AnHeart Therapeutics, a global clinical-stage biopharmaceutical company, has recently established an exclusive license agreement with Nippon Kayaku Co., Ltd for the marketing and distribution of their lead investigational therapy, taletrectinib, in Japan. Taletrectinib is a cutting-edge ROS1 tyrosine kinase inhibitor (TKI) designed to treat ROS1-positive non-small cell lung cancer (NSCLC).

Under this partnership, AnHeart is set to receive an initial payment of $40 million and stands to gain potential regulatory and sales milestone payments, as well as royalties based on annual net sales of taletrectinib in Japan. Nippon Kayaku will take on the responsibility of obtaining regulatory approvals and commercializing taletrectinib for ROS1-positive NSCLC in Japan. Additionally, they will have the rights to further develop taletrectinib for new indications in the region. AnHeart, on the other hand, will be responsible for overseeing the clinical development of taletrectinib for ROS1-positive NSCLC and providing the drug to Nippon Kayaku for future commercialization in Japan.

AnHeart has recently shared promising data from two Phase 2 trials conducted in 2023, demonstrating that taletrectinib has the potential to become a leading therapy for individuals with ROS1-positive NSCLC, a group of lung cancer patients in need of better treatment options. In both trials, interim results showed that taletrectinib led to tumor shrinkage in over 90% of patients with ROS1-positive NSCLC who had not previously received a ROS1 TKI (TKI naïve) and over 50% of patients who had received a previous ROS1 TKI (TKI pre-treated). These responses were durable, and taletrectinib was well tolerated, with a low incidence of neurological adverse events.

AnHeart's CEO, Jerry Wang, expressed excitement about partnering with Nippon Kayaku and bringing taletrectinib to people with ROS1-positive NSCLC in Japan. The company's positive interim trial data from the global pivotal TRUST-II trial is a significant step forward in their mission to provide a new treatment option for this patient population.

Taletrectinib is an oral, potent, and brain-penetrating ROS1 inhibitor with the potential to become the best-in-class treatment for ROS1-positive NSCLC.

AnHeart is currently evaluating taletrectinib in ROS1-positive NSCLC patients through two Phase 2 trials: TRUST-I in China and TRUST-II, a global pivotal trial. Positive interim results from TRUST-II, presented at the European Society of Medical Oncology Congress 2023, showed a confirmed objective response rate of 92% in ROS1 TKI naïve patients and 57% in patients previously treated with a ROS1 TKI. Taletrectinib also demonstrated strong intracranial activity in patients with brain metastases. Median progression-free survival for TKI naïve patients was not reached, while it was 11.7 months for TKI pre-treated patients.

Earlier data from the TRUST-I trial in China also revealed impressive response rates and survival outcomes for ROS1-positive NSCLC patients.

Overall, taletrectinib has shown good tolerability, with the most common treatment-related adverse events being increased liver enzymes and gastrointestinal issues, most of which were mild. Neurological adverse events were infrequent, with dizziness being the most common.

ROS1-positive NSCLC is a specific subtype of non-small cell lung cancer. It is estimated that a small percentage of NSCLC patients are ROS1-positive, and there are limited treatment options available for this group. Many patients also suffer from brain metastases, further underscoring the need for improved therapies in this area.

 

Source: businesswire.com

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