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24/7 Market News: LIXTE Targets Large, Unmet Oncology Markets

Current Clinical Trial Focus is MSS Colorectal Cancer, Ovarian Clear-Cell Carcinoma, and Soft-Tissue Sarcoma

DENVER, Aug. 25, 2025 (GLOBE NEWSWIRE) — 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, revisits LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage pharmaceutical company focused on developing novel cancer therapies by targeting the modulation of key cellular pathways. The company is advancing its clinical strategy by focusing on high-need, high-value cancer indications that currently offer limited treatment options. The company’s lead compound, LB-100, is being evaluated in several investigator-led clinical studies aimed at enhancing the effectiveness of both chemotherapy and immunotherapy in treatment-resistant cancers.

Microsatellite-Stable (MSS) Colorectal Cancer

Colorectal cancer is among the most prevalent cancers globally, with the colorectal cancer drug market projected to surpass $18 billion by 2028. A significant challenge in the field is that approximately 85% of colorectal cancer cases are microsatellite-stable (MSS) and typically do not respond to existing immunotherapies such as checkpoint inhibitors.

At the Netherlands Cancer Institute, LB-100 is being studied in combination with atezolizumab, Roche’s anti–PD-L1 immunotherapy, in a clinical trial focused specifically on patients with MSS colorectal cancer. The trial is designed to assess whether inhibition of PP2A with LB-100 can improve immune response in these tumors, which are generally considered immunologically “cold.”

Ovarian Clear-Cell Carcinoma (OCCC)

OCCC is a rare but aggressive subtype of ovarian cancer, accounting for about 5–10% of cases. The current standard treatments have limited efficacy, and patients often have poor long-term outcomes. The global market for ovarian cancer therapies was valued at over $2 billion in 2023, with growth expected due to rising incidence and expanded treatment approaches.

LB-100 is being evaluated in combination with dostarlimab, GlaxoSmithKline’s anti–PD-1 checkpoint inhibitor, in a study enrolling patients with ovarian clear-cell carcinoma at MD Anderson Cancer Center and Northwestern University. Interim data from this trial are expected in Q4 2025.

Soft-Tissue Sarcoma

Soft-tissue sarcomas are a diverse group of rare cancers with limited treatment advances in recent decades. Doxorubicin remains a frontline standard, despite modest response rates and long-standing resistance challenges. The global market for soft-tissue sarcoma therapies is projected to reach $1.5 to $2 billion by 2030.

In collaboration with the Spanish Sarcoma Group (GEIS), LIXTE is supporting a Phase 1b clinical study evaluating LB-100 in combination with doxorubicin. The trial is designed to assess whether LB-100 can enhance the effectiveness of chemotherapy by disrupting tumor cell stress-response and DNA repair pathways. Initial clinical results are anticipated later this year.

Ongoing Development Strategy

LIXTE’s clinical programs are aligned with indications that represent significant commercial opportunities and unmet therapeutic needs, particularly in tumors with poor responses to current immunotherapies. LB-100 is a first-in-class inhibitor of PP2A, a master regulatory enzyme involved in multiple oncogenic signaling pathways. Its novel mechanism of action is designed to sensitize tumors to other treatments, including both immune checkpoint blockade and standard chemotherapy.

The company’s development strategy is focused on combination approaches that aim to improve outcomes in indications with historically poor response rates, thereby addressing both clinical and commercial gaps in the oncology market.

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About LIXTE Biotechnology Holdings, Inc.

LIXTE is a clinical-stage pharmaceutical company focused on discovering and developing innovative cancer therapies targeting the protein phosphatase 2A (PP2A) pathway, a previously underexplored avenue in cancer treatment. The company’s lead compound, LB-100, is a first-in-class PP2A inhibitor that has demonstrated strong preclinical results and early-stage clinical tolerability. LIXTE is currently advancing proof-of-concept trials in Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma.

More information can be found at: www.lixte.com

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Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company’s ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company’s filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.

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