UroGen Submits Investigational New Drug Application Supporting Planned Phase 1 Clinical Study of UGN-301 (zalifrelimab) Intravesical Solution in Recurrent Non-Muscle Invasive Bladder Cancer
-- UGN-301 is an investigational immunotherapy designed for monotherapy and combination therapy in treating low-grade and high-grade disease --
“UroGen has shown that combination immunotherapy, when delivered intravesically, is potentially synergistic. While CTLA-4 has long been considered a good target for overcoming the immune suppression produced by tumor cells, anti-CTLA4 antibodies are associated with toxicities when administered systemically,” said
In the nonclinical study of UGN-301 in cynomolgus monkeys, UroGen assessed the potential toxicity via instillation into the urinary bladder delivered with RTGel reverse thermal hydrogel. The results showed that instillation of UGN-301 at different dose concentrations for a pre-defined period was not associated with mortality, changes in body weights, organ weight differences or meaningful changes among other endpoints, or macroscopic or microscopic findings following a specified recovery period.
According to
About
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel™ reverse-thermal hydrogel, 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 first commercial product and the investigational treatment UGN-102 (mitomycin) for intravesical solution in development for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means. UroGen is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the planned Phase 1 studies of UGN-301 (zalifrelimab) and the design thereof; the potential benefits of the intravesical delivery of zalifrelimab using our RTGel™ proprietary technology; the development of UGN-301 and other investigational agents; and our opportunities to evaluate a variety of novel immunomodulatory drug combinations. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: there is no guarantee that our submitted IND for zalifrelimab will be cleared by the FDA, and without that clearance, we will be unable to advance zalifrelimab into a Phase 1 clinical trial; results from nonclinical studies are not necessarily indicative of results that may be observed in clinical trials; clinical trial site initiation and enrollment challenges that may impact the expected timing of our planned clinical trials, including challenges related to the ongoing COVID-19 pandemic; the timing and success of clinical trials and potential safety and other complications thereof; UroGen’s ability to attract or retain key management, members of the board of directors and personnel; and any negative effects on UroGen’s business, commercialization and product development plans caused by or associated with COVID-19. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Form 10-Q filed with the
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INVESTOR:
Senior Director, Investor Relations
vincent.perrone@urogen.com
609-460-3588 ext. 1093
MEDIA:
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
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