Kairos Pharma and PreCheck Health Collaborate on Biomarkers for Cancer Drug Resistance in Prostate and Lung Cancer

LOS ANGELES, Sept. 24, 2024 – Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical firm, has announced a significant partnership with PreCheck Health Services Inc., a clinical laboratory certified by CLIA and accredited by CAP, specializing in genetic sequencing. This collaboration aims to develop companion biomarkers for Kairos Pharma's cancer therapy, ENV105, targeting prostate and lung cancers. The agreement focuses on enhancing precision in patient screening and monitoring during Kairos Pharma's Phase 1 and Phase 2 clinical trials. The ultimate goal is to improve cancer treatment by identifying patients who will benefit most from ENV105.

Kairos Pharma and PreCheck Health Services will employ advanced molecular diagnostics to validate and further develop biomarkers previously identified in a Phase 2 clinical trial. These biomarkers are intended to predict patient responses to ENV105 before treatment, enabling a more personalized approach to cancer care. Under this 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 focus is to confirm the predictive capabilities of these biomarkers and discover new ones that can identify suitable candidates for the novel therapy.

The partnership will utilize PreCheck’s proprietary SolidTumorCheck+ platform for gene expression profiling of tumor biopsies. This technology will analyze samples from patients with both lung and prostate cancer. Additionally, the analysis of circulating tumor cells aims to provide non-invasive insights, potentially leading to the development of liquid biopsy tests for future patient screening and therapy monitoring.

Key Clinical Trials in Oncology Research:

1. NCT05401110: A Phase 1 trial targeting patients with EGFR-driven lung cancer resistant to osimertinib. Pre-treatment biopsies will undergo somatic gene expression profiling using the SolidTumorCheck+ platform to identify biomarkers predicting a favorable response to ENV105.
2. NCT05534646: A Phase 2 trial for patients with castrate-resistant prostate cancer (CRPC) resistant to multiple androgen receptor signaling inhibitors. This trial will focus on the somatic profiling of circulating tumor cells and tumor biopsies to confirm previously identified biomarkers and identify new ones related to ENV105’s efficacy.

Both trials aim to integrate advanced biomarker analysis into treatment plans, ensuring accurate identification of patients most likely to benefit from ENV105.

Development of Companion Diagnostics:

A companion diagnostic is an FDA-approved test to identify patients most likely to benefit from a therapeutic product. A key outcome of this partnership is developing a companion diagnostic for ENV105. PreCheck will develop a three-gene PCR analysis or other genetic tools to predict patient response to the therapy. This diagnostic will seek FDA approval as a crucial tool for identifying suitable patients with prostate or lung cancer, guiding inclusion for treatment in Phase 3 clinical trials.

Dr. Neil Bhowmick, Kairos Pharma’s Chief Scientific Officer, expressed positive expectations about the collaboration, stating, “Leveraging PreCheck’s extensive genetic testing experience provides significant advancement in developing our therapies. Their expertise will enhance our ability to identify patients who will benefit from ENV105 and guide the development of non-invasive liquid biopsy tests.”

Advancements in Cancer Treatment:

The development of these companion biomarkers is set to revolutionize cancer treatment for patients with resistant forms of prostate and lung cancer. Integrating biomarkers and liquid biopsy technologies will enable more precise targeting of therapies, reducing ineffective treatments and increasing the chances of positive outcomes.

Dr. John Yu, Kairos Pharma’s CEO, stated, “This collaboration is an exciting advancement for Kairos Pharma. Working with PreCheck Health Services, we are moving forward in our mission to provide personalized cancer treatment solutions. The biomarkers we develop will allow us to tailor therapies to individual patients, improving their chances of a successful response to ENV105.”

About Kairos Pharma Ltd.:

Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) leads oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. With a diverse pipeline of investigational therapies, the company is dedicated to reversing the harmful effects of cancer and improving patient outcomes through innovative treatments.

About PreCheck Health Services Inc.:

PreCheck Health Services Inc. is a CLIA-certified and CAP-accredited clinical laboratory renowned for its expertise in genetic sequencing, providing advanced diagnostic services to support precision medicine, particularly in oncology.