On June 4, 2019 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported a poster on Sunday, June 2, 2019, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that exhibited expanded clinical data from Part A of the Phase 1/2a study of VBI-1901 in recurrent Glioblastoma (GBM) patients (Press release, VBI Vaccines, JUN 4, 2019, View Source [SID1234536896]).
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The poster presented data on a total of 18 patients enrolled in Part A of the study, which was a multi-center, open-label, dose-escalation study across three dose cohorts of VBI’s vaccine immunotherapeutic, VBI-1901 – 0.4 µg, 2.0 µg, and 10.0 µg. Part A was designed to evaluate the safety and tolerability of VBI-1901, and to define the optimal immunogenic dose level to test in the Part B extension phase of the study, which is expected to initiate enrollment mid-year 2019. Part B of the trial will further assess immunologic responses and potential correlations with tumor and clinical responses.
Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Infrastructure at Herbert Irving Comprehensive Cancer Center, and principal investigator of the study commented, "Though early, the data we’ve seen to-date in this Phase 1/2a study of VBI-1901 are intriguing, yet of course require confirmation in later phase and additional trials. The patients in this study, and more generally in the recurrent GBM setting, are immunocompromised and have very few effective treatment options available to them. Any treatment that could demonstrate even some benefit would be incredibly meaningful for these patients and their families. I look forward to seeing additional data from Part B of the study."
Highlights from Poster Presentation (Poster #237, Abstract #2048)
Safety:
The vaccine immunotherapeutic was well-tolerated at all doses, with no safety signals observed
Grade 2, 3, or 4 adverse events occurred in 66%, 22%, and 11% of participants, respectively – none were related to the vaccine immunotherapeutic
Immunogenicity and Tumor/Clinical Responses:
Six (6) patients immunologically responded to VBI-1901, with evidence of robust boosting of cytomegalovirus (CMV)-specific immune responses against both glycoprotein B (gB) and pp65 antigens.
Median progression-free survival (PFS) was longer among responders (14.5 weeks) vs. non-responders (6 weeks).
Three out of six (3/6) patients in the high-dose, 10 µg, cohort had evidence of stable disease (SD) by magnetic resonance imaging (MRI), compared to one out of six (1/6) in the low-dose cohort and zero out of six (0/6) in the intermediate-dose cohort.
"The tumor responses seen in three of the six patients in the high-dose cohort are promising, with all three having immunologic responses to VBI-1901 as well," said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. "In Part B of the study, we are narrowing the enrollment criteria to ensure a more homogenous patient population that may better assess the potential correlation between immunogenicity and tumor and clinical responses to VBI-1901. Enrollment of 10 patients in Part B, all first-recurrent GBM patients, is expected to initiate mid-year this year, 2019."
The full poster can be viewed on the "Events/Presentations" page in the Investor Section of the VBI Vaccines website.
VBI Press Release
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 28 patients with recurrent GBM:
Part A: Dose-escalation phase to define the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients. This phase enrolled 18 patients across three dose cohorts.
Part B: A subsequent extension of the optimal dose level, as defined in the dose escalation phase. This phase is expected to enroll an expanded cohort of approximately 10 additional patients.
VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. 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.