USPTO Grants Patent for Precision Biologics' Lead Antibody NEO-201 for Targeting Treg Cells

BETHESDA, Md., July 22, 2024 -- Precision Biologics, Inc. has announced the approval of a new patent for its primary clinical asset, NEO-201, by the United States Patent and Trademark Office (USPTO) on July 16, 2024. This notable achievement highlights the ongoing development in Phase 2 human Clinical Trials for the immunotherapy and oncology-focused company.

NEO-201 is a humanized IgG1 monoclonal antibody exhibiting multiple action mechanisms. It effectively targets cancer cells expressing truncated Core 1 O-glycans, a feature present in many types of cancer, while sparing most normal tissues. Additionally, NEO-201 binds to immune suppressor cells, notably regulatory T cells (Treg cells) and granulocytic myeloid-derived suppressor cells (gMDSCs), which can impede cancer immunotherapy's effectiveness.

The newly granted patent (Patent No. US 12,037,410B2) focuses on NEO-201's capacity to bind to Treg cells and its potential application in targeting these cells. The patent outlines NEO-201's use for isolating and detecting Treg cells and its ability to mediate the killing of these cells through complement-mediated cytotoxicity (CDC) in vitro. Therapeutic methods and combination therapies involving NEO-201 and other anti-cancer agents are also detailed within the patent.

In the Phase I clinical trial, NEO-201 was tested as a single agent for patients with advanced solid tumors that did not respond to standard treatments. The trial demonstrated that NEO-201 could bind to and reduce the number of circulating Tregs in patients with stable disease post-treatment. These results underpin the ongoing Phase II clinical trial, which is evaluating the efficacy of NEO-201 combined with pembrolizumab (Keytruda) in adults with solid tumors resistant to previous checkpoint inhibitors. The trial is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancer, Endometrial Cancer, and Cervical Cancer who have shown disease progression despite prior checkpoint inhibitor therapy, including Keytruda.

The primary goal of the Phase 2 trial is to determine if combining NEO-201 with Keytruda can restore the efficacy of checkpoint inhibitors when they have ceased to work. Data presented on June 1, 2024, at the ASCO Annual Meeting corroborate that NEO-201 reduces regulatory T cells and gMDSCs in the peripheral blood mononuclear cells (PBMCs) of cancer patients, correlating this reduction with sustained disease stabilization.

An independent study by Drs. Atsushi Tanaka and Shimon Sakaguchi from Osaka University, Japan, conducted further analysis via flow cytometry. This study confirmed NEO-201's ability to recognize Treg cells in PBMCs from healthy donors, paralleling Precision Biologics' findings in cancer patients. Results of this study were presented as a poster at the Association for Cancer Research (AACR) Annual Meeting on April 8, 2024.

Precision Biologics, established in 2012, is a clinical-stage biotechnology company concentrating on therapeutic and diagnostic products for cancer detection and treatment. The company specializes in developing antibody drug candidates and diagnostics that target tumors while minimizing harm to healthy cells. Precision Biologics is leveraging its proprietary cancer vaccines, several of which have shown success in human trials, to create innovative therapeutics with the potential to transform cancer detection and treatment.