Nuvation Bio Announces FDA Partial Clinical Hold for Phase 1 Study of NUV-422 in Solid Tumors

Jun 27, 2022

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. The Company’s Phase 1 trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose. Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the Company proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward. While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study.

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