Nuvation Bio Inc. announced that the 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 advanced breast 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). The Company began a monotherapy Phase 1/2 study 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 Phase 1 dose-escalation portion of the study.

"FDA clearance of our second IND application for NUV-422 is an important milestone for our lead investigational CDK 2/4/6 inhibitor program as we develop our deep pipeline of innovative new cancer therapeutics," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We are encouraged by the differentiated and broad potential of NUV-422 to address multiple tumor types. We look forward to sharing data from the Phase 1 dose-escalation portion in the second half of 2022."

With the clearance of this IND in advanced breast cancer, Nuvation Bio will be initiating a Phase 1/2 study in patients with HR+/HER2- advanced breast cancer who have received prior hormonal therapy combined with an approved CDK 4/6 inhibitor. This study (Protocol NUV-422-03) will begin with a Phase 1b dose-escalation portion designed to evaluate safety and tolerability of the NUV-422 plus fulvestrant combination and to determine a recommended Phase 2 combination dose of NUV-422. The Phase 2 portion is a randomized, non-comparative study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy.