On October 12, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, and Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported a collaboration to evaluate the combination of VBI-1901, VBI’s cancer vaccine immunotherapeutic, and balstilimab, Agenus’ monoclonal antibody (mAb) targeting the programmed death receptor-1 (PD-1) protein, in primary glioblastoma (GBM) patients as part of the adaptive platform trial, INSIGhT (Press release, VBI Vaccines, OCT 12, 2022, View Source [SID1234621950]). Under the agreement, VBI will be the study sponsor and will be responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support.
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Despite being the most common primary brain cancer with approximately 14,000 new cases diagnosed in the United States each year, GBM patients have few effective treatment options and face low survival rates. Even with the standard of care – which includes surgical resection, chemotherapy, and radiation therapy in the frontline setting – primary GBM patients have a five-year survival rate of approximately 10%, with median overall survival of only 15-18 months after diagnosis.1,2
David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, commented, "GBMs are notoriously one of the most immunosuppressive solid tumors, which is why there are few effective treatment options. Based upon the encouraging data we have observed to date, we believe VBI-1901 has the potential to activate and boost specific T cell immunity capable of trafficking to the tumor microenvironment. We are now adding an anti-PD-1 monoclonal antibody to the treatment regimen as it may help to further enhance and sustain a meaningful anti-tumor immune response – an anti-PD-1 is designed to prolong the life of these T cells so that they may have greater opportunity to infiltrate and kill tumor cells. Given this potential synergy, we are excited to be partnering with Agenus in this clinical collaboration."
Steven O’Day, M.D., Agenus’ Chief Medical Officer, added, "This clinical collaboration with VBI is aligned with our priority of developing balstilimab as a component of novel combination therapies across a range of tumor types. Balstilimab is a promising anti-PD-1 therapy that has been studied in over 750 patients. Balstilimab has demonstrated clinically meaningful results alone and combined with anti-CTLA-4 therapy in advanced cervical cancer. Combining balstilimab with VBI’s vaccine enhances innate and adaptive anti-tumor immunity and may offer promise to patients with GBM, an aggressive and difficult to treat cancer."
In the recurrent setting, VBI-1901 is in an ongoing Phase 2a study and has demonstrated encouraging tumor responses and improvement in overall survival compared to historical controls. In the arm that will be advanced into the primary setting, there have been two (2) partial responses and five (5) stable disease observations among 16 patients with recurrent GBM. One of the patients with a partial response has been on treatment protocol for more than two and a half years with a sustained tumor response reduction of 93% relative to baseline. These tumor responses have translated to clinical benefit with a median overall survival rate of 12.9 months, which compares favorably to the 8-month overall survival historical control in the recurrent setting after treatment with a monotherapy.3
About VBI-1901 and GBM
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.
To learn more about VBI’s ongoing Phase 1/2a study in recurrent GBM and the INSIGhT trial in the frontline setting, visit clinicaltrials.gov (Respective Identifiers: NCT03382977 and NCT02977780).
About Balstilimab
Balstilimab blocks PD-1 in order to restimulate exhausted T cells and enhance their cytotoxicity. Anti-PD-1 therapy has demonstrated benefit in a number of tumor types and can be well-tolerated when used in combination with other therapeutic approaches. Balstilimab has demonstrated superior tumor-killing potential compared to marketed anti-PD-1 therapies in preclinical models, strong anti-tumor potential in cervical cancer clinical studies and a strong track record of safety and tolerability.4
References
National Cancer Institute. Glioblastoma – Unraveling the Threads: A Q&A with Drs. Mark Gilbert and Terri Armstrong of the NIH Neuro-Oncology Branch. August 2017. View Source
The University of Texas MD Anderson Cancer Center. Glioblastoma. Accessed June 2022. View Source
Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomized controlled phase 2 trial. Lancet Oncol. 2014; 15: 943-953
O’Malley DM, et al. Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study. J Clin Oncol. 2022 Mar 1;40(7):762-771.