Kairos Pharma Ltd. (NYSE American: KAPA) has reported 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 announced that no Grade 3 or higher treatment-related adverse events were observed among the 13 patients treated with ENV-105 to date, indicating a manageable safety profile that supports continued advancement of the program toward an early efficacy readout.
ENV-105 is a monoclonal antibody designed to inhibit CD105, a protein associated with acquired drug resistance. By targeting CD105, the therapy aims to restore sensitivity to osimertinib, the current standard of care for EGFR-mutated NSCLC. 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 by addressing acquired resistance after disease progression, a significant unmet medical need in lung cancer treatment.
Kairos Pharma, based in Los Angeles, California, is focused on oncology therapeutics that leverage structural biology to overcome drug resistance and immune suppression. ENV-105 is also being investigated in a Phase 2 clinical trial for castrate-resistant prostate cancer. As of the date of this press release, ENV-105 has not been approved as safe or effective by the U.S. 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.
This development is significant for patients with EGFR-mutated NSCLC who face limited options after developing resistance to osimertinib. If successful, ENV-105 could provide a new therapeutic approach to restore drug sensitivity and improve outcomes. The full press release is available at https://ibn.fm/SmdwW.
