.
The Company is presently devoting much research to the tumor stroma and microenvironment for a better understanding of tumor escape mechanisms. This will allow us the ability to better attack the tumor with specific adaptive immunotherapy. This work is in progress and early results are producing exciting results.
======================================= OncBioMune Pharmaceuticals CEO Dr. Jonathan Head presented at the 2016 BIO CEO & Investor Conference on February 9, 2016 at the Waldorf Astoria in New York City. Dr. Head’s presentation provided a corporate overview of OncBioMune and provided details on the company’s promising pipeline of drugs in development, including ProscaVax, OncBioMune’s novel vaccine in clinical trials as a new therapy for early stage prostate cancer patients. http://oncbiomune.com/oncbiomune-bio-ceo-and-investors-conference-2016/
One-Year Follow-Up Shows 71.4% Progression-Free Survival in 14 Prostate Cancer Patients Treated with ProscaVax in Phase 1 Clinical Trial
Published: Dec 21, 2017 11:26 a.m. ET
100% Overall Survival Rate in 14 Evaluable Patients at One-Year Follow-Up
BATON ROUGE, La., Dec 21, 2017 (GLOBE NEWSWIRE via COMTEX) --
OncBioMune Pharmaceuticals, Inc. (otcqb:OBMP) ("OncBioMune" or the "Company"), a revenue-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology, targeted cancer therapies and commercialization of a portfolio of products internationally, is pleased to provide one-year follow-up results from the Company's Phase 1 clinical trial of ProscaVax for prostate cancer.
In the trial, hormone-na�ve and hormone-independent recurrent prostate cancer patients with increasing prostate specific antigen (PSA) were treated with six intradermal injections of ProscaVax. ProscaVax is OncBioMune's novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
The latest data shows: •Progression-Free Survival 71.4%: 10 of 14 patients (71.4%), who have been followed for one year after initiation of ProscaVax therapy, continue to have stable disease •Overall Survival 100%: None of the 14 evaluable patients have died at one-year follow-up •As previously disclosed, four patients had disease progression within 19 weeks (3 PSA progression and 1 radiological progression). No further progression has been noted from week 19 to one year •Data continues to confirm there were no drug-related serious adverse events or dose-limiting toxicities resulting from ProscaVax therapy •Six of the 20 patients enrolled in the trial have not yet been followed for one year, evaluations to follow
"I continue to be impressed with the clinical results on ProscaVax. These results support the benefit of this first-in-class immunotherapy and offers hope to cancer patients in great need," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "These are men who have tried conventional treatments only to have their cancer return and where ProscaVax now seems to be delivering a therapeutic benefit. While Progression-Free Survival and Overall Survival are benchmarks of later-stage studies and not the primary endpoints in our Phase 1 clinical trial, it is hard to overlook the finding that patients with progressing disease now have stable disease following ProscaVax therapy. We need to conduct a larger-scale clinical trial and build more complete data sets to confirm these results, but all signs at this time are pointing to ProscaVax having a meaningful effect by increasing PSA doubling time and inhibiting tumor growth in prostate cancer. It is reason to be optimistic about the next stage of research."
OncBioMune Awaits Approval from Regulatory Committee to Commence Phase 2 Trial of ProscaVax as Front Line Prostate Cancer Treatment
BATON ROUGE, LA–(August 31, 2017) – OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP)(“OncBioMune” or the “Company”), a revenue-stage biopharmaceutical company engaged in the development of targeted cancer therapies, a proprietary cancer vaccine technology and commercialization of a portfolio of products internationally, is pleased to report that the protocol for the planned Phase 2 study of ProscaVax for early-stage prostate cancer is now under review by the Regulatory Committee at Beth Israel Deaconess Medical Center/Harvard Medical School, the host hospital network for the study.
In the trial, ProscaVax, OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of tumor-associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), will be evaluated for safety, tolerability and efficacy in treatment-naïve prostate cancer patients at disease presentation. Per the protocol, patients to be enrolled in the study will be newly diagnosed with prostate cancer, deciding in collaboration with their oncologist to forego standard approved therapies, such as a radical prostatectomy, radiation or brachytherapy, in favor of careful monitoring for disease progression, a process known more commonly as “active surveillance.” Presently, there are no FDA-approved treatments for prostate cancer patients in active surveillance.
“The Regulatory Committee is a component of the Institutional Review Board and integral to the protocol approval process to commence the study,” commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “I interpret the protocol now being in their hands as a signal that we are getting close to conducting the first ever trial of ProscaVax as a front-line treatment for prostate cancer.”
On May 11, 2018, the Institutional Review Board and Scientific Review Committee at the Dana-Farber Cancer Institute approved the clinical trial of ProscaVax™, the Company’s lead immunotherapy product from its platform, at Beth Israel Deaconess Medical Center and Dana-Farber. The Principal Investigator is Rupal Bhatt, MD, PhD with Co-Investigator Glenn Bubley, MD. It is expected that the clinical trial will be enrolling patients in the near future. The clinical trial is titled: “A Phase 2, Randomized Study of Proscavax, a PSA/IL-2/ GM-CSF Vaccine, in Treatment-naive Patients with Clinically Localized Prostate Cancer Versus an Active Surveillance Strategy”.
The information contained in this Item 7.01 of this Current Report on Form 8-K is being furnished pursuant to Item 7.01. This information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
OncBioMune has received all necessary approvals from the host hospital, associated committees and the U.S. Food and Drug Administration to begin the Phase 2 trial. All requisite information has been submitted to clinicaltrials.gov, with the expectations that the summary of the trial will soon be available for public viewing.