Organization Description
Cleara Biotech is a senolytic company founded on Peter de Keizer’s invention of FOXO4-DRI, a technology that interrupts an interaction between two proteins on which senescent cells rely for survival.
Cleara is focused on what they term “scarred” senescent and cancer cells rather than senescent cells in general. These “scarred” cells contain nuclear PML/FOXO4 foci flanked by p53 phosphorylated on specific sites, and are found in several chronic diseases and late-stage cancer in humans.
Peter de Keizer is Managing Director; the CMO is Nick Sarlis. Tobias Madl is the scientific cofounder.
Although the accumulation of senescent cells with age contributes to multiple age-related diseases, senescent cells play important physiological roles in resolving wounds and preventing fibrosis and cancer when they first form. By targeting and removing only the harmful “scarred” cells, Cleara Biotech aims to restore tissue function and alleviate the burden of age-related diseases without the potential risks associated with indiscriminately destroying all senescent cells.
CL04177 and CL04183
Cleara has optimized its fourth-generation FOXO4-based peptides, CL04177 and CL04183, for selective destruction of “scarred” senescent cells and for highly favorable pharmacokinetic characteristics. Cleara has tested its lead compound, CL04183/Pivot, in multiple preclinical disease models across oncology, neurodegeneration, liver diseases, and cardiovascular disease. They also say that they have done earlier work in unspecified diseases related to beta-catenin.
Dr. de Keizer has said that Cleara has chosen therapy-resistant cancers as their first indication. Such cancers tend to upregulate the FOXO-p53 complex seen in “scarred” cells, and an oncology indication wuld only require Phase II studies to go to market. That approval will make targeting age-related disease easier, he argues. “In 2D cells, 3D organoid and mouse in vivo models for metastatic colon cancer (mCRC) and triple-negative breast cancer (TNBC), CL04177/4183 potently counter metastatic burden and infiltration. Importantly, this [therapeutic effect] is matched with the presence of biomarkers, and Cleara designed a preclinical and clinical development strategy towards progressing these lead development compounds towards clinical trials in solid tumors as well as hematological malignancies.”
In 2025, Cleara completed GLP-Tox studies in rats and nonhuman primates and GMP-grade Drug Substance work, and progressed into the Drug Product phase for submission of a clinical trial application to FDA.
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