Kairos Pharma Ltd. (NYSE American: KAPA) has reported 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 announced that among 13 patients treated with ENV-105 to date, no Grade 3 or higher treatment-related adverse events were observed, 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, with all reported side effects being 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.
The implications of these interim results are significant for the lung cancer treatment landscape. Osimertinib is a cornerstone therapy for EGFR-mutated NSCLC, but acquired resistance inevitably develops in most patients, limiting its long-term effectiveness. If ENV-105 can safely reverse or delay this resistance, it could provide a new treatment option for patients who have progressed on osimertinib alone. The absence of high-grade adverse events in the initial cohort is encouraging, as combination therapies often carry increased toxicity risks. The manageable safety profile suggests that ENV-105 may be combined with osimertinib without compromising patient tolerability.
Kairos Pharma is focused on oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. ENV-105 is also being evaluated in a Phase 2 clinical trial for castrate-resistant prostate cancer, addressing significant unmet medical needs. As of the date of the 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.
For more details, the full press release is available at https://ibn.fm/SmdwW. The latest news and updates relating to KAPA are available in the company’s newsroom at https://ibn.fm/KAPA.
