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Article source: Pharmaceutical Guanlan
On May 28th, a recombinant humanized PD-L1 single-domain antibody (Envolimab, KN035) strategically cooperated by Corning Jereh, Sildi Medicine, and Simcere, was published in The Oncologist, an internationally renowned medical journal.
According to the press release, Envolimab injection is the PD-L1 single-domain antibody Fc fusion protein developed by Corning Jereh.
In November 2020, Envolimab submitted a new drug marketing application to the China National Medical Products Administration (NMPA).
The online publication this time is the first phase 1 clinical trial of Envolimab in humans, and the indication is for advanced solid tumors.
▲Tumor response observed in the study (Source of screenshots: Reference [2])
The results of the test showed that a total of 3 subjects had confirmed partial remission, and the therapeutic response was observed as low as 0.
During the dose-escalation phase, no dose-limiting toxicity was observed, and the maximum tolerated dose was not reached.
In the dose exploration phase, when 300 mg Q4W is used, the steady-state half-life can be as long as 23 days.
In terms of safety, the most common treatment emergency adverse events were fatigue (29%), nausea (18%), diarrhea (14%) and hypothyroidism (14%).
Note: The original text has been deleted
Reference materials:
[1] US Phase I clinical data of envolimab was published in The Oncologist.
[2]First-in-Human Phase I Study of Envafolimab, a Novel Subcutaneous Single-Domain Anti-PD-L1 Antibody, in Patients with Advanced Solid Tumors.