On November 22, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the presentation of interim data from Part B of the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients in a poster presentation at the 24th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) (Press release, VBI Vaccines, NOV 22, 2019, View Source [SID1234551615]).
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Though early in the enrollment process for Part B, the tumor and immunologic responses seen thus far have aligned with the responses and benefit observed in Part A of the study. The second patient enrolled in Part B demonstrates sustained stable disease (SD) after four monthly vaccinations of VBI-1901, following a 33% reduction in tumor size after the first vaccination. Among patients evaluable for response and survival in Part A, follow-up analysis showed the 6-month overall survival (OS) to be 100% in vaccine responders (6/6) compared with 63% in vaccine non-responders (5/8). Median OS in the high-dose cohort of Part A, and more broadly among vaccine responders in Part A, have not yet been reached.
"The clinical outcomes from Part A, the tumor responses we’ve seen in three of the six patients in the high-dose cohort in Part A, and now again the tumor response seen in one of the two patients enrolled and evaluable to-date in Part B continue to be encouraging," said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. "In an effort to better understand these early tumor response data, we are also characterizing baseline biomarkers and immunologic responses, notably T cell responses. Correlations between immunological biomarkers and tumor/clinical responses will be refined as more patients are enrolled in Part B of the study."
To-date, the ongoing Phase 1/2a open-label multicenter study has enrolled all 18 recurrent GBM patients in Part A of the study and four first-recurrent GBM patients in Part B. As of the cut-off date of November 18, 2019, of the four patients enrolled in Part B of the study, two were evaluable for immunologic responses, and one was evaluable for tumor response.
Highlights from Poster Presentation
●Safety:
○VBI-1901 continues to be well-tolerated, with no vaccine-related safety signals observed
●Immunogenicity:
○The first patient enrolled in Part B demonstrated a robust immune response, including a substantial increase in T cells – though the patient continues to be clinically stable, surgical resection and analysis are ongoing to assess status of tumor response
○The second patient enrolled in Part B demonstrated a 33% reduction in tumor size after the first vaccination of VBI-1901 – classification of stable disease (SD) based on two consecutive Magnetic Resonance Imaging (MRI) scans
○In the high-dose cohort of Part A, vaccine response correlated with tumor response, with all three vaccine responders demonstrating SD for greater than 12 weeks – median overall survival in these patients has not yet been reached
○Two patients in the high-dose cohort of Part A experienced a 60% reduction in the size of primary tumor – VBI-1901 also induced and expanded robust T cell responses in these patients
○Correlations between immunologic biomarkers and tumor/clinical responses will be refined as more patients are enrolled in Part B of the study
The poster presentation is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.
Poster Presentation/Session Details
-Title: Interim Results of the Extension Phase of a Phase I/IIa Trial of a Therapeutic CMV Vaccine Against Recurrent Glioblastoma (GBM)
-Abstract: ATIM-26
-Date: Friday, November 22, 2019
-Time: 7:30PM – 9:30PM MST
-Location: Marriott Desert Ridge Hotel in Phoenix, Arizona, Ballroom Lawn
About the Phase 1/2a Study Design
VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:
Part A:
Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients, with any number of prior recurrences.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
Enrollment completed in December 2018
Part B:
Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or AS01B as immunomodulatory adjuvants.
Enrollment of the 10 patients in the GM-CSF arm is ongoing, initiation of enrollment of the 10 patients in the AS01B arm is expected around year-end 2019, subject to FDA acceptance of the amended protocol and investigational site institutional review board approvals.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and will be administered intramuscularly when adjuvanted with AS01B adjuvant system. Patients in both phases of the study will receive the vaccine immunotherapeutic every four weeks until tumor progression.
Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.