Date: 16-Oct-2020

US FDA Accepts Nuvation Bios IND Application For NUV-422 To Treat Highgrade Gliomas

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, announced that the US 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 US 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.

NUV-422 is a selective small molecule resulting from Nuvation Bio's cyclin-dependent kinase (CDK) inhibitor program. CDK4/6 inhibitors are known clinical entities with proven efficacy, but cancer cells can evade these treatments by increasing signaling through CDK2. Inhibition of CDK2 in addition to CDK4/6 cuts off the tumor's natural escape route. NUV-422 is a potent inhibitor of CDK 2, 4 and 6. Preclinical studies have shown that NUV-422 has favorable blood-brain barrier penetration.

Primary tumors of the central nervous system (CNS) remain among the most difficult to treat, with a 5-year overall survival of approximately 35%. Gliomas, which begin in the glial or supportive tissue, represent 75% of malignant primary brain tumors in adults. Glioblastoma multiforme (GBM) accounts for 50% to 70% of all gliomas. More than 10,000 people in the United States each year are diagnosed with this aggressive, difficult-to-treat brain tumor. No treatment advances have been made in GBM since 2009 when bevacizumab was approved by the US FDA. Temozolomide and radiation are considered the current standard of care for newly diagnosed patients with glioblastoma