NEW YORK – AnHeart Therapeutics on Monday said it signed a licensing agreement giving Nippon Kayaku exclusive rights to market and distribute its ROS1 tyrosine kinase inhibitor taletrectinib in Japan.
Nippon Kayaku will pay AnHeart $40 million upfront plus potential regulatory and sales milestone payments and royalties based on annual net sales of taletrectinib in the country. AnHeart will be responsible for developing taletrectinib as a treatment for patients with ROS1-positive non-small cell lung cancer and will supply the drug to Nippon Kayaku for commercialization. Nippon Kayaku will be responsible for regulatory and commercialization activities in Japan and will have the right to develop it in new indications in the region.
AnHeart recently reported results from TRUST-II showing a 92 percent objective response rate in patients who hadn't received a ROS1 inhibitor before and a 57 percent objective response rate in previously treated patients. The drug also showed promising activity against lung cancers that had spread to the brain with an 80 percent intracranial objective response rate among treatment-naïve patients and 63 percent objective response rate in pre-treated patients. Median progression-free survival was not reached in the treatment-naïve group and was 11.7 months in the pre-treated group.
These results were similar to data reported from TRUST-I, in which ROS1 inhibitor-naïve patients had a 93 percent response rate, and those previously treated with Pfizer's ROS1 inhibitor Xalkori (crizotinib) had a 53 percent response rate.
New York-based AnHeart is also developing safusidenib as a treatment for patients with IDH1-mutant glioma. It began a Phase II trial of safusidenib in patients with grade 2 or 3 recurrent or progressive IDH1-mutant glioma in September.