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.
AstraZeneca secures US approval for Truqap combination in PTEN‑deficient prostate cancer
Transcend Therapeutics acquired by Otsuka Pharmaceutical
Rocket Pharmaceuticals closes USD180m Rare Pediatric Disease voucher sale
Airiver Medical treats first chronic rhinosinusitis patient in Drug Coated Balloon clinical study
Precigen and the RRPF recognise International RRP Awareness Day
Guardant Health expands FDA-approved companion diagnostic use for HERNEXEOS
FDA grants priority review for Genentech's Tecentriq in stage III dMMR/MSI-H colon cancer
Formosa Pharmaceuticals signs Vietnam licensing deal with Samil Pharmaceuticals
Harbour BioMed IND for HBM7004 accepted by China's NMPA
Organon secures FDA approval expanding TOFIDENCE indications for CRS and paediatric COVID-19
FDA grants rare paediatric disease designation to RedHill's opaganib
GSK to acquire Nuvalent for USD10.6bn to expand lung cancer portfolio
Galmed Pharmaceuticals to acquire Colospan for GI-focused platform development
Alvotech reports FDA review acceptance for Entyvio biosimilar candidate AVT16
Sanofi secures EU approval for subcutaneous Sarclisa with on-body injector