On October 2, 2023 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported that on September 26, 2023, the USPTO granted a patent for its lead clinical asset, NEO-201, which is currently being tested in Phase 2 human Clinical Trials in the US (Press release, Precision Biologics, OCT 2, 2023, View Source [SID1234635575]).
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NEO-201 is a humanized IgG1 monoclonal antibody with multiple mechanisms of action. It has been shown previously to kill cancer cells expressing its target (truncated glycans) which is expressed in numerous cancers; however, it does not bind to most normal tissues. In addition, NEO-201 binds to immune suppressor cells, including regulatory T cells (Tregs) and granulocytic myeloid-derived suppressor cells (gMDSCs), which are thought to diminish the efficacy of cancer immunotherapy.
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. Based on the safety and activity of NEO-201 in its Phase I completed study, a Phase II study is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancer, Endometrial Cancer and Cervical Cancer, whose disease has previously progressed through prior checkpoint inhibitor therapy (including prior Keytruda.) (View Source) This ongoing Phase 2 trial is testing to see if combining NEO-201 with Keytruda can reactivate the effectiveness of checkpoint inhibitors when they no longer work.
Data from the ongoing Phase 2 trial was recently presented at CRI-ENCI-AACR 7th International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) Sept 22, 2023, Milan, Italy. This data demonstrated that NEO-201 reduces the quantity of regulatory T cells in PBMCs of cancer patients and this reduction is associated with stabilization of disease. (click here).
Additional data regarding the effects of NEO-201 on reducing gMDSCs will be presented at the upcoming SITC (Free SITC Whitepaper) Annual Meeting in San Diego in early November.