FERRING PHARMACEUTICALS AND THERALASE TECHNOLOGIES ANNOUNCE CLINICAL DEVELOPMENT AGREEMENT TO INVESTIGATE COMBINATION THERAPY IN BLADDER CANCER

Ferring Pharmaceuticals and Theralase Technologies Inc. entered into a collaborative clinical development agreement on Jan. 9, 2026. The Agreement builds 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 (Bacillus Calmette-Guerin) non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumours (plus or minus Ta/T1).

Under the terms of the agreement, Theralase will remain the sponsor of the study, with both parties providing 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 written agreement may expand into Canada or other countries.

"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," said Dr. Ashish Kamat, MD, MBBS, endowed professor of urologic oncology (surgery) and cancer research at the University of Texas MD Anderson Cancer Center in Houston, Tex., and president of the international bladder cancer group. "As the BCG-unresponsive treatment paradigm continues to evolve, the combination of complementary therapies may offer additional treatment options to definitive therapy. 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."

The collaboration between Ferring and Theralase underscores their shared commitment to advancing innovative therapies for patients with BCG-unresponsive bladder cancer. 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) for high-risk BCG-unresponsive NMIBC CIS with or without papillary tumours (plus or minus Ta/T1) that delivers the human interferon alpha-2b gene directly to bladder cells, prompting local secretion of interferon that exerts multiple anti-cancer and immunomodulatory effects. 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.

"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 Dr. Daniel Shoskes, MD, MSc, FRCS (C), vice-president and global medical director for uro-oncology, Ferring Pharmaceuticals.

Roger DuMoulin-White, BSc, PEng, ProDir, president, chief executive officer and chairman of the board of Theralase, added: "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."

Study details

In study II NCT03945162, Theralase is clinically investigating light-activated Ruvidar in the treatment of patients diagnosed with BCG-unresponsive NMIBC CIS. Theralase has enrolled and successfully treated 88 out of a planned 90 patients in study II and plans to complete enrolment and treatment of the remaining two patients by Q1 2026, with follow-up completed by Q2 2027.

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.

About NMIBC

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, fourth among men, and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the United States in 2025. Historically, 75 per cent of bladder cancer presents as NMIBC. In patients with high-risk NMIBC, intravesical BCG remains the first-line standard of care; however, approximately one-third of patients with NMIBC will not respond to BCG therapy and 50 per cent of those with an initial response will experience recurrence or progression of their disease. Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).

About Ruvidar

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.

About Adstiladrin

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 tumours (plus or minus Ta/T1). It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder's cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body's own natural defences against the cancer.

Adstiladrin has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC, who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on the Clinical Trials website (NCT02773849) and final five-year follow-up analysis published in the Journal of Urology).

About Theralase Technologies Inc.

Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light-, radiation-, sound- and drug-activated small-molecule compounds and their associated formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses, with minimal impact on surrounding healthy tissue.

We seek Safe Harbor.