→ While Affimed $AFMD works to shake off the FDA hold on its Phase I program, the team is still making preclinical progress with its innate cell engager-based cancer therapies. The German biotech said its big partner at Genentech has issued an unspecified payment for a preclinical milestone — hopefully the first of many in a collaboration worth up to $5 billion.
→ Puma Biotechnology has posted positive data for neratininb from a PhII study involving HER2-mutated cervical cancer patients $PBYI. Out of 11 patients researchers counted “3 patients with confirmed partial responses and 3 patients with stable disease that lasted greater than 16 weeks. The median progression free survival was 7.0 months.”
→ Antibiotics developer Iterum Therapeutics $ITRM has collected four more qualified infectious disease product (QIDP) designations for sulopenem in the following indications: community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease. Designed to incentivize drug development in face of growing microbial resistance, QIDP grants drugs an additional five-year extension of exclusivity among other provisions. Iterum’s drug has previously earned the designation for three other indications, all currently tested in pivotal Phase III.
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