Swiss biopharmaceutical company Ferring Pharmaceuticals reported over USD570m in investment in nadofaragene firadenovec (rAd-IFN/Syn3) for treating patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC) in partnership with Blackstone Life Sciences.
Under the terms of the agreement, Blackstone will invest USD400m and Ferring will invest up to USD170m in FerGene. Additionally, Ferring will potentially launch and commercialize nadofaragene firadenovec outside of the US.
In conjunction, FerGene, a new gene therapy company and Ferring subsidiary, has been created to potentially commercialize nadofaragene firadenovec (rAd-IFN/Syn3) in the US as well as to advance the global clinical development.
Nadofaragene firadenovec, an investigational novel gene therapy currently in late Phase 3 development, has received US FDA Breakthrough Therapy designation and its Biologics License Application's Priority Review. FerGene will hold its marketing authorization.
The Phase 3 clinical trial results will be presented at the Society of Urologic Oncology (SUO) 20th Annual Meeting in Washington, DC on 5 December 2019 by Dr Colin Dinney, professor and chairman of the Department of Urology at the University of Texas MD Anderson Cancer Center (MDACC) and a founder and past president of the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC).
Bladder cancer is reportedly one of the most frequently occurring cancers, with an estimated 430,000 patients diagnosed worldwide each year, making it the ninth most common cancer worldwide.
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA
Ionis receives FDA Breakthrough Therapy designation for ION582 in Angelman syndrome
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15