Innate Pharma gains rights to AZ's recently approved leukaemia drug

France’s Innate Pharma has gained rights to AstraZeneca's recently approved leukaemia drug Lumoxiti, in a deal that expands a collaboration that began more than three years ago.

The companies announced a deal in April 2015, which included combining Innate’s IPH2201, an antibody designed to stimulate natural killer cells to attack cancer, with AZ’s checkpoint inhibitor Imfinzi (durvalumab).

Under the new agreement, AZ will take a 9.8% equity stake in the French biotech as part of the deal strengthening its presence in immuno-oncology.

Innate will get full US and EU commercial rights to AZ’s recently-approved Lumoxiti (moxetumomab pasudotox-tdfk), approved in the US in adults with relapsed or refractory hairy cell leukaemia last month.

Lumoxiti could also be developed in combination with drugs from Innate’s pipeline. With support from AZ, Innate will continue EU development and marketing, if European regulators approve the drug following a filing.

Innate will recognise revenues and co-market Lumoxiti with AstraZeneca in the US and will take full responsibility by mid-2020.

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.

Meanwhile, AZ has been so impressed with results from IPH2201, now named monalizumab, that it has exercised an option to take full rights for the drug for $100 million, due in the first quarter of 2019.

A further $100 million is due at the start of phase III development under the terms of the 2015 agreement.

Results from a single-arm phase II trial of monalizumab in combination with cetuximab in head and neck cancer patients were presented at the European Society for Medical Oncology (ESMO) conference this week showing “deep and durable” responses in 40 patients with an overall response rate of 27.5%, and progression-free survival of 5.0 and overall survival of 10.3 months, respectively.

Among the 40 patients enrolled in the cohort expansion, the safety findings were consistent with previously presented data.

The companies currently share phase II development for monalizumab in combination studies in both head and neck and colorectal cancer, with additional studies underway in other solid tumours.

AZ is also entering into a development collaboration and option for further co-development and marketing for Innate’s CD39 monoclonal antibody, IPH5201.

CD39 is a membrane-bound extracellular enzyme overexpressed on both regulatory T-cells and tumour cells in several cancer types, and is thought to play a role in suppressing the immune system's activity against cancer.

AZ will pay Innate $50 million upfront, plus undisclosed option fees, milestones and royalties, and Innate could choose to co-promote and share profits in the EU.

Finally, AZ has paid $20 million to Innate for an option to choose to exclusively license four molecules from Innate’s pre-clinical 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.