Innovent announced the preliminary results of the Phase Ia dose escalation study of IBI315 (anti-Her2/PD-1 bispecific antibody) in patients with advanced solid tumors at the CSCO annual meeting in 2021

Innovent Biopharmaceutical Group will report the preliminary results of the Phase Ia clinical study of IBI315 (the world's first anti-Her2/PD-1 bispecific antibody) at the 2021 China Clinical Oncology Conference (CSCO)
.
As of May 25, 2021, a total of 27 patients with advanced solid tumors expressing Her2 who failed the standard treatment were enrolled in this study, and received 0.
03mg/kg QW～15 mg/kg Q3W, respectively, at 7 study preset dose levels.
No dose-limiting toxicity (DLT) occurred, and the maximum tolerated dose (MTD) was not reached
.
Among all subjects who received the expected effective dose (≥ 1 mg/kg), a total of 15 patients completed at least one tumor assessment, and the objective response rate (ORR) was 20%
.
At the same time, the biomarker analysis results are consistent with the clinical efficacy, and the proliferation and activation of peripheral immune cells in those who respond to the treatment is higher
.
Professor Xichun Hu from the Cancer Hospital of Fudan University said: "IBI315 has shown good safety and preliminary effectiveness in the phase Ia study, and preliminary verification of the bispecific antibody design combining targeted therapy and immunotherapy
.
In the phase Ia study The data that has been obtained greatly increases our confidence in the follow-up study of IBI315, and supports the further exploration of the therapeutic effect of this molecule in more Her2-expressing tumor types
.
" Dr.
Zhou Hui, senior vice president of Cinda Biotech, said: "IBI315 is the world's first An anti-Her2/PD-1 bispecific antibody
.
We are very pleased to observe the good safety, tolerability and preliminary efficacy signals of IBI315 in this study, and preliminary verification of the anti-Her2/PD-1 bispecific antibody antibodies designed druggability
.
we will proceed apace phase Ib study to further explore IBI315 alone or in combination with chemotherapy in Her2-positive as well as the safety and preliminary effectiveness of Her2 low expressing tumors
.
we look forward to further expand the field of anti-Her2 therapy IBI315 , Highlighting the advantages of immunotherapy for the long-term survival of Her2-positive patients, and bringing clinical benefits to more patients
.
"