First Patient Dosed with LIXTE’s LB-100 and GSK’s Immunotherapy Dostarlimab-gxly in Ovarian Clear Cell Carcinoma Trial
LIXTE Biotechnology Holdings, Inc. announced the dosing of the first patient in a Phase 1b/2 clinical trial to evaluate the potential of adding LB-100 to GSK's dostarlimab-gxly in treating ovarian clear cell carcinoma. The trial is conducted at The University of Texas MD Anderson Cancer Center, based on the observation that reducing PP2A pharmacologically with LB-100 may enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody in patients with OCCC lacking the genetic reduction in PP2A.
The initiation of a Phase 1b/2 clinical trial by LIXTE Biotechnology Holdings, in collaboration with GSK and The University of Texas MD Anderson Cancer Center, represents a significant step in the development of combination therapies for ovarian clear cell carcinoma (OCCC). The focus on LB-100 as a potential enhancer of the immunotherapy effect provided by GSK's dostarlimab-gxly is based on the hypothesis that pharmacological reduction of PP2A, a protein phosphatase, may improve patient response to PD-1 inhibitors.
PP2A is known to play a role in the regulation of various cellular processes, including the cell cycle and apoptosis. In the context of cancer, PP2A can act as a tumor suppressor and its inhibition has been proposed to potentially disrupt tumor growth. However, the therapeutic window for PP2A inhibitors is narrow, given the enzyme's role in normal cellular functions. Therefore, the safety profile of LB-100 in combination with dostarlimab-gxly will be closely monitored throughout the trial.
The outcome of this trial could have substantial implications for the treatment landscape of OCCC, a subtype of ovarian cancer with limited effective treatments. If LB-100 is found to enhance the effectiveness of dostarlimab-gxly, it could lead to a new standard of care. This would not only benefit patients but could also significantly impact LIXTE's market valuation and future revenue streams, contingent upon successful trial results and subsequent regulatory approval.
Ovarian clear cell carcinoma is a rare and aggressive form of ovarian cancer that often presents resistance to conventional chemotherapy. The utilization of immunotherapy, particularly PD-1 inhibitors like dostarlimab-gxly, has emerged as a promising approach in oncology. The rationale behind the combination therapy being tested is that LB-100 might modulate the tumor microenvironment to overcome resistance mechanisms and enhance the efficacy of immunotherapy.
For patients with OCCC, especially those lacking the genetic reduction in PP2A, this trial could represent a beacon of hope. The advancement to a Phase 1b/2 trial indicates preliminary confidence in the safety of LB-100, although efficacy and optimal dosing regimens are yet to be determined. Should the trial demonstrate positive outcomes, it could lead to a paradigm shift in how OCCC is treated and potentially extend to other tumor types where immunotherapy is applicable.
From a clinical perspective, the trial's design and the partnership with a reputable institution like MD Anderson provide credibility to the research. It also underscores the importance of academia-industry collaborations in advancing cancer treatment. Continuous updates on trial progress and results will be of high interest to the oncology community and could influence treatment guidelines in the future.
The strategic collaboration between LIXTE, GSK and MD Anderson highlights a trend in the biotechnology industry towards partnerships that leverage the strengths of both biotech innovators and established pharmaceutical companies. This trial's initiation could potentially be a catalyst for investor interest in LIXTE, particularly if the combination therapy shows a significant clinical benefit.
Investors will be closely monitoring the trial's progress, as positive data could lead to an increase in the stock's liquidity and potentially attract partnership or acquisition interest from larger pharmaceutical companies. The focus on a niche oncology indication like OCCC, which has a high unmet medical need, could also position LIXTE favorably in a market that rewards innovation and specificity in targeted therapies.
It is important to note that the biotech sector is highly volatile, with stock prices often heavily influenced by clinical trial outcomes. Therefore, while the initiation of the trial is positive news, the true impact on LIXTE's business and stock will depend on the trial's results and the subsequent steps towards commercialization. Investors should consider the inherent risks associated with clinical development when evaluating LIXTE's potential.
01/29/2024 - 08:30 AM
PASADENA, CA, Jan. 29, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW ) (“LIXTE” or the “Company”), today announced the dosing of the first patient in a Phase 1b/2 clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC).
The clinical trial was initiated by and is being conducted at The University of Texas MD Anderson Cancer Center. LIXTE is providing LB-100; GSK is providing dostarlimab-gxly and financial support for the clinical trial.
The clinical trial (NCT06065462) is based on the observation by the lead clinical investigator of the trial, Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, that a genetically acquired reduction in PP2A may enhance sensitivity to immunotherapyi . This raises the possibility that reducing PP2A pharmacologically with LB-100 may enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody, dostarlimab-gxly, in patients with OCCC lacking the genetic reduction in PP2A.
About LIXTE Biotechnology Holdings, Inc.
LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has demonstrated that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activityii . Based on extensive published preclinical data (see www.lixte.com ), LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies or immunotherapies. LIXTE's new approach has no known competitors and is covered by a comprehensive patent portfolio. Proof-of-concept clinical trials are in progress.
Forward-Looking Statement Disclaimer
This announcement contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future activities, including the continuing development of proprietary compounds, the planning, funding, coordination and potential results of clinical trials, the patent and legal costs to protect and maintain the Company's intellectual property worldwide, and the Company’s ability to obtain and maintain compliance with Nasdaq’s continued listing requirements, are all forward-looking statements. These statements are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect" or the negative of such terms or other comparable terminology.
The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash resources, research results, competition from other similar businesses, and market and general economic factors.
Readers are urged to read the risk factors set forth in the Company’s filings with the United States Securities and Exchange Commission at https://www.sec.gov . The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information about LIXTE, Contact: info@lixte.com
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i Hinchcliff EM, Patel A, Fellman B, Westin SN, Sood A, Soliman P, Shafer A, Meyer L, Fleming N, Bathala Y, Ganeshan D, Hwu P, Lu K, Jazaeri A . Loss-of-function mutations in PPP2R1A Correlate with Exceptional Survival in Ovarian Clear Cell Carcinomas Treated with Immune Checkpoint Inhibitors. National oral presentation at SGO Annual Meeting, March 2022ii Chung V et. al. Safety, Tolerability, and Preliminary Activity of LB-100, an Inhibitor of Protein Phosphatase 2A, in Patients with Relapsed Solid Tumors: An Open-Label, Dose Escalation, First-in-Human, Phase I Trial. Clin Cancer Res. 2017;23(13):3277-84.
What is the purpose of the Phase 1b/2 clinical trial announced by LIXTE Biotechnology Holdings, Inc.?
The trial aims to assess whether adding LIXTE's LB-100 to GSK's dostarlimab-gxly may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC).
Where is the clinical trial being conducted?
The clinical trial is being conducted at The University of Texas MD Anderson Cancer Center.
What is the observation that led to the initiation of the clinical trial?
The lead clinical investigator observed that a genetically acquired reduction in PP2A may enhance sensitivity to immunotherapy, leading to the possibility that reducing PP2A pharmacologically with LB-100 may enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody in patients with OCCC lacking the genetic reduction in PP2A.
What is the NCT number of the clinical trial?
The NCT number of the clinical trial is NCT06065462.
