Vienna's Hookipa Biotech starts first-in-human CMV vaccine trial

One month after luring influential biotech entrepreneur Jörn Aldag to serve as its CEO, Vienna, Austria’s Hookipa Biotech is taking a cytomegalovirus vaccine candidate into a first-in-human trial. Dubbed HB-101, the vaccine will undergo Phase I testing in 54 individuals, producing interim data late this year and early next year.

The vaccine is based on Hookipa’s Vaxwave platform, which the startup says can boost the immune system through repeated applications by stimulating B-cell and CD8+ T-cell responses. The vaccine--a bivalent candidate with two rLCMV vectors--has shown promise in preclinical studies, Aldag said in a statement.

The 15-month trial will test the vaccine at low, middle and high doses, as well as against placebo; the primary endpoint is safety.

Vaccine development against cytomegalovirus, which is common throughout the world but serious for immunocompromised patients and infants, has been named at the “highest priority by the US Institute of Medicine,” Aldag said in a statement. A successful vaccine could reduce morbidity, mortality and costs associated with the virus.

Since its inception in 2011, the company--which takes its name from a world-famous windsurfing beach in Hawaii--has raised about $30 million from investors including Sofinnova Partners, Forbion Capital Partners, Boehringer Ingelheim Venture Fund, Takeda Ventures and BioMedPartners.

For Aldag, the move to Hookipa follows his separation from uniQure, a gene therapy pioneer that has experienced tumult since getting the first gene therapy approval in Europe. He stepped down at the end of last year and in June joined Hookipa.

Pfizer ($PFE) is also working in cytomegalovirus with a preclinical vaccine candidate acquired through its 2015 purchase of Switzerland’s RedVax.

- here's the release

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