VBI-1901 Cancer Vaccine Clinical Trials, Dosage, Indication, News
VBI Vaccines, Inc. (VBI) VBI-1901 is a novel bivalent gB/pp65 immunotherapeutic cancer vaccine candidate. The Company's enveloped virus-like particle (eVLP) technology targets two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. VBI-1901 aims to boost immune responses to them by enhancing its ability to trigger an immune response by attracting immune dendritic cells to the site where the vaccine is injected. VBI-1901 is designed to coax the body to produce antibodies and white blood cells to kill tumor cells with these antigens. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM), says VBI. VBI has applied its eVLP Platform to develop a glioblastoma multiforme therapeutic vaccine candidate. With its novel approach, VBI intends to create a GBM immunotherapy that will stimulate the patient's immune system to identify and kill GBM cancer cells to develop a commercially viable, more effective, tolerable therapy than current treatments. VBI-1901 is designed to kill glioblastoma and medulloblastoma tumor cells infected with CMV, as many are. The immune system already targets cells infected by viruses. VBI-1901 also includes a granulocyte-macrophage colony-stimulating factor that gives the vaccine more punch.
On June 22, 2022, VBI Vaccines announced that the U.S. FDA granted Orphan Drug Designation for VBI-1901. In June 2021, the FDA also granted Fast Track Designation for VBI-1901 in July 2021 to treat recurrent GBM in patients with first tumor recurrence. As of September 2023, the first patients were dosed in the randomized, controlled Phase 2b study of VBI-1901 in patients with first recurrent glioblastoma (rGBM). The study will assess the safety, tolerability, tumor response rates, and survival following treatment with VBI-1901 as monotherapy at ten leading neuro-oncology centers across the U.S. On September 7, 2023, the first patients were dosed in the randomized, controlled Phase 2b study of VBI-1901. Expected initiation of VBI-1901 study arm, as part of Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus Inc.'s anti-PD-1, balstilimab, in primary GBM patients in late 2023. In 2024, Interim data analyses from the Phase 2b study in recurrent GBM patients are expected, subject to the speed of patient enrollment.
On April 3, 2024, VBI announced that David E. Anderson, Ph.D., VBI's Chief Scientific Officer, will present early tumor response data from the ongoing Phase 2b multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as monotherapy in rGBM patients. Early data from patients eligible for evaluation at week 12 show two observations of stable disease, indicating no tumor progression, in the VBI-1901 treatment arm (n=2/5; 40% disease control rate [DCR]). By comparison, no tumor responses have been observed in the control arm (n=0/6; 0% DCR), with all patients seeing a 2-8x increase in tumor size by week 6.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet infectious disease and immuno-oncology needs.
VBI-1901 Indication
VBI-1901 is an immunotherapy cancer vaccine that will stimulate the patient's immune system to identify and kill GBM cancer cells. GBM is a common and aggressive malignant primary brain tumor in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. However, GBM progresses rapidly and is exceptionally lethal even with aggressive treatment, says the Company.
VBI-1901 Dosage
VBI-1901 is co-administered with GM-CSF via the intradermal route in the phase 1 and 2 studies.
VBI-1901 News
April 3, 2024 - Dr. Anderson commented: "In recurrent GBM, tumors typically double or triple in size within six weeks, with no effective treatments available to improve survival. Early indications from this ongoing study suggest tumor growth behavior in line with expectations for the standard-of-care arm and the VBI-1901 arm, based on positive data from the Phase 1/2a study. While early, I am very excited by these results and hope to see the trends continue to confirm the results seen in earlier studies, where VBI-1901 improved median overall survival by ~5 months compared to historical controls – ~13 months vs. ~8 months1 – and achieved a 44% DCR."
September 7, 2023 - Andrew B. Lassman, M.D., Chief of Neuro-Oncology at Columbia University Vagelos College of Physicians and Surgeons, Associate Director for Clinical Trials at the NCI-designated Herbert Irving Comprehensive Cancer Center, and principal investigator of the study, commented, "Based on the pre-clinical and clinical data seen in earlier stages of this study, I look forward to demonstrating the potential value of VBI-1901, relative to the current standard of care, in my patients in this next phase of clinical development, with the hope to provide meaningful benefit against a brain tumor that is notoriously aggressive with a high mortality rate."
August 14, 2023 - "Q2 was a period of transition for VBI as we worked to more efficiently align resource deployment and headcount with the opportunities for value creation," said Jeff Baxter, VBI's President and CEO.
June 22, 2022 - Jeff Baxter, the President and CEO of VBI, commented in a press release, "As recently presented at ASCO, we continue to see strong tumor response data and improvements in overall survival data compared to historical controls in the Phase 2a study of VBI-1901. With this orphan drug status, we look forward to working closely with the FDA and clinical investigators to build on that data, advancing the potential of this program to be a valuable part of the fight against GBM."
January 26, 2022 - VBI Vaccines Inc. announced that David E. Anderson, Ph.D., VBI's Chief Scientific Officer, will present an overview of VBI-1901, the Company's cancer immunotherapeutic for the treatment of glioblastoma, at B. Riley's Oncology Investor Conference on January 28.
December 1, 2021 - VBI Vaccines Inc. announced updated 12-month and 18-month overall survival (O.S.) data from the Phase 2a study investigating VBI-1901. Building on the data reported in June 2021, which supported the U.S. FDA granting VBI-1901 Fast Track Designation for the treatment of recurrent GBM patients with first tumor recurrence, the updated data includes Study arm 1: VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF), 18-month O.S.: 30% (n=3/10), One patient remains on protocol past week 86, with a 93% tumor reduction relative to initiation of treatment at the beginning of the study, Two additional patients achieved O.S. of at least 20 months, but are no longer on protocol; Study arm 2: VBI-1901 + GSK's AS01 adjuvant system, 12-month O.S.: 70% (n=7/10), 18-month O.S. not yet reached.
August 2, 2021 - VBI Vaccines Inc. published a corporate update. June 2021: FDA Fast Track Designation granted for VBI-1901 + GM-CSF in first recurrent GBM patients; Q4 2021: Expected initiation of a randomized, controlled clinical study with registration potential.
June 8, 2021 - VBI Vaccines Inc. announced that the U.S. FDA granted Fast Track Designation for VBI-1901, VBI's cancer vaccine immunotherapeutic candidate for treating recurrent glioblastoma patients with first tumor recurrence.
March 2, 2021 - VBI Vaccines Inc. announced financial results for the fourth quarter and twelve months ended December 31, 2020. The Company also provided a corporate update and its outlook for 2021. November 2020: Positive data announcement from the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients, including two partial responses (P.R.s), observed with more than 50% tumor reduction and seven stable disease observations. H2 2021: Expected initiation of a randomized, controlled clinical study with the potential to yield registrational data.
September 14, 2020 - VBI Vaccines Inc. announced an abstract highlighting additional biomarker data from the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate recurrent glioblastoma patients, was selected for an e-poster presentation at The European Society for Medical Oncology Virtual Congress 2020.
May 6, 2020 - Based upon a review of safety data from the first three patients enrolled, the independent Data and Safety Monitoring Board (DSMB) unanimously recommended continuing Phase 2a VBI-1901 + AS01B study arm without modification.
March 3, 2020 - VBI provided an update on Part A of the ongoing Phase 1/2a study of VBI-1901, the cancer vaccine immunotherapeutic candidate, to treat patients with recurrent glioblastoma. For patients who had an immunologic response to the vaccine, considered to be vaccine responders, the 12-month overall survival (O.S.) rate was 83% (n=5/6), compared to 33% for vaccine non-responders (n=3/9). Similarly, among patients evaluable for response and survival in Part A, vaccine responders saw a 6.25-month improvement in median O.S. (14.0 months) compared to vaccine non-responders (7.75 months). VBI-1901 continues to be safe and well-tolerated at all doses tested, with no safety signals observed.
VBI-1901 Clinical Trials
To learn more about VBI's ongoing Phase 1/2a study and the INSIGhT trial, visit clinicaltrials.gov. (NCT03382977 and NCT02977780).
Phase 1/2a Study Data Highlights – VBI-1901 10µg + GM-CSF Study Arms (n=16); 44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (S.D.) + partial tumor response (P.R.) + complete tumor response (C.R.); 2 partial responses (P.R.) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline; 5 additional patients demonstrated stable disease (S.D.) for a sustained period of time; All patients with a tumor response (P.R. or S.D.) (n=7/16) reached a minimum survival of 12 months; Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care2
Clinical Trial NCT03382977: Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects. This is a two-part dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of the optimal dose level in recurrent GBM subjects. As of March 22, 2024, 17 patients have been randomized 1:1 to either the active VBI-1901 treatment arm or to the control, standard-of-care treatment arm.
