ImmuneBio has a problem; it depends on BCG availability.
Coming from the highest instance in the bladder arena; IBCG (International Bladder Cancer Group).
https://www.ibcg.info/newsletter New activity in the BCG Unresponsive Space
Despite its success, many patients with high-risk non-muscle-invasive bladder cancer treated with BCG eventually develop BCG-unresponsive disease. Bladder sparing therapeutic options for these patients remains limited. Two studies were reported in the BCG Unresponsive space at ASCO-GU 2022. In a phase 3 trial assessing combination therapy using IL-15RαFc superagonist N-803 (Anktiva) and BCG, Dr. Sam Chang reported complete response rates of 71% (95% CI 60.1 – 80.5%) at any time, with median duration of response of 24.1mo and a 55% probability of maintaining response for ≥18mo in a cohort of 83 patients with CIS containing BCG Unresponsive NMIBC. The cystectomy-free rate in responders was 93%. Among 77 patients with papillary only disease, the 12-month disease free rate was 57% and 53% at 18-month. Similarly, a 95% cystectomy-free rate was seen at 20.7-month median follow-up. The treatment combination was also well tolerated, with no treatment-related grade 4/5 adverse events, and no immune-related adverse events. Despite these exciting results, treatment efficacy does depend on combination with BCG, and administration of this combination will be impacted by the ongoing global BCG shortage.