Yuhan Corporation has bought its way into a cancer space targeted by Boehringer Ingelheim and Takeda, wagering up to $325 million to get its hands on a preclinical HER2 tyrosine kinase inhibitor (TKI).
The oral drug candidate, which Korea’s Yuhan is licensing from its compatriot J INTS BIO, is designed for use in non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations. Around 3% of NSCLC patients have HER2 mutations, and around 90% of those mutations are exon 20 insertions. The potential to improve outcomes in that subset of patients has attracted a clutch of drug developers.
Spectrum Pharmaceuticals sought FDA approval for poziotinib in NSCLC harboring HER2 exon 20 insertion mutations late in 2021 but deprioritized the program after receiving a rejection notice last year. Rival drug candidates remain in active clinical development, with Boehringer studying BI 1810631 in a phase 1 trial and Takeda securing approval two years ago for mobocertinib, a TKI that targets EGFR and HER2 insertions.
Flanked by deep-pocketed rivals with more advanced programs, J INTS BIO has pitched its TKI candidate as a potential best-in-class molecule. The claim, which is backed by in vitro and in vivo models showing it is potent against HER2 exon 20 insertions, has helped the Korean biotech land a deal for the therapy.
Yuhan has taken the other side of the agreement. The Korean drugmaker, which owns a 15% stake in J INTS BIO, is paying $1.9 million upfront as part of a deal worth up to $325 million to secure rights to the JIN-A04 drug candidate.
At Yuhan, JIN-A04 will slot into a pipeline led by the EGFR TKI lazertinib. Johnson & Johnson paid Yuhan $50 million upfront and committed to $1.2 billion in milestones for rights to the small molecule outside of Korea in 2018. Yuhan went on to launch the drug in Korea, under the Leclaza name, as a second-line treatment for NSCLC while continuing to study the molecule in other settings.