China’s Innovent holds potential to change pancreatic cancer treatment landscape with bispecific antibody IBI389, says GlobalData

June 14, 2024 – Biotechnology, PharmaceuticalGlobalData, Innovent, clinical trials, oncology, therapies

14 June 2024 – China-based Innovent Biologics recently presented phase 1 study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results from the phase 1 study (NCT05164458) of IBI389 demonstrated promising efficacy in pancreatic ductal adenocarcinoma (PDAC) and the bispecific antibody is expected to evolve as a promising therapeutic option for PDAC in China and globally, says GlobalData, a leading data and analytics company.

IBI389 is an anti-CLDN18.2 T cell-engaging bispecific antibody that redirects T cells to tumor cells by binding both CLDN18.2 expressed on tumor cells and CD3 on T cells, inducing T cell-mediated cell killing. Preliminary results from 72 CLDN18.2-positive patients with advanced unresectable or metastatic PDAC showed encouraging efficacy even with relatively low expression of CLDN18.2. Safety was similar to that of the overall population (pancreatic carcinoma, gastric adenocarcinoma, advanced or metastatic solid tumors).

According to GlobalData’s Pharma Intelligence Center, the number of diagnosed prevalent cases of PDAC in urban China is expected to increase at an annual growth rate (AGR) of 5.71% from 19,871 in 2023 to 25,777 in 2029.

Nadim Anwer, Pharma Analyst at GlobalData, comments: “Despite recent advances in therapeutic approaches to treat pancreatic cancer, along with the introduction of drugs with novel mechanisms of action, the unmet need remains high. IBI389, the world’s first bispecific antibody targeting CLDN18.2/CD3, could have a positive impact on the PDAC treatment landscape.”

PDAC is classified as an exocrine pancreatic cancer and is considered to be the most common type of pancreatic cancer, accounting for more than 85% of all pancreatic cancers.

Currently, chemotherapy remains the mainstay of treatment across the first and second line for advanced pancreatic cancer. Most agents in development have varied safety and efficacy profiles and are aimed at treating advanced or metastatic patients in either the first or second-line settings. Moreover, high clinical trial discontinuation and failure rates among late-stage agents highlight research and development (R&D) challenges faced by companies in the pancreatic cancer disease space.

As per GlobalData’s Pharma Intelligence Center, there are only two bispecific antibodies targeting CLDN18.2/CD3 in clinical development, including Innovent’s asset. The second asset, AZD-5863 from AstraZeneca, is in phase 2/3 clinical development for PDAC, and results are expected in December 2026. Innovent is also developing IBI343, an innovative anti-CLDN18.2 antibody-drug conjugate (ADC) for PDAC. Recently, IBI343 Phase I clinical data (NCT05458219) was presented at ASCO.

Anwer concludes: “With two assets targeting different mechanisms, Innovent would like to strengthen its position and deliver differentiated innovation for PADC, making it difficult for competitors. Innovent’s two promising assets with different mechanisms (CLDN18.2/CD3 and CLDN18.2 ADC) would bring a significant shift in current treatment approaches for PDAC, if successful in clinical trials and gaining approvals. Moreover, it would provide a competitive edge considering the high unmet need. Notably, with these innovative assets, the company can attract and expand its strategic collaborations with foreign players.” 

About China Innovent: Since founding in 2011, thier mission has been to develop, manufacture and commercialize high-quality innovative medicines that people in need, regardless of background, can access. Their pioneering innovations in the fields of oncology, cardiovascular and metabolic diseases, autoimmune diseases and ophthalmology have since been able to treat some of the most intractable diseases. On October 31, 2018, Innovent was listed on the main board of the Hong Kong Stock Exchange, and have since achieved many more milestones toward their mission. Visit: https://www.innoventbio.com/

About GlobalData: 4,000 of the world’s largest companies, including over 70% of FTSE 100 and 60% of Fortune 100 companies, make timelier and better business decisions thanks to GlobalData’s unique data, expert analysis, and innovative solutions, all in one platform. GlobalData’s mission is to help our clients decode the future to be more successful and innovative across a range of industries, including the healthcare, consumer, retail, financial, technology and professional services sectors. Visit: https://www.globaldata.com/

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