On September 28, 2021 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 the preliminary results of the Phase Ia study of IBI315 (first-in-class anti-Her2/PD-1 bispecific antibody) in an oral presentation at the 2021 Annual Meeting of Chinese Society of Clinical Oncology (CSCO) (Press release, Innovent Biologics, SEP 28, 2021, View Source [SID1234590427]).
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By data cutoff date of May 25, 2021, 27 patients have been enrolled and received IBI315 at one of seven pre-specified dose levels of 0.03mg/kg QW to 15mg/kg Q3W. No dose limited toxicity (DLT) was observed, and maximum tolerated dose (MTD) has not been reached. Among 15 patients who have completed at least one post-treatment tumor assessment at active dose levels (≥1mg/kg), objective response rate (ORR) was 20%. Biomarker analyses also supported the clinical results that clinical responders showed higher proliferation and activation of peripheral immune cells.
Professor Xichun Hu from Fudan University Shanghai Cancer Center, stated, "The satisfying safety profile and preliminary efficacy data of IBI315 seen in current study support the concept of bispecific antibody designed with targeted- and immune- therapies. We are confident to expect more positive results from the upcoming trials of IBI315 in more types of tumors expressing Her2. "
"IBI315 is a first-in-class anti-Her2/PD-1 bispecific antibody. We are excited to see that IBI315 was well tolerated with a manageable safety profile. The efficacy signal was also encouraging," said Dr. Hui Zhou, Senior Vice President of Innovent. "These results have proved the druggability and developability of IBI315. We will start a phase Ib study of IBI315 promptly to further explore the efficacy of IBI315 monotherapy and in combination with chemotherapy in Her2 positive and low-expressed tumors. We are expecting to enlarge the anti-Her2 therapeutic area with our first-in-class agent IBI315 and benefit more patients in the near future."
About CIBI315A101 Study
CIBI315A101 is a phase Ia/Ib open label, dose escalation and expansion study to evaluate the safety, tolerability and efficacy of IBI315 monotherapy and in combination with chemotherapy in advanced Her2 expressing solid tumors. This is the first-in-human study of IBI315. The phase Ia part of the study has 7 prespecified dose levels from 0.03mg/kg to 15mg/kg with dosing frequencies of QW, Q2W, or Q3W. The dose escalation follows a classic 3+3 design. The phase Ia part is ongoing. The phase Ib part is cohort expansions of IBI315 monotherapy or in combination with chemotherapy in specific tumor types.
About IBI315
IBI315 is developed through the collaboration between Innovent and Hanmi, and Innovent is leading its clinical development in China. IBI315 is a first-in-class recombinant fully human IgG1 bispecific antibody that targets PD-1 on the surface of T cells and HER2 expressed by tumor cells simultaneously. In preclinical studies, IBI315 has demonstrated potent anti-tumor activities with blockade of PD-1/PD-L1 and Her2 pathways, as well as a bridging effect between T cells and tumor cells.