Subcutaneous injection of PD-L1 antibody Phase 1 clinical data published in the United States | The On...

Article source: Pharmaceutical Guanlan

On May 28th, a recombinant humanized PD-L1 single-domain antibody (Envolimab, KN035) strategically cooperated by Corning Jerry, Sidi Medicine and Simcere, was published in the internationally renowned medical journal The Oncologist Published full-text online data from a Phase 1 clinical trial in the United States.

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.

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