Innovent Presents Phase 1b Clinical Data of IBI188 (Anti-CD47 Monoclonal Antibody) at the 2022 American Society of Hematology Annual Meeting

Rhea-AI Summary

Innovent Biologics presented clinical data for IBI188, an anti-CD47 monoclonal antibody, at the 2022 ASH Annual Meeting. This Phase Ib study assessed IBI188 coupled with Azacitidine in newly diagnosed higher risk myelodysplastic syndrome (MDS). The results showed a 100% objective response rate (ORR) after 6 cycles and a 63.3% complete response rate (CRR) in 30 patients. 94.6% of participants experienced treatment-related adverse events, yet the therapy demonstrated promising anti-tumor activity. Further updates on clinical findings are expected as the study progresses.

Positive

• 100% objective response rate (ORR) after 6 treatment cycles.
• 63.3% complete response rate (CRR) observed in patients after 6 cycles.
• Ongoing clinical study with potential for further efficacy data.

Negative

• 94.6% of patients experienced treatment-related adverse events.
• 7.5% of patients discontinued IBI188 due to adverse events.

ROCKVILLE, Md. and SUZHOU, China, Dec. 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 oncology, autoimmune, metabolic, ophthalmology and other major diseases, announced that clinical data of IBI188 (anti-CD47 monoclonal antibody) as first-line treatment in newly diagnosed higher risk myelodysplastic syndrome (MDS) is presented at the 2022 American Society of Hematology (ASH) Annual Meeting, held Dec 10-13, 2022.

Efficacy and Safety of IBI188 (anti-CD47 mAb) in Combination with Azacitidine (AZA) in First Line Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS): Updated Results from a Phase Ib Study

IBI188 is an IgG4 recombinant human anti-CD47 monoclonal antibody developed by Innovent Biologics. The Phase Ib study aims to evaluate the efficacy and safety of IBI188 in combination with AZA as first line therapy for newly diagnosed higher risk MDS.

• As of the data cutoff date (Oct 20, 2022), 93 treatment-naïve newly diagnosed higher risk MDS patients received IBI188 (from 0.1 mg/kg priming dose to 30mg/kg maintenance, QW) combined with AZA.
• 30 patients had received treatment ≥ 6 cycles. The Objective Response Rate (ORR) was 100% (30/30), complete response rate (CRR) was 63.3% (19/30).
• 42 patients had received treatment ≥ 4 cycles, ORR was 97.6% (41/42), CRR was 45.2% (19/42).
• 49 patients had received treatment ≥ 3 cycles, ORR was 93.9% (46/49), CRR was 38.8% (19/49).
• The median duration of response was not reached yet.
• For safety results, 88 (94.6%) patients experienced at least 1 treatment-related adverse event (TRAE). The most common TRAEs were platelet count decreased, anemia, white blood cell count decreased, neutrophil count decreased, etc. TRAEs leading to discontinuation of IBI188 occurred in 7 (7.5%) patients. IBI188 combined AZA in first line newly diagnosed higher risk MDS continues showing robust anti-tumor activity and favorable safety. The study is ongoing with the clinical data continuing to mature and will be disclosed in the future academic conference/journals.

Professor Miao Miao, The First Affiliated Hospital of Suzhou University, stated: "Data showed that the incidence of MDS globally is about (2~12)/100 000 per year, and in China the incidence is approximately (0.23~1.51)/100 000 per year. The incidence rates increase significantly along with age. The median overall survival of higher risk MDS is only 0.8-1.6 years and 25%-30% patients develop into AML if untreated. Hypomethylating agents, include AZA, were the most common used drugs in the treatment of higher risk MDS, but only 40%-50% patients can be benefit from this treatment. Despite of the efficacy, the disease will relapse within 2 years and the median overall survival after recurrence is only about 4.3 months. IBI188 plus AZA indicate promising antitumor activity and manageable safety profile in untreated higher risk MDS patients, suggesting that it is worth further exploring the safety and efficacy of IBI188 combination therapy in this indication."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2022 ASH Meeting. IBI188 in combination with AZA demonstrated encouraging efficacy and safety data in newly diagnosed higher risk MDS. We will continue to update on PoC data readout for IBI188. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune checkpoint inhibitors, and we hope it could benefit more patients in need soon."

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

About IBI188

IBI110 is an IgG4 recombinant human anti-CD47 monoclonal antibody independently developed by Innovent Biologics. Based on the mechanism of action and preclinical data of IBI188, it is assumed that IBI188 can inhibit CD47 binding to SIRPα expressed on the surface of macrophages to achieve phagocytosis enhancement and anti-tumor effect. Based on the urgent clinical needs, Innovent has carried out clinical studies to explore PK/PD characteristics of IBI188 single agent and combined with hypomethylating agents in human body as well as its efficacy and safety in various advanced tumors (solid tumors and hematological malignancies).

About Innovent

In December 2018, Innovent and Incyte entered into a strategic collaboration. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib in Mainland China, Hong Kong, Macau and Taiwan.

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.

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.

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

Disclaimer:

1. The indications are still under clinical study, which haven'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 materialize or turn out to be incorrect.

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SOURCE Innovent Biologics

FAQ

What are the clinical results of IBI188 presented at the 2022 ASH Annual Meeting?

IBI188 demonstrated a 100% objective response rate and a 63.3% complete response rate after 6 treatment cycles in newly diagnosed higher risk MDS patients.

What is the significance of the Phase Ib study for IBI188?

The Phase Ib study indicates promising anti-tumor activity of IBI188 combined with Azacitidine, suggesting potential advancements in MDS treatment.

What were the safety concerns related to IBI188?

The study reported that 94.6% of patients experienced treatment-related adverse events, with 7.5% discontinuing treatment due to these effects.

What are the next steps following the presentation of IBI188 data?

Innovent aims to continue updating on proof-of-concept data as the clinical study progresses and data matures.