OncBioMune Pharmaceuticals is advancing its investigative ovarian cancer vaccine OvcaVax into human clinical trials to test its safety and efficacy in the adjuvant (after surgery) setting. OncBioMune announced it will meet in coming weeks to discuss trial protocol, location, and budget.
OvcaVax works similarly to the company’s experimental vaccine ProscaVax, which targets the PSA protein in prostate cancer patients. But in this case, the new vaccine immunizes patients against the cancer antigen 125 (CA-125), a protein that is highly elevated in ovarian cancer cells.
OncaVax combines the CA-125 protein with two immune system activators, interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). The strategy is expected to boost immune activity against all cancer cells that are positive for the CA-125 protein.
“Recently, we collected very compelling data on ProscaVax eliciting an increased immune response and slowing tumor progression in prostate cancer and believe the same is possible in late-stage ovarian cancer, where women are left with very few therapeutic options,” Dr. Jonathan Head, CEO of OncBioMune, said in a press release.
OncBioMune will be meeting shortly with the contract research organization Theradex Oncology to determinate a trial budget, as well as its protocol and location. The company will also schedule CA-125 manufacturing according to current good manufacturing practice (cGMP) standards.
The pharmaceutical company’s goal is to conduct a small trial with approximately 20 ovarian cancer patients at different stages of the disease. Participants will receive the vaccine after their cancer has been surgically removed.
The trial is expected to evaluate the safety of the vaccine, its ability to prevent cancer recurrence or progression, and overall survival.
“During our in-house trials, we previously treated four ovarian cancer patients with advanced disease with no signs of toxicity,” Head said. “That data, combined with hundreds of other patients receiving vaccinations from the platform technology, has us confident in the safety profile of OvcaVax.”
OncBioMune plans to pursue regulatory pathways with the U.S. Food and Drug Administration (FDA) that can help expedite the vaccine’s development, including applications for Orphan Drug and Fast Track designations. These will also provide additional trademark protection once OvcaVax completes clinical development and if it is given FDA marketing approval.
“I firmly believe that immunotherapeutic cancer vaccines will one day be a part of standard of care for hard-to-treat disease,” Head said. “Our vaccine technology is on the leading edge of this paradigm shift, so I am eager to initiate these studies of OvcaVax.”