24/7 Market News: LIXTE Biotech Advances Precision Oncology Pipeline with First Phase 1B/2 Trial Readout Expected in 2H 2025

Breakthrough Protein Phosphatase 2A inhibitor LB-100 Targets Ovarian Clear Cell Carcinoma, Advanced Soft Tissue Sarcoma, and MSS Metastatic Colon Cancer

24/7 Market News Issues Corrected Information on Previously issued Press Release with same title

DENVER, Aug. 14, 2025 (GLOBE NEWSWIRE) -- 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, spotlights 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.

2H 2025 is shaping up to be a defining year for LIXTE. With a focus on its lead compound LB-100, a first-in-class small molecule inhibitor of protein phosphatase 2A (PP2A), a master regulator of cell signaling and DNA damage response. By inhibiting PP2A, LB-100 sensitizes tumors to DNA-damaging agents, including chemotherapy, radiation, and immunotherapy, LIXTE is targeting high-unmet needs in the $200 billion global oncology market (Grand View Research, 2025 projection). Potential upcoming catalysts in 2025, including a first trial result, position LIXTE as a potential disruptor in resistant cancers, where traditional treatments fail due to limited efficacy and toxicity.

Upcoming Catalysts: Anticipated Trial Results in 2H 2025

1B/2 Trial – Ovarian Clear Cell Carcinoma (OCCC)

Ovarian clear cell carcinoma is an aggressive and chemoresistant subtype of epithelial ovarian cancer, accounting for ~5–10% of all ovarian malignancies but disproportionately contributing to ovarian cancer mortality.

The Phase 1B/2 study of LB-100 plus the checkpoint inhibitor dostarlimab (GSK) is designed leverage LB-100’s synergistic enhancement of immune checkpoint blockade.

• Status: Enrolled, with interim safety completed
• Upcoming Milestone: Preliminary safety and efficacy data expected Q4 2025
• Potential Market Impact: Global OCCC treatment market is projected to exceed $750 million by 2028 due to rising incidence and limited targeted therapies
  

1B/2 Trial – Advanced Soft Tissue Sarcoma (STS)

Soft tissue sarcomas are a diverse and difficult-to-treat group of cancers arising from connective tissues. For patients with advanced or metastatic disease, prognosis remains poor.
LIXTE’s Phase 1B/2 study evaluates LB-100 in combination with doxorubicin, the current standard of care, in patients with advanced STS.

• Status: Dose escalation completed.
• Upcoming Milestone: Safety report Q4 2025
• Potential Market Impact: The global STS drug market is estimated to reach $2.1 billion by 2030, driven by the emergence of combination therapies and unmet medical need
  

1B Trial – Metastatic Microsatellite Stable (MSS) Colon Cancer

MSS colon cancer, representing roughly 85% of metastatic colorectal cancer (mCRC), remains unresponsive to checkpoint inhibitors.

LIXTE is conducting a Phase 1B trial assessing the safety and activity of LB-100 in combination with+ atezolizumab ( Roche ) (an ICI), seeking to overcome immune resistance in this cold tumor type.

• Status: Trial open, first patients recruited
• Potential Market Impact: The global colorectal cancer therapeutics market is expected to surpass $18 billion by 2030, with MSS disease representing the majority of treatment-resistant cases

Platform Potential and Market Opportunity

LIXTE’s strategy of targeting PP2A to potentiate multiple treatment modalities positions LB-100 as a versatile combination agent with broad applicability across solid tumors. The platform’s potential spans oncology subtypes with high unmet need, limited innovation, and growing incidence.

• Strong IP Position: Multiple issued and pending patents covering composition, methods of use, and combinations
• Pipeline Expansion: Additional tumor types and investigator-sponsored studies are under review, including glioblastoma.
• Partnership Potential: Ongoing discussions with academic institutions and biopharma partners for co-development opportunities
  

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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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