The partnership will see Vaccibody conduct development of its cancer vaccine, VB10.NEO, through to the end of Phase 1b trials, while Genentech, which is part of the Roche Group, will be responsible for the vaccine’s development and commercialization, thereafter.
Vaccibody said the licensing agreement will enable it to accelerate and expand its other internal R&D programs including work to further develop its VB10.16 and other shared neoantigen cancer vaccines along with infectious diseases vaccines and, in addition, leverage its in-house expertise to develop novel immunotherapeutic products in new strategic areas.
Under the terms of the deal, the Norwegian innovator will receive US$200m in initial upfront and near-term payments. It will also be eligible to receive up to a further US$515m in potential payments and milestones, plus 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.
VB10.NEO is currently being evaluated in the VB N-01 Phase 1 trial in multiple cancer types. The trial is fully enrolled.
According to Vaccibody, VB N-01 is a basket trial for patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. In that study, the safety, feasibility and efficacy of treatment with the personalized VB10.NEO vaccine is being evaluated. One arm of the trial will asses the combination of VB10.NEO and bempegaldesleukin (NKTR-214) in patients with head and neck cancer. The trial has been recruiting patients from seven clinical sites in Germany.
BioPharma-Reporter (BPR) spoke to Vaccibody CEO, Michael Engsig, to get some insights into the neoantigen cancer vaccine space.
BPR: What evidence is there to date that targeting neoantigens has the potential to transform the treatment landscape for many types of cancers?
ME: There is broad activity in the cancer vaccine companies targeting neoantigens. Vaccibody had very promising clinical data [to share] at the Society for Immunotherapy of Cancer 34th Annual Meeting & Pre-Conference Programs (SITC 2019) from the first 14 patients across tumor types.
VB10.NEO uniquely targets encoded antigens to antigen presenting cells, which are essential for generating potent T cell responses required for cancer therapy. It has demonstrated the ability to induce an immune response against the majority of the neoantigens targeted by the vaccine.
Preliminary results from the Phase I/IIa clinical trial suggest a link between selection of high quality neoepitopes, generation of broad neoepitope-specific CD8+ T cell responses and potential clinical benefit.
BPR: Do neoantigen vaccines need to be combined with immune checkpoint inhibition therapy or radiotherapy and chemotherapy to achieve better therapeutic effects?
ME: It is early days, and the treatment regime including optimal combinations may depend on tumor type and treatment setting. Vaccibody has performed a monotherapy study with a therapeutic HPV vaccine based on the same unique platform technology, which also indicated a link between vaccine-induced immune responses and clinical efficacy in precancerous cervical lesions; hence we believe the vaccine induces the optimal immune responses for clinical efficacy. Vaccibody’s vaccine has also shown to be well tolerated which opens the opportunity for a range of combinations that may further enhance the vaccine efficacy.
BPR: Is there still need for greater understanding of the mechanisms underlying tumor development in order to expand the application of neoantigen vaccines in the future?
ME: Genentech is world leading in the field of cancer immunotherapy performing enlightening research and developing products based on engaging the full cancer immunotherapy cycle needed to create optimal immunotherapies. Cancer vaccines including neoantigen vaccines are one essential and unique component to ensure optimal efficacy by creating truly antigen-specific immune responses and we see cancer vaccines as a natural component of all cancer immunotherapies in the future.
Through the neoantigen program, we have generated insight into selection of optimal neoantigens for induction of strong and clinically relevant immune responses. This work will continue through the collaboration with Genentech. Importantly, Vaccibody’s targeted vaccine has proven to induce unique broad and strong CD8 T cell responses which we believe is essential for clinical efficacy.
BPR: The company’s cancer vaccine against Human Papilloma Virus 16 (HPV16) linked cancer is VB10.16, what work is being done to further develop that vaccine?
ME: Vaccibody is currently enrolling patients in the VB C-02 trial in advanced cervical cancer, testing VB10.16 in combination with Atezolizumab (Tecentriq) from Roche. The first patients were dosed this summer.
As VB10.16 has a broad applicability within all HPV16+ cancer types, the ambition is to maximize the potential of VB10.16 and address other HPV16+ positive cancers in the future.
BPR: What is Vaccibody’s portfolio focus in relation to infectious diseases?
ME: We are very enthusiastic about the [capabilities] of the Vaccibody platform [in relation to] infectious diseases. We have generated a lot of promising preclinical data, both with viral and bacterial antigens, and we believe there is a huge potential for single dose efficacy and/or low doses due to the unique targeting to antigen presenting cells. Rapid, robust and cost-effective manufacturing, which we have proven in the neoantigen trial, will also be a huge benefit within the field of infectious diseases, including pandemics and epidemics. We will present the strategy later this year.
BPR: What therapeutic applications beyond cancer and infectious diseases is Vaccibody looking at?
ME: We have many exciting ideas and discoveries based on our core expertise within molecular biology creating novel molecules with desired properties and applications; however, we are filing IP at the moment and will disclose more information at a later date.