Kairos Pharma, Ltd.

Kairos Pharma announced a strategic collaboration with Bayer to evaluate its lead antibody ENV-105 in combination with Bayer's XOFIGO for metastatic castration-resistant prostate cancer involving bone. ENV-105 is a first-in-class CD105/BMP signaling inhibitor, and XOFIGO is the only FDA-approved alpha-emitting radiopharmaceutical for this indication. The combination targets a global addressable market estimated at $570 million to $1.3 billion. Kairos Pharma's Phase 2 data for ENV-105 showed an 86% clinical benefit rate in resistant mCRPC, with median progression-free survival exceeding 13 months. The collaboration aims to address drug resistance by re-sensitizing tumors to XOFIGO's targeted alpha therapy.

Kairos Pharma announced interim safety data from its Phase 1 trial of ENV-105 combined with AstraZeneca's Tagrisso in advanced EGFR-mutated non-small cell lung cancer, showing no serious adverse events across 13 treated patients. The trial is evaluating ENV-105, a first-in-class CD105 antibody, as a way to resensitize patients who have developed resistance to osimertinib, the standard-of-care therapy that generates about $6 billion in annual sales. The EGFR-mutated NSCLC market is valued at approximately $10 billion and projected to exceed $13 billion by 2030. Kairos Pharma's approach targets CD105, a protein pathologically elevated in resistant patients, with the goal of extending the clinical utility of osimertinib. The company also noted that ENV-105 has shown a median progression-free survival exceeding 13 months in an ongoing Phase 2 trial for castrate-resistant prostate cancer.