NEW YORK--(BUSINESS WIRE)--AnHeart Therapeutics (“AnHeart”), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced it has entered into an exclusive license agreement with Nippon Kayaku Co., Ltd (“Nippon Kayaku”) to market and distribute AnHeart’s lead investigational therapy, taletrectinib, in Japan. Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI) being developed for the treatment of ROS1-positive non-small cell lung cancer (NSCLC).

Under the terms of the agreement, AnHeart will receive an upfront payment of $40 million and is entitled to potential regulatory and sales milestone payments and royalties based on annual net sales of taletrectinib in Japan. Nippon Kayaku will be responsible for regulatory approvals and commercialization of taletrectinib for ROS1-positive NSCLC in Japan, and will have rights to further develop taletrectinib for new indications in the region. AnHeart will be responsible for the clinical development of taletrectinib for ROS1-positive NSCLC and for supplying taletrectinib to Nippon Kayaku for future commercialization purposes in Japan.

AnHeart has reported positive data from two Phase 2 trials in 2023 showing taletrectinib has the potential to be a best-in-class therapy for people with ROS1-positive NSCLC, an underserved group of lung cancer patients in great need of new options. In both trials, interim results showed taletrectinib shrank tumors in more than 90% of patients with ROS1-positive NSCLC who had not previously received a ROS1 TKI (TKI naïve) and more than 50% of patients who had previously received a ROS1 TKI (TKI pre-treated), and responses were durable. Taletrectinib was generally well tolerated with a low incidence of neurological adverse events.

“We are excited to partner with Nippon Kayaku and look forward to working with a leading oncology company to bring taletrectinib to people with ROS1-positive NSCLC living in Japan,” said Jerry Wang, PhD, Chief Executive Officer of AnHeart. “We have strategically selected partners across Asia to support our efforts to further develop and commercialize taletrectinib in the region. With the recently reported positive interim data from our global pivotal TRUST-II trial, we are well on our way to realizing our vision of bringing people with ROS1-positive NSCLC a new option.”

About Taletrectinib

Taletrectinib is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor being evaluated for the treatment of ROS1-positive NSCLC.

AnHeart is evaluating taletrectinib in ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial.

At the recent European Society of Medical Oncology Congress 2023, AnHeart reported positive interim results from the global pivotal TRUST-II trial showing a confirmed objective response rate (cORR) as assessed by independent review committee (IRC) of 92% in ROS1 TKI naïve patients (n=25) and 57% in patients previously treated with a ROS1 TKI (n=21). Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain (80% intracranial ORR in TKI naïve patients, n=5; 63% intracranial ORR in TKI pre-treated patients, n=8). Median progression-free survival (IRC-assessed) was not reached for TKI naïve patients and was 11.7 months for TKI pre-treated patients.

Earlier this year, AnHeart reported data from the TRUST-I trial in China, which showed a cORR of 93% in ROS1 TKI naïve patients (n=67) and 53% in crizotinib pre-treated patients (n=38), as assessed by IRC. A pooled analysis of TRUST-I and Phase 1 trials with taletrectinib showed median progression-free survival of 33.2 months and 11.8 months in ROS1 TKI naïve and crizotinib pre-treated patients, respectively.

Across all trials to date, taletrectinib has generally been well tolerated. The most common treatment emergent adverse events (TEAEs) have been increased liver enzymes and gastrointestinal-related adverse events, the majority of which were Grade 1 or Grade 2. Incidence of neurological TEAEs were low; the most common was dizziness (19%), most of which was Grade 1.

About ROS1-Positive NSCLC

More than one million people are anticipated to be diagnosed with NSCLC, the most common form of lung cancer, in the United States, Europe, China and Japan in 2023. It is estimated that approximately 1-2% of people with NSCLC in western countries and approximately 3% in China are ROS1-positive, meaning more than 22,000 people will be diagnosed with ROS1-positive NSCLC in these regions in 2023. There are two FDA approved first-generation TKIs for people with newly diagnosed advanced or metastatic ROS1-positive NSCLC and no FDA approved therapies for people whose ROS1-positive NSCLC has progressed following treatment with these medicines. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment.

About AnHeart Therapeutics

AnHeart Therapeutics (“AnHeart”) is a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer. Our lead investigational therapy, taletrectinib, is a next-generation ROS1-inhibitor currently in pivotal Phase 2 trials for ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration and the China National Medical Products Administration. AnHeart’s second investigational therapy, safusidenib, is a mIDH1-inhibitor being evaluated in a Phase 2 trial for IDH1-mutant glioma.

Our mission is to improve the lives of people with cancer. We are supported by leading life sciences investors and have built an organization with deep oncology drug discovery and development expertise, with offices in New York and Shanghai. For more information, visit https://www.anhearttherapeutics.com/ or follow us on LinkedIn at https://www.linkedin.com/company/anheart-therapeutics-official/.

About Nippon Kayaku

Nippon Kayaku was founded in 1916 as the first industrial explosives manufacturer in Japan. We have developed products to meet the needs of the time by utilizing, combining and transforming our core technologies in the company’s main areas, explosives, dyes, pharmaceuticals and resins. The Nippon Kayaku Group operates in the Mobility & Imaging Business Unit, the Fine Chemicals Business Unit, and the Life Science Business Unit. We will continue to create high-value-added products that are indispensable to the world by concentrating our unique technologies.

In the Pharmaceuticals Business, a part of Life Science Business Unit, Nippon Kayaku specializes in anticancer drugs and other cancer-related products, handling a range of products from new drugs to biosimilars and generics. It strives to provide trustworthy information crucial for understanding anticancer drugs to medical institutions. Please visit the company website at “https://www.nipponkayaku.co.jp/english/” for more information.

Contacts

Charlotte Arnold, Chief Corporate Affairs Officer

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