On April 3, 2023 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported the publication of its first in human Phase I clinical trial with its novel monoclonal antibody, NEO-201, targeting the truncated core-1 O-glycan (Press release, Precision Biologics, APR 3, 2023, View Source [SID1234629777]). This trial was performed in patients with refractory solid tumors and has been published in the Journal of Experimental and Clinical Cancer Research.

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As discussed in the article, based on the safety and activity of NEO-201, a Phase II study is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancers, Endometrial Cancer and Cervical Cancer, who have already been treated with checkpoint inhibitor therapy (including prior Keytruda). (View Source). NEO-201 is a unique monoclonal antibody with multiple mechanisms of action. It has been shown previously to kill cancer cells expressing its target. In the Phase I clinical trial, NEO-201 was found to reduce immune suppressive cells that may be responsible in diminishing cancer-killing activity for checkpoint inhibitors like Keytruda. This ongoing Phase 2 trial is testing to see if combining of NEO-201 with Keytruda can reactivate the effectiveness of checkpoint inhibitors when they don’t work alone.