Krystal Biotech has announced the initiation of the KYANITE-1 Phase 1 trial of inhaled KB707 gene therapy in patients with advanced solid lung tumors. Inhaled KB707 received Fast Track designation from the FDA for this indication earlier this year.
The open-label KYANITE-1 dose escalation and dose expansion study is expected to enroll 80 patients who will received KB707 therapy via nebulization. Approximately 60 patients, including 40 with non-small cell lung cancer, are expected to participate in the dose expansion portion of the study. According to the study record, the expected completion date for the study is February 2027.
Krystal Biotech Senior VP of Clinical Development David Chien commented, “Cytokine therapy holds significant potential for the treatment of solid tumors but its utility has been limited by a lack of safe and effective delivery options. Cytokine delivery via inhalation is a first-of-its-kind therapeutic approach made possible by the unique attributes of Krystal’s HSV-1-based vector platform. Together with intratumoral KB707, inhaled KB707 has the potential to significantly expand the clinical utility of cytokine therapy to treat a wide range of otherwise difficult-to-treat and standard of care refractory solid tumors. Dosing the first patient in KYANITE-1 is an exciting step toward our goal of delivering a new class of cancer immunotherapies.”
Krystal President, R&D, Suma Krishnan said, “Dosing the first patient in our inhaled KB707 trial is another important milestone for our oncology program and for Krystal. KYANITE-1 is our second active clinical trial evaluating KB707 and along with KB407 and KB408, our inhaled genetic medicine candidates for the treatment of cystic fibrosis and alpha-1 antitrypsin deficiency, respectively, KB707 is our third clinical stage drug candidate delivered via inhalation. With a deep pipeline of active clinical trials, we are looking forward to data readouts starting later in 2024, which we expect will showcase the breadth and potential of our proprietary, HSV-1 based gene delivery platform.”
Read the Krystal Biotech press release.
