VBI Vaccines & Agenus Announce Collaboration to Evaluate VBI-1901 in Combination With Anti-PD-1 Balstilimab in a Phase 2 Study in Primary Glioblastoma Patients

VBI Vaccines Inc. and Agenus recently announced 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. 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.

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.

David E. Anderson, PhD, VBI’s Chief Scientific Officer, said “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, MD, 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.

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).

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.

VBI Vaccines Inc. (VBI) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (VLPs), including a proprietary enveloped VLP (eVLP) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, visit www.vbivaccines.com.

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. The company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). The company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com.