AstraZeneca Ups Betting Ante On Moderna's Messenger RNA Technology
This article was originally published in Scrip
Emboldened by results from their existing alliance on mRNA drugs for cardiovascular, metabolic and regenerative disease, AstraZeneca PLC and privately held Moderna Therapeutics LLC have decided to extend their focus to include candidates for the treatment of a range of cancers.
The move, announced Jan. 11, will combine protein engineering and cancer biology expertise from AstraZeneca's biologics division MedImmune with Moderna's mRNA technology that produces human proteins, antibodies and totally novel protein constructs within patient cells, which are in turn secreted or active intra-cellularly.
Alliance Expanded With Two Specific Oncology Programs
The duo will thus collaborate on two specific immuno-oncology programs, based on promising pre-clinical data, including pharmacology in tumor models.
Moderna will fund and be responsible for discovery and preclinical development of product candidates, with the aim of delivering one Investigational New Drug (IND) application-ready molecule for each of the two programs. Moderna's efforts will be led by its oncology-focused venture, Onkaido.
AstraZeneca, which is betting heavily on its oncology and immunology pipeline, will be responsible for early clinical development, led by MedImmune. Moderna and AstraZeneca will share the costs of late-stage clinical development and co-commercialize any products in the US under a 50:50 profit sharing arrangement. AstraZeneca will lead commercialization efforts outside the US, with Moderna "receiving tiered royalties up to substantial double digits on ex-US sales," the companies said without elaborating.
The arrangement builds on their original option agreement where the British pure pharma paid $240m upfront for an exclusive collaboration to discover, develop and commercialize mRNA drugs in the cardiovascular, metabolic, renal and oncology spaces and under which Moderna could earn more than $1b. Through that original pact, AstraZeneca holds exclusive access to select any target of its choice in cardiometabolic diseases, as well as select targets in oncology, over a period of up to five years for subsequent development in mRNA. Several projects from that are progressing towards clinical development, and a first-in-human study is expected to commence in late 2016, the companies said, without elaboration.
"Since our companies' original strategic agreement in March 2013, Moderna's relationship with AstraZeneca has been very fruitful. This new agreement with AstraZeneca demonstrates the effectiveness of our existing relationship and the power of our mRNA technology," Moderna CEO Stéphane Bancel said in a statement.
Under the original 2013 deal AstraZeneca holds options to select up to 40 mRNA drug candidates for preclinical and clinical development and commercialization. Beyond the $240m up-front payment that agreed, Moderna can also earn up to $180m in "technical milestones."
Commenting on the expanded alliance, AstraZeneca CEO Pascal Soriot said: "We're pleased to be expanding our relationship with Moderna with this new collaboration, to advance the potential of pioneering messenger RNA technology in developing game-changing new treatments for cancer patients."
Moderna Also Unveils Vaccine Deal With Merck & Co
Moderna the same day announced that Merck & Co licensed a vaccine program against an undisclosed viral target, including mRNA 1566, and a set of related novel vaccine candidates, as part of their ongoing collaboration to discover and develop vaccines and passive immunity treatments against viral diseases using modified messenger RNA.
The inclusion of the new program, which was not part of their original collaboration deal, follows the rapid progress made in the first year of the collaboration. Moderna's contribution is led by Valera, its infectious disease-focused venture.
"Since signing our first agreement in January 2015, the Merck and Moderna teams have accomplished something quite unprecedented in drug development. In just 10 months, they were able to move an idea for a new vaccine from concept clear through to the nomination of a vaccine candidate that entered pre-clinical development in November 2015. That innovative vaccine candidate is anticipated to enter the clinic in 2016," Moderna CEO Bancel said in a statement.
Moderna will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestone payments related to the new target, as well as tiered royalties on net sales of resulting products.
Consistent with the existing collaboration, Merck will lead the development of the candidate and commercialization of any products resulting from the agreement, while Moderna will design and synthesize the mRNA vaccine candidates directed against selected targets.
As part of the initial three-year research agreement, Merck made an upfront cash payment of $50m and a $50m equity investment to utilize granted licenses to commercialize five product candidates.