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Vaccibody enters agreement with Genentech and accelerates R&D programs

Agnete B Fredriksen and Michael Engsig

Vaccibody has announced that it has entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development and commercialization of DNA-based individualized neoantigen vaccines for the treatment of cancers.

Vaccibody will conduct development through the end of Phase 1b and Genentech will be responsible for development and commercialization thereafter. The transaction will combine Genentech’s global cancer immunotherapy research, development and commercial leadership with Vaccibody’s targeted DNA-based vaccine platform to realize a potential new treatment paradigm of individualized cancer vaccines.

The start of a new era for Vaccibody

“We are very excited to have entered into this transformative agreement that marks the start of a new era for Vaccibody. Genentech is widely recognized as one of the foremost leaders in leveraging the immune system to develop therapies for cancer and is a scientific pioneer within the neoantigen cancer vaccine space. They are therefore the partner of choice for the further development and commercialization of our innovative next-generation cancer vaccine platform for generating individualized therapies,” says Michael Engsig, CEO of Vaccibody.

USD 200 million in initial upfront and near-term payments

Under the terms of the agreement, Vaccibody will receive USD 200 million in initial upfront and near-term payments. Additionally, Vaccibody will be eligible to receive up to a further USD 515 million in potential payments and milestones, plus low double-digit tiered royalties on sales of commercialized products arising from the partnership. Following completion of the Phase 1b study, Genentech will have responsibility and bear all costs for clinical, regulatory, manufacturing and commercialization activities.

Clinical trials

Through this partnership, Genentech and Vaccibody will progress Vaccibody’s investigational product, VB10.NEO, into clinical trials in the U.S. and in Europe.

VB10.NEO, an individualized DNA-based neoantigen vaccine, uniquely targets encoded antigens to antigen presenting cells which are essential for generating potent T cell responses required for cancer therapy. The vaccine is designed to be produced on-demand according to the neoantigen profile of an individual patient. Neoantigens are proteins generated by tumor-specific mutations not present in normal tissues, and are thus an attractive target for cancer immunotherapy as they may be recognized as foreign by the immune system.

“It is widely believed that the clinical use of cancer vaccines has been limited by the ability to efficiently present the antigens to the immune system and the limited insight into what constitutes clinically relevant antigens. Vaccibody’s immunotherapy platform has been shown to address those challenges with preclinical and clinical data indicating induction of unique CD4+ and importantly CD8+ tumor-specific T cell responses against selected antigens essential for clinical responses,” says Agnete B. Fredriksen, Co-Founder, President & Chief Scientific Officer of Vaccibody.

Vaccibody’s future R&D focus and strategy

The payments and milestones received under the terms of this licensing agreement will enable Vaccibody to accelerate and expand its other internal R&D programs under the Vaccibody technology platform. Vaccibody will focus its R&D efforts on further development of VB10.16 and explore other share.

“This transformative collaboration with Genentech marks the beginning of an exciting new journey for Vaccibody. The proceeds from this deal will enable us to begin accelerating and broadening our vaccine pipeline which we believe will maximize the company’s potential for patients and shareholders. We will also pursue further licensing and collaboration agreements including forming strategic partnerships focused on our technology platform,” says Michael Engsig.

Vaccibody has built a cross-functional team and will continue to grow the organization to deliver on this plan. In addition, the company will pursue further strategic partnerships, where appropriate, it states.

Accelerating the development of vaccine candidates in cancer and infectious disease

Today, Vaccibody has two compounds in the clinic: 1) VB10.16 – its cancer vaccine against Human Papilloma Virus 16 (HPV16) linked cancer. The candidate is currently in Phase II development collaboration with Roche in advanced cervical cancer and has significant 2 commercial potential in other HPV16+ cancer indications, e.g., cancer of the head and neck; 2) VB10.NEO – its highly innovative individualized neoantigen cancer vaccine which is now exclusively licensed to Genentech.

Vaccibody will focus on advancing and expanding its pipeline of product candidates in the areas of oncology e.g. shared antigen cancer vaccines and infectious diseases.

“Vaccibody has already demonstrated the ability of its platform to select clinically relevant antigens and to induce best-in-class, tailored immune responses, linked to clinical efficacy in both its clinical programs. The clinical and pre-clinical results we have seen so far underpin our confidence in the technology’s potential and our ambition to optimize utilization of Vaccibody’s platform, by developing multiple assets, such as best-in class shared cancer vaccines and vaccines for infectious diseases,” says Agnete B. Fredriksen.

Read more: Interview with Caspar Foghsgaard, Director of Business Development at Vaccibody

Listing on Merkur Market

Vaccibody has applied for a listing of its shares on the Norwegian trading platform Merkur Market (‘Merkur’), owned and operated by Oslo Børs (the Oslo Stock Exchange). The first day of trading on Merkur is expected to be on or about October 7, 2020.

Photo of Agnete B Fredriksen and Michael Engsig