Kairos Pharma Reports Favorable Interim Phase 1 Safety Data for ENV-105 in EGFR-Mutated Lung Cancer

Kairos Pharma Ltd. (NYSE American: KAPA) announced favorable interim safety results from its ongoing Phase 1 clinical trial evaluating ENV-105 (carotuximab) in combination with osimertinib (Tagrisso) for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have developed resistance to osimertinib. The company reported that among 13 patients treated with ENV-105 to date, no Grade 3 or higher treatment-related adverse events have occurred, 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. The Phase 1 study is evaluating the safety, tolerability, and recommended Phase 2 dose of the combination therapy. All reported side effects have been 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.

For more details, the full press release is available at https://ibn.fm/SmdwW. Kairos Pharma is based in Los Angeles, California, and focuses on oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. The company's lead candidate, ENV-105, is an antibody targeting CD105, identified as a key driver of resistance and disease relapse in response to standard therapy. ENV-105 aims to reverse drug resistance 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 this Phase 1 trial for non-small cell lung cancer, both 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. The latest news and updates relating to KAPA are available in the company’s newsroom at https://ibn.fm/KAPA.

The positive safety data mark a critical step forward for Kairos Pharma, as the combination therapy could provide a new treatment option for patients with EGFR-mutated NSCLC who have progressed on osimertinib. The implications of this announcement are significant for the field of oncology, as acquired resistance to targeted therapies remains a major challenge. If ENV-105 successfully restores osimertinib sensitivity, it could change the standard of care for this patient population. The interim results demonstrate that the combination is well-tolerated, which is encouraging for the ongoing trial and potential future studies.