Nuvation Bio Announces FDA Acceptance of Investigational New Drug (IND) Application for NUV-422 for Treatment of Patients with High-grade Gliomas
NEW YORK, Oct. 13, 2020 /PRNewswire/ -- Nuvation Bio, Inc., an oncology company focused on revolutionizing cancer treatment by discovering, developing and delivering next-generation therapies that target the greatest needs in oncology, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for NUV-422, an investigational CDK2/4/6 inhibitor. The company plans to initiate enrollment in a Phase 1/2 study of NUV-422 in patients with high-grade gliomas by the first quarter of 2021.
"The FDA's acceptance of the IND for NUV-422 is an important milestone for Nuvation Bio. We look forward to initiating the Phase 1/2 study, our first-in-human trial of a compound derived from our deep pipeline, which includes six novel and mechanistically distinct early-stage oncology programs, each targeting multiple difficult-to-treat cancers," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "We have advanced NUV-422 through preclinical studies that have informed a robust clinical development plan to treat recurrent high-grade gliomas, including glioblastoma multiforme, which are known to carry significant alterations of CDK function. Based on this data, we believe that NUV-422 has the potential to offer significant clinical benefit to patients with high-grade gliomas, a devastating cancer for which treatment options are very limited."
Nuvation Bio's open-label, Phase 1/2 dose-escalation and multiple expansion cohort study is expected to enroll approximately 80 adult patients with recurrent or refractory high-grade gliomas at trial sites in the United States. The Phase 1 dose-escalation part of the study will evaluate the safety, tolerability and pharmacokinetics of oral doses of NUV-422. The company anticipates reporting top-line data from that part of the study in 2022.
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i Tachamo N, Nazir S, Lohani S, Le B, Alweis R. Glioblastoma management: challenges in the elderly population.
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SOURCE Nuvation Bio, Inc.