Johnson & Johnson’s Janssen Pharmaceuticals has licensed Bavarian Nordic's Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN®) technology toward development of new vaccines for human immunodeficiency virus (HIV) and hepatitis B virus (HBV), under an up-to-$879 million agreement that expands the companies’ ongoing collaboration.

Janssen Pharmaceuticals, part of J&J’s Janssen Pharmaceutical Companies, has gained exclusive rights to MVA-BN, which it will combine with Janssen’s own AdVac® technology platform as the companies develop new vaccines for HIV and HBV.

“This agreement builds upon the science and data we have seen to date, which has shown the potential that a combination of our two platforms could serve many patients in a wide range of disease areas,” Bavarian Nordic president and CEO Paul Chaplin, Ph.D., said in a statement.

The agreement was announced yesterday. Three days earlier, J&J trumpeted positive first-in-human clinical data generated by Janssen for its investigational HIV-1 vaccine regimen.

Presenting results from the Phase I/IIa APPROACH study (HIV-V-A004/NCT02315703) at the 9th IAS Conference on HIV Science (IAS 2017), J&J said Janssen’s “mosaic”-based vaccine regimen appeared to be well-tolerated and elicited HIV-1 antibody responses in all of the study’s 393 healthy volunteers in the U.S., Rwanda, Uganda, South Africa, and Thailand.

Mosaic-based vaccines contain immunogens created using genes from different HIV subtypes responsible for HIV-1 infections worldwide. The immunogens are delivered through viral vectors, including Janssen’s AdVac technology based on adenovirus serotype 26 (Ad26). The viral vectors are combined with other components, such as soluble proteins, to form mosaic-based prime-boost vaccine regimens designed to produce stronger and longer-lasting immunity to HIV.

“We welcome this expansion of what has already been a fantastic relationship between our two companies,” Chaplin added.

The companies are already combining their technologies in developing vaccines for human papillomavirus (HPV) and Ebola virus. Janssen first licensed MVA-BN for use in a heterologous prime-boost Ebola vaccine regimen in 2014, and a year later gained an additional MVA-BN license for HPV.

In the companies’ latest collaboration, Janssen has agreed to pay $10 million upfront to Bavarian Nordic, which will also receive a $33 million equity investment from J&J's venture capital subsidiary, Johnson & Johnson Innovation–JJDC, via subscription of new Bavarian Nordic shares.

Janssen also agreed to shell out up to $836 million in payments tied to achieving development, regulatory, and sales milestones plus tiered royalties on future sales.

As with their earlier agreements, Janssen has agreed to oversee all clinical development, with Bavarian Nordic overseeing manufacturing of MVA-BN.

The companies’ exclusive license and collaboration agreement is subject to clearance under the Hart–Scott–Rodino Antitrust Improvements Act and is expected to close during the third quarter.

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