Jacobio Pharma Unveils SHP2 and KRAS G12C Data at ASCO

BEIJING and SHANGHAI and CHICAGO, June 1, 2024 — Jacobio Pharma, a clinical-stage oncology company focusing on undruggable targets, showcased promising updates on its KRAS G12C inhibitor glecirasib (JAB-21822) combined with SHP2 inhibitor (JAB-3312) for treating frontline non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation. This presentation was made at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting through an oral presentation. Additionally, updated data from a pivotal Phase II study of glecirasib were also presented.

As of April 7, 2024, a Phase II trial (NCT05288205) enrolled 194 participants, including 102 frontline NSCLC patients. The median follow-up period was 10.1 months.

During the oral abstract session (Abstract No. 3008), Professor Jun Zhao from Beijing Cancer Hospital, the principal investigator of the study, shared clinical findings. Among the 102 frontline NSCLC patients across seven dose cohorts, the confirmed objective response rate (cORR) hit 64.7% (66/102), and the disease control rate (DCR) stood at 93.1% (95/102). The median progression-free survival (mPFS) was 12.2 months.

The trial evaluated seven different dosage cohorts, determining that the optimal combination was 800 mg of glecirasib daily and 2 mg of JAB-3312 daily on a one-week-on, one-week-off schedule. In this optimal group, the cORR was 77.4% (18/31), with 54.8% (17/31) showing significant tumor reduction of over 50%. The mPFS data were still maturing.

Safety analysis from the 194-patient cohort revealed a 43.8% incidence of grade 3 or 4 treatment-related adverse events (TRAE), with no treatment-related fatalities. Common TRAEs included anemia and hypertriglyceridemia. The safety profile in frontline NSCLC patients was consistent with the overall study population, and the treatment was generally manageable.

Professor Jie Wang from Beijing Cancer Hospital commented on the safety and efficacy data, highlighting the potential of the combination therapy. He mentioned that if subsequent trials confirm the superiority of this combination over existing therapies (such as chemo-immunotherapy), patients might avoid the side effects associated with conventional treatments.

Jacobio Pharma is now conducting a Phase III clinical trial on this combination for frontline NSCLC patients with the KRAS G12C mutation in China. Andrea Gillam-Wang, M.D., Ph.D., Chief Medical Officer and Global Head of R&D at Jacobio, expressed excitement about comparing this novel therapy against the current standard of care. She emphasized the potential of replacing multiple intravenous agents with two oral drugs, enhancing patient convenience.

Additionally, glecirasib as a monotherapy for second-line NSCLC with KRAS G12C mutation received Priority Review designation from China's Center for Drug Evaluation (CDE) on May 21, 2024. During an educational session at ASCO, Professor Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences provided updates on the Phase II registration trial data of glecirasib.

Jacobio Pharma plans to hold a data discussion call on June 3 at 20:00 Beijing time.

About Glecirasib:
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. It is being tested in various Phase I/II trials across China, the United States, and Europe for advanced solid tumors with the KRAS G12C mutation. These trials include combination studies with JAB-3312 in NSCLC and cetuximab in colorectal cancer. Glecirasib has received orphan drug designation for pancreatic cancer in the United States and breakthrough therapy designation in China.

About JAB-3312:
JAB-3312 is a highly selective SHP2 allosteric inhibitor. Jacobio is conducting clinical trials for JAB-3312 as both a monotherapy and in combination with other agents, including glecirasib, across China, the United States, and Europe. The Phase III study combining JAB-3312 with glecirasib has been approved by China CDE.

Jacobio Pharma (1167.HK) aims to lead in drug development, focusing on innovative products targeting critical molecular pathways. Jacobio operates R&D centers in Beijing, Shanghai, and Boston, utilizing advanced platforms such as the Induced Allosteric Drug Discovery Platform (IADDP) and the iADC Platform.

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