AstraZeneca stops monotherapy study at centerpiece of $500M buyout

AstraZeneca has stopped (PDF) monotherapy development of a PD-1 drug it acquired in a $500 million (€400 million) biotech buyout. The candidate, MEDI0680, was the centerpiece of AstraZeneca’s takeover of Amplimmune.

MEDI0680 is a PD-1 checkpoint inhibitor AstraZeneca picked up in its 2013 takeover of Amplimmune. AstraZeneca paid $225 million upfront and committed to up to $275 million in milestones to buy the firm in 2013. The statement to disclose the takeout focused squarely on MEDI0680, then known as AMP-514. The rest of Amplimmune’s pipeline was only mentioned in passing. 

AstraZeneca went on to move MEDI0680 into three early-phase trials, only one of which is still active. That trial is testing MEDI0680 in combination with AstraZeneca’s PD-L1 drug Imfinzi in patients with advanced malignancies. The trial pitted the PD-1/PD-L1 cocktail against Bristol-Myers Squibb’s rival checkpoint inhibitor Opdivo. 

MEDI0680 as a monotherapy was jettisoned from the pipeline as part of a pruning that affected a few other drugs. The R&D team also axed asthma hopeful tralokinumab after it came up short in three phase 3 trials.

Tralokinumab has been a dead drug walking since AstraZeneca disclosed it had failed to move the needle in two phase 3 trials in November. Those failures followed an earlier phase 3 flop and a miss in phase 2b. The drug lurched on after those setbacks but the last two phase 3 fails have finally killed off the program.

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Anti-IL-13 antibody tralokinumab was the most advanced clinical candidate to slip off AstraZeneca’s pipeline this quarter. It is joined on the scrapheap by a phase 2 asset, MEDI0680, and another drug that never made it past the first round of human tests.

The phase 2 asset is MEDI-573, an anti-IGF1/2 monoclonal antibody AstraZeneca moved into a clutch of solid tumor trials around the start of the decade. Three of the trials wrapped up years ago but a midphase study in hormone-sensitive, HER-2 negative metastatic breast cancer is still ticking along. That trial is now set to come to a close as AstraZeneca drops the drug from its pipeline.

AstraZeneca is also scrapping asthma asset AZD9898. The Big Pharma acquired the leukotriene C4 synthase inhibitor from Orexo in 2016 and started testing in healthy volunteers last year. That trial quickly went off the rails, though. AstraZeneca terminated it based on an interim review.