Kairos Pharma Ltd. (NYSE American: KAPA) announced favorable interim safety data 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 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 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 announcement highlights the importance of tackling drug resistance in lung cancer treatment. Osimertinib, a third-generation EGFR tyrosine kinase inhibitor, is widely used as first-line therapy for EGFR-mutated NSCLC, but most patients eventually develop resistance. CD105 has been identified as a key driver of resistance and disease relapse in response to standard therapy. By targeting CD105, ENV-105 aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types.
Kairos Pharma is currently conducting a Phase 2 clinical trial for ENV-105 in castrate-resistant prostate cancer and this Phase 1 trial for NSCLC. The favorable safety profile observed in the interim analysis de-risks the program and supports moving forward to assess efficacy. 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 full press release can be accessed at https://ibn.fm/SmdwW. For more information about Kairos Pharma, visit its newsroom at https://ibn.fm/KAPA.
