AstraZeneca has pulled out of a pneumonia collaboration with Aridis Pharmaceuticals, sending the biotech’s phase 3 plans into a tailspin over the company’s alleged failure to hand over the agreed upfront payment two years ago.
As part of their 2021 agreement, Aridis agreed to pay $11 million upfront to AstraZeneca’s MedImmune unit for the rights to the monoclonal antibody suvratoxumab. The deal also gave AstraZeneca an equity stake in Aridis and allowed the Big Pharma first negotiations on future licensing, as well as potentially $115 million to follow in milestone payments.
In addition, Aridis secured up to 25 million euros from the EU Commission’s Innovative Medicines Initiative to support a phase 3 trial for suvratoxumab, also known as AR-320.
But it sounds like things haven’t gone to plan. Aridis said it was informed in writing on March 20, 2023, that AstraZeneca had terminated the license agreement “for non-payment of the upfront cash payment which was due on December 31, 2021.” For its part, Aridis said in the same Securities and Exchange Commission filing yesterday that it “does not agree that it is in material breach of the license agreement.”
Responding in kind, Aridis said that on March 24 MedImmune was notified that it was in breach of a section of the licensing agreement that ensures the AstraZeneca unit provides access to “know-how” relevant to AR-320. Aridis has “requested that the material breach be cured as soon as possible,” according to yesterday’s filing.
AstraZeneca’s decision to end the agreement means that Aridis has to put its phase 3 study of the therapy on hold, the biotech said. The trial, which is still recruiting, was due to enlist over 560 mechanically ventilated adults and adolescents to determine the antibody’s ability to prevent nosocomial pneumonia.
Fierce Biotech has contacted AstraZeneca and Aridis for further details of the dispute.
The breakdown of the suvratoxumab agreement marks the continuation of a mixed year for Aridis so far. The company kicked off 2023 with another monoclonal antiboby, dubbed AR-301, flunking a phase 3 trial in patients with bacterial infections. Aridis had touted AR-301 as complementary to suvratoxumab when it signed up the latter therapy from AstraZeneca in 2021.
Better news was to come earlier this month, when AR-501—an inhaled formulation of gallium citrate—hit its primary and secondary endpoints in a phase 2 trial in cystic fibrosis patients with confirmed Pseudomonas aeruginosa bacterial and other potential infections.