US-based biotechnology company Krystal Biotech has dosed the first subject in the Phase I KYANITE-1 clinical trial for its inhaled oncology candidate, KB707, aimed at treating patients with locally advanced or metastatic solid lung tumours.
A modified HSV-1 vector, KB707 can deliver genes that encode human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the lung.
The trial is an open-label, multicentre study designed to assess the drug's safety and tolerability in adult patients whose disease has progressed after standard care treatment or who are unable to tolerate such treatments.
The study's dose escalation phase will follow a standard 3+3 design to determine the optimal dose of KB707 monotherapy, which will then be further evaluated in the expansion phase.
Patients participating in both the dose escalation and dose expansion phases will receive KB707 via nebulisation weekly for three weeks.
Treatment will continue every three weeks for up to two years, or until certain endpoints such as tumour progression or unacceptable toxicity are reached.
Krystal Biotech Clinical Development senior vice president David Chien said: “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 tumours.”
Earlier this year, the US Food and Drug Administration (FDA) granted fast track designation for inhaled KB707 to treat solid tumour patients with pulmonary metastases that have relapsed or are refractory to standard care.
Last July, intratumoral KB707 received fast track status for the treatment of melanoma patients who have relapsed after anti-PD-1 therapy.
In the same month, Krystal Biotech dosed the first patient in the Phase I CORAL-1/US trial of KB407, a gene therapy designed to treat cystic fibrosis.
