BiondVax Pharmaceuticals Ltd (BVXV)

[midastouch017]

BVXV: Planning Continues for M-001 Phase 3 Program …


Zacks Small Cap ResearchDecember 12, 2017
By David Bautz, PhD

NASDAQ:BVXV

Business Update

Planning Continues for Phase 3 Program

BiondVax’s ( BVXV) strategy for commercializing M-001 involves testing it in a pivotal Phase 3 program as a standalone influenza vaccine to assess its clinical efficacy. The first Phase 3 trial will be conducted in Europe and the company has already initiated discussions with the European Medicines Agency (EMA) regarding the trial design. We anticipate the EMA providing feedback soon. The trial is being conducted in Eastern Europe since there are not recommendations in some of those countries to get the yearly influenza vaccine, thus making it much easier to enroll sufficient numbers of subjects who have not been previously immunized with the yearly influenza vaccine. In addition, the company is working to align the Phase 3 plan with FDA requirements. Lastly, BiondVax is nearing selection of a Contract Research Organization (CRO) to conduct the trial.

The general outline for the Phase 3 trial is shown below. The company is planning to enroll approximately 7700 patients and will focus on patients over the age of 50. Approximately half of those subjects will be enrolled prior to the first influenza season. The trial is designed such that a certain overall rate of influenza infection is required for the trial to be properly powered. Thus, unblinding of the data following the first influenza season will be dictated by the overall rate of infection (i.e., how severe of an influenza season it is). If it is a mild influenza season, then additional subjects will likely need to be enrolled in Season 2 and the subjects from Season 1 will be followed as well. This process will continue until a sufficient number of influenza infections occur in the entire cohort, potentially into Season 3. Subjects from Season 1 will be followed up regardless of when the study is unblinded to determine long-term effectiveness of M-001.

The primary outcome of the trial will be safety and clinical efficacy of M-001, defined as a reduction in illness rate and severity. The company is hoping to be able to initiate the trial in Fall 2018 before the start of the 2018/2019 influenza season. A U.S. based contract manufacturing organization (CMO) will likely produce the first batch of M-001 for use in the first cohort of patients, while BiondVax will produce the subsequent batches in the new manufacturing facility. Investors should be aware that this is only a preliminary outline of the potential study design and the details may change, however the general outline of the trial shouldn’t. We will provide additional updates to the trial design as they become known.
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Positive Results from Phase 2b Trial of M-001

Earlier this year, BiondVax announced results from the company’s Phase 2b clinical trial of M-001, the universal influenza vaccine candidate. The trial, which was funded through a grant from the European Union and was conducted in conjunction with the European UNISEC Consortium, enrolled a total of 219 participants aged 18 to 60 years. Each participant received two injections of 0.5 mg M-001, 1.0 mg M-001, or placebo prior to a partial dose of avian H5N1 pandemic vaccine.

The trial hit both primary endpoints for safety and immunological response. The company had previously reported positive preliminary safety results based on blinded data from the trial, and has since confirmed that treatment with M-001 was safe and well tolerated. To test for immunological response, T cell activation was measured in in vitro assays through the release of the cytokines interleukin (IL)-2, interferon (INF)-?, and tumor necrosis factor (TNF)-a. The following figure on the left shows that statistically significant T cell activation was found in participants that received 1.0 mg M-001 when compared to the placebo group. The following figure on the right shows that the there was a significant increase in T cells that expressed two cytokines, which have been shown to be functionally superior to single-cytokine producing T cells (Kannanganat et al., 2007).

https://finance.yahoo.com/news/bvxv-planning-continues-m-001-170000524.html