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The firm will evaluate its EGFR-targeted ADC ALX2004 in advanced non-small cell lung, head and neck, esophageal, and colorectal cancers.
Precigen had sought accelerated approval for Papzimeos, but the FDA opted to grant it full approval after reviewing data from a Phase I/II trial.
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The firm will use the funding to support a Phase I/II umbrella trial of three TCR T-cell candidates and its preclinical pipeline.
The firm plans to submit CMC data for DTX401 informed by the FDA's observations related to an application for its Sanfilippo syndrome type A gene therapy.
The firm will pick two lead agents targeting PSMA and CLDN18.2 later this year and a third STEAP1-targeting drug next year.
If there are no dose-limiting toxicities, the company will test the CAR T-cell therapy at higher doses in more patients with FLT3-expressing refractory AML.
SNUG01 showed favorable safety and signs of early clinical efficacy in a recently completed investigator-initiated trial in China, the firm said.
The company will instead focus resources on its last remaining clinical asset, PRT7732, a chemically distinct SMARCA2 degrader.
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