Nuvation Bio Announces Updates and Upcoming Presentations for its ROS1 Inhibitor, Taletrectinib

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) announced updates for its taletrectinib program, a ROS1 inhibitor for non-small cell lung cancer (NSCLC). Key highlights include:

• Presentation of pooled data from pivotal Phase 2 TRUST-I and TRUST-II studies at ESMO Congress 2024, supporting the New Drug Application (NDA) in the US
• Presentation of global Phase 2 TRUST-II study data at WCLC 2024
• FDA granted Orphan Drug Designation for taletrectinib in ROS1-positive NSCLC and other NSCLC indications

The company aims to commercialize taletrectinib in 2025. The Orphan Drug Designation provides development incentives, including tax credits and potential market exclusivity. Taletrectinib is being evaluated in two pivotal Phase 2 studies for ROS1-positive NSCLC patients.

Company to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the European Society of Medical Oncology (ESMO) Congress 2024, which will support Nuvation Bio’s New Drug Application (NDA) in the United States

Company to present data from the global, pivotal Phase 2 TRUST-II study at the 2024 World Conference on Lung Cancer (WCLC)

Taletrectinib granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ROS1-positive non-small cell lung cancer (NSCLC) and other NSCLC indications

NEW YORK--(BUSINESS WIRE)-- Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced multiple updates for its taletrectinib program. Data from the global, pivotal Phase 2 TRUST-II study has been accepted for an oral presentation at WCLC 2024 taking place September 7-10 in San Diego, California. Pooled data from both pivotal Phase 2 studies, TRUST-I and TRUST-II, has been accepted for a poster presentation at ESMO 2024 taking place September 13-17, in Barcelona, Spain. The pooled data presented at ESMO will support the Company’s NDA in the United States. Additionally, the U.S. FDA has granted Orphan Drug Designation to taletrectinib for the treatment of multiple NSCLC indications, including ROS1-positive NSCLC.

“We are excited to share these program updates as we continue toward our goal of bringing taletrectinib to patients with ROS1-positive NSCLC. We look forward to sharing the latest TRUST-II data at WCLC 2024 and pooled TRUST-I and TRUST-II data at ESMO 2024. The pooled data to be presented at ESMO will support our NDA in the U.S. and, we believe, position us to commercialize taletrectinib in 2025,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Further, we are pleased with the FDA’s recent determination that taletrectinib qualifies for Orphan Drug Designation, which represents another key regulatory milestone for this important program.”

Taletrectinib was granted Orphan Drug Designation for the treatment of ROS1- positive, NTRK-positive, ALK-positive, LTK-positive, ACK1-positive, or DDR1-positive NSCLC. The FDA's Office of Orphan Drug Products grants this designation to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees and potential market exclusivity for seven years upon FDA approval.

Taletrectinib is being evaluated for the treatment of patients with ROS1-positive NSCLC in two pivotal Phase 2 studies, TRUST-I (NCT04395677) in China and TRUST-II (NCT04919811), a global pivotal study.

WCLC Presentation Overview:

Title: Efficacy and Safety of Taletrectinib in Patients with ROS1+ Non–Small Cell Lung Cancer: The Global TRUST-II Study
Presenter: Geoffrey Liu, MD
Date: September 10, 2024
Session Time: 11:15 a.m. – 12:30 p.m. PDT
Session: MA06 - New Strategies in ALK, ROS1, NTRK, BRAF, and MET NSCLC
Abstract: 1752

ESMO Presentation Overview:

Title: Pooled Efficacy and Safety From 2 Pivotal Phase 2 Trials of Taletrectinib in Patients (Pts) With Advanced or Metastatic ROS1+ Non–Small Cell Lung Cancer (NSCLC)
Presenter: Maurice Perol, M.D.
Date: September 14, 2024
Session Time: Poster Lunch, 12:00-1:00 p.m. CEST (on display from 9:00 a.m. - 5:00 p.m. CEST)
Session: Poster Display, NSCLC, Metastatic
Abstract: 1289P

The materials will be made available on the Publications section of nuvationbio.com the day of the respective presentations.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Taletrectinib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ROS1-positive NSCLC and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 tyrosine kinase inhibitors (TKIs).

About ROS1-positive NSCLC

More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 1-3% of people with NSCLC are ROS1-positive. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC who remain in need of new options.

About Nuvation Bio

Nuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-868 (BET), and NUV-1511 (DDC). 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, San Francisco, and Shanghai. For more information, please visit www.nuvationbio.com and https://www.linkedin.com/company/nuvationbio/.

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, our expectations regarding a U.S. NDA, the expected timing of becoming a commercial organization, and the potential therapeutic benefit of taletrectinib. 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 studies 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 14, 2024 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.

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Nuvation Bio Investor Contact:

ir@nuvationbio.com



Nuvation Bio Media Contact:

nuvation@argotpartners.com

Source: Nuvation Bio Inc.

FAQ

What is the latest update on Nuvation Bio's taletrectinib for ROS1-positive NSCLC?

Nuvation Bio (NUVB) will present pooled data from Phase 2 TRUST-I and TRUST-II studies at ESMO 2024, supporting their NDA. They'll also present TRUST-II data at WCLC 2024. Taletrectinib received FDA Orphan Drug Designation for ROS1-positive NSCLC and other NSCLC indications.

When does Nuvation Bio plan to commercialize taletrectinib?

Nuvation Bio (NUVB) aims to commercialize taletrectinib, their ROS1 inhibitor for non-small cell lung cancer, in 2025.

What benefits does the FDA Orphan Drug Designation provide for taletrectinib?

The FDA Orphan Drug Designation for taletrectinib (NUVB) provides development incentives, including tax credits for eligible clinical trials, waiver of application fees, and potential market exclusivity for seven years upon FDA approval.

Where and when will Nuvation Bio present the TRUST-II study data for taletrectinib?

Nuvation Bio (NUVB) will present data from the global, pivotal Phase 2 TRUST-II study at the World Conference on Lung Cancer (WCLC) 2024, taking place September 7-10 in San Diego, California.

What types of NSCLC does taletrectinib's Orphan Drug Designation cover?

Taletrectinib (NUVB) received Orphan Drug Designation for ROS1-positive, NTRK-positive, ALK-positive, LTK-positive, ACK1-positive, and DDR1-positive non-small cell lung cancer (NSCLC).