Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-422 for the Treatment of Prostate Cancer


NEW YORK, Dec. 13, 2021 /PRNewswire/ -- 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 that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of prostate cancer. The FDA accepted the Company's first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (GBM), and a second IND for the treatment of advanced breast cancer in December 2021.

The Company began a monotherapy Phase 1/2 study (Protocol NUV-422-02) in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer (with and without brain metastases) and metastatic castration resistant prostate cancer (mCRPC). The Company is continuing to enroll patients in the monotherapy Phase 1 dose escalation portion of the study.

"FDA clearance of our third IND application for NUV-422 is another important achievement for our lead investigational CDK 2/4/6 inhibitor program as we develop our deep pipeline of innovative new cancer therapeutics across a variety of tumor types," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We look forward to sharing data from the Phase 1 monotherapy dose escalation portion in the second half of 2022."

With the clearance of this IND in prostate cancer, Nuvation Bio will be initiating a Phase 1b/2 study in patients with mCRPC who have received prior treatment with abiraterone acetate. This study (Protocol NUV-422-04) will begin with a Phase 1b dose escalation portion designed to evaluate safety and tolerability of NUV-422 plus enzalutamide combination and to determine a recommended Phase 2 combination dose of NUV-422. The Phase 2 portion will be an open-label, single-arm study designed to evaluate efficacy and further explore safety of NUV-422 in combination with enzalutamide in previously treated mCRPC patients who can have measurable or nonmeasurable disease.   

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio's proprietary portfolio includes six novel and mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit

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