VBI Vaccines Inc. ( VBIV Quick Quote VBIV - Free Report) announced promising interim data from a phase Ib/IIa study evaluating its novel recombinant, protein-based immunotherapeutic candidate, VBI-2601, as a potential treatment for chronic hepatitis B virus (HBV) infection. The company is developing the candidate in collaboration with private-biotech, Brii Biosciences.
The two-part clinical study is evaluating safety, tolerability, and antiviral activity of different dose levels of VBI-2601, unadjuvanted and adjuvanted, in combination with a nucleos(t)ide analogue (NUC) therapy. The company announced early data from the low-dose cohorts, which demonstrated human proof-of-concept by restoring antibody and T cell responses in chronically-infected HBV patients.
Potent re-stimulation of T cell responses to HBV surface antigens was observed in 67% and 78% of evaluable patients in unadjuvanted and adjuvanted arms, respectively. Meanwhile, 60% of evaluable patients in the unadjuvanted arm and 67% in the adjuvanted arm achieved antibody responses against HBV surface antigens. Moreover, data from the low-dose cohorts of the study showed that the candidate was well tolerated. VBI Vaccines believes that immune responses achieved in the study are promising. The company is also exploring various combinations regimens of VBI-2601 with other therapeutic modalities for the next phase of development.
Please note that data from high-dose cohorts of the study is anticipated in the first quarter of 2021.
VBI Vaccines’ shares have skyrocketed 369.4% in the year so far compared with the
industry’s growth of 5.9%.
Apart from VBI-2601, the company has few other candidates in its pipeline, targeting different indications. The company has selected one trivalent vaccine — VBI-2901 — and a monovalent vaccine — VBI-2902 — as coronavirus vaccine candidates to evaluate in a phase I/II study, with the potential to be one-dose vaccines. The study is expected to start toward the end of this year, subject to regulatory approval. Meanwhile, we note that three coronavirus vaccine candidates from other players have already reached final-stage of development. While
Pfizer ( PFE Quick Quote PFE - Free Report) may file for Emergency Use Authorization in the United States within a few days, Moderna and AstraZeneca ( AZN Quick Quote AZN - Free Report) may file for the same by year-end.
The company has successfully completed its pivotal phase III program on Sci-B-Vac, a tri-antigenic prophylactic hepatitis B vaccine, earlier this year. The company expects to file regulatory applications in the United States, Europe, and Canada seeking approval for the candidate by year-end.
The company’s cancer vaccine immunotherapeutic program, VBI-1901, targets cytomegalovirus proteins present in tumor cells, including glioblastoma (“GBM”), breast cancer and pediatric medulloblastoma. The company presented expanded immunologic data and tumor imaging data from the VBI-1901 study, with the GM-CSF study arm in Part B of the study in mid-2020. Initial immunologic data from the same study, with
GlaxoSmithKline’s ( GSK Quick Quote GSK - Free Report) AS01B arm in Part B of the study, is expected by year-end. Zacks Rank
VBI Vaccine currently carries a Zacks Rank #3 (Hold).
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