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.”
