On October 30, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that the first patient was dosed in Australia for its proprietary anti-Claudin18.2 monoclonal antibody-drug conjugate(ADC) (R&D code: IBI343) in Phase I clinical trial for the treatment of patients with advanced solid tumors (Press release, Innovent Biologics, OCT 30, 2022, View Source [SID1234622598]). It is the first ADC candidate drug to enter clinical phase in Innovent’s pipeline.
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The study (NCT05458219) is an open-label, multi-center Phase I study evaluating the safety, tolerability, and preliminary efficacy of IBI343 in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).
IBI343 is a recombinant human anti-Claudin 18.2 monoclonal ADC. After IBI343 binds to the Claudin 18.2-expressing tumor cells, the Claudin 18.2 dependent ADC internalization occurred and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect". In both Claudin 18.2 high and low expression mice tumor bearing models, IBI343 exhibited potent tumor growth inhibition efficacy, and it also demonstrated tolerable safety profile in preclinical in vivo models.
Dr. Andrea Tazbirkova, Pindara Private Hospital Located in Queensland, Australia, stated： "Claudin 18.2 has emerged as an ideal anti-tumor target and has been clinically validated by different modalities including mono-antibodies and CAR-T therapy with manageable toxicity. Nonetheless, the efficacy is selective and limited within cancer patients with CLDN18.2-high expression, leaving unmet need for patients with CLDN18.2 low-expressing tumors. IBI343 is Claudin 18.2 targeting ADC with bystander effect and has demonstrated promising anti-tumor effect in Claudin 18.2-high and low in-vivo models with tolerable safety profile. We look forward to the positive results in the safety/tolerability and efficacy of IBI343 in the clinic."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: " At present, target treatment options are limited for gastric and pancreatic cancer where imply huge unmet clinical needs. High expression of Claudin 18.2 in aforesaid tumors suggests its high potential and Innovent has been actively rolling out a cluster of Claudin 18.2 drug candidates across different modalities to seek for differentiated therapeutic values while guarantee druggability. We are pleased that the first patient dose of IBI343 has been completed in Australia. In parallel, the IND for IBI343 has been filed in China last month. We are looking forward to the positive results of IBI343 in patients with advanced solid tumors. IBI343 is our first ADC molecule to initiate clinical study in both Australia and China, adding a valuable clinical asset in our R&D pipeline that represents Innovent’s global innovation strategy. The company will also accelerate the development of more innovative molecules with high global potential, taking advantage of cross-regional R & D and clinical resources, adhering to the long-term development strategy of ‘driven by innovation, developed through globalization’with an aim to benefit cancer patients worldwide."
About Claudin 18.2
Claudin18.2 is a member of the Claudin protein family, which is a highly tissue-specific protein expressed only in differentiated epithelial cells on the gastric mucosa under normal physiological conditions. Previous studies have revealed that Claudin18.2 is highly expressed in multiple types of cancer such as gastric cancer, pancreatic cancer, esophageal adenocarcinoma, and colorectal cancer. The unique feature of limited expression in normal tissues and highly specific expression in cancer makes Claudin18.2 an ideal target for developing the immunotherapeutic for solid tumors.
Globally, there are many candidate therapies in clinical development. The drug modalities under development include monoclonal antibodies, bispecific antibodies, antibody-conjugated drugs and CAR-T cell products. However, currently no drug targeting Claudin18.2 has been approved.
About IBI343
IBI343 is a recombinant human anti-Claudin 18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the Claudin 18.2-expressing tumor cells, the Claudin 18.2 dependent ADC internalization will occurr and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect". Currently, Phase I study of IBI343 has been conducted in Australia (NCT05458219) to assess the safety, tolerability, and preliminary efficacy of IBI343 in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).