On July 22, 2024 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported that on July 16, 2024, the USPTO granted another 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, JUL 22, 2024, View Source [SID1234645007]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 Core 1 O-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 (Treg cells) and granulocytic myeloid-derived suppressor cells (gMDSCs), which are thought to diminish the efficacy of cancer immunotherapy.
The patent granted by USPTO on July 16, 2024 (Patent No. US 12,037,410B2) describes the ability of NEO-201 to bind to Treg cells, and its use in targeting Treg cells. NEO-201 may be used for isolation and detection of Treg cells. In addition, the patent claims that NEO-201 can mediate the killing of Treg cells through complement mediated cytotoxicity (CDC) in vitro. Therapeutic methods and combination therapies using NEO-201 in combination with another anti-cancer agent are also described in the patent.
According to claims of the patent, in the Phase I clinical trial, using NEO-201 as single agent for the treatment of subjects with advanced solid tumors which have progressed on or not responded to standard treatments, NEO-201 was proven to bind and reduce the amount of circulating Tregs in subjects with stable disease after treatment.
This finding supported the rationale of the ongoing phase II clinical trial evaluating the activity of NEO-201 with pembrolizumab (Keytruda) in adults with solid tumors resistant to prior checkpoint inhibitors. This trial 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 on June 1st, 2024, at ASCO (Free ASCO Whitepaper) Annual Meeting 2024, at the Mc Cormick Convention Center, Chicago, Illinois, USA. This data demonstrated that NEO-201 reduces the quantity of regulatory T cells and gMDSCs in peripheral blood mononuclear cells (PBMCs) of cancer patients and this reduction is associated with durable stabilization of disease. (click here).
In addition, a recent study, performed by Drs. Atsushi Tanaka and Shimon Sakaguchi from Osaka University, Japan, independently analyzed by flow cytometry the ability of NEO-201 to recognize Treg cells in from PBMCs from healthy donors, confirming findings from Precision Biologics in PBMCs from cancer patients. This study was presented as poster at the Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 on April 8th, 2024. Here there is the link to the poster: View Source