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Nuvation Bio Inc. (NYSE: NUVB) announced a partial clinical hold on its Phase 1 study of NUV-422 due to the emergence of uveitis in patients. The study, which began in December 2020, was exploring higher doses for various solid tumors. Enrollment of new patients is paused while current participants will continue treatment. The company has $737.7 million in cash as of March 31, 2022, enabling it to continue developing its portfolio. An internal risk-benefit analysis will guide future directions after consulting with the FDA.
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The company has $737.7 million in cash as of March 31, 2022, allowing ongoing development of its product candidates.
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A partial clinical hold has been placed on the NUV-422 trial due to safety concerns regarding uveitis.
Enrollment of new patients in the trial is paused, potentially delaying further study progress.
NEW YORK--(BUSINESS WIRE)--
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 the Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. The Company’s Phase 1 trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose. Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the Company proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward. While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study.
"We are committed to patient safety across all of our studies and to working collaboratively with the FDA to develop, as efficiently as possible, new medicines where existing therapies are inadequate,” said David Hung, M.D., founder, president and chief executive officer of Nuvation Bio. “Based upon the recent development of uveitis as a potential safety signal, we will conduct an overall risk/benefit analysis of the NUV-422 program. Our goal is always to ensure that we deploy our resources on programs that have the highest probability of success and of generating value for patients and our investors. With $737.7 million in cash as of March 31, 2022, we are well positioned to continue developing all of our internal product candidates.
The Company will provide updates on the direction of the NUV-422 program after it has completed its internal risk-benefit analysis which will factor in feedback from FDA.
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 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, the statement regarding the adequacy of Nuvation Bio’s cash resources to develop its product candidates. 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 subject to a number of risks and uncertainties, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical trials due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 9, 2022, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
What caused the partial clinical hold on Nuvation Bio's NUV-422 trial?
The partial hold was due to the emergence of uveitis in patients receiving NUV-422, prompting a review for patient safety.
What is NUV-422 being tested for?
NUV-422 is being tested for treating solid tumors, including high-grade glioma, HR+/HER2- advanced breast cancer, and metastatic castration-resistant prostate cancer.
How long has the NUV-422 trial been ongoing?
The NUV-422 trial began enrolling patients 19 months ago, in December 2020.
What are the next steps for Nuvation Bio after the clinical hold on NUV-422?
Nuvation Bio will conduct an internal risk-benefit analysis and consult with the FDA before determining the pathway forward.
