GSK Launches Phase II Trial of Anti-PD-1 Dostarlimab in China, Takeda Tianqing Initiates Phase III Study of Bispecific HER2 ADC TQB2102, and Jacobio Terminates SHP2 Inhibitor JAB-3068 Development

Aug 26, 2024 18:14 CST Updated 18:14

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Jacobio

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GSK's Anti-PD-1 Monoclonal Antibody Dostarlimab Initiates Phase 2 Clinical Trial in China

China Drug Clinical Trial Registration and Information Disclosure Platform Official Website announced that GlaxoSmithKline (GSK) has initiated dostarlimab,Product Name:Jemperli) Phase 2 Clinical Study in China, which primarily targets previously untreated dMMR/MSI-H locally advanced rectal cancer subjects in China.

It is reported that dostarlimab is a PD-1 antibody drug that can bind to the PD-1 receptor and block its interaction with PD-1 ligands PD-L1 and PD-L2. In April 2021, dostarlimab received accelerated approval from the U.S. FDA and conditional approval from the EU EMA for marketing. To date, this product has been approved for multiple indications, including dMMR advanced or recurrent endometrial cancer, dMMR or MSI-H primary advanced or recurrent endometrial cancer, and dMMR recurrent or advanced solid tumors.

GSK has launched a Phase 2, single-arm, open-label study in China. The primary objective of the trial is to evaluate the efficacy of dostarlimab monotherapy in previously untreated subjects with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer. The primary endpoint is cCR12 (sustained complete clinical response at month 12 as assessed by ICR), with the 12-month period starting from the first disease assessment after the last dose of the study drug (cCR confirmed by ICR).

CHIATAI TIANQING's ADC New Drug TQB2102 Initiates Phase 3 Clinical Trial for Breast Cancer

The official website of the China Drug Clinical Trial Registration and Information Disclosure Platform recently announced that CHIATAI TIANQING has initiated a Phase 3 clinical study of TQB2102 for injection. The indication targets subjects with locally advanced or metastatic breast cancer who have HER2 low expression and have not received chemotherapy at the recurrent or metastatic stage.

TQB2102 is a bispecific antibody-drug conjugate (ADC) targeting two non-overlapping epitopes, ECD2 and ECD4, of HER2. Compared with monoclonal antibodies and monoclonal antibody ADCs, this HER2 bispecific ADC demonstrates stronger binding, internalization efficiency, and cytotoxic effects on tumor cells, offering advantages for tumors with medium to low HER2 expression. Additionally, the specificity of dual epitopes and the mechanism of action of the ADC are expected to effectively address resistance associated with monoclonal antibodies and monoclonal antibody ADCs.

CHIATAI TIANQING has initiated the first Phase 3 clinical trial of TQB2102 for injection. The aim of the trial is to evaluate whether TQB2102 for injection can significantly prolong progression-free survival (PFS) compared to investigator-selected chemotherapy in subjects with HR-positive, HER2-low recurrent/metastatic breast cancer. In this study, TQB2102 for injection is administered intravenously every 3 weeks, with each 3-week period constituting one treatment cycle.

In addition, CHIATAI TIANQING has conducted multiple Phase 2 clinical studies on TQB2102 for injection, targeting indications including HER2 gene-mutant non-small cell lung cancer, HER2-positive cholangiocarcinoma, HER2 IHC 0 recurrent/metastatic breast cancer, and HER2-positive breast cancer patients, among others.

Jacobio Terminates Clinical Development of an SHP2 Allosteric Inhibitor Drug

Jacobio Issues a Supplementary Announcement to the 2023 Interim Report and 2023 Annual Report, Disclosing That "the Board Has Resolved to Terminate the Clinical Development of JAB-3068." This Is an SHP2 Allosteric Inhibitor That Has Advanced to Phase II Clinical Trials.

Notably, in July 2023, AbbVie terminated its collaboration with Jacobio on SHP2 inhibitors JAB-3068 and JAB-3312 based on portfolio and strategic decisions. Now, Jacobio has chosen to further terminate the JAB-3068 project, marking the official end of this drug's development process.

The announcement further shows that, based on the progress of JAB-3068 and the prioritized development of Glecirasib (KRAS inhibitor), the board believes that canceling the net proceeds ratio originally allocated for preparing the pivotal clinical trials and registration applications of JAB-3068 in relevant regions, and increasing the net proceeds ratio allocated to the clinical development of Glecirasib as well as other ongoing and planned early drug discovery and development, is beneficial to Jacobio's overall R&D progress.

Editor: Wu Yun