Krystal Biotech granted RMAT designation for KB707 in NSCLC

Krystal Biotech (KRYS) announced that the United States Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to KB707, the Company’s redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment, for the treatment of advanced or metastatic non-small cell lung cancer. Data to support the FDA’s RMAT designation included early clinical evidence from the Company’s ongoing KYANITE-1 study that demonstrated consistent and meaningful antitumor activity, including durable responses and clinically significant tumor reductions, in patients with heavily pre-treated advanced NSCLC receiving inhaled KB707. Enrollment in KYANITE-1 is ongoing, and further details will be presented at upcoming scientific conferences.