On November 13, 2024 ImmuneOnco Biopharma reported that Company has initiated the Phase II clinical trial of IMM27M for estrogen receptor positive (ER+) advanced breast cancer that failed after endocrine therapy or recurred and has enrolled the first patient (Press release, ImmuneOnco Biopharma, NOV 13, 2024, View Source [SID1234655705]). In addition, the Phase I dose-escalation study of IMM27M was completed in late 2023, demonstrating the following results (as of August 6, 2024): • In the Phase I trial, a total of eight evaluable ER+ advanced or metastatic breast cancer patients were enrolled. Among them, two achieved partial response (PR) and four patients had stable disease (SD), resulting in an overall response rate (ORR) of 25.0% and a disease control rate (DCR) of 75.0%; • Positive preliminary efficacy signals were demonstrated; and • IMM27M was found to be safe and well-tolerated, with no dose-limiting toxicity observed at the highest explored dose level of 7.5 mg/kg in Phase I.
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The recommended Phase II dose (RP2D) for monotherapy has been determined to be 5.0 mg/kg administered once every three weeks (Q3W).
ABOUT IMM27M
IMM27M is a new generation cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) activity. It caninduce potent immune responses targeting CTLA-4 overexpressed immune-suppressive Tregulatory (Treg) cells and promote Treg depletion from the tumor microenvironment (TME),thus enhancing T-cell antitumor response.