Nuvation Bio Announces FDA Acceptance of Investigational New Drug (IND) Application for NUV-422 for Treatment of Patients with High-grade Gliomas

--First compound from pipeline of six early-stage oncology programs to advance into clinical development--

--Company anticipates initiating Phase 1/2 clinical trial of NUV-422 by Q1 2021--

NEW YORK, NY, USA I October 13, 2020 I 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.

About NUV-422
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.

About High-Grade Gliomas
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.i No treatment advances have been made in GBM since 2009 when bevacizumab was approved by the FDA. Temozolomide and radiation are considered the current standard of care for newly diagnosed patients with glioblastoma.ii

About Nuvation Bio
Nuvation Bio is an oncology company focused on revolutionizing cancer treatment by discovering, developing and delivering next-generation therapies that target the greatest needs in oncology. Nuvation Bio's proprietary portfolio includes six novel and mechanistically distinct early-stage oncology programs, each targeting the most devastating types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, 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 www.nuvationbio.com.

i Tachamo N, Nazir S, Lohani S, Le B, Alweis R. Glioblastoma management: challenges in the elderly population.
J Community Hosp Intern Med Perspect. 2016; 6(5). Published online 2016 Oct 26. https://www.tandfonline.com/doi/full/10.3402/jchimp.v6.32372. Accessed October 13, 2020.
ii Fernandes C, Costa A, Osorio L, et al. Current standards of care in glioblastoma. https://www.ncbi.nlm.nih.gov/books/NBK469987/. Accessed October 13, 2020.

SOURCE: Nuvation Bio

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