Private equity giant Blackstone Life Sciences is putting $400m into a joint venture with Swiss pharma company Ferring that will focus on the development of gene therapies for bladder cancer and other diseases.
Ferring is putting $170m into the new company – to be called FerGene – whose bladder cancer therapy nadofaragene firadenovec (rAd-IFN/Syn3) is already filed for approval in the US with a decision by the FDA due next year.
FerGene will operate as a subsidiary of Ferring, and will focus initially on bringing the gene therapy to the US market and continuing its clinical development elsewhere. If approved outside the US nadofaragene firadenovec will be sold by Ferring.
The gene therapy is being developed for non-muscle invasive bladder cancer (NMIBC), a low-grade tumour that is currently usually treated with Merck & Co’s TICE Bacille Calmette-Guérin (BCG) product.
BCG is administered directly into the bladder and is intended to boost the ability of the immune system to fight the tumour, but has been in short supply in the US due to increasing global demand, despite Merck boosting production.
FerGene’s gene therapy – which has breakthrough status from the FDA – is currently on phase 3 development as a treatment option for the 30 to 40% of patients with NMIBC who don’t respond to BCG therapy and may have to resort to drastic measures such as surgery to remove the bladder.
It works by introducing a gene into cells lining the bladder that codes for interferon-alfa2b, a cytokine that fights cancer and has also been used as a treatment alongside BCG refractory NMIBC.
Phase 3 data is due to be presented at the Society of Urologic Oncology (SUO) annual meeting in Washington, DC next month. The trial – which started in 2016 – will include around 150 NMIBC patients when fully enrolled.
Bladder cancer is one of the most frequently occurring cancers with an estimated 430,000 new cases being reported worldwide each year.
Blackstone’s backing means that FerGene “will have the resources and team needed to help us potentially bring nadofaragene firadenovec to patients”, said Ferring chairman Frederik Paulsen.
“Bringing a novel gene therapy to the market requires dedicated focus and capabilities,” he added.
Ferring acquired rights to nadofaragene firadenovec from Finnish biotech FKD Therapies last year, saying at the time it intended to set up a new oncology division to handle the development and commercialisation of the product.
The Swiss company’s main activities lie in speciality therapeutics for women’s health, gastroenterology and urology.
Blackstone got into the life sciences business when it acquired investment firm Clarus last year, and since then has also invested $250m into the launch of Anthos Therapeutics, a company developing a new anticoagulant drug, in partnership with Novartis.