Innovent Release Phase 1 Results of IBI322 (anti-PD-L1/CD47 bispecific antibody) in patients with advanced solid tumors at AACR Annual Meeting 2022

SAN FRANCISCO and SUZHOU, China, April 10, 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 cancer, metabolic, autoimmune and other major diseases, announced that the results of the Phase I study for IBI322 (anti-CD47 /PD-L1 bispecific antibody) in patients with advanced solid tumors were presented today at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Poster No. CT513).

This is a first-in-human, phase Ia/Ib dose escalation/expansion study of IBI322 monotherapy in patients with advanced solid tumors who failed standard of care treatment. 58 subjects were enrolled in the study, 16 of which (27.6%) had previously received PD-1/L1 treatment. The highlights for the study results were as follows:

• 20 patients with various advanced solid tumors at active doses of IBI310 ≥10 mg/kg group were evaluable per RECISTv1.1, 4 achieved PR, with investigator assessed ORR 20%.
• Among 9 patients with NSCLC treated at active doses of IBI310 ≥10 mg/kg group, 3 achieved PR, with investigator assessed ORR 33.3% and the DCR 88.9%.
• IBI322 was well tolerated and showed a favorable safety profile. Treatment related adverse events (TRAEs) occurred in 74.1% (43/58) patients, most frequent TRAEs including anemia, platelet count decreased, pyrexia. The majority of the TRAEs were in grade 1-2. No treatment related death occurred as the cut-off date.

Phase Ia dose expansion study with IBI322 monotherapy has kept updating with longer follow-up after the cut-off date. Preliminary response and disease control have been observed in specific indications (such as SCLC). More clinical data will be mature and presented in the future.

Furthermore, given that IBI322 has demonstrated promising efficacy signals and favorable safety and tolerability profile, phase Ib trial has been conducted to further explore the safety and efficacy of IBI322 in multiple indications.

Professor Jie Wang, principal investigator of the study, Chief of Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, stated: "Immune checkpoint inhibitors (ICI) have shown promising efficacy in various tumor types, but many clinical challenges still remain. With the increasing prescription of ICI in first-line setting, many patients developed into ICI resistance or has poor response rate in clinical practice. Therefore, it is of great clinical significance to develop next generation bi-specific immune checkpoint inhibitors. CD47 is one of the most promising targets in immunotherapy. With innovate bispecific antibody development technology, IBI322 showed favorable safety and preliminary efficacy signals in subjects who had failed previous standard treatment, which increased our confidence in the subsequent expansion cohort study."

Dr. Hui Zhou, Vice President of Innovent, stated: "IBI322 is a bispecific antibody that specifically targeting recombinant anti-differentiation cluster 47 (CD47) and anti-programmed death ligand 1 (PD-L1).IBI322 is independently developed by Innovent Biologics and the company owns  global proprietary rights. We are very excited to observe preliminary efficacy and manageable safety profile in patients with advanced malignancy who failed standard of care treatment. We will continue to proceed the phase Ib expansion cohort study and further explore the safety and efficacy of IBI322 in multiple indications. By developing a comprehensive and advanced pipeline of next generation immune checkpoint inhibitors, we hope to bring clinical benefit to more patients."

About IBI322

IBI322 is a recombinant anti-human CD47/PD-L1 bispecific antibody developed by Innovent Biologics. As a bispecific antibody, IBI322 targets CD47 on the surface of tumor cells, blocks SIRPα/CD47 pathway and activates macrophages to attack the tumor cells. Furthermore, IBI322 target PD-L1 on the surface of tumor cells, blocks the PD-1/PD-L1 pathway, which counteracts the inhibition of T cells and activates the T cells to attack the tumor cells. By inhibiting two different targets, IBI322 can not only activate both innate immune pathway and adaptive immune pathway, which provides synergistic effect, but also reduce the red blood cell destruction. IBI322 has received IND approvals from both the NMPA and the U.S. FDA and has been actively developed globally.

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 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, metabolic, autoimmune diseases and other major therapeutic areas, with 7 products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), PEMAZYRE® (pemigatinib), olverembatinib (BCR ABL inhibitor) and Cyramza® (ramucirumab), 1 asset under NMPA NDA review, 5 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.

Disclaimer:

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

2. 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 materialise or turn out to be incorrect.

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SOURCE Innovent Biologics