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On September 13th, Youzhiyou Bio announced that the company will announce its self-developed recombinant anti-EpCAM and CD3 bispecific antibody drug for injection (code: M701) at the 2021 European Society of Medical Oncology (ESMO) annual meeting for malignant Interim results of phase 1 clinical trials conducted in patients with ascites
.
Studies have shown that M701 monotherapy has shown good ascites control effects, and has shown good safety and tolerability
Recombinant anti-EpCAM and CD3 bispecific antibody drugs for injection showed good ascites control effect for patients with malignant ascites M701 monotherapy, and showed good safety and tolerability
M701 is a recombinant anti-EpCAM and CD3 bispecific antibody.
It can specifically bind to EpCAM-positive tumor cells and at the same time bind to the T cell surface antigen CD3.
It recruits and activates T cells to kill tumor cells
.
Pre-clinical research data shows that this effect of activating immune cells occurs in the vicinity of EpCAM-positive cells, thereby increasing the specific activation and killing of T cells, and improving the safety of the drug
According to the press release, the phase 1 clinical trial announced this time is an open-label, dose-climbing, multi-center clinical study aimed at evaluating the safety, tolerability, and preliminary of M701 single-drug intraperitoneal infusion for patients with malignant ascites Observe effectiveness
.
As of February 2021, 23 subjects have been enrolled in the group, of which 16 subjects have completed the core phase of administration and safety evaluation, and the remaining 7 subjects withdrew from the study due to the epidemic situation, the progress of the primary disease, etc.
Among the 16 subjects who completed the core phase treatment, M701 drug single agent showed good ascites control effect.
Among them, 10 subjects had reduced or disappeared ascites (3 cases of ascites CR, 7 cases of ascites PR), and the remaining 6 The ascites of two subjects did not increase significantly (6 cases of SD).
The overall objective response rate (ORR) of ascites lesions was 62.
5%, and the disease control rate (DCR) was 100%
.
In the ascites of subjects with CR and PR, the continuous decrease of EpCAM positive cells and the increase of CD45 positive cells indicate that the drug can recruit T cells and eliminate tumor cells in the ascites
The overall objective response rate (ORR) of ascites lesions is 62.
MOS in patients with ovarian cancer is 148 days, mOS in patients with gastric cancer is 209 days
In addition, in all 23 subjects who received drug treatment, M701 showed good safety and tolerability
.
Among the 23 subjects, 19 subjects had any level of TRAE (treatment-related adverse reactions), mainly including hypoalbuminemia, anemia, hypokalemia, and low sodium, and 5 of them had the possibility of level 3 Hematological toxicities related to treatment, including anemia, hypokalemia, and hyperglycemia, no non-hematological toxicities of grade 3 and above, no cytokine release syndrome (CRS), and no hepatotoxicity was observed
Reference materials:
Reference materials:[1] The interim results of the phase I clinical trial study of EpCAM/CD3 dual antibody for the treatment of malignant ascites at the ESMO annual meeting in 2021 are online.
[1] The interim results of the phase I clinical trial study of EpCAM/CD3 dual antibody for the treatment of malignant ascites at the ESMO annual meeting in 2021 are online.
Retrieved Sep 13.
2021.
from https://mp.
weixin.
qq.
com/s/uKRytToz1p-0n4EZbFi2jw
