AstraZeneca, and its global biologics research and development arm MedImmune, have formed a new multi-term agreement with Innate Pharma, a Marseille, France-based biopharmaceutical company, to build on an existing collaboration that adds to AstraZeneca’s immuno-oncology portfolio with preclinical and clinical drug candidates. AstraZeneca also is licensing its rights to a recently approved rare-disease drug to Innate and is taking a 9.8% equity stake in Innate.

Under the deal, AstraZeneca will obtain full oncology rights to Innate’s humanized anti-NKG2A antibody, monalizumab, to expand its partnership with Innate from the companies’ initial collaboration announced in 2015. AstraZeneca also gains option rights to IPH5201, an antibody targeting CD39, which is thought to be involved with immunosuppression, as well as four preclinical molecules from Innate’s pipeline. Innate is licensing from AstraZeneca the US and European Union (EU) commercial rights for AstraZeneca’s recently FDA approved rare-disease drug, Lumoxiti (moxetumomab pasudotox), for treating hairy cell leukemia (HCL).

Innate will pay AstraZeneca $50 million upfront for Lumoxiti and $25 million for future commercial and regulatory milestones, in consideration for its intellectual property and clinical and manufacturing development of the medicine. Innate is licensing the US commercial rights and with support from AstraZeneca, will continue EU development and commercialization, pending regulatory submission and approval. Lumoxiti is a CD22-directed cytotoxin for treating adult patients with relapsed or refractory HCL who have received at least two prior systemic therapies, including treatment with a purine nucleoside analogue. Approximately 1,000 people are diagnosed with HCL in the US each year, a subset of which would be eligible for Lumoxiti, according to information from the companies. Innate will recognize revenues and co-commercialize Lumoxiti with AstraZeneca in the US and will take full responsibility by mid-2020.

In addition, AstraZeneca will pay Innate $100 million in the first quarter of 2019 for the expansion of the companies’ monalizumab collaboration. Building on a 2015 collaboration with Innate, AstraZeneca is exercising its option to obtain full oncology rights to monalizumab, a humanized anti-NKG2A antibody. NKG2A is a checkpoint receptor expressed on tumor-infiltrating cytotoxic T-cells and natural killer cells that inhibits their anti-cancer functions. The companies currently shared Phase II development for monalizumab in combination trials in both head and neck and colorectal cancer, with additional trials underway in other solid tumors.

Further, AstraZeneca will pay Innate $50 million upfront for the development collaboration and option for further co-development and co-commercialization of Innate’s CD39 monoclonal antibody, IPH5201, plus an option exercise fee, milestones, and royalties. Innate will have the potential for co-promotion and profit sharing in the EU. CD39 is a membrane-bound extracellular enzyme overexpressed on both regulatory T-cells and tumor cells in several cancer types. CD39 plays an important role in promoting immunosuppression through the pathway that degrades adenosine triphosphate into adenosine. Adenosine pathway is thought to be involved in tumor immunosuppression and will complement AstraZeneca’s current portfolio in this area, according to the company.

AstraZeneca will also pay Innate $20 million upfront for an exclusive license option on four to-be-agreed molecules from Innate’s preclinical portfolio. These options can be exercised before the molecules reach clinical development, triggering an option exercise fee in addition to milestones and royalties. Innate will have the potential for co-promotion and profit sharing in the EU, dependent on future progress.

AstraZeneca will also acquire a 9.8% equity stake in Innate Pharma through the issuance of 6,260,500 new shares to AstraZeneca at EUR 10 ($11.4)/share.

Source: AstraZeneca and Innate Pharma