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.
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies
Emmaus Life Sciences' Endari label enhancements receive US FDA approval
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress