It’s clear now that HIV and hepatitis B are two additional infectious diseases Johnson & Johnson kept mum about when it expanded a vaccine technology deal with Bavarian Nordic in 2015. The two companies have just partnered up to tackle those two targets using Bavarian Nordic’s MVA-BN vaccine tech.
In a deal worth up to $879 million, the Danish company is granting J&J's Janssen unit the rights to combine MVA-BN with Janssen’s own AdVac platform in the HIV and HBV programs. Janssen will pay Bavarian Nordic $10 million upfront and up to $836 million in milestones, while the remaining $33 million will come in the form of an equity investment by Johnson & Johnson Innovation.
Bavarian Nordic will design, produce and deliver whatever MVA is needed based on its platform, while Janssen will take care of R&D, according to a media aide for the Kvistgaard, Denmark-based company.
Previous studies have shown the potential of combining the two platforms in many disease areas, BN President and CEO Paul Chaplin said in a statement, likely referring to two earlier licensing deals. Janssen licensed MVA-BN for a heterologous prime-boost Ebola vaccine in 2014, and, in 2015, adopted the tech for HPV in a $171 million pact.
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The announcement came hard on the heels of positive early-phase data from Johnson & Johnson’s own “mosaic” HIV vaccine. In a phase 1/2a trial dubbed Approach, the vaccine triggered HIV-1 antibody responses in all healthy volunteers. That vaccine's immunogens are delivered using the company's AdVac technology.
But J&J will likely use the BN license for a therapeutic HIV vaccine as well, unless it chooses to explore its application in a preventative one later, Ronan Collins, a J&J spokesman told FiercePharma. The idea of such a combination has already been proved in a preclinical study on primates.
A study, carried out by scientists at Beth Israel Deaconess Medical Center, the Walter Reed Army Institute of Research, together with Janssen and Gilead, combined an adenovirus serotype 26 vector vaccine (based on AdVac) and an MVA vector vaccine with a TLR7 agonist that works on a protein of the immune system, to be administered alongside antiviral treatments. Scientists found that the combination induced much better immune response than either component alone. Janssen has already started a phase 1/2a to examine the safety and immunogenicity of the combo.
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The HBV vaccine realm is also filled with competition. GSK’s Engerix-B has been hogging the market as the standard of care for decades, but that might change.
The industry is watching Dynavax’s Heplisav-B, which is heading into an FDA Advisory Committee meeting this Friday, looking for a third shot at an approval. The FDA knocked down the candidate twice not because of its efficacy—in fact, Dynavax’s version outperformed the GSK shot in a head-to-head phase 3—but for potential heart attack risks. That safety issue will likely be the focus of the upcoming FDA panel.
Adding to the race is Sci-B-Vac by VBI Vaccines, a hep B vaccine already approved in 15 countries worldwide but not in the U.S. or Europe. The Cambridge, Massachusetts-based biotech is confident that its shot matches up to Engerix-B in younger adults, but can beat it in elderly people. A two-part phase 3 clinical program is set to begin for VBI to prove its stand.
RELATED: Bavarian Nordic sees 'huge potential' in cancer vaccine combos, CEO says
Bavarian Nordic is also forging ahead with a universal RSV vaccine, but it seems to be putting more effort into cancer vaccines, where CEO Chaplin sees “huge potential,” especially in combination therapies.
Working with the National Cancer Institute, the company is testing its lead immunotherapy candidate Prostavc—which also uses the MVA-BN tech—in a phase 3 against metastatic prostate cancer. The company also just paired Prostvac with Bristol-Myers Squibb’s Opdivo and Yervoy in clinical studies. Another MVA-BN-based candidate called CV301 has been paired up with Opdivo, as well as Roche's Tecentriq, in combination cancer tests.