Brain Cancer Vaccine Candidate Presents Positive Study Results
A Massachusetts based biopharmaceutical company announced 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.
VBI Vaccines’s poster presentation on November 22, 2019, at the Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, reported ‘though early in the enrollment process for Part B, the tumor and immunologic responses seen thus far have aligned with the responses and benefits observed in Part A of the study.’
And, the 2nd patient enrolled in Part B demonstrates sustained stable disease (SD) after 4 monthly vaccinations of VBI-1901, following a 33 percent reduction in tumor size after the 1st vaccination.
Among patients evaluable for response and survival in Part A, follow-up analysis showed the 6-month overall survival (OS) to be 100 percent in vaccine responders (6/6) compared with 63 percent in vaccine non-responders (5/8).
The 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 a press release.
“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.”
The company also said 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.
The poster presentation is available on the “Events/Presentations” page in the “Investors” section of the VBI Vaccines website.
VBI Vaccines Inc. is a commercial-stage biopharmaceutical company developing next-generation vaccines to address unmet needs in infectious disease and immuno-oncology.
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