Kairos Pharma Ltd. (NYSE American: KAPA) announced favorable interim safety results from its ongoing Phase 1 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 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. 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.
This interim data is significant because acquired resistance to osimertinib remains a major clinical challenge. Approximately 10-15% of NSCLC patients in the U.S. have EGFR mutations, and while osimertinib is highly effective initially, most patients eventually develop resistance. If ENV-105 can successfully restore sensitivity, it could offer a new treatment option for these patients, potentially delaying disease progression and improving outcomes.
Kairos Pharma is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. The company'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, aiming to address significant unmet medical needs.
For more information on the full press release, visit https://ibn.fm/SmdwW. The latest news and updates relating to KAPA are available in the company’s newsroom at https://ibn.fm/KAPA. 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.
