Kairos Pharma (NYSE American: KAPA) announced favorable interim safety results from its ongoing Phase 1 trial evaluating ENV-105 (carotuximab) in combination with osimertinib (Tagrisso(R)) for patients with advanced EGFR-mutated non-small cell lung cancer (“NSCLC”) who have developed resistance to osimertinib. The company reported no Grade 3 or higher treatment-related adverse events among 13 patients treated with ENV-105 to date, supporting continued advancement of the program toward an early efficacy readout. ENV-105 is designed to inhibit CD105, a protein associated with acquired drug resistance, with the goal of restoring sensitivity to osimertinib.
Kairos said the Phase 1 study is evaluating the safety, tolerability and recommended Phase 2 dose of the combination therapy, with all reported side effects manageable through standard supportive care. The company believes ENV-105 has the potential to extend the clinical utility of osimertinib, the current standard of care for EGFR-mutated NSCLC, by addressing acquired resistance after disease progression.
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About Kairos Pharma, Ltd.
Based in Los Angeles, California, Kairos Pharma Ltd. ( NYSE American: KAPA ) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Kairos Pharma’s lead candidate, ENV-105, is an antibody that targets CD105—a protein identified as a key driver of resistance and disease relapse in response to standard therapy. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV-105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for non-small cell lung cancer aimed at addressing significant unmet medical needs. As of the date of this press release, ENV-105 has not been approved as safe or effective by the United States Food and Drug Administration or any other comparable foreign regulator.
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