Innovent Biologics and AnHeart Therapeutics Receive NMPA Breakthrough Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

Rhea-AI Summary

Innovent Biologics and AnHeart Therapeutics announced that the Center for Drug Evaluation (CDE) of China's NMPA granted Breakthrough Therapy Designation to taletrectinib for ROS1-positive non-small cell lung cancer (NSCLC). This designation is based on Phase 2 trial results where taletrectinib showed a 90.5% objective response rate in treatment-naïve patients. The drug targets ROS1 fusion mutations, which affect 1-2% of NSCLC cases, and demonstrated good safety and efficacy profiles. Ongoing trials aim to further evaluate its potential for NSCLC patients.

Positive

• NMPA granted Breakthrough Therapy Designation for taletrectinib, indicating a faster review process.
• Phase 2 TRUST trial results show a 90.5% objective response rate in TKI-naïve patients.
• Taletrectinib displays strong efficacy against crizotinib-resistant mutations and good safety profile.

Negative

• Potential for market competition as other therapies may enter the pipeline for ROS1-positive NSCLC.
• Reliance on ongoing Phase 2 trial results, which could lead to uncertainties in future approvals.

SAN FRANCISCO and SUZHOU, China, Feb. 28, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, together with AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapies, today jointly announced that the Center for Drug Evaluation (CDE) of China's Nation Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to taletrectinib (Innovent R&D code: IBI-344, Anheart R&D code: AB-106) for both first-line tyrosine kinase inhibitor (TKI)-naïve and second-line TKI-pretreated patients with ROS1-positive non-small cell lung cancer (NSCLC).

The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors. According to the data presented (cut-off date: June 16, 2021) at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting, in the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21). In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16). In addition, taletrectinib showed promising efficacy in patients with crizotinib-resistant G2032R mutation, intracranial antitumor activity in brain metastatic patients with few neurological adverse events. Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased.

"We are glad to see the NMPA grant Breakthrough Therapy Designation based on the Phase 2 data of taletrectinib," said Dr. Hui Zhou, Senior Vice President of Innovent. "ROS1 fusion-positive patients currently have limited treatment options. Taletrectinib has demonstrated good efficacy and safety results, which indicated its potential to be a novel therapy for those patients in urgently need. We look forward to obtaining more data from the ongoing Phase 2 trial and bringing hope to patients with ROS1 fusion-positive NSCLC."

"There is a high unmet medical need for lung cancer patients with ROS1 fusion mutations," said Bing Yan, MD, Co-Founder and Chief Medical Officer at AnHeart Therapeutics. "The results from the Phase 2 trial evaluating taletrectinib in patients with ROS1 fusion mutations are encouraging and provide a strong basis for our future potential regulatory filing in this indication."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite development and review of an investigational drug to treat serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but also allow the sponsor to obtain timely advice and communications from the CDE to accelerate the approval and launch in order to address the unmet clinical needs of patients at an accelerated pace. Click here for the published list of drugs which have been granted BTD by NMPA.

Additional information on clinical trials for taletrectinib (NCT04395677 and NCT04919811) is available at www.clinicaltrials.gov.

About Taletrectinib (IBI-344)

Taletrectinib is a novel best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusion mutations with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers. Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse effects were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib. More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at https://clinicaltrials.gov. For questions about the ongoing trials, please contact trials@anhearttherapeutics.com.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 29 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 6 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI), 5 assets in Phase 3 or pivotal clinical trials, and an additional 18 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

Disclaimer:

1. This indication is still under clinical study, which hasn't been approved in China.

2. Innovent does not recommend any off-label usage.

3. For medical and healthcare professionals only.

About AnHeart Therapeutics

AnHeart Therapeutics ("AnHeart"), a Cayman Islands entity (registered name AnBio Therapeutics Ltd.), is a clinical-stage global biopharmaceutical group company developing a broad pipeline of novel next-generation precision oncology therapeutics with high unmet medical needs. Its lead asset, taletrectinib, is a best-in-class next-generation ROS1 inhibitor currently in Phase 2 trials for the first-line TKI-naïve and second-line TKI-pre-treated patietns with ROS1 fusion positive non-small cell lung cancer (NSCLC). The Company's pipeline also includes AB-218, a mIDH1 inhibitor in Phase 2 trials with good brain penetration for multiple solid tumors with mIDH1 mutations and AB-329, an AXL inhibitor in Phase 1 studies to be used in combination with checkpoint inhibitor or chemotherapies in NSCLC or other solid tumors. The Company operates from offices in the US and China. For more information, please visit www.anhearttherapeutics.com.

Innovent's Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

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SOURCE Innovent Biologics

FAQ

What is the significance of the Breakthrough Therapy Designation for taletrectinib (IVBIY)?

The Breakthrough Therapy Designation by NMPA facilitates faster review and approval of taletrectinib for patients with ROS1-positive NSCLC.

What were the results of the Phase 2 trial for taletrectinib (IVBIY)?

In the Phase 2 trial, taletrectinib achieved a 90.5% objective response rate among TKI-naïve patients.

How does taletrectinib (IVBIY) compare to existing treatments for NSCLC?

Taletrectinib demonstrates superior efficacy against crizotinib-resistant mutations and shows good safety, addressing a high unmet medical need.

What are the next steps for taletrectinib (IVBIY) after receiving Breakthrough Therapy Designation?

Innovent and AnHeart will continue ongoing trials to gather more data to support regulatory filings.