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.