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.

纽约--（商业新闻短讯）--Nuvation Bio Inc.（纽约证券交易所：NUVB）是一家临床晚期的全球生物制药公司，致力于解决肿瘤学中一些最大的未满足需求，今天宣布对其taletrectinib计划进行多次更新。来自全球关键的第二阶段TRUST-II研究的数据已被接受，将于9月7日至10日在加利福尼亚州圣地亚哥举行的2024年WCLC上进行口头演示。

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..

来自关键的第二阶段研究TRUST-I和TRUST-II的汇总数据已被接受用于9月13日至17日在西班牙巴塞罗那举行的ESMO 2024海报展示。ESMO提供的汇总数据将支持该公司在美国的NDA。此外，美国食品和药物管理局（FDA）已将孤儿药指定给他来替尼，用于治疗多种NSCLC适应症，包括ROS1阳性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.

“随着我们继续朝着为ROS1阳性非小细胞肺癌患者提供他列替尼的目标迈进，我们很高兴分享这些计划更新。我们期待在WCLC 2024年分享最新的TRUST-II数据，并在ESMO 2024年分享TRUST-I和TRUST-II数据。ESMO上提供的汇总数据将支持我们在美国的NDA。

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.”.

Nuvation Bio的创始人、总裁兼首席执行官David Hung医学博士说：“我们相信，我们将在2025年使他来曲替尼商业化。此外，我们对FDA最近确定他来曲替尼符合孤儿药资格感到高兴，这代表了这一重要计划的另一个关键监管里程碑。”。

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.

Taletrectinib被授予孤儿药名称，用于治疗ROS1阳性，NTRK阳性，ALK阳性，LTK阳性，ACK1阳性或DDR1阳性NSCLC。美国食品和药物管理局（FDA）孤儿药品办公室（Office of Orphan Drug Products）授予这一称号，以支持针对服务不足的患者群体或罕见疾病（影响美国不到20万人）开发的候选药物。

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..

孤儿药指定使候选人有资格获得各种开发奖励，包括符合条件的临床试验的税收抵免，在FDA批准后七年内免除申请费和潜在的市场排他性。。

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.

在中国的TRUST-I（NCT04395677）和TRUST-II（NCT04919811）（一项全球关键研究）两项关键的2期研究中，正在评估Taletrectinib治疗ROS1阳性NSCLC患者。

WCLC Presentation Overview:

WCLC演示概述：

Title: Efficacy and Safety of Taletrectinib in Patients with ROS1+ Non–Small Cell Lung Cancer: The Global TRUST-II Study

标题：Taletrectinib治疗ROS1+非小细胞肺癌患者的疗效和安全性：全球TRUST-II研究

Presenter: Geoffrey Liu, MD

主持人：Geoffrey Liu，医学博士

Date: September 10, 2024

日期：2024年9月10日

Session Time: 11:15 a.m. – 12:30 p.m. PDT

会议时间：太平洋夏令时上午11:15–下午12:30

Session: MA06 - New Strategies in ALK, ROS1, NTRK, BRAF, and MET NSCLC

会议：MA06-ALK，ROS1，NTRK，BRAF和MET NSCLC的新策略

Abstract: 1752

摘要：1752年

ESMO Presentation Overview:

ESMO演示概述：

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)

标题：来自2项关键的他列替尼2期临床试验对晚期或转移性ROS1+非小细胞肺癌（NSCLC）患者的汇总疗效和安全性

Presenter: Maurice Perol, M.D.

主持人：莫里斯·佩罗（MauricePerol），医学博士。

Date: September 14, 2024

日期：2024年9月14日

Session Time: Poster Lunch, 12:00-1:00 p.m. CEST (on display from 9:00 a.m. - 5:00 p.m. CEST)

会议时间：海报午餐，CEST下午12:00-1:00（CEST上午9:00-下午5:00展出）

Session: Poster Display, NSCLC, Metastatic

会议：海报展示，非小细胞肺癌，转移性

Abstract: 1289P

摘要：1289P

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

这些材料将在各自演示当天在nuvationbio.com的出版物部分提供。

About Taletrectinib

关于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是一种口服，有效，中枢神经系统活性，选择性的下一代ROS1抑制剂，专门用于治疗晚期ROS1阳性NSCLC患者。Taletrectinib正在两项2期单臂关键研究中评估治疗晚期ROS1阳性NSCLC患者：中国的TRUST-I（NCT04395677）和全球研究TRUST-II（NCT04919811）。

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.

Taletrectinib已被美国食品和药物管理局（FDA）授予孤儿药名称，用于治疗ROS1阳性NSCLC患者，并被美国FDA和中国国家医药产品管理局（NMPA）授予突破性治疗名称，用于治疗晚期或转移性ROS1阳性NSCLC患者。

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)..

根据TRUST-I临床研究的结果，中国NMPA已接受并优先审查了用于治疗局部晚期或转移性ROS1阳性NSCLC的成年患者的他列替尼新药申请，这些患者以前曾或未接受过ROS1酪氨酸激酶抑制剂（TKIs）治疗。。

About ROS1-positive NSCLC

关于ROS1阳性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.

全球每年有100多万人被诊断出患有NSCLC，这是最常见的肺癌形式。据估计，大约1-3%的NSCLC患者ROS1阳性。高达35%的新诊断为转移性ROS1阳性NSCLC的人的肿瘤已经扩散到他们的大脑，对于那些在初始治疗后癌症进展的人来说，增加了高达55%。

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..

虽然其他类型肺癌患者取得了巨大进展，但ROS1阳性非小细胞肺癌患者仍需要新的选择，进展有限。。

About Nuvation Bio

关于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是一家临床后期的全球生物制药公司，通过开发差异化和新颖的候选产品来解决肿瘤学中一些最大的未满足需求。Nuvation Bio的开发候选者组合包括taletrectinib（ROS1），safusidenib（mIDH1），NUV-868（BET）和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/..

Nuvation Bio于2018年由生物制药行业资深医生David Hung医学博士创立，他之前创立了Medivation，Inc.，该公司为患者带来了世界领先的前列腺癌药物之一。Nuvation Bio在纽约、旧金山和上海设有办事处。有关更多信息，请访问www.nuvationbio.com和https://www.linkedin.com/company/nuvationbio/..

Forward Looking Statements

前瞻性声明

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.

根据1995年《美国私人证券诉讼改革法案》的安全港条款，本新闻稿中包含的某些非历史事实的声明是前瞻性声明。前瞻性陈述有时伴随着“相信”、“可能”、“会”、“估计”、“继续”、“预期”、“打算”、“期望”、“应该”、“会”、“计划”、“预测”、“潜在”、“看起来”、“寻求”、“未来”、“展望”等词语，以及预测或指示未来事件或趋势或不属于历史事项陈述的类似表达。

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.

这些前瞻性声明包括但不限于我们对美国NDA的期望，成为商业组织的预期时间以及他列替尼的潜在治疗益处。。

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.

这些前瞻性声明受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与前瞻性声明预期的结果不同，包括但不限于由于监管过程中的困难或延迟，招募受试者或制造或获取必要产品而导致的与药物发现和启动或进行临床研究相关的挑战；不良事件或其他不良副作用的出现或恶化；与初步和中期数据相关的风险，可能不代表更成熟的数据；和竞争发展。

Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed wi.

Nuvation Bio面临的风险和不确定性在其10-Q表格wi中有更全面的描述。