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Nuvation Bio Gets New Drug Application Clearance From FDA for Solid Tumor Treatment

By Dean Seal

Nuvation Bio said federal regulators have cleared an investigational new drug application for its treatment of advanced solid tumors, NUV-1511.

The biopharmaceutical company said Monday that the Food and Drug Administration's clearance makes NUV-1511 the first clinical candidate from the company's novel drug-drug conjugate platform.

"This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents," Chief Executive David Hung said.

The company said it expects to launch a Phase 1/2 study of NUV-1511 in the first half of this year.

Write to Dean Seal at dean.seal@wsj.com

 

(END) Dow Jones Newswires

January 08, 2024 16:43 ET (21:43 GMT)

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