Commercial-stage biotechnology company Krystal Biotech Inc (NASDAQ:KRYS) announced on Tuesday that the US Food and Drug Administration (FDA) has granted Fast Track designation for inhaled KB707 to treat solid tumours with pulmonary metastases that are relapsed or refractory to standard therapy.
KB707, a modified HSV-1 vector designed to deliver interleukin-12 and interleukin-2 genes to the tumour microenvironment, aims to promote immune-mediated tumour clearance.
In January 2024 the FDA cleared the Investigational New Drug (IND) application for Phase 1 clinical trial KYANITE-1, set to commence in the first half of 2024, targeting patients with locally advanced or metastatic solid tumours of the lung.
This is the second Fast Track for KB707, following the FDA's previous approval for intratumoral KB707 in melanoma treatment.
Genprex research collaborators to present positive data on Reqorsa Gene Therapy at SITC 2024
hVIVO reports positive results from RSV antiviral human challenge trial
BerGenBio reveals preliminary safety data from Phase 1b BGBC016 study in first-line NSCLC patients
Liquidia and Pharmosa expand collaboration for inhaled treprostinil
Alvotech launches confirmatory study for Entyvio biosimilar
Merck's KEYTRUDA receives new approvals in Japan for lung and urothelial cancers
Innate Pharma receives FDA clearance of IND for IPH4502, a Nectin-4 targeting ADC for solid tumours
Intas Pharmaceuticals reports positive opinion for HETRONIFLY in Europe
Insilico Medicine reveals positive preliminary results from ISM001-055Phase IIa clinical trial
NeoGenomics to present breakthrough data at ESMO 2024 on ctDNA and NGS for cancer diagnostics
OSE Immunotherapeutics initiates Phase 3 trial for cancer vaccine Tedopi
AbbVie advances solid tumour pipeline with new data at ESMO 2024
Amgen showcases promising data for IMDELLTRA in small cell lung cancer at WCLC 2024