BiondVax surges after results of flu vaccine study

Shares of the Israeli developer of universal flu vaccine candidate climb in Tel Aviv after ‘positive’ clinical trial results

Shoshanna Solomon is The Times of Israel's Startups and Business reporter

Illustrative: A child receives a vaccination shot (Shutterstock/JTA)
Illustrative: A child receives a vaccination shot (Shutterstock/JTA)

Shares of BiondVax Pharmaceuticals Ltd. surged on the Tel Aviv Stock Exchange after the firm said a Phase 2 study clinical trial of an universal flu vaccine candidate it is developing had shown “statistically significant positive results.”

The company’s shares were trading 19 percent higher at 3:08 p.m. in Tel Aviv.

The study of the M-001 vaccine candidate had two primary targets, BiondVax said: to check its safety and the cellular immune responses specific to influenza. “Both endpoints were achieved,” the statement said.

The primary safety results showed that M-001 has a good safety profile and is well tolerated, the company said in a statement. These same findings were reported by the company in November, as preliminary results of the study.

The study also showed that compared with the placebo group, “statistically significant elevated T-cell dependent immune responses” were found in the two dosages of M-001 administered. In addition, a study looking into the antibody response to avian flu H5N1, after the vaccination of M-001 or a placebo, found a statistically significant elevation of antibodies in participants who had received M-001, in one of the four H5N1 strains tested, BiondVax said in a statement.

BiondVax said it is now considering proceeding directly to testing the clinical efficacy of a vaccination with M-001 alone in a pivotal Phase 3 clinical trial, in light of “these encouraging clinical trial results” that confirmed previous study results, the company said.

In the trial, clinical efficacy is to be assessed by measuring a reduction of flu illness rate and severity.

“These significant results confirm that the M-001 is a unique and innovative influenza vaccine that elicits strong T-cell responses and is expected to provide multi-strain and multi-season protection against influenza illness,” said Tamar Ben-Yedidia, BiondVax’s Chief Science Officer. “Along with the substantial funding recently brought to BiondVax we can now concentrate on performing all activities needed to launch the pivotal Phase 3 clinical trial.”

Earlier this week the firm, whose shares are traded in Tel Aviv and on the Nasdaq, said it will soon start construction of a new manufacturing facility in Jerusalem with the capacity to produce tens of millions of doses annually of the M-001 universal flu vaccine candidate, either in single-dose syringe or in bulk. Last month the BiondVax said it reached a €20 million loan agreement with the European Investment Bank and in March it said it received a grant from Israel’s Ministry of Economy.

BiondVax, established in 2005, licensed the technology from the Weizmann Institute, where it was developed in the mid-90s.

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