dm+d

Unassigned

New Medicines

High-grade non-muscle invasive bladder cancer (NMIBC) in pts with carcinoma in situ (CIS) who are unresponsive to BCG and are candidates for radical cystectomy

Information

New molecular entity
enGene
enGene

Development and Regulatory status

None
None
Phase II Clinical Trials
Dec 20US FDA grant Fast Track Designation.[2]

Category

Intravesical gene therapy encoding RIG-I (retinoic acid-inducible gene I) activators and IL-12 which stimulate the innate and adaptive immune system. Uses a synthetic polymer carrier called DDX rather than a viral carrier to deliver the genes.
The overall incidence of bladder cancer in the UK is 11.4 per 100,000 population. At diagnosis, only about 5% of patients have metastatic disease, usually to lymph nodes, lung, liver, bone and central nervous system. Around 30% have involvement of the muscle layer. Around 70% have superficial disease, of which 10% is CIS [1].
High-grade non-muscle invasive bladder cancer (NMIBC) in pts with carcinoma in situ (CIS) who are unresponsive to BCG and are candidates for radical cystectomy
Intravesical

Trial or other data

Feb 22Interim results from the LEGEND study show that EG 70 is safe, well-tolerated and shows encouraging clinical efficacy as 5 of the 6 pts who have reached the 3-month efficacy assessment achieved complete response. No serious adverse events or dose-limiting toxicity has been observed. Adverse events related to EG 70 included intermittent pain while urinating, urinary tract pain, restlessness, and low back pain. The trial has a primary completion date of July 2024. [3,4]
Mar 21PI/II LEGEND non-randomised, open-label trial (NCT04752722, n=222) initiated to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of intravesicular EG 70 and its effect on bladder tumours in patients with BCG unresponsive non-muscle invasive bladder cancer, who have failed BCG therapy and are recommended for radical cystectomy (EG-70-101; NCT04752722).[2,3]