HCW Biologics Gets FDA Clearance to Proceed With Cancer-Treatment Trial

By Chris Wack

HCW Biologics Inc. said it has been cleared by the U.S. Food and Drug Administration to proceed to evaluate its lead drug candidate, HCW9218, in a first-in-human Phase 1b clinical trial in patients with advanced pancreatic cancer.

The biopharmaceutical company said its HCW9218 is an injectable, fusion protein complex designed to drive bifunctional, anti-tumor activity by activating desired immune responses to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities.

HCW said that in preclinical studies, it showed that HCW9218 enhanced the anti-tumor efficacy of chemotherapy docetaxel and gemcitabine plus nab-paclitaxel against melanoma and pancreatic cancer, respectively, and simultaneously alleviated the off-target, unwanted effects of chemotherapies on normal tissues.

In experimental animal models, HCW9218 was also shown to augment anti-tumor activities of therapeutic and checkpoint antibodies, which are currently standard-of-care anti-cancer treatment for certain solid tumors.

HCW Biologics shares were up 12%, to $3.28, in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 28, 2021 07:36 ET (11:36 GMT)

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