On June 11, 2023 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, reported that Phase 1 clinical data of the globally first anti-CD47/PD-L1 bispecific antibody IBI322 for the treatment of anti-PD-(L)1-resistant patients with classic Hodgkin lymphoma was presented in oral presentation at the 28th Annual Meeting of the European Society of Hematology (EHA 2023) (Press release, Innovent Biologics, JUN 11, 2023, View Source [SID1234632627]). The EHA (Free EHA Whitepaper) Annual Meeting was held in Frankfurt, Germany, from June 8 to 15, 2023.

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Title: CD47/PD-L1 bispecific antibody (IBI322) in anti-PD-1 or PD-L1 treatment-resistant classical Hodgkin lymphoma: a Phase 1 study
Session: s445 Hodgkin lymphoma – Clinical, 11/06/2023, 11:30 – 12:45 (CEST)
Final Abstract Code: S216
Presenting Author: Dr. Jingwei Yu, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China

The presented data was based on an dose-expansion cohort from a Phase 1 study (NCT04795128) aiming to evaluate the safety and preliminary antitumor activity of IBI322 in patients with anti-PD-(L)1 treatment-resistant classic Hodgkin lymphoma. Eligible patients receive IBI322 (45 mg/kg intravenous Q2W) until unacceptable toxicity or disease progression, or up to 24 months. A total of 24 patients currently included, of which 23 patients were efficacy evaluable.

Among the 23 patients, the objective response rate (ORR) and disease control rate (DCR) were 47.8% (95% CI: 26.8-69.4) and 91.3% (95% CI: 72.0-98.9), respectively. Among the 7 patients with primary resistance, the ORR was as high as 57.1% (95% CI: 18.4-90.1), and 3 patients achieved complete response (CR).

In terms of safety, the incidence of treatment-related adverse reactions (TRAE) was 91.7%, and the most common TRAE were decreased lymphocyte count (62.5%), anemia (62.5%), decreased white blood cell count (20.8%), and decreased platelet count (20.8%). The incidence of grade ≥ 3 TRAE was 41.7%, with the most common ≥ grade 3 TRAE (>5%) associated with decreased lymphocyte count (29.2%). There were no TRAE leading to permanent treatment discontinuation or death. As of the data cut-off, 12 patients were still receiving IBI322 monotherapy.

Overall, IBI322 monotherapy showed promising anti-tumor efficacy with a manageable safety profile in anti-PD-1 or PD-L1 treatment-resistant classical Hodgkin lymphoma patients. Abstract Link

Professor Ting Niu, the principal investigator of this study, West China Hospital of Sichuan University, said: "This phase 1 study shows that IBI322 monotherapy is effective and safe in the treatment of PD-1 or PD-L1 treatment-resistant classical Hodgkin lymphoma, and we look forward to longer follow-up results and larger sample sizes in the future. IBI322 has the potential to be an effective treatment option for the treatment of immunotherapy-resistant classical Hodgkin lymphoma and other types of lymphoma to meet the unmet clinical needs. "

Dr. Hui Zhou, Senior Vice President of Innovent, said: "With the widespread application of anti-PD-(L)1 monoclonal antibodies in the field of classical Hodgkin lymphoma, immunotherapy resistance has emerged as an urgent clinical need. IBI322, as globally the first anti-CD47/PD-L1 bispecific antibody for the treatment of anti-PD-1 or PD-L1 treatment-resistant classic Hodgkin lymphoma, showed encouraging anti-tumor efficacy and a manageable safety profile in the Phase 1 clinical study, exhibiting its potential to overcome immunotherapy resistance for patients with classical Hodgkin lymphoma. "

About Hodgkin lymphoma

Hodgkin lymphoma is a special type of lymphoma containing Reed-Sternberg cells, which accounts for about 8.54% of lymphoma. The current incidence rate is about 0.6 cases per 100,000 population. After first-line radiotherapy + chemotherapy ABVD (doxorubicin + bleomycin + vincristine + dacarbazine), ASCT (autologous stem cell transplantation) has achieved a 5-year survival rate of more than 80% for patients, but the treated rate is limited in China due to several reasons, including the poor tolerability for certain patients, the relatively low mental acceptance, and limited medical resources; Another 15-20% of patients do not respond to initial treatment and develop relapsed or refractory classical Hodgkin lymphoma after immunotherapy resistance, which is currently an urgent clinical need.

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.