On April 10, 2022 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, reported 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) (Free AACR Whitepaper) Annual Meeting 2022 (Poster No. CT513) (Press release, Innovent Biologics, APR 10, 2022, View Source [SID1234611859]).
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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.