Ovarian Cancer Vaccine Development: An Update
OncBioMune Pharmaceuticals, a clinical-stage bio-pharmaceutical company, is advancing its developments in vaccine technology to help boost the immune system to target cancer cells without causing harm to the patient. They have worked on prostate cancer vaccines and are working on ovarian cancer vaccines.
Their lead product, ProscaVax for prostate cancer, is nearly towards the end of a phase 1 trial. ProscaVax is a non-toxic vaccine that has been developed for treating men with recurrent prostate cancer. Due to the fact that prostate cancer cells contain highly-elevated levels of prostate specific antigen (PSA), the vaccine targets the PSA protein, along with two immune system activators: granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2). Based on the gathered data, the vaccine helped lower the levels of PSA and it did not cause any severe side effects. Moreover, it did not cause any unfavorable dose-limiting actions during the first month after vaccination, therefore targeting the trial’s initial objective.
Phase 1a of the study involved the participation of 20 patients with prostate cancer, who had increasing levels of PSA for more than 6 months, prior to the start of the trial. So far, 4 patients withdrew from the trial because their disease advanced. During the analysis process, 14 patients received 6 injections of the vaccine. 9 of those patients showed an increase in PSA time, suggesting that ProscaVax was slowing down tumor growth. What’s more, immune responses to PSA increased in over 80% of the patients. “These results are exactly in line with what we were expecting in the Phase 1a study, no toxicity and indications of a therapeutic benefit with ProscaVax therapy” said Dr. Jonathan Head, CEO at OncBioMune.
“The data is supportive of both of our upcoming Phase 2 trials of ProscaVax, one in a similar patient population in Mexico and a second, first-of-its-kind trial of a therapeutic vaccine at disease presentation” said Dr. Head. He added “we greatly look forward to mid-stage trials to further examine the safety and benefit of ProscaVax for so many patients in need of treatments without the well-documented, dreadful side effects of today’s therapies”. Currently, ProscaVax is moving into the phase 2 trial in the category named “Active Surveillance”– an early stage of prostate cancer for which there are currently no treatment options available without causing significant death rates.
OvcaVax, a new ovarian cancer vaccine
OncBioMune Pharmaceuticals is also researching a new therapeutic ovarian cancer vaccine, known as OvcaVax. Similarly to the vaccine ProscaVax, which targets the levels of PSA in patients with prostate cancer, OvcaVax immunizes patients against the cancer antigen 125 (CA-125), which is a highly-elevated protein in ovarian cancer cells. The ovarian cancer vaccine consists of a combination of the CA-125 protein, along with two immune system activators: granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2). Currently, OvcaVax is indicated for testing in human clinical trials for the purpose of identifying its safety and efficiency in patients with ovarian cancer after they have undergone surgery to remove the cancer. It is expected to boost activity within the immune system and target 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” said Dr. Head.
Taking care of specifics
OncBioMune is expected to meet up with a research organization, known as Theradex Oncology, for the purpose of formulating a budget, as well as identifying a location and its protocol for the new vaccine. OncBioMune is also expected to schedule manufacturing of CA-125 according to current good manufacturing practice (cGMP) standards. The biopharmaceutical company’s overall objective for this vaccine is to conduct a small trial of 20 patients with ovarian cancer at various stages of the disease. They hope that the trial will be able to uncover the overall safety of the vaccine, its ability to slow down the progression of cancer or prevent cancer recurrence, as well as identify its overall survival rate. “During our in-house trials, we previously treated four ovarian cancer patients with advanced disease with no signs of toxicity. That data, combined with hundreds of other patients receiving vaccinations from the platform technology, has us confident in the safety profile of OvcaVax” said Dr. Head.
OncBioMune plans to work alongside the U.S. Food and Drug Administration (FDA) to help advance OvcaVax’s development, including pathways such as Fast Track and Orphan Drug designations. This, in turn, will help provide additional trademark protection once the development of OvcaVax is concluded and should the FDA approve the vaccine for commercialization. “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. I firmly believe that immunotherapeutic cancer vaccines will one day be a part of standard of care for hard-to-treat disease. Our vaccine technology is on the leading edge of this paradigm shift, so I am eager to initiate these studies of OvcaVax concurrent with the mid-stage studies of ProscaVax” said Dr. Head. Certainly, OncBioMune is becoming a company whose vaccine developments have generated much attention among the public and their upcoming work is eagerly anticipated.
Other ovarian cancer vaccine opportunities
Similar to OncBioMune, TapImmune also uses the latest vaccine technologies to develop immunotherapies for different types of cancer. Currently, the company is testing its T-cell vaccine, known as TPIV 200, in women with ovarian cancer. TPIV 200 is aimed to target the protein known as folate receptor alpha, which is a highly-elevated protein in ovarian cancer cells. The study is taking place at the Sarah Cannon Research Institute in Nashville and while it initially aimed to enroll the participation of 80 patients with platinum-sensitive advanced ovarian cancer, it is now recruiting 120 patients. This number of participants will allow researchers to analyze the vaccine’s overall impact in preventing cancer recurrence, as well as its potential in being an available form of maintenance therapy aimed for women with ovarian cancer. “Our investigators, as well as their ovarian cancer patients, are enthusiastic about this trial, which is intended to demonstrate enhanced progression-free survival for women prior to their first recurrence” said Dr. Richard Kenney, head of clinical development at TapImmune.
The vaccine TPIV 200 is in its phase 2 trial and patients will be randomly assigned either adjuvant TPIV 200 vaccine along with GM-CSF immune system activator or GM-CSF adjuvant alone. An adjuvant therapy is a type of therapy that is given following the initial treatment, which in this case is chemotherapy and aims to lower the risk of cancer recurrence. “Shifting our focus to earlier in the treatment cycle enables TapImmune to showcase the potential of our novel T cell vaccine in a much larger patient population. Furthermore, should TPIV 200 demonstrate a significant benefit for these women in prolonging the time to disease recurrence, the company will be well positioned within the current treatment paradigm for ovarian cancer, which now includes the PARP inhibitor niraparib for treating patients with recurrent disease” said Dr. Kenney. In the phase 1 trial conducted on patients with ovarian cancer and breast cancer, the vaccine showed long-term immune responses. The results of the phase 2 trial are expected to come out by December 2020.
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