Krystal Biotech, Inc. (NASDAQ: KRYS), a biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for inhaled KB707. This designation aims to expedite the development and review process of KB707 for treating patients with solid tumors featuring pulmonary metastases that have relapsed or are refractory to standard therapy.

Dr. Daniel Johnson, MD, Director of the Center for Innovative Cancer Therapies at Ochsner MD Anderson Cancer Center Medical Center, expressed enthusiasm about this development, highlighting the lung as a predominant site of metastasis for many cancers. He emphasized the challenge of administering cytokine therapy systemically due to associated toxicities, and the difficulty in delivering immunotherapies directly to the lungs. He sees promise in KB707's potential to provide localized cytokine expression in the lung, offering hope for this patient population.

KB707 is an innovative treatment utilizing a modified HSV-1 vector to deliver genes encoding human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the tumor microenvironment. This approach aims to induce systemic immune-mediated tumor clearance. Following FDA clearance of an amendment to the Investigational New Drug application in January 2024, Krystal Biotech plans to initiate a Phase 1 clinical trial (KYANITE-1) for inhaled KB707 in patients with locally advanced or metastatic solid lung tumors. The trial is set to commence in the first half of 2024.

This marks the second Fast Track Designation for KB707. The first was granted in July 2023 for intratumoral KB707 to treat anti-programmed cell death protein-1 relapsed/refractory locally advanced or metastatic melanoma.

Krystal Biotech, expressed confidence in KB707's potential, citing promising preclinical data and acknowledging the urgent need for effective treatments for lung metastases. The Fast Track Designation reflects both the severity of the medical need and the promising data generated so far.

Fast Track Designation expedites the development and review process for drugs targeting serious conditions with unmet medical needs. Clinical programs with this designation benefit from enhanced communication with the FDA and may be eligible for Accelerated Approval and Priority Review if specific criteria are met.

KB707 aims to utilize IL-2 and IL-12, cytokines known for their roles in promoting cell-mediated immunity, to elicit anti-tumor responses. Despite their potential efficacy, systemic administration of IL-2 and IL-12 is challenging due to toxicity and short half-lives. KB707 addresses these challenges by delivering these cytokines directly to tumors via a modified HSV-1 vector, offering a promising approach for cancer immunotherapy.

 

Source: globenewswire.com

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