13 November 2019 - - US-based biopharmaceutical company UroGen Pharma Ltd. (NASDAQ: URGN) has entered into an exclusive worldwide license agreement with Agenus Inc (NASDAQ: AGEN) to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) via intravesical delivery in combination with UGN-201 for the treatment of urinary tract cancers, the company said.
This worldwide license does not include Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions.
This combination is based on encouraging preclinical data utilizing UroGen's proprietary sustained release technology, which is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option while minimising systemic exposure and potential side effects.
UroGen's initial indication for development will be high-grade non-muscle invasive bladder cancer (HG NMIBC).
Zalifrelimab (AGEN1884, anti-CTLA-4 antibody) is currently being evaluated by Agenus in combination with Agenus' anti-PD-1 antibody balstilimab (AGEN2034) in second line cervical cancer with anticipated BLA filing in 2020.
UGN-201 is a TLR-7/8 agonist that is in early stage development at UroGen for HG NMIBC.
Under the terms of the agreement and in exchange for the worldwide exclusive license to AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery, Agenus will receive an upfront payment of USD 10m, in addition to up to USD 115m for achieving certain clinical development and regulatory milestones, up to USD 85m upon achieving certain commercial milestones, as well as royalties on net sales of licensed products in the 14-20% range.
UroGen will be responsible for all development and commercialization activities.
UroGen's lead investigational candidates, UGN-101 (mitomycin gel) for instillation, and UGN-102 (mitomycin gel) for intravesical instillation, are designed to potentially ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer (LG UTUC) and low-grade non-muscle invasive bladder cancer (LG NMIBC), respectively.
UGN-101 has been granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations by the US Food and Drug Administration for the treatment of LG UTUC.
UroGen Pharma Ltd. (NASDAQ: URGN) is a clinical-stage biopharmaceutical company developing advanced non-surgical treatments to address unmet needs in the field of urology, with a focus on uro-oncology.
The company has developed RTGel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs.
UroGen's sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option.
UroGen's lead investigational candidates, UGN-101 (mitomycin gel) for instillation, and UGN-102 (mitomycin gel) for intravesical instillation, are designed to potentially ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer and bladder cancer, respectively.
UroGen is headquartered in New York, NY with operations in Los Angeles, CA and Israel.