LIXTE Biotechnology Holdings, Inc.  a clinical stage pharmaceutical company, today announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a new clinical trial in immune therapy unresponsive (MSI Low) metastatic colon cancer.

As part of the new clinical trial, listed as NCT06012734 at clinicaltrials.gov, LIXTE will provide its lead compound, LB-100, and Roche will provide atezolizumab (Tecentriq^®, a PD-L1 inhibitor) through the imCORE Network, an academic-industry collaboration that aims to accelerate cancer immunotherapy research through institution-sponsored studies.

“This is an exciting new clinical trial,” said Neeltje Steeghs, M.D., Ph.D., medical oncologist from NKI and Antoni van Leeuwenhoek Hospital, who is serving as principal investigator of the trial. “Only about 15% of colon cancers are responsive to immunotherapy, the so-called MSI High cancers. However, approximately 85% of colon cancers are MSI Low where immunotherapy has no activity at all. 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.”

Bas van der Baan, LIXTE’s Chief Executive Officer, said, “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, following the start of a clinical trial earlier this year that is being funded by GSK for the treatment of clear cell ovarian cancer.”

NKI is one of the world’s leading comprehensive cancer centers. René Bernards, Ph.D., a leader in the field of molecular carcinogenesis and Senior Staff Scientist at the Netherlands Cancer Institute, is a member of LIXTE’s Board of Directors.

A recent publication of new pre-clinical data in the journal EMBO Reports showed that LIXTE’s lead compound, LB-100, can turn immunologically “cold” tumors “hot,” thereby potentially enhancing the response to immunotherapy. This publication builds on a large body of scientific and emerging clinical evidence that LB-100 has strong synergy with checkpoint immunotherapy.

Tecentriq^® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.