On December 14, 2022 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported the successful completion of the safety phase and the enrollment of new patients into the expansion of the Phase 2 Clinical Trial Combining Precision Biologics NEO-201 monoclonal antibody with Pembrolizumab (Keytruda) (Press release, Precision Biologics, DEC 14, 2022, View Source [SID1234625285]).
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The study is enrolling patients at the National Cancer Institute, part of the National Institutes of Health, Bethesda, MD, 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)
This ongoing Phase 2 trial is testing to see if the combining of NEO-201 with Keytruda can reactivate the killing activity once checkpoint inhibitors no longer work alone.
Christina M Annunziata, MD, PhD, Clinical Director of the Women’s Malignancy Branch at the NCI has been working both preclinically and overseeing this ongoing clinical trial.
"In our laboratory, we have been studying how this antibody can be used in various cancer treatments. Based on the main mechanisms of action, we have moved forward with a phase 2 clinical trial in combination with pembrolizumab," said Dr. Annunziata.
NEO-201 is a unique monoclonal antibody with multiple mechanisms of action. It has been shown previously to kill cancer cells expressing its target. Additionally, it has been shown in early clinical trials to reduce immune suppressive cells that may be responsible in diminishing cancer killing activity for drugs like Keytruda.