JAB-3312

Jacobio Pharma chairman and CEO Dr Yinxiang Wang (right) and Jinxiang Du (left) at the agreement signing ceremony. Credit: JACOBIO PHARMACEUTICALS GROUP CO., LTD. Jacobio Pharma has out-licensed the China rights of its assets, glecirasib and JAB-3312, to Shanghai Allist Pharmaceuticals. Glecirasib is a Kirsten rat sarcoma glycine 12 to cysteine inhibitor. JAB-3312 is a Src homology-2 domain-containing protein tyrosine phosphatase 2 inhibitor. The agreement includes mainland China, Hong Kong, Macau and Taiwan rights. Jacobio is entitled to receive 200m yuan ($28m) in the near term, which includes 150m yuan in upfront payment and 50m yuan for research and development expenses and other payments The agreement also includes milestone payments of 700m yuan contingent upon meeting specific development, regulatory and commercial goals. See Also: RegenxBio touts positive data for rare disease drug RGX-121 Ocaliva approval in Europe withdrawn following data re-assessment Jacobio is entitled to receive tiered royalty payments on net product sales from Allist. Royalty payments for JAB-3312 could reach 20%. Allist will handle the commercialisation of the assets in China and cover subsequent expenditures for their clinical development. A new drug application for glecirasib monotherapy for second-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation received priority review in May 2024 and breakthrough therapy designation in December 2022 in China. In April 2024, data from a Phase II study of glecirasib showed a confirmed objective response rate of 47.9% in second-line NSCLC patients. The disease control rate was 86.3%, with median progression-free survival of 8.2 months and median overall survival of 13.6 months. The first subject was recently dosed in a Phase III clinical trial of the glecirasib and JAB-3312 combination versus standard care. In addition to NSCLC, glecirasib is undergoing pivotal studies for second-line or above pancreatic cancer and in combination with cetuximab for colorectal cancer. Jacobio Pharma chairman and CEO Dr Wang Yinxiang stated: “Allist has strong commercialisation capabilities in the field of lung cancer, and the first indication for glecirasib submitted the new drug application is lung cancer. We believe that with the deep fit of the advantages of both parties, this collaboration will demonstrate great clinical and commercial value. “In addition to the co-operation with glecirasib, Allist also licensed-in the SHP2 inhibitor JAB-3312, the first SHP2 inhibitor entering a registrational trial globally. It is expected to become a first-line therapy in combo with glecirasib, which reflects Allist’s foresight into the future of pipelines.”

The deal establishes Allist as a front-runner in China’s emerging KRAS market. Shanghai Allist Pharmaceuticals has bought itself a starring role in China’s KRAS market, paying Jacobio Pharma 150 million Chinese yuan ($21 million) for rights to a near-approval inhibitor of the oncogene and a potentially complementary molecule.The deal covers the Chinese rights to the KRAS G12C inhibitor glecirasib and the SHP2 inhibitor JAB-3312. Jacobio filed for approval of glecirasib in non-small cell lung cancer in China in May, hot on the heels of a data drop that suggested the molecule’s efficacy is in the same ballpark as rival drugs. Jacobio identified safety and tolerability as an area it may have an edge over the competition.Allist secured Chinese rights to glecirasib as part of a deal that included JAB-3312, the drug candidate that AbbVie walked away from last year. AbbVie picked up global rights to the molecule in 2020 but axed the asset as part of a portfolio review.Jacobio bounced back by offloading the Chinese rights to JAB-3312 to Allist in a two-asset deal that could support combination therapy. Studies suggest inhibiting SHP2 could boost the effect of KRAS blockers by increasing the amount of the KRAS target and inhibiting reactivation of other RAS isoforms. Pharma interest has cooled on SHP2, with Bristol Myers Squibb, Genentech and Sanofi all pulling back in recent years. Yet, Allist has seen value including JAB-3312 in its glecirasib deal. As well as the upfront fee, Allist will pay 50 million yuan ($7 million) in near-term R&D expenses and potentially up to 700 million yuan ($99 million) in milestones.   The deal establishes Allist as a front-runner in China’s emerging KRAS market. While Amgen’s Lumakras and Bristol Myers Squibb’s Krazati are competing for the U.S. market, Innovent Biologics is making the running in China. Innovent claimed a first when the Chinese regulator accepted its KRAS G12C inhibitor for priority review in November.