Parsippany-based Ferring Pharmaceuticals and Theralase Technologies Inc. have agreed to a collaborative clinical development agreement on Jan. 9. The collaboration showcases their shared commitment to advancing innovative therapies for patients with bladder cancer.
It builds on Theralase’s existing clinical program (NCT03945162) with a new cohort investigating its investigational light-activated small molecule Ruvidar (TLD-1433) in combination with Ferring’s intravesical non-replicating gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg).
This combination is for adult patients diagnosed with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors.
“Underscoring our ambition to establish ADSTILADRIN as the backbone therapy in NMIBC, this collaborative clinical study with Theralase aims to explore whether combination approaches can further enhance patient outcomes, building on the strong foundation ADSTILADRIN has established in treating this challenging disease,” said Daniel Shoskes, M.D., MSc, FRCS (C), vice president and global medical director for uro-oncology, Ferring Pharmaceuticals.
The new cohort of patients will explore the potential benefit of combining two innovative and complementary mechanisms of action. ADSTILADRIN is the first and only intravesical gene therapy approved by the U.S. Food and Drug Administration (FDA).
“We are honored to collaborate with Ferring, a worldwide leader in uro-oncology with deep expertise in bladder cancer treatment,” said Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, president, chief executive officer and chairman of the board of Theralase.
“As we approach completion of our clinical study and regulatory submissions for Ruvidar, this partnership provides the perfect opportunity to investigate whether we can deliver even greater benefits to patients through innovative combinational approaches.”
Under the terms of the agreement, Theralase will remain the sponsor of the study, with both parties providing a clinical overview of the new cohort through a joint development committee.
The new cohort will be enrolled and treated in the United States, and then subject to a written agreement, may expand into Canada or other countries.
