Ferring, Theralase partner to study combo therapy in bladder cancer

Ferring Pharmaceuticals and Theralase Technologies have entered into a collaborative clinical development agreement that will add a new cohort to Theralase’s existing clinical program investigating the company’s experimental light-activated small molecule, Ruvidar, in combination with Ferring’s intravesical non-replicating gene therapy, Adstiladrin in high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors.

Under the terms of the deal, 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 U.S. and possibly Canada.

The new cohort of patients will explore the potential benefit of combining two innovative and complementary mechanisms of action.

Approved by the U.S. FDA in December 2022, Adstiladrin is an intravesical, non-replicating adenoviral vector-based gene therapy indicated for adult patients with high-risk BCG-unresponsive NMIBC. The therapy delivers the human interferon alpha-2b gene directly to bladder cells, prompting local secretion of interferon that exerts multiple anticancer 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.

“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,” said Roger DuMoulin-White, president and CEO for Theralase.