Innovent Presents Clinical Data of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

SAN FRANCISCO and SUZHOU, China, June 6, 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, today announced that clinical data of IBI110 (anti-LAG-3 monoclonal antibody) from three clinical trials will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3-7, 2022. This includes clinical data from a Phase Ia/Ib clinical study and preliminary results from two Phase Ib Proof-of-Concept (PoC) clinical studies for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) and advanced gastric cancer (GC).

IBI110 (anti-LAG-3 mAb) as a single agent or in combination with sintilimab (anti-PD-1 mAb) in patients with advanced solid tumors: updated results from the Phase Ia/Ib dose-escalation study

Poster Presentation, Abstract #: 2650

This is a first-in-human, Phase Ia/Ib study of IBI110 in patients with advanced solid tumors, including Phase Ia IBI110 monotherapy and Phase Ib combination therapy of IBI110 and sintilimab. The highlights for the study results were as follows:

• 39 patients with advanced solid tumors who failed standard of care therapy were treated with IBI110 (≥ 3 mg/kg) in combination with sintilimab and received at least 1 post-baseline tumor assessment. 6 patients achieved partial response (PR); the objective response rate (ORR) was 15.4% and the disease control rate (DCR) was 64.1%.
• 31 patients with advanced NSCLC who failed standard of care, and 6 patients achieved PR; the ORR and DCR were 19.4% and 74.2%, respectively.
• For safety results, no dose limiting toxicity (DLT) was observed in either Phase Ia or Ib dose escalation. In Phase Ib dose escalation, treatment-related adverse events (TRAEs) occurred in 75.6% (34/45) patients, most of which were grade 1-2, and the most common TRAEs were aspartate aminotransferase increased (28.9%), anemia (24.4%) and alanine aminotransferase increased (22.2%).

Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in first-line advanced squamous non-small cell lung cancer (sqNSCLC): initial results from a Phase Ib study

Abstract #: e21145

In this Phase Ib study, the efficacy and safety of IBI110 in combination with sintilimab as first-line therapy for advanced sqNSCLC was evaluated.

• 20 untreated advanced sqNSCLC patients received 200 mg IBI110 combined with sintilimab and chemotherapy and received at least 1 post-baseline tumor assessment. As of the data cutoff date of Jan 20, 2022, 16 patients achieved PR, the ORR was 80%. The study is still ongoing and will continue to monitor depth of response overtime.
• For safety results, the most common TRAEs ≥ grade 3 were neutrophil count decreased (30%) and white blood cell count decreased (20%). Immune-related AEs occurred in 11 patients (55%) and most were grade 1-2. There were no treatment-related deaths or TRAEs led to treatment discontinuation.
• IBI110 alone or plus sintilimab indicate a manageable safety profile andpromising antitumor activity from the preliminary data. The study is ongoing with the clinical data in squamous NSCLC is continuing to mature and will be presented in the future.

Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: preliminary results from a Phase Ib study

Abstract #: e16097

In this Phase Ib study, the efficacy and safety of IBI110 in combination with sintilimab as first-line therapy for advanced GC was evaluated.

• 15 untreated advanced GC patients received 200 mg IBI110 combined with sintilimab and chemotherapy and received at least 1 post-baseline tumor assessment. At the cut-off date of January 20, 2022, 9 patients achieved PR; the ORR and DCR were 60% and 100%, respectively. Up to the press release date, the ORR reached 76.5% and most patients were still in treatment.
• The most common TRAEs ≥ grade 3 were neutrophil count decreased (11.1%), platelet count decreased (11.1%) and hepatic function abnormal (11.1%). Immune-mediated AEs occurred in 7 pts (38.9%). One patient discontinued treatment due to coronary artery disease. There were no treatment-related deaths.

Professor Caicun Zhou, Shanghai Pulmonary Hospital, stated: "Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide, of which non-small cell lung cancer accounts for about 80%. In recent years, PD-1/PD-L1 inhibitors have shown promising efficacy in non-small cell lung cancer. However, persistent response to immune checkpoint inhibitor monotherapy remains a challenge in clinical practice. IBI110 plus sintilimab indicate a manageable safety profile and promising antitumor activity in untreated squamous non-small cell lung cancer patients. The ORR reached 80%, suggesting that it is worth further exploring the safety and efficacy of IBI110 combination therapy in this indication."

Professor Nong Xu, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Immune checkpoint inhibitors have shown good efficacy in a variety of tumors, but clinical challenges still remain. A key part of the mechanism of action is the synergistic inhibition of LAG-3 and PD-1 could have the potential to enhance the immune response and inhibit tumor growth. We are encouraged by the results we've seen to date in this study and the potential of this medicine."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2022 ASCO Meeting. IBI110 in combination with sintilimab demonstrated encouraging efficacy and safety data in sqNSCLC and GC. We will continue to update on PoC data readout for IBI110 in treatment areas such as lung cancer and plan to initiate subsequent pivotal clinical studies. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune checkpoint inhibitors, among which IBI110 represents a high-potential LAG-3 asset, and we hope it could benefit more patients in need soon."

To learn more about Innovent's R&D updates and activities at 2022 ASCO, please visit https://investor.innoventbio.com/cn/investors/webcasts-and-presentations/.

About IBI110

IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody independently developed by Innovent Biologics (Suzhou). Based on the mechanism of action and preclinical data of IBI110, it is assumed that IBI110 can inhibit the immune checkpoint signaling to achieve anti-tumor effect, which may further improve the efficacy of immunotherapy, overcome the primary drug resistance, and overcome the drug resistance after anti-PD-1 /PD-L1 monoclonal antibody treatment. Based on the urgent clinical needs, Innovent Biologics has carried out clinical studies to explore PK/PD characteristics of IBI110 single drug and combined with sintilimab in human body as well as its efficacy and safety in various advanced tumors. This is the first in human clinical study of IBI110.

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, metabolic, 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 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 32 valuable assets in the fields of cancer, autoimmune, metabolic, 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) and olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab) , 2 asset under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 19 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, Adimab, Incyte, MD Anderson Cancer Center, Hanmi 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.

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