FerGene Submits IPO Prospectus to Advance Commercialization of Nadofaragene Firadenovec for BCG-Unresponsive Bladder Cancer

On November 26, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Ferring Pharmaceuticals and Blackstone Life Sciences jointly announced an investment of $570 million to establish the gene therapy company FerGene, with Blackstone investing $400 million and Ferring Pharmaceuticals investing $170 million.

Upon completion of this financing round, FerGene will focus on the development and commercialization of the gene therapy nadofaragene firadenovec (rAd-IFN/Syn3) for the treatment of patients with high-grade non-muscle-invasive bladder cancer (NMIBC) who have an inadequate response to bacillus Calmette-Guérin (BCG).

FerGene, headquartered in Switzerland, is a gene therapy company spun off from Ferring Pharmaceuticals. The company was established with the aim of developing novel gene therapies to improve clinical outcomes and quality of life for patients with tumors such as bladder cancer. Currently, FerGene is advancing the clinical development and commercialization of nadofaragene firadenovec.

Nadofaragene firadenovec is an adenovirus vector-based gene therapy for the treatment of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have an inadequate response to bacillus Calmette-Guérin (BCG). This therapy utilizes an adenoviral vector to deliver the interferon alfa-2b gene into bladder wall cells, prompting these cells to take up the gene, translate its sequence, and secrete interferon alfa-2b protein—a class of natural proteins that combat cancer. This gene therapy transforms patients’ own bladder wall cells into interferon-producing cells, thereby effectively enhancing the body’s natural defense mechanisms against cancer.

Dr. Colin Dinney, a professor at MD Anderson Cancer Center (MDACC) and founder of the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), pioneered the discovery of nadofaragene firadenovec and co-led its development program with Dr. Nigel R. Parker, founder of the Finnish gene therapy company FKD Therapies Oy (FKD). Reportedly, FKD was primarily responsible for the development and regulatory filings of nadofaragene firadenovec, and conducted the Phase 3 clinical trials of this therapy in collaboration with SUO-CTC.

Currently, nadofaragene firadenovec has been granted Breakthrough Therapy designation, and the FDA has accepted its Biologics License Application (BLA) and approved priority review. Ferring Pharmaceuticals stated that the Phase 3 clinical trial results will be presented on December 5, 2019, at the 20th Annual Meeting of the Society of Urologic Oncology (SUO) in Washington, D.C.

Bladder cancer is one of the most common cancers, with approximately 430,000 patients diagnosed globally each year. It is the sixth most common cancer in the United States, where more than 80,000 new cases are reported annually. The recurrence rate exceeds 60% in patients with advanced non-muscle-invasive bladder cancer (NMIBC) treated with bacillus Calmette-Guérin (BCG), and even radical cystectomy, which can prevent cancer spread, is associated with a high recurrence rate. Therefore, there is an urgent need for new treatment options for patients with advanced NMIBC.

Frederik Paulsen, Chairman of Ferring Pharmaceuticals, stated, “Bringing novel gene therapies to market requires substantial effort. FerGene boasts abundant resources and a specialized team, offering new hope to patients. Through the joint investment by Ferring Pharmaceuticals and Blackstone Life Sciences, nadofaragene firadenovec will soon become available, improving the quality of life for patients with advanced non-muscle-invasive bladder cancer (NMIBC).”

Dr. Nick Galakatos, Head of Blackstone Life Sciences, stated, “Our partnership with Ferring Pharmaceuticals underscores our commitment to bringing transformative therapies to market. Our expertise and clinical development experience will further advance the development of innovative treatments.”

Blackstone Life Sciences is the investment platform of Blackstone, a leading asset management firm, primarily providing capital support to life sciences companies. The firm invests across the entire product lifecycle, helping businesses bring drugs and technologies with the potential to improve patients’ lives to market.

Ferring Pharmaceuticals, founded in 1950 and headquartered in Switzerland, is a science-driven multinational biopharmaceutical group. The company is a leader in reproductive medicine, maternal health, gastroenterology, and urology, dedicated to developing innovative therapies and medicines to improve the quality of life for patients worldwide. Ferring Pharmaceuticals has subsidiaries in nearly 60 countries and exports its products to 110 countries and regions.

(Compiled by Xu Xiaoxue)