Innovent Announces First Patient Dosing in Australia in Phase I Study of IBI343 (Recombinant anti-Claudin18.2 Monoclonal Antibody-drug Conjugate) in Patients with Advanced Solid Tumors

ROCKVILLE, Md. and SUZHOU, China, Oct. 30, 2022/PRNewswire/ -- 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, announced 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. It is the first ADC candidate drug to enter clinical phase in Innovent's pipeline.

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 Chinalast 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).

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection), HALPRYZA (rituximab biosimilar injection), Pemazyre (pemigatinib oral inhibitor), olverembatinib （BCRABLTKI）,Cyramza (ramucirumab) and selpercatinib. An additional 2 assets are under NMPA NDA review, 4 assets are in Phase 3 or pivotal clinical trials, and 21 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

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