Kairos Pharma collaborates with PreCheck on ENV105 companion biomarkers

Kairos Pharma announced a collaboration with PreCheck Health Services Inc., a CLIA-certified and CAP-accredited clinical laboratory specializing in genetic sequencing. The partnership focuses on the development of companion biomarkers for Kairos Pharma’s cancer therapy, ENV105, which targets prostate and lung cancers. This strategic agreement aims to advance the precision of patient screening and therapy monitoring for Kairos Pharma’s Phase 1 and Phase 2 clinical trials, with the aim of advancing cancer treatment by identifying patients who will benefit most from ENV105. Kairos Pharma and PreCheck Health Services will utilize advanced molecular diagnostics to corroborate and further develop biomarkers previously identified in a Phase 2 clinical trial. These biomarkers are designed to predict patient responses to ENV105 prior to treatment, offering a more personalized approach to cancer care. Under the agreement, PreCheck will analyze biopsy tissues and circulating tumor cells from patients enrolled in Kairos Pharma’s ongoing clinical trials, including a Phase 2 randomized, multi-institutional trial in prostate cancer and a Phase 1 trial in lung cancer. The goal is to confirm the predictive capabilities of these biomarkers and to discover new biomarkers that can identify suitable candidates for the novel therapy. The collaboration will rely on PreCheck’s proprietary SolidTumorCheck+ platform, which allows for gene expression profiling of tumor biopsies. This technology will be employed to examine samples from patients with both lung and prostate cancer. Furthermore, the analysis of circulating tumor cells aims to offer non-invasive insights, potentially leading to the development of liquid biopsy tests for future patient screening and therapy monitoring. The biomarkers will be tested in two key clinical trials: NCT05401110: A Phase 1 trial targeting patients with EGFR-driven lung cancer who have developed resistance to osimertinib. Pre-treatment biopsies will undergo somatic gene expression profiling using the SolidTumorCheck+ platform to identify biomarkers that can predict a favorable response to ENV105. NCT05534646: A phase 2 trial for patients with castrate-resistant prostate cancer who have shown resistance to multiple androgen receptor signaling inhibitors. Here, the focus will be on the somatic profiling of circulating tumor cells and tumor biopsies to confirm previously identified biomarkers and identify any new ones tied to ENV105’s efficacy. Both trials aim to integrate biomarker analysis into treatment plans, ensuring that patients most likely to benefit from ENV105 are accurately identified.