Innovent Presents Phase Ib Clinical Data of IBI939 (Anti-TIGIT Monoclonal Antibody) in Previously Untreated PD-L1-selected NSCLC at the 2022 European Society For Medical Oncology Immuno-Oncology Congress

ROCKVILLE,Md. and SUZHOU,China,Dec 9,2022 -- 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 clinical data of IBI939 (anti-TIGIT monoclonal antibody) is presented at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO),Dec 7-9,2022.

A Phase Ib Study to Evaluate the Safety,Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected NSCLC

Poster #: 77P

IBI939 is a recombinant fully human anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) monoclonal antibody developed by Innovent Biologics. This Phase Ib study aimed to evaluate safety,tolerability,and efficacy of combination therapy of IBI939 with sintilimab in patients with previously untreated,locally advanced unresectable or metastatic PD-L1 TPS≥50% NSCLC without sensitizing mutations. As of October 15th,2022,42 pts were randomized (2:1) to receive IBI939 plus sintilimab (experimental arm) or sintilimab monotherapy (control arm). The study results were as follows:

Baseline characteristics: in the experimental arm (n=28),median age was 65 and 7 (25%) patients have brain metastasis; in the control arm (n=14),median age was 58 and 1 (7.1%) patient has brain metastasis.

As of the data cutoff date,among 40 efficacy evaluable patients (27 vs. 13). The median follow-up duration was 11.0 mos (95%CI,9.6-11.3) in experimental arm and 9.8 mos (95%CI,8.1-10.9) in control arm. Confirmed objective response rate (ORR) was 64.3% vs 57.2% and the disease control rate (DCR) was 85.7% vs 78.6% in experimental arm and control arm,respectively. The median PFS was 11.2 mos (95%CI,6.7-NA) in experimental arm vs 6.4 mos (95% CI,1.4-NA) in control arm (HR: 0.55);

For safety results,the incidence of TRAEs was 96.4% vs 71.4% (4 vs 5 pts experienced grade ≥ 3 TRAEs),in experimental arm vs control arm,respectively. Two patients in experimental arm and one patient in control arm experienced TRAE leading to study treatment discontinuation. No grade 5 TRAE happened in experimental arm.

The study is still ongoing; primary efficacy data will be further evaluated and presented in future medical conferences.

Professor Ying Cheng,Jilin Cancer Hospital,stated: "PD-L1 TPS≥50% NSCLC is sensitive to PD-1/PD-L1 inhibitors as first-line systemic therapy indicating promising survival benefits for patients[1]. IBI939 plus sintilimab bring encouraging efficacy to patients and present a manageable safety profile in the Phase Ib study. The study is still ongoing,and we look forward to the follow-up results of positive efficacy data in the future."

Dr. Hui Zhou,Senior Vice President of Innovent,stated: "We are pleased to present the clinical development updates of IBI939 at the 2022 ESMO-IO Meeting. IBI939,in combination with sintilimab,demonstrated encouraging efficacy and safety data in the Phase Ib clinical study. PFS benefit and tolerable safety profiles were observed. We will continue to provide updates on the PoC data readout for IBI939 in treatment areas such as lung cancer and plan to initiate subsequent pivotal clinical studies. As immunotherapy moves into the next era,we continue to focus on developing and commercializing high-quality biopharmaceuticals that are affordable to ordinary people."

To learn more about Innovent's R&D updates and activities,please visit https://investor.innoventbio.com/cn/investors/webcasts-and-presentations/.

About IBI939

IBI939 is an IgG4κ recombinant human anti-TIGIT monoclonal antibody developed by Innovent Biologics. Targeting TIGIT on T cells and NK cell membranes in the tumor microenvironment,this drug candidate can prevent the binding of CD155 overexpressed on the cancer cell membrane to TIGIT,thereby restoring the activation of cytotoxic T cells and NK cells,and exerting tumor killing effects[2]. TIGIT and PD-1 are both immunosuppressive checkpoint receptors. Inhibition of TIGIT and PD-1 can synergistically promote immune cells to kill tumors and enhance anti-tumor immune response[3].

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 (BCR ABL TKI),Cyramza® (ramucirumab) and selpercatinib. An additional 2 assets are under NMPA NDA review,5 assets are in Phase 3 or pivotal clinical trials,and 20 more molecules are in clinical studies.

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.

Selpercatinib (Eli Lilly). Selpercatinib was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer:

This indication is still under clinical study,which hasn't been approved in China or the U.S.

Innovent does not recommend any off-label usage.

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.

Reference

[1] 中华医学会肺癌临床诊疗指南（2022版）

[2] Manieri,N. A.,Chiang,E. Y.,& Grogan,J. L. TIGIT: A Key Inhibitor of the Cancer Immunity Cycle. Trends Immunol. 2017Jan;38(1):20-28

[3] Solomon BL,Garrido-Laguna I. TIGIT: a novel immunotherapy target moving from bench to bedside. Cancer Immunol Immunother. 2018 Nov;67(11):1659-1667