Nuvation Bio Doses First Patient in Phase 1b Combination Study of NUV-868

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) has commenced a Phase 1b study, dosing its first patient with NUV-868 in combination with olaparib for advanced solid tumors, including ovarian and pancreatic cancer. This study aims to assess the safety and optimal dosing of NUV-868, a BD2-selective BET inhibitor. A second regimen will evaluate NUV-868 in conjunction with enzalutamide for metastatic castration-resistant prostate cancer. The CEO, David Hung, highlighted this milestone as a step toward addressing significant unmet needs in oncology.

Positive

• Initiation of Phase 1b study for NUV-868 indicates significant progress in clinical trials.
• NUV-868 is being tested in combination therapies targeting multiple aggressive cancers.

Negative

• None.

Phase 1b study designed to determine the safety and dose of NUV-868 in combination with olaparib or enzalutamide for the treatment of advanced solid tumors

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 it has dosed the first patient in a Phase 1b study of its BD2-selective BET inhibitor, NUV-868, in combination with olaparib.

The Phase 1b study will be conducted under two separate dosing regimens. Patients in the first regimen will be dosed with NUV-868 in combination with olaparib for the treatment of ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors. Patients in the second regimen will be dosed with NUV-868 in combination with enzalutamide for the treatment of mCRPC.

“We are excited to build upon the progress of our Phase 1 monotherapy study of NUV-868 with the initiation of dosing in this Phase 1b combination study. We expect this study to provide a deeper understanding of the potential benefit that NUV-868 can offer a wide range of patients with advanced solid tumors,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “This milestone underscores the continued clinical momentum of our pipeline as we work to tackle some of the greatest unmet needs in oncology.”

As part of the Phase 1b study, NUV-868 will be administered at escalating dose levels in combination with olaparib until the recommended Phase 2 combination dose is determined.

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, statements regarding the potential therapeutic benefit of 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 that may cause actual results to differ from those anticipated by the forward-looking statements, 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; risks related to cost reduction efforts; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on November 3, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221219005673/en/

Nuvation Bio Investor Contact:

ir@nuvationbio.com

Nuvation Bio Media Contact:

Argot Partners

Leo Vartorella

leo@argotpartners.com

Source: Nuvation Bio Inc.

FAQ

What is the purpose of the NUV-868 Phase 1b study?

The Phase 1b study aims to determine the safety and optimal dosing of NUV-868 in combination with olaparib and enzalutamide for treating advanced solid tumors.

Which cancers are targeted in the NUV-868 study?

The study targets ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer, and triple-negative breast cancer.

What is the significance of dosing the first patient in the study?

Dosing the first patient marks a critical milestone in the development of NUV-868, potentially leading to new treatment options for patients with hard-to-treat cancers.

When was the Phase 1b study for NUV-868 announced?

The Phase 1b study was announced in a press release issued on the date of the first patient dosing.

How does NUV-868 work in combination with other treatments?

NUV-868 is designed to be used with olaparib and enzalutamide, aiming to enhance therapeutic efficacy against advanced solid tumors.