Toronto, Ontario — January 12, 2026 — Leads & Copy — Ferring Pharmaceuticals and Theralase® Technologies Inc. have entered into a collaborative clinical development agreement, effective January 9, 2026, to evaluate a combination therapy for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
The agreement will build on Theralase®’s existing clinical program (NCT03945162) with a new cohort investigating Theralase®’s investigational light-activated small molecule Ruvidar® (TLD-1433) in combination with Ferring’s intravesical non-replicating gene therapy ADSTILADRIN® (nadofaragene firadenovec-vncg) for adult patients diagnosed with high-risk BCG-unresponsive NMIBC Carcinoma In-Situ (CIS) with or without papillary tumors (±Ta/T1).
Under the terms of the agreement, Theralase® will remain the study sponsor. Both parties will provide clinical overview of the new cohort through a joint development committee. The new cohort will be enrolled and treated in the United States and may later expand into Canada or other countries via written agreement.
Ashish Kamat, MD, MBBS, Endowed Professor of Urologic Oncology (Surgery) and Cancer Research at University of Texas MD Anderson Cancer Center, Houston, Texas, and President of the International Bladder Cancer Group, stated that ADSTILADRIN’s introduction filled a critical unmet need for patients with BCG-unresponsive NMIBC. He added that the combination of complementary therapies may offer additional treatment options to definitive therapy and that this study offers an opportunity to explore the possibility of enhancing efficacy and durability of response with a combination of a promising, investigational light-activated small molecule with the leading gene therapy in NMIBC.
The collaboration underscores the shared commitment of Ferring and Theralase® to advancing innovative therapies for patients with BCG-unresponsive bladder cancer. The new patient cohort 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) for high-risk BCG-unresponsive NMIBC CIS with or without papillary tumors (±Ta/T1). Ruvidar® is an investigational small molecule that penetrates cancer cell walls and, upon light activation, delivers targeted cytotoxic effects to destroy cancer cells, while inducing immunogenic cell death, stimulating both innate and adaptive immune responses.
Daniel Shoskes, M.D., M.Sc, FRCS (C), Vice President and Global Medical Director for Uro-Oncology, Ferring Pharmaceuticals, said that this study aims to explore whether combination approaches can further enhance patient outcomes.
Roger DuMoulin-White, B.Sc, P.Eng, Pro.Dir, President, Chief Executive Officer and Chairman of the Board of Theralase®, added that the partnership provides the perfect opportunity to investigate whether they can deliver even greater benefits to patients through innovative combinational approaches.
In Study II NCT03945162, Theralase® is clinically investigating light-activated Ruvidar® in the treatment of patients diagnosed with BCG-unresponsive NMIBC CIS (Study II). Theralase® has enrolled and successfully treated 88 out of a planned 90 patients in Study II and plans to complete enrollment and treatment of the remaining 2 patients by 1Q2026 with follow-up completed by 2Q2027.
In the Collaborative Clinical Study, Theralase® will apply to the FDA to add a new cohort to Study II. This cohort will be treated with Theralase®’s lead small molecule, light-activated Ruvidar®, followed by treatment with Ferring’s FDA-approved ADSTILADRIN.
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall. In the United States, bladder cancer is the sixth most common cancer, and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025. In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care.
Ruvidar® (TLD-1433) is a small molecule, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses.
ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk BCG-unresponsive NMIBC CIS with or without papillary tumors (±Ta/T1).
Media Contact: Carol Ready, Director, Brand Communications, (973) 765-7307, carol.ready@ferring.com
Source: Theralase® Technologies Inc.
