On August 30, 2024 Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, reported that it has granted the China rights (including mainland China, Hong Kong, Macau, and Taiwan) of KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 to Shanghai Allist Pharmaceuticals Co., Ltd (688578.SH) (Press release, Jacobio Pharmaceuticals, AUG 30, 2024, View Source [SID1234646259]).
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According to the terms of the agreement, Jacobio shall receive around RMB200 million in the near term, which includes an upfront payment of RMB150 million, and around RMB50 million of compensation for research and development expenses and other payments. Additionally, the potential milestone payments upon achieving certain development, regulatory and commercial milestones are up to RMB700 million. Jacobio is also entitled to receive tiered double-digit royalty payments on net sales of glecirasib and JAB-3312 from Allist, among which the royalty payments on net sales of JAB-3312 is up to 20%. The above amount includes value-added tax. Allist will be responsible for the commercialization of glecirasib and JAB-3312 in China and pay the subsequent clinical development costs in China. This marks that Jacobio has officially entered the commercialization stage, and the research and development of SHP2 has also ushered in a new milestone.
Dr. Wang Yinxiang, Chairman and CEO of Jacobio, said: "We are delighted to reach this cooperation with Allist. Allist has strong commercialization 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 cooperation with glecirasib, Allist also licensed-in the SHP2 inhibitor JAB-3312, which is 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. We also look forward to jointly accelerating the development and commercialization of the two products to meet the clinical needs of more patients. "
Jinhao Du, the Chairman and general manger of Allist, said: "we are please to cooperate with Jacobio, and the cooperation will surely benefit the growth of both companies. For many years, Allist has taken ‘Technology Cares for Life’ as our corporate mission, focusing on scientific exploration and drug development in the field of cancer therapies, and is committed to developing and introducing superior pipelines consisting of best-in-class and first-in-class drugs. While we successfully independently developed and launched furmonertinib, we have built a commercial team that focuses on lung cancer, has professional academic promotion capabilities, and has a wide sales channel coverage. Since its launch, furmonertinib has achieved remarkable sales performance. Jacobio is a very outstanding innovative biotech company that has successfully developed and promoted a number of excellent products with great clinical value, including the KRAS G12C inhibitor glecirasib and the SHP2 inhibitor JAB-3312. We are very optimistic about the clinical advantages and market prospects of these two products. In this cooperation, Allist will give full play to its advantages in clinical development and commercialization capabilities to benefit more Chinese patients and create value for both companies."
The new drug application for glecirasib monotherapy for second-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation was granted priority review on May 21, 2024. In December 2022, it was granted breakthrough therapy designation (BTD) Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the second-line and above treatment of patients with advanced or metastatic NSCLC with KRAS G12C mutation. In April 2024, the data of the pivotal Phase II study of glecirasib published by Jacobio in the ASCO (Free ASCO Whitepaper) Plenary Series showed that in patients with second-line NSCLC, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months.
The first patient dosed in the Phase III clinical trial of KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 versus standard care (chemotherapy and anti-PD-1 antibody) in front-line KRAS G12C mutant NSCLC in August 2024. According to the Phase I/IIa data presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, the optimal dose group was glecirasib at 800mg daily combined with JAB-3312 at 2mg daily one week on and one week off. The cORR of the optimal dose group was 77.4% (24/31), and 54.8% (17/31) of patients achieved a deep response with tumors shrinking by more than 50%. Regarding on the safety data, among the 194 all-dosage patients, the incidence of grade 3 or 4 treatment-related adverse events (TRAE) was 43.8%, and there was no treatment-related death. The overall safety is manageable.
In addition, the pivotal studies of glecirasib monotherapy for second-line or above pancreatic cancer, glecirasib monotherapy and in combination with cetuximab for colorectal cancer with are also undergoing. In terms of pancreatic cancer, in April 2024, glecirasib was granted orphan drug designation from Food and Drug Administration (FDA) for pancreatic cancer indications; in August 2023, it was granted BTD by CDE of NMPA for the treatment of second-line or above pancreatic cancer patients with KRAS G12C mutations. The combination of glecirasib and cetuximab for the treatment of colorectal cancer was approved for registrational phase III clinical trial in China in May 2024.
About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.
About JAB-3312
JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor glecirasib has been approved by China CDE in Feb 2024.