A cancer drug under clinical hold, an mRNA therapy, a kidney med: AstraZeneca punts three early-stage programs

10 Nov 2022
endpts.com
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Just over a year ago, the FDA slapped AstraZeneca with a clinical hold on its MCL-1 inhibitorMCL-1 inhibitor to look into safety information. The Phase I trial has since been in limbo.
Now, the British pharma giant is washing its hands of the drug.
AZD5991, which was being tested for relapsed or refractory hematologic malignancies, is one of three new molecular entities to be swept out of the early-stage pipeline as part of AstraZeneca’s Q3 housecleaning. The other two are a Moderna-partnered mRNA therapy for solid tumors and an antibody aimed at chronic kidney disease.
At the time the FDA placed AZD5991 on hold, AstraZeneca noted that it had already suspended dosing voluntarily after observing an elevation in cardio “laboratory parameters” for a patient with relapsed/refractory acute myeloid leukemia who took the drug in combination with venetoclax.
There had been questions of safety around the MCL-1 class, with Amgen being hit by a clinical hold two years prior due to signs of cardiac toxicity.
On its website, though, AstraZeneca categorized the reason for discontinuation as “strategic.”
The second Phase I program it’s terminating is dubbed MEDI1191. At a 2021 conference, the company actually reported early results showing “promising safety, tolerability, and efficacy” for the drug, an IL-12 mRNA drug administered intratumorally to kick up an immune response, followed by its PD-L1 inhibitorPD-L1 inhibitor Imfinzi.
Updated results presented at AACR suggest that three out of 31 patients in a trial saw partial responses, and eight others had stable disease. AstraZeneca lists “efficacy/safety” as the reason for MEDI1191’s termination.
Finally, there’s MEDI8367, an antibody designed to bind the integrin αvβ8, thereby preventing αvβ8-mediated TGFβ activation in the kidney. In preclinical studies, the drug ameliorated kidney dysfunction and reduced fibrosis.
As previously announced, AstraZeneca also scrapped AZD8233, a PCSK9-targeting antisense oligonucleotide from Ionis, after deciding it didn’t meet the bar for a big Phase III investment.
The company dropped a number of other indications across its Phase II and III portfolio, shedding trials that were meant to expand the scope of certain programs.
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