Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-868 for the Treatment of Advanced Solid Tumors

NEW YORK, Jan. 20, 2022 /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 cleared its investigational new drug (IND) application to evaluate NUV-868, a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor, for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration resistant prostate cancer (mCRPC), and triple negative breast cancer (TNBC).

"The clearance of our IND application for NUV-868 is an important milestone for Nuvation Bio as it marks the fourth IND in the last 14 months across our deep pipeline of innovative cancer therapeutics targeting multiple tumor types," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We are encouraged by the selectivity and potentially improved tolerability demonstrated by NUV-868 in preclinical studies, and we look forward to advancing the program into Phase 1 development in mid-2022."

NUV-868 inhibits BRD4, which is a key member of the BET family that epigenetically regulates proteins that control tumor growth and differentiation. NUV-868 is designed to be more selective for BD2 than BD1 in an attempt to avoid the therapeutic limiting toxicities of other BRD4 inhibitors like gastrointestinal (GI) and bone marrow toxicities. Preclinical studies have demonstrated NUV-868 is almost 1,500 times more selective for BD2 than BD1. Non-selective BD1/2 inhibitors in development have been associated with tolerability issues, potentially due to too much BD1 inhibition.

With the clearance of this IND for NUV-868 in advanced solid tumors, Nuvation Bio will be initiating a Phase 1/2 study of NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in multiple tumor types. This protocol (NUV-868-01) will begin with a Phase 1 monotherapy dose escalation study in advanced solid tumor patients. A Phase 1b study will then be initiated exploring NUV-868 in combination with olaparib in previously treated ovarian cancer, pancreatic cancer, mCRPC, and TNBC patients and in combination with enzalutamide for mCRPC patients followed by a Phase 2b study to further explore safety and efficacy once the recommended Phase 2 combination dose is determined. A Phase 2 monotherapy study will also be initiated in mCRPC patients as well to further explore safety and efficacy.

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 initiation. 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. Actual events and circumstances, many of which are beyond Nuvation Bio's control, are difficult or impossible to predict and may cause actual results to differ materially from those anticipated by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the inherent uncertainty associated with pharmaceutical product development and clinical trials; the risk of unexpected emergence of adverse events or other undesirable side effects; delays in clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; disruptions to normal business operations relating to the COVID-19 pandemic; and developments in the competitive landscape. The risks and uncertainties facing Nuvation Bio are discussed more fully in its 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. 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 anticipated by the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio's expectations, plans or forecasts of future events and views only as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause its 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.

Nuvation Bio Investor Contact:
[email protected]

Nuvation Bio Media Contact:
Argot Partners
Leo Vartorella
[email protected]

SOURCE Nuvation Bio, Inc.