LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW), a trailblazer in clinical stage pharmaceutical development, has embarked on a groundbreaking clinical trial in partnership with Roche and the Netherlands Cancer Institute (NKI) to address immune therapy unresponsive metastatic colon cancer. This collaboration focuses on MSI Low metastatic colon cancer, which constitutes approximately 85% of colon cancer cases and typically shows no response to existing immunotherapies.

Innovative Clinical Trial to Enhance Cancer Treatment

The trial, registered under NCT06012734 at clinicaltrials.gov, leverages LIXTE’s lead compound, LB-100, in combination with Roche’s atezolizumab (Tecentriq, a PD-L1 inhibitor), provided through the imCORE Network. This network is an academic-industry collaboration aimed at accelerating cancer immunotherapy research. The objective is to sensitize MSI Low tumors to immunotherapy, potentially expanding effective treatment options to a broader segment of colon cancer patients.

Neeltje Steeghs, M.D., Ph.D., a medical oncologist from NKI and Antoni van Leeuwenhoek Hospital and the principal investigator of the trial, highlighted the potential impact of this study: “If we are able to sensitize these tumors to immunotherapy with LB-100, we could bring immunotherapy as an effective treatment option to a large group of colon cancer patients.”

Strategic Collaborations and Scientific Support

This initiative represents LIXTE’s ongoing efforts to harness the potential of LB-100 in conjunction with established immunotherapy agents. Following a similar collaboration earlier this year with GSK for clear cell ovarian cancer treatment, this trial underscores the broad applicability and promising prospects of LB-100.

Bas van der Baan, CEO of LIXTE, expressed confidence in the scientific foundation and potential of LB-100: “The ongoing interest in and support of this clinical trial underscores the strength of the scientific rationale and potential of our lead compound, LB-100. This is the second recent clinical trial combining LB-100 with immunotherapy that is supported by a major pharmaceutical company.”

Scientific Innovations and Future Directions

Recent preclinical findings published in EMBO Reports suggest that LB-100 can convert immunologically “cold” tumors into “hot” ones, enhancing their response to immunotherapy. This discovery is part of LIXTE’s innovative approach in the new field of cancer biology known as activation lethality. LIXTE’s pioneering efforts are backed by a robust patent portfolio, with ongoing proof-of-concept clinical trials across multiple cancer types, including colon, small cell lung, and sarcoma cancers.

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