Hookipa Biotech and Gilead Ink Deal to Develop HIV and Hepatitis B Therapies

Published: Jun 05, 2018 By

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Hookipa Biotech, based in Vienna, and Gilead, headquartered in Foster City, California, inked a research collaboration deal to develop and commercialize therapeutics for hepatitis B (HBV) and HIV.

Gilead will utilize Hookipa’s TheraT and Vaxwave arenavirus vector-based immunization technologies. Under the deal, Gilead will pay Hookipa $10 million. Hookipa will be eligible for milestone payments that could hit more than $400 million. Gilead will fund all research and development operations. Hookipa will also be eligible for royalties.

“Gilead, a world leader in innovative therapies against major viral diseases, is the ideal partner for us to drive our pipeline development in this area for the benefit of patients in need,” said Joern Aldag, Hookipa’s chief executive officer, in a statement. “This partnership is strong recognition of our unique immunization technology, and helps us concentrate our own energy and resources on immuno-oncology. The collaborative HIV and HBV programs nicely complement our significant efforts in the infectious disease area with an exciting proprietary prophylactic CMV vaccine.”

In late March, Hookipa presented new data from its Phase I clinical trial of HB-101, a vaccine against human cytomegalovirus (CMV). It was presented at the World Vaccine Congress by Camille Kotton, clinical director of Transplant and Immunocompromised Host Infectious Diseases at the Massachusetts General Hospital.

In December 2017, Hookipa raised $60 million in a Series C financing to fund its CMV program into Phase II. Gilead was one of the investors.

Only a few days ago, Gilead and Galapagos announced results from their Phase II EQUATOR trial of filgotinib, a selective JAK1 inhibitor, in patients with moderate to severe psoriatic arthritis. They also announced that an independent Data Monitoring Committee (DMC) had conducted a planned interim futility analysis of the filgotinib Phase IIb/III ulcerative colitis study, SELECTION. The DMC recommended it continue into Phase III.

Much of the company’s most recent news has been on its immunology or oncology efforts. However, on May 30, it reported that the China Drug Administration (CDA) had approved its Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) to treat adults with genotype 1-6 chronic hepatitis C. The CDA also approved Epclusa in combination with ribavirin for adults with HCV and decompensated cirrhosis.

The approval was built on five international Phase III trials, ASTRAL-1 through ASTRAL-5.

“As the first once-daily, interferon-free single tablet regimen for HCV patients regardless of genotype, Epclusa offers physicians in China an important new option for effectively treating their patients while potentially helping to reduce the significant burden of HCV at a population level,” said John Milligan, Gilead’s president and chief executive officer, in a statement. “Gilead has now launched two direct-acting antiviral treatments in China, and we are committed to supporting efforts to screen and link patients to treatment, to help address the country’s HCV epidemic.”

The drug already received approval by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in 2016. It has been approved for use in 54 countries.

Regarding today’s deal, Bill Lee, Gilead’s executive vice president of Research, stated, “Gilead is committed to advancing innovative approaches directed at functional cures against HIV and HBV. We are convinced that Hookipa’s unique therapeutic vaccine technology, which has demonstrated excellent safety and immunogenicity in Phase I clinical studies, has strong potential to have a synergistic effect with other Gilead cure efforts in both of these diseases areas. Our ultimate long-term goal is to eliminate the need for life-long antiviral therapy for millions of patients around the world.”

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