Theralase, Ferring sign clinical development agreement

Executive Summary

• Ferring Pharmaceuticals and Theralase Technologies Inc. entered into a collaborative clinical development agreement on January 9, 2026, to investigate a combination therapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
• The new clinical cohort will evaluate Theralase’s investigational light-activated small molecule, Ruvidar (TLD-1433), in combination with Ferring’s FDA-approved intravesical gene therapy, Adstiladrin (nadofaragene firadenovec-vncg).
• Theralase remains the sponsor of the study, which builds upon its existing clinical program (NCT03945162). The new cohort will initially enroll patients in the United States, with potential expansion to Canada or other countries subject to written agreement.

Key Details

• Agreement Structure: Collaborative clinical development agreement between Ferring Pharmaceuticals and Theralase Technologies Inc.
• Target Indication: Adult patients diagnosed with high-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumours (plus or minus Ta/T1).
• Therapeutic Combination:
  • Ruvidar (TLD-1433): Theralase’s investigational light-activated small molecule that penetrates cancer cell walls and delivers targeted cytotoxic effects upon light activation, inducing immunogenic cell death.
  • Adstiladrin (nadofaragene firadenovec-vncg): Ferring’s FDA-approved intravesical non-replicating gene therapy delivering the human interferon alpha-2b gene directly to bladder cells.
• Study Governance: Theralase remains the sponsor of the study. Both parties will provide clinical oversight through a joint development committee.
• Enrollment and Timeline:
  • The new cohort will be added to existing study II (NCT03945162).
  • Theralase has enrolled and treated 88 of 90 planned patients in the original study, with completion of enrolment and treatment expected by Q1 2026.
  • Follow-up for the original study is expected to be completed by Q2 2027.
  • The new combination cohort will be treated with Ruvidar followed by Adstiladrin.
• Geographic Scope: Initial enrollment and treatment in the United States; potential expansion to Canada or other countries subject to written agreement.
• Market Context: NMIBC accounts for approximately 75% of bladder cancer cases. Approximately one-third of NMIBC patients do not respond to BCG therapy, and 50% of responders experience recurrence or progression. Current options for BCG-unresponsive patients are limited, with guidelines often recommending cystectomy.

Notable Quotes

• "The introduction of Adstiladrin as the first intravesical gene therapy filled a critical unmet need for patients with BCG-unresponsive NMIBC who faced limited treatment options and needed an alternative to invasive bladder removal surgery... This new 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." — Dr. Ashish Kamat, MD, MBBS, University of Texas MD Anderson Cancer Center.
• "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." — Dr. Daniel Shoskes, MD, MSc, FRCS (C), Ferring Pharmaceuticals.
• "We are honoured to collaborate with Ferring, a worldwide leader in uro-oncology with deep expertise in bladder cancer treatment. 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." — Roger DuMoulin-White, President, CEO, and Chairman of the Board, Theralase Technologies Inc.