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Nuvation Bio Announces Discontinuation of NUV-422 Clinical Development Program

Tuesday, August 02, 2022

Nuvation Bio Inc., a biopharmaceutical company dedicated to addressing significant unmet needs in oncology through the development of innovative and distinct therapeutic candidates, has announced its decision to prioritize NUV-868 and the advancement of its novel small molecule DDC platform, while discontinuing the clinical development of NUV-422.

The choice to halt the clinical development of NUV-422 follows an internal risk-benefit analysis that considered feedback received from the U.S. Food and Drug Administration (FDA) in the form of partial clinical hold letters. The FDA placed a partial clinical hold on the Phase 1 dose escalation portion of the NUV-422-02 study in June 2022 due to the emergence of uveitis, a form of eye inflammation, as a safety concern. In response, the company proactively paused enrollment of new patients and was requested by the FDA to provide a mitigation plan to address the adverse event. However, given the unpredictable nature and lack of understanding regarding the etiology of uveitis associated with NUV-422, developing an effective mitigation plan would require substantial further research.

Nuvation Bio will now shift its focus and allocate resources toward the clinical development of NUV-868, a BD2-selective BET inhibitor, and identifying a lead clinical candidate from its novel small molecule DDC platform. The Phase 1 monotherapy study of NUV-868 is ongoing, and the company has planned Phase 1b studies to explore NUV-868 in combination with olaparib or enzalutamide to maximize its potential efficacy across various tumor types.

To align with the program discontinuation of NUV-422, Nuvation Bio will reduce its workforce by 35% and implement other cost-saving measures. These actions will enable the company to extend its financial runway through 2028, with an expected cash, cash equivalents, and marketable securities balance of approximately $703.8 million as of June 30, 2022.

Dr. David Hung, Founder, President, and Chief Executive Officer of Nuvation Bio, expressed the company's commitment to advancing innovative therapies for cancers lacking adequate treatment options. He acknowledged the rigorous and data-driven approach taken by the company, which led to the decision to discontinue the NUV-422 program after an extensive analysis of the Phase 1 dose escalation study in solid tumors. Dr. Hung expressed gratitude to the patients, investigators, and employees involved in the NUV-422 clinical program, emphasizing the difficult nature of the decision and recognizing their contributions.

Dr. Hung further emphasized that the prioritization of other programs over NUV-422 based on the most recent clinical data is a disciplined and data-driven approach, aimed at increasing the probability of success in bringing groundbreaking drugs to patients in need. He expressed enthusiasm for the ongoing enrollment of patients in the NUV-868 Phase 1 study and the progress made with the novel small molecule DDC platform. With a substantial cash balance and a highly skilled drug development team, Nuvation Bio is well positioned to advance these priority programs targeting some of the most challenging-to-treat cancers.

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