Nuvation Bio Announces FDA Approval of Investigational New Drug Application for NUV-422 for the Treatment of Prostate Cancer | national news

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NEW YORK, December 13, 2021 / PRNewswire / – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company addressing some of the world’s largest unmet needs in oncology by developing differentiated and innovative drug candidates, today announced that the Food and Drug Administration (FDA) in the United States has cleared its new New Drug Investigation Application (IND) to evaluate NUV-422, a 2/4/6 cyclin-dependent kinase (CDK) inhibitor, for the treatment of prostate 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), and a second IND for the treatment of advanced breast cancer in december 2021.

The Company has started a Phase 1/2 monotherapy study (Protocol NUV-422-02) in december 2020 in high-grade gliomas and subsequently modified the protocol in Q2 2021 to include advanced HR + / HER2- breast cancer (with and without brain metastases) and metastatic castration-resistant prostate cancer (mCRPC) . The Company continues to enroll patients in the phase 1 monotherapy dose escalation portion of the study.

“The FDA clearance of our third IND application for NUV-422 is another significant achievement for our investigational lead CDK 2/4/6 inhibitor program as we develop our extensive pipeline of innovative new cancer therapies on a variety of tumor types, ”said David hung, MD, Founder, President and CEO of Nuvation Bio. “We look forward to sharing Phase 1 monotherapy dose escalation data in the second half of 2022.”

With the authorization of this IND in prostate cancer, Nuvation Bio will enter a phase 1b/ 2 in patients with mCRPC who have received previous treatment with abiraterone acetate. This study (Protocol NUV-422-04) will begin with a Phase 1b dose escalation portion designed to assess the safety and tolerability of NUV-422 plus enzalutamide and to determine a recommended combined phase 2 dose of NUV-422. The Phase 2 portion will be an open label, single arm study designed to assess the efficacy and further explore the safety of NUV-422 in combination with enzalutamide in previously treated mCRPC patients who may or may not have measurable disease. measurable.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company addressing some of the greatest unmet needs in oncology by developing differentiated and innovative drug candidates. Nuvation Bio’s proprietary portfolio includes six new mechanically distinct oncology therapeutic product candidates, each targeting some of the most difficult to treat cancer types. Nuvation Bio was founded in 2018 by a veteran of the biopharmaceutical industry David hung, MD, who previously founded Medivation, Inc., which brought one of the world’s leading prostate cancer drugs to patients. Nuvation Bio has offices at 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 the 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”, “should”, ” plan ”,“ predict ”,“. appear “,” seek “,” future “,” prospect “and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, without limitation, statements regarding the potential therapeutic benefit of Nuvation Bio’s product candidates and the expected timing of clinical trial initiation and data release. These statements are based on various assumptions, whether or not identified in this press release, and on expectations current results of the Nuvation Bio management team and are not predictions of actual performance. These forward-looking statements are provided for informational purposes only and are not intended to serve as, and should not be relied upon as, any guarantee, assurance, prediction or definitive statement of fact or probability. Actual events and circumstances are difficult or improper. possible to predict and will differ from the assumptions. Many real events and circumstances are beyond the control of Nuvation Bio. These forward-looking statements are subject to a number of risks and uncertainties, including the factors discussed in the Quarterly Report on Form 10-Q filed with the SEC on November 10, 2021, under “Risk Factors” and other documents that Nuvation Bio has filed or will file with the SEC. If any of these risks materialize or if Nuvation Bio’s assumptions turn out to be incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Nuvation Bio is not currently aware of, or that Nuvation Bio currently considers to be immaterial, which could also cause actual results to differ from those contained in forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio’s expectations, plans or forecasts regarding future events and views as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause the assessments of Nuvation Bio to change. However, although Nuvation Bio may choose to update these forward-looking statements at some time in the future, Nuvation Bio specifically disclaims any obligation to do so. These forward-looking statements should not be taken as representing the assessments of Nuvation Bio as of a date subsequent to the date of this press release. Therefore, one should not place undue reliance on forward-looking statements.

Nuvation Bio Investor Contact:

[email protected]

Nuvation Bio media contact:

Argot Partners

Leo Vartorella

[email protected]

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SOURCE Nuvation Bio, Inc.


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