NEW YORK, March 11, 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 granted Orphan Drug Designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with malignant gliomas.
The FDA's Office of Orphan Drug Products grants Orphan Drug Designation to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees and market exclusivity for seven years upon FDA approval.
"We are pleased to receive the FDA's Orphan Drug Designation, which underscores the potential of NUV-422 to address the significant unmet need of patients with high-grade gliomas," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "We look forward to continuing the development of NUV-422 through our ongoing Phase 1/2 study."
Patient enrollment and dosing is ongoing in the Phase 1/2 study of NUV-422 in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM). The Phase 1 dose escalation part of the study is designed to evaluate safety and tolerability, as well as to determine a recommended Phase 2 dose based on the tolerability profile and pharmacokinetic properties of NUV-422. The Phase 2 dose expansion part of the study is expected to initially focus on patients with high-grade gliomas and is designed to evaluate overall response rate, duration of response and survival. Data from the Phase 1 portion of this study is expected 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.
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 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 www.nuvationbio.com.
Forward Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential therapeutic benefit of Nuvation Bio's product candidates and the expected timing of clinical trial data. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Nuvation Bio. These forward-looking statements are subject to a number of risks and uncertainties, including those factors discussed in the proxy statement/prospectus filed with the SEC on January 20, 2021, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file, with the SEC. If any of these risks materialize or Nuvation Bio's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Nuvation Bio does not presently know, or that Nuvation Bio currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio's expectations, plans or forecasts of future events and views as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause Nuvation Bio's assessments to change. However, while Nuvation Bio may elect to update these forward-looking statements at some point in the future, Nuvation Bio specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nuvation Bio's assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
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.
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