- U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422.
- It is a Cyclin-Dependent Kinase (CDK) 2/4/6 inhibitor, for the treatment of advanced breast 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).
Nuvation Bio Inc. 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 cleared its investigational new drug (IND) application to evaluate NUV-422, a Cyclin-Dependent Kinase (CDK) 2/4/6 inhibitor, for the treatment of advanced breast 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). The Company began a monotherapy Phase 1/2 study in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer (with and without brain metastases) and metastatic castration resistant prostate cancer (mCRPC). The Company is continuing to enroll patients in the Phase 1 dose escalation portion of the study.
“FDA clearance of our second IND application for NUV-422 is an important milestone for our lead investigational CDK 2/4/6 inhibitor program as we develop our deep pipeline of innovative new cancer therapeutics,” said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. “We are encouraged by the differentiated and broad potential of NUV-422 to address multiple tumor types. We look forward to sharing data from the Phase 1 dose escalation portion in the second half of 2022.”
With the clearance of this IND in advanced breast cancer, Nuvation Bio will be initiating a Phase 1/2 study in patients with HR+/HER2- advanced breast cancer who have received prior hormonal therapy combined with an approved CDK 4/6 inhibitor. This study (Protocol NUV-422-03) will begin with a Phase 1b dose escalation portion designed to evaluate safety and tolerability of the NUV-422 plus fulvestrant combination and to determine a recommended Phase 2 combination dose of NUV-422. The Phase 2 portion is a randomized, non-comparative study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy.
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.
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 Quarterly Report on Form 10-Q filed with the SEC on November 10, 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.