Innovent to Present anti-CLDN18.2 ADC Data at 2024 ASCO for Advanced Pancreatic and Biliary Tract Cancer

Innovent Biologics, Inc., a prominent biopharmaceutical company known for developing and producing high-quality medicines for a variety of severe illnesses, has recently presented Phase 1 clinical data of IBI343 (TOPOi anti-CLDN18.2 ADC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study focuses on the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) and biliary tract cancer (BTC). Additionally, Innovent will share findings related to advanced gastric or gastroesophageal tumors from this trial at the upcoming ESMO Gastrointestinal Cancers Congress 2024.

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, expressed excitement over the positive clinical signals exhibited by IBI343, particularly in subjects with advanced pancreatic cancer, noting the low incidence of severe gastrointestinal adverse events. This development marks a significant achievement for CLDN18.2 ADCs in treating such challenging cancers. Innovent plans to continue analyzing the clinical data to explore the broader therapeutic potential of IBI343, including its use in combination therapies for other solid tumors such as gastric cancer.

The Phase 1 study, conducted in China and Australia, aims to assess the safety, tolerability, and preliminary efficacy of IBI343 in patients with advanced solid tumors. As of December 19, 2023, 35 patients with PDAC or BTC were enrolled, all of whom had undergone at least one prior systemic treatment. Among these patients, 25 had post-baseline tumor evaluations by January 15, 2024. Results showed a 28% objective response rate (ORR) and an 80% disease control rate (DCR). In particular, the 6 mg/kg dose group exhibited higher efficacy with a 38.5% ORR and an 84.6% DCR among subjects with high CLDN18.2 expression.

Regarding safety, 80% of participants experienced treatment-related adverse events (TRAEs), including common side effects such as anemia, decreased neutrophil count, nausea, vomiting, and lowered white blood cell count. Notably, 25.7% of subjects encountered grade 3 or higher TRAEs, but no treatment-related deaths occurred.

Professor Xianjun Yu from Fudan University Shanghai Cancer Center highlighted the rapid progression and poor prognosis of advanced pancreatic cancer and biliary tract cancer, often diagnosed at late stages. Current treatment options, primarily chemotherapy, offer limited benefits, especially for second-line treatments, which have low response rates and short median survival times. The promising efficacy of the novel TOPOi anti-CLDN18.2 ADC IBI343 in patients with high CLDN18.2 expression suggests potential for introducing new treatment options for these malignancies.

IBI343, a recombinant human anti-Claudin 18.2 monoclonal antibody-drug conjugate (ADC), works by targeting Claudin 18.2-expressing tumor cells, leading to their internalization and subsequent apoptosis. The drug also exerts a "bystander killing effect" by affecting neighboring cells. Early clinical studies of IBI343 have demonstrated its tolerable safety profile and encouraging efficacy signals. Innovent is currently exploring its therapeutic potential in various tumor types, including gastric and pancreatic cancers.

In May 2024, China’s National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) to IBI343 for treating claudin 18.2–positive gastric or gastroesophageal junction adenocarcinoma in patients who had progressed after two prior systemic treatments. A multi-center Phase 3 trial is in preparation for this indication.

Founded in 2011, Innovent Biologics aims to provide affordable, high-quality biopharmaceuticals to patients worldwide. The company focuses on discovering, developing, manufacturing, and commercializing innovative medicines for cancers and other severe diseases. With a strong pipeline and numerous partnerships, Innovent remains committed to advancing the biopharmaceutical industry and making groundbreaking treatments more accessible.