NEO-201

BETHESDA, Md., July 22, 2024 /PRNewswire/ -- Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, announced today 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. 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). () 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 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) Annual Meeting 2024 on April 8th, 2024. Here there is the link to the poster: About Precision Biologics Founded in 2012, Precision Biologics, Inc. is a clinical stage biotechnology corporation focused on developing therapeutic and diagnostic products for the detection and treatment of cancer. The company's antibody drug candidates and diagnostics are designed to detect and target the tumor with minimal damage to healthy cells. Precision Biologics is uniquely positioned to create innovative therapeutics through the use of proprietary cancer vaccines, several of which have demonstrated success in human trials. By marrying this platform with today's breakthrough technologies, the company is developing antibody therapeutics that could change the way we detect and treat cancer. For more information on Precision Biologics, please visit . SOURCE Precision Biologics

BETHESDA, Md., May 30, 2024 /PRNewswire/ -- Precision Biologics, Inc. reports that novel findings from its ongoing phase 2 clinical trial, combining NEO-201 with pembrolizumab for the treatment of patients resistant to prior checkpoint inhibitor therapy, will be presented in a poster at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, McCormick Place Convention Center, Chicago, Illinois, USA, June 1st, 2024. Poster title: Reduction of circulating naïve Tregs and gMDSCs and low levels of soluble MICA are prognostic for efficacy of combined NEO-201 and pembrolizumab Presentation of the poster in person will be made at the McCormick Place Convention Center in Chicago, Illinois, USA, on Saturday June 1st, 2024, Hall A from 9am - 12pm, Session: Developmental Therapeutics-Immunotherapy, poster board #9, poster # 2530. BACKGROUND: The employment of immune checkpoint inhibitors (ICIs), such as pembrolizumab (anti-PD-1 mAb), in cancer immunotherapy has been shown to enhance activity of the immune system against cancer cells. Although ICIs show efficacy and improved survival of certain cancer patients, the response rate of PD-1/PD-L1 blockade against solid tumors is around 20-30% in the first line setting and significantly lower in checkpoint refractory disease. One cause identified for this low response rate is the infiltration of the tumor microenvironment (TME) by immunosuppressive cells, such as regulatory T cells (Tregs) and granulocytic myeloid-derived suppressor cells (gMDSCs). The accumulation of these immunosuppressive cells in the TME impairs the antitumor immunity triggered by ICIs. A strategy to restore antitumor immunity and overcome tumor resistance to ICIs is to combine ICIs with anticancer drugs able to bind to and deplete Tregs and gMDSCs. NEO-201 is a humanized IgG1 monoclonal antibody that binds to Core 1 and/or extended Core 1 O-glycans expressed by several human solid and blood tumors, as well as mature granulocytes, but it does not bind to most normal tissues and human immune cell subsets (B cells, CD4+ T cells, CD8+ T cells, NK cells, monocytes). Previous studies showed that NEO-201 can bind and mediate the killing of Tregs via CDC. Further studies presented at AACR in 2023 showed that NEO-201 can bind and mediate the killing of gMDSCs via ADCC. The ability of NEO-201 to mediate the killing of immunosuppressive cells served as the rationale for combination of NEO-201 with pembrolizumab in the ongoing phase II clinical trial (NCT03476681) for the treatment of patients with NSCLC, head and neck, cervical and endometrial cancers who were refractory to multiple lines of standard treatment, including ICIs. Preliminary findings from this ongoing clinical trial presented at the CRI-ENCI-AACR in September 2023 in Milan, Italy and at the SITC annual meeting in November 2023 in San Diego, CA, USA, revealed that, after combination treatment with NEO-201 and pembrolizumab some patients experienced durable stable disease (SD). Patients with durable SD (>84 days) demonstrated a decreasing trend in circulating gMDSCs and Tregs. Conversely, patients with progressive disease (PD) exhibited an increasing trend of circulating gMDSCs and Tregs. This preliminary data suggests that elimination of circulating gMDSCs and Tregs mediated by NEO-201 may enable patients to overcome resistance to PD-1/PD-L1 checkpoint inhibitors, in subjects for whom pembrolizumab is currently indicated and with solid tumors resistant to prior ICIs treatment. STUDY PRESENTED AT ASCO 2024: NEO-201 uses Natural Killer (NK) cells as effector cells to mediate the killing of its target cells through ADCC. Several studies reported that cancer cells inhibit NK cell antitumor activity by releasing soluble factors into the bloodstream, such as soluble MHC class 1 chain-related protein A (MICA.) Elevated serum levels of soluble MICA (sMICA) have been correlated with impairment of NK cell activity, cancer progression and metastasis. This study reports that median serum levels of sMICA pre-treatment were 33-fold higher in patients with PD compared to patients with SD and that levels of sMICA remained elevated in patients with PD and low in patients with SD at all time points post treatment. High levels of sMICA in patients with PD can impair NK cell activity. This impairment negatively impacts the NK cell mediated ADCC triggered by NEO-201 against cancer cells, Tregs and gMDSCs. Consequently, the effectiveness of NEO-201 and pembrolizumab treatment is reduced, leading to disease progression in these patients. Conversely, low levels of sMICA pre- and post-treatment do not hinder the antitumoral activity of NK cells. This allows NEO-201 to effectively mediate the killing of its target cells, including cancer cells, Tregs and gMDSCs, through ADCC. As a result, this phenomenon can lead to the durable stabilization of the disease. This study reports that low levels of sMICA, together with the reduction of both circulating Tregs and gMDSCs mediated by NEO-201, were associated with durable SD in cancer patients refractory to prior ICIs and that they could be favorable prognostic markers for clinical benefit following combination treatment with NEO-201 and pembrolizumab. Ongoing enrollment in this clinical trial will validate these findings in larger cohorts.