Kairos Pharma Ltd. (NYSE American: KAPA) reported 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 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. All reported side effects have been manageable through standard supportive care, according to the company.
The positive safety data is significant because osimertinib is the current standard of care for EGFR-mutated NSCLC, but patients often develop resistance, leading to disease progression. By targeting CD105, ENV-105 aims to reverse this resistance and extend the clinical utility of osimertinib. If successful, ENV-105 could address a critical unmet need for patients with limited options after progression on osimertinib.
Kairos Pharma is focused on oncology therapeutics, using 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. As of the date of the 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.
For leaders in business and technology, this news highlights the ongoing innovation in cancer therapeutics, particularly in addressing drug resistance—a major challenge in oncology. The favorable safety profile of ENV-105 suggests it could become a viable combination partner for osimertinib, potentially improving outcomes for a large patient population. Investors and industry watchers will be keenly awaiting the early efficacy readout, which could provide further validation of the CD105 inhibition approach.
More information on Kairos Pharma can be found in the company’s newsroom at https://ibn.fm/KAPA. The full press release is available at https://ibn.fm/SmdwW.
