LIXTE Biotechnology Expands Ovarian Cancer Trial with MD Anderson and GSK

LIXTE Biotechnology Holdings announced an expansion of its collaboration with The University of Texas MD Anderson Cancer Center and pharmaceutical manufacturer GSK on an ongoing clinical trial evaluating its proprietary compound LB-100 in combination with GSK's Dostarlimab for the treatment of ovarian clear cell cancer. The trial, initiated in January 2024 and led by Amir Jazaeri, MD, at MD Anderson, has added a second site at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University under the direction of Emily M. Hinchcliff, MD, MPH, and is expected to double enrollment to 42 patients following completion of its initial 21-patient target. The company also expects data from the initial cohort to be presented in the first half of 2026.

This expansion matters because ovarian clear cell cancer represents a particularly aggressive and treatment-resistant subtype of ovarian cancer, often showing poor response to conventional therapies. The collaboration brings together LIXTE's novel PP2A inhibitor LB-100 with GSK's established immunotherapy Dostarlimab, potentially creating a synergistic treatment approach that could address the limitations of current options. By doubling the patient enrollment and adding a prestigious academic medical center like Northwestern University, the trial gains both statistical power and geographic diversity in its patient population, which could strengthen the validity of its findings.

The importance of this development extends beyond the immediate trial parameters. LIXTE's LB-100 represents a first-in-class approach targeting protein phosphatase 2A (PP2A), a regulatory enzyme that plays a crucial role in cancer cell survival and treatment resistance. According to extensive preclinical data available at https://www.lixte.com, LB-100 has demonstrated potential to enhance both chemotherapies and immunotherapies, suggesting it could become a versatile component in combination cancer treatments. The current trial specifically tests whether LB-100 can improve the effectiveness of Dostarlimab, an anti-PD-1 immunotherapy already approved for certain cancers, in a difficult-to-treat ovarian cancer subtype.

From a clinical development perspective, the expansion signals confidence in the safety profile observed in the initial phase of the trial. LIXTE has previously demonstrated that LB-100 is well-tolerated in cancer patients at doses associated with anti-cancer activity, which is particularly important when combining multiple therapeutic agents. The addition of Northwestern University as a second site also facilitates broader patient access and accelerates enrollment, potentially bringing meaningful results to patients sooner. Additional information about LIXTE's broader research program can be found at https://lixte.com/.

The implications of this trial extend to the broader field of cancer treatment, particularly the emerging concept of activation lethality that LIXTE is pioneering. This approach represents a paradigm shift from traditional inhibition strategies to selectively activating certain cellular pathways to induce cancer cell death. Success in this ovarian cancer trial could validate this novel biological approach and open doors for applications in other cancer types. The comprehensive patent portfolio covering LIXTE's approach suggests the company is positioned to capitalize on any positive clinical outcomes, potentially bringing new treatment options to patients with limited alternatives.