LIXTE Biotechnology Holdings Announces New Colon Cancer Clinical Trial Collaboration

LIXTE Biotechnology Holdings, Inc. has announced a significant collaboration with Roche and the Netherlands Cancer Institute (NKI) to initiate a groundbreaking clinical trial aimed at tackling immune therapy-resistant (MSI Low) metastatic colon cancer. This innovative trial, cataloged as NCT06012734 on clinicaltrials.gov, will combine LIXTE’s leading compound, LB-100, with Roche’s atezolizumab (Tecentriq®, a PD-L1 inhibitor), facilitated through the imCORE Network. The collaboration aims to accelerate cancer immunotherapy research through institution-sponsored studies.

Dr. Neeltje Steeghs, a medical oncologist associated with NKI and Antoni van Leeuwenhoek Hospital, will lead the trial as its principal investigator. Currently, only about 15% of colon cancers, categorized as MSI High, respond to immunotherapy. However, the remaining 85% are classified as MSI Low, where immunotherapy has traditionally shown no efficacy. Dr. Steeghs expressed optimism about the trial, stating that if LB-100 can sensitize these MSI Low tumors to immunotherapy, it could significantly broaden the effective treatment options available for a large segment of colon cancer patients.

Bas van der Baan, Chief Executive Officer of LIXTE, emphasized the scientific potential and strength of LB-100. Highlighting ongoing support for the trial, van der Baan indicated that this is the second recent clinical study combining LB-100 with immunotherapy, the first being a trial funded by GSK aimed at treating clear cell ovarian cancer.

NKI, one of the foremost comprehensive cancer centers globally, boasts René Bernards, Ph.D., a molecular carcinogenesis expert and Senior Staff Scientist, on its Board of Directors. Recent pre-clinical data published in EMBO Reports indicated that LB-100 could transform immunologically "cold" tumors into "hot" ones, thus improving their response to immunotherapy. This research supports the accumulating evidence that LB-100 has a synergistic effect when paired with checkpoint immunotherapy.

LIXTE Biotechnology Holdings, Inc., a clinical-stage pharmaceutical company, focuses on discovering new targets for cancer therapy development. The company's pioneering lead compound, LB-100, has shown promise in cancer patients at doses correlated with anti-cancer activity. Extensive preclinical data suggest that LB-100 could substantially enhance both chemotherapy and immunotherapy, potentially improving patient outcomes.

LB-100 is a first-in-class PP2A inhibitor and represents a pioneering effort in a new cancer biology field known as activation lethality. This approach is protected by a comprehensive patent portfolio and aims to establish a new treatment paradigm. LIXTE is currently conducting proof-of-concept clinical trials for colon, small cell lung, and sarcoma cancers.

This collaboration marks a significant step forward in cancer treatment, particularly for those suffering from forms of cancer that have been unresponsive to existing immunotherapy options. If successful, the trial could pave the way for new, effective treatments for a broader range of cancer patients, marking a pivotal moment in the ongoing battle against cancer.