NEW YORK – Kairos Pharma said Tuesday that it is collaborating with PreCheck Health Services to develop companion response biomarkers for its prostate and lung cancer drug candidate, ENV105.
The goal is to create a companion diagnostic for ENV105, either based on PCR or "other genetic tools," which the partners plan to submit to the US Food and Drug Administration and hope to use to select patients for Phase III clinical trials.
Under the agreement, the firms will use "advanced molecular diagnostics" to validate and further develop response biomarkers previously identified in a Phase II clinical trial and to discover novel biomarkers that can predict the drug's efficacy.
Specifically, PreCheck Health, a CLIA-certified and CAP-accredited laboratory based in Miami will analyze both biopsy tissues and circulating tumor cells from patients enrolled in Los Angeles-based Kairos Pharma’s ongoing clinical trials using its SolidTumorCheck+ gene expression profiling platform.
The trials include NCT05534646, a Phase II trial for patients with castration-resistant prostate cancer who have shown resistance to multiple androgen receptor signaling inhibitors, and NCT05401110, a Phase I trial targeting patients with EGFR-driven lung cancer who have developed resistance to AstraZeneca's Tagrisso (osimertinib).
Financial terms of the deal were not disclosed.
"Leveraging PreCheck’s vast experience in genetic testing provides a considerable advance in the development of our therapies," Kairos Pharma CSO Neil Bhowmick said in a statement. "The integration of their expertise will significantly enhance our ability to identify patients who will benefit from ENV105 and guide the development of noninvasive liquid biopsy tests."