Innovent Announces First Patient Dosing in Australia in Phase 1 Study of IBI363 (PD-1/IL-2 Bispecific Antibody Fusion Protein) in Patients with Advanced Malignancies

ROCKVILLE,Md. and SUZHOU,China,Aug. 23,2022 -- 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,announced that the first patient dosing in Australia for its proprietary PD-1/IL-2 bispecific antibody fusion protein (R&D code: IBI363) in Phase I clinical trial for the treatment of patients with advanced solid tumors or lymphomas. It is first candidate drug to conduct clinical trial in Australia in Innovent's pipeline.

The study (NCT05290597) is an open-label,multi-center Phase I study evaluating the safety,tolerability,and preliminary efficacy of IBI363 in subjects with advanced solid tumors or lymphoma,and to determine the recommended Phase 2 dose (RP2D).

Interleukin 2 (IL-2),a cytokine secreted mainly by antigen-activated CD4 + T cells,is vital for maintaining CD4 + regulatory T cell (Treg) level,CD4 + T cell differentiation,and maintaining CD8 + T cell and natural killer cell activity. IL-2 was the first cytokine to be discovered and identified as playing a pivotal role in T-cell growth and expansion. Aldesleukin (IL-2) was approved by U.S. Food and Drug Administration for metastatic renal cell carcinoma and metastatic melanoma in the early 1990s,but it has not been widely used in clinic due to poor selectivity,narrow therapeutic window,and side effects.

IBI363,potential First-in-Class candidate drug,was independently developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity,whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore,IBI363 has both functions of simultaneously blocking PD-1/PD-L1 pathway and activating IL-2 pathway,allowing more precise and efficient targeting and activation of tumor specific T cells. IBI363 not only showed promising anti-tumor activity in a variety of tumor-bearing pharmacological models,but also exhibited prominent antitumor efficacy in PD-1 resistant and metastatic models; meanwhile,IBI363 demonstrated a good safety profile in preclinical in vivo models.

Dr. Morteza Aghmesheh,Southern Medical Day Care CentreLocated in New South Wales,Australia,stated："Wild type IL-2 is clinically validated as monotherapy,but limited by toxicity and low response rate due to poor selectivity. IBI363,a novel PD-1/IL-2 bispecific molecule,designed to selectively activates PD-1 positive T cells by cis-activating IL-2,but not PD-1 negative bystanders or naïve T cells,with the potential to significantly decrease toxicity related to IL-2 and potentially overcome immunotherapy resistance. We look forward to the positive results in the safety/tolerability and efficacy of IBI363 in the clinic."

Dr. Hui Zhou,Senior Vice President of Innovent,stated:"Most patients will develop primary or secondary resistance after treatments of immune checkpoint inhibitors. At present,treatment options are limited upon progression after immunotherapy,and there is a huge unmet clinical needs. IBI363,developed by scientists at Innovent Academy,can enhance anti-tumor immune response by reversing T cell exhaustion,improving the efficacy of immune checkpoint inhibitors especially for patients with resistance to immunotherapy or "cold tumors",while minimizing IL-2related side effects. We are pleased that the first patient dose of IBI363 has been completed in Australia. In parallel,the IND for IBI363 has been approved by NMPA in China. We are looking forward to the positive results of IBI363 in patients with advanced solid tumors or lymphoma. IBI363 is our first molecule to initiate clinical study in Australia,which marks a solid step of 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 IBI363

IBI363,was self-developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein,which simultaneously blocks PD-1/PD-L1 pathway and activates IL-2 pathway to stimulate T cell activation and proliferation,thus killing tumor cells and inhibiting tumor growth. Currently,Phase 1 studies of IBI363 are conducted in China and Australia (NCT05460767,NCT05290597) to assess the safety,and to determine the 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 oncology,ophthalmology 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 that includes R&D,CMC (Chemistry,Manufacturing,and Controls),clinical development and commercialization capabilities. Leveraging the platform,the company has built a robust pipeline of 34 valuable assets in the fields of cancer,ophthalmology and other major therapeutic areas,with 7 products approved for marketing in China – TYVYT® (sintilimab injection),BYVASDA® (bevacizumab biosimilar injection),SULINNO® (adalimumab biosimilar injection),HALPRYZA® (rituximab biosimilar injection),Pemazyre® (pemigatinib oral inhibitor),olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab),3 assets under NMPA NDA review,4 assets in Phase 3 or pivotal clinical trials,and an additional 20 molecules 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.

Note:

TYVYT® (Sintilimab Injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection),and SULINNO® (adalimumab 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.

Disclaimer:

1. This indication is still under clinical study and hasn't been approved in China.

2. Innovent does not recommend the use of any unapproved drug/indication.

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