Krystal Biotech, which has been developing both injectable and inhaled formulations of its KB707 gene therapy for the treatment of solid tumors, announced that it will now focus on the inhaled therapy for the treatment of non-small cell lung cancer (NSCLC). According to Krystal, the FDA has scheduled an End of Phase 2 meeting regarding inhaled KB707 for October based on positive data from the KYANITE-1 Phase 1/2 trial in patients with lung cancer.
The company notes that it recently presented data from the Phase 1/2 trial at the annual meeting of the American Society of Clinical Oncology showing a 36% response rate (4 of 11 ‘efficacy-evaluable patients) and that “Median duration of response and progression free survival were not reached.” The KYANITE-1 study is still enrolling patients.
Krystal Biotech President of Research and Development Suma Krishnan commented, “The acceleration of our work on inhaled KB707 is a reflection of both the clear and acute unmet need that exists for new treatments of NSCLC and the promising efficacy profile we have observed to date with inhaled KB707. We look forward to meeting with the FDA and bringing another urgently needed therapeutic option to patients.”
Read the Krystal Biotech press release
