Ferring Pharmaceuticals and Theralase(R) Technologies Announce Clinical Development Agreement to Investigate Combination Therapy in Bladder Cancer

Executive Summary

• Ferring Pharmaceuticals and Theralase Technologies entered a collaborative clinical development agreement to evaluate ADSTILADRIN® combined with Ruvidar® in BCG‑unresponsive high‑risk NMIBC CIS patients.
• The new cohort will be added to Theralase’s existing Study II (NCT03945162), which has already enrolled 88 of 90 planned patients, with the additional combination arm expected to begin enrollment shortly.
• Both companies aim to enhance efficacy and durability of response by pairing ADSTILADRIN’s intravesical gene therapy with Ruvidar’s light‑activated small‑molecule therapy.

Key Details

• Agreement Date: January 9 2026 (press release dated Jan 12 2026).
• Study Design: New cohort within Study II (NCT03945162) – patients receive Ruvidar® followed by ADSTILADRIN®.
• Theralase Role: Remains sponsor; joint development committee with Ferring to oversee clinical overview.
• Geography: Initial enrollment and treatment in the United States; potential expansion to Canada or other countries per written agreement.
• Existing Study II Status: 88 of 90 patients enrolled and treated; remaining two patients expected to be completed by 1Q 2026, with follow‑up through 2Q 2027.
• Regulatory Plan: Theralase will file an FDA amendment to add the combination cohort to Study II.
• Therapeutic Rationale: ADSTILADRIN delivers interferon‑α2b gene locally; Ruvidar is a light‑activated small molecule that induces cytotoxicity and immunogenic cell death, offering complementary mechanisms of action.
• Quotes:
• Ashish Kamat, MD – highlighted the unmet need for BCG‑unresponsive NMIBC therapies and potential of combination approaches.
• Daniel Shoskes, M.D., Ferring – emphasized goal to establish ADSTILADRIN as backbone therapy in NMIBC.
• Roger DuMoulin‑White, CEO Theralase – noted collaboration aligns with both companies’ commitment to innovative bladder cancer treatments.
• Safety & Indication Information: ADSTILADRIN is FDA‑approved for high‑risk BCG‑unresponsive NMIBC CIS (±Ta/T1); Ruvidar remains investigational.

Notable Quotes

“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…” – Daniel Shoskes, M.D., Vice President & Global Medical Director, Ferring Pharmaceuticals

“We are honored to collaborate with Ferring… this partnership provides the perfect opportunity to investigate whether we can deliver even greater benefits to patients through innovative combinational approaches.” – Roger DuMoulin‑White, CEO, Theralase Technologies