AstraZeneca and its biologics R&D arm MedImmune have signed a deal with Moderna Therapeutics to discover, co-develop and co-commercialise messenger RNA-based therapeutics targeting a range of cancers.
The companies are intending to couple MedImmune’s protein engineering and cancer biology expertise with Moderna’s technology platform to produce mRNA-based therapies. These enable the body to produce therapeutic protein in vivo, and thus potentially offer a new treatment approach for a wide range of diseases.
The firms have agreed to work together on two specific immuno-oncology programmes, based on promising preclinical data. Moderna will fund and be responsible for discovery and preclinical development of candidates, while AstraZeneca will be responsible for early clinical development, led by MedImmune. Moderna and AZ will share the costs of late-stage clinical development.
Under the terms of the deal, the companies will co-commercialise resulting products in the US under a 50:50 profit sharing arrangement, while elsewhere AZ will take the lead, with Moderna receiving tiered royalties up to double digits on ex-US sales.
The agreement is in addition to that signed by the companies back in 2013, focusing on the development of mRNA therapeutics for the treatment of cardiovascular, metabolic and renal diseases as well as some targets in oncology. Several projects are progressing towards clinical development under the arrangement, and a first-in-human study is expected to commence in late 2016.
Meanwhile, AZ also announced that is has entered into a clinical trials collaboration with Incyte to test a combination of two therapies in patients with a certain form of non-small cell lung cancer.
The companies will work together on a Phase I/II trial evaluating dual treatment with Incyte’s Janus-associated kinase (JAK) 1 inhibitor, INCB39110, and AZ’ next generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso (osimertinib), to explore their potential synergies.
Safety and efficacy of the combo will be assessed as a second-line treatment for patients with EGFR mutation-positive NSCLC, who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the resistance mutation T790M.
This agreement builds on an existing deal between the two companies, announced in May 2014, combining AZ’ anti-PD-L1 immune checkpoint inhibitor durvalumab and Incyte’s oral indoleamine dioxygenase-1 inhibitor, epacadostat (INCB24360).