Cancer Vaccine Immunotherapeutic Candidate Launches Phase 2a Study
A Cambridge Massachusetts based biopharmaceutical company announced that the 1st patient has been dosed in the second study arm in the ongoing Phase 2a clinical study of VBI-1901, a cancer vaccine immunotherapeutic candidate.
VBI Vaccines, Inc. said in a press release on March 2, 2020, the Phase 2a study is a two-arm, open-label study, enrolling 20 first-recurrent GBM (Glioblastoma Multiforme ) patients to receive VBI-1901 in combination with either GM-CSF or AS01, GSK proprietary adjuvant system, as immunomodulatory adjuvants.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and will be administered intramuscularly when adjuvanted with the AS01 adjuvant system. Patients in the study will receive the vaccine immunotherapeutic every 4-weeks until clinical disease progression.
“We are excited to initiate enrollment in this study arm to evaluate VBI-1901 in combination with AS01B, GSK’s effective proprietary adjuvant system,” said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, in the press release.
“AS01B has been shown to boost T-cell mediated immunity and, building on the encouraging early immunologic and tumor response data we’ve seen to date from the VBI-1901 with GM-CSF study arm.”
“We look forward to evaluating the benefit this combination could have for patients with GBM, a devastating disease with few treatment options.”
VBI’s ongoing two-part study is being conducted at The Neurological Institute of New York Columbia University Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, and the Ronald Reagan UCLA Medical Center.
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
- The 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 GSK’s proprietary AS01B adjuvant system as immunomodulatory adjuvants.
- Enrollment in each study arm is ongoing.
Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrial: NCT03382977.
Cancer vaccine development news published at Vax-Before-Cancer.