The clinical development plan for inodiftagene vixteplasmid in non-muscle-invasive bladder cancer (NMIBC) consists of two clinical studies that we believe together constitute a pathway to potential approval. The Codex Trial is open for enrollment (click here for more information on the study at ClinicalTrials.gov).
The two trials provide independent routes to potential approval in two separate (but related) indications.
The treatment scheme for NMIBC patients is illustrated below. We believe there are two areas of substantial unmet need for patients as they progress through the algorithm of surgical and medical therapy with BCG. We are planning trials in both of these indications.
The Codex study is a single arm trial for registration. It will enroll approximately 140 patients with NMIBC who have been treated with at least two courses of BCG and have experienced subsequent tumor recurrence; this population is considered to have BCG-unresponsive disease. After resection of tumor, patients will be treated with inodiftagene administered intravesically for two years or until disease recurrence. The primary endpoint of the study is the complete response rate in patients with CIS. For more information, click here or visit ClinicalTrials.gov (Identifier: NCT03719300).
Third-line patients: high-risk BCG-unresponsive NMIBC after two failed courses of BCG
N = approximately 140 patients
Our second registrational trial, the Leo study, is a randomized clinical trial. This study has been granted a Special Protocol Assessment (SPA) by the FDA, a regulatory endorsement that the study design may support approval if it meets its endpoints.
The patient population of the Leo Trial is at an earlier stage in their treatment course than in the Codex trial. Patients eligible for Leo will have NMIBC and have been treated with a single course of BCG and suffered recurrence but still considered eligible for BCG therapy. This study will compare inodiftagene vixteplasmid and BCG combination therapy with BCG therapy alone. After resection of recurrent tumor, subjects will be randomized to the combination or to a standard second course of BCG. The primary endpoint of this randomized trial is time to recurrence.
Second-line patients: intermediate or high-risk NMIBC after one failed courses of BCG
N = approximately 495