Jacobio Licenses Glecirasib and JAB-3312 to Allist for China Market

Jacobio Licenses Glecirasib and JAB-3312 to Allist for China Market

By, Admin 3 September 2024

Overview

Jacobio Pharma has announced the transfer of rights for its KRAS G12C inhibitor, glecirasib, and SHP2 inhibitor, JAB-3312, to Shanghai Allist Pharmaceuticals for China, including mainland China, Hong Kong, Macau, and Taiwan.

Glecirasib: Under Trial

  • Glecirasib, developed by Jacobio, is currently undergoing several clinical trials across China, the United States, and Europe for patients with advanced solid tumours harbouring the KRAS G12C mutation. 
  • These trials include combination therapies with the SHP2 inhibitor JAB-3312 for non-small cell lung cancer (NSCLC) and with cetuximab for colorectal cancer.

ODD by US & BTD by China 

The U.S. has granted orphan drug designation for the treatment of pancreatic cancer, while China has given breakthrough therapy designation.

About JAB-3312

  • JAB-3312, a highly selective SHP2 allosteric inhibitor with potential for best-in-class status, is also being tested in clinical trials both as a monotherapy and in combination with other treatments, including glecirasib, across China, the U.S., and Europe. 
  • The Phase III trial combining JAB-3312 with glecirasib received approval from China’s Centre for Drug Evaluation (CDE) in February 2024.

Terms of The Agreement

  • Under the agreement, Jacobio will receive approximately RMB 200 million upfront, which includes an initial payment of RMB 150 million and an additional RMB 50 million to cover research and development costs and other expenses. 
  • Jacobio is also eligible for milestone payments of up to RMB 700 million, contingent on meeting certain development, regulatory, and commercial milestones. 

Future Royalties on Sale of Glecirasib And JAB-3312

  • Furthermore, Jacobio will receive tiered double-digit royalties on net sales of glecirasib and JAB-3312 from Allist, with royalties on JAB-3312 sales reaching up to 20%. 
  • Allist will handle the commercialization of both drugs in China and will cover subsequent clinical development costs in the region. 
  • This agreement signifies Jacobio's entry into the commercialization phase and marks a significant milestone in their SHP2 research and development.

Jacobio on the Partnership

  • Jacobio expressed enthusiasm for the partnership with Allist, noting Allist's strong capabilities in the commercialization of lung cancer treatments. 
  • The first indication for glecirasib in this collaboration is lung cancer. 
  • Jacobio believes that the synergy between both companies will generate significant clinical and commercial value. 

Additional Rights for JAB-3312

  • In addition to glecirasib, Allist has also secured rights to the SHP2 inhibitor JAB-3312, the first SHP2 inhibitor globally to enter a registrational trial. 
  • Jacobio is eager to advance the development and commercialization of these products to address unmet clinical needs.

Allist on the Collaboration

  • Allist, in turn, expressed optimism about the collaboration, citing Jacobio’s achievements in developing innovative therapies like glecirasib and JAB-3312. 
  • Allist’s commitment to cancer therapy research and drug development aligns well with this partnership. 

Allist: Strong Team

  • With the success of its lung cancer drug, furmonertinib, Allist has built a strong commercial team with extensive sales channels. 
  • The company is confident that combining its expertise with Jacobio’s innovations will benefit patients in China and create mutual value.

NDA for Glecirasib Status

  • The new drug application for glecirasib as a monotherapy for second-line NSCLC with KRAS G12C mutation was granted priority review in May 2024. 
  • Previously, in December 2022, the drug received breakthrough therapy designation from China’s National Medical Products Administration (NMPA) for treating advanced or metastatic NSCLC. 
  • Data from a pivotal Phase II study released by Jacobio in April 2024 showed a confirmed objective response rate (cORR) of 47.9% in patients with second-line NSCLC, with a disease control rate (DCR) of 86.3%. 
  • The median progression-free survival (mPFS) was 8.2 months, while median overall survival (mOS) was 13.6 months.

Phase III Trial 1st Dosing 

  • In August 2024, the first patient was dosed in a Phase III trial comparing the combination of glecirasib and JAB-3312 against standard care in frontline KRAS G12C mutant NSCLC. 
  • Earlier Phase I/IIa data presented at the ASCO Annual Meeting indicated a cORR of 77.4% for the optimal dose group, with more than half of the patients experiencing significant tumour shrinkage.
  • The safety profile was manageable, with 43.8% of patients experiencing grade 3 or 4 treatment-related adverse events.

Other Studies on Glecirasib for Different Cancers

  • Additionally, pivotal studies are ongoing for glecirasib as a monotherapy in second-line or later stages of pancreatic cancer and in combination with cetuximab for colorectal cancer. 
  • In April 2024, glecirasib received orphan drug designation from the U.S. FDA for pancreatic cancer, and in August 2023, it was granted breakthrough therapy designation by China’s CDE for treating second-line or later-stage pancreatic cancer patients with KRAS G12C mutations.