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Clinical Development
Programs
Clinical Development
Programs
Our Dually Derivatized Oligochitosan® (DDX) platform, which enables a carrier designed to penetrate mucosal tissue and deliver a wide range of sizes and types of cargo, powers a deep pipeline of novel non-viral genetic developmental medicines across oncology and beyond.
Program
Discovery
IND-Enabling
Phase 1/2
Phase 3
ONCOLOLGY
EG-70
(detalimogene voraplasmid)
*Fast Track Designation
RESPIRATORY
EG-i08
Advancing a powerful non-viral gene therapy option for patients with NMIBC
More than half a million new cases of bladder cancer are diagnosed each year, and most new cases (about 70-80%) are non-muscle invasive bladder cancer (NMIBC). Patients suffering from Bacillus Calmette-Guerin (BCG)-unresponsive NMIBC with carcinoma in situ (Cis) are particularly underserved and have limited treatment options, and patients who fail BCG generally resort to having a radical cystectomy (bladder removal) – a life-altering, invasive and challenging procedure that significantly impairs patients’ quality of life. Furthermore, there is a chronic global shortage of BCG, making it difficult for these patients to get the therapy they need in the first place.
EG-70 has the potential to improve the standard of care for patients with NMIBC because of its optimized delivery to the bladder, safety in handling, and ease of administration.
EG-70 is a novel non-viral gene therapy designed to elicit a local immune response following the delivery to the bladder urothelium. This approach has the potential to induce a potent local immune response at the site of the tumor, resulting in greater therapeutic benefit while reducing undesirable systemic toxicity.
EG-70 in Patients with NMIBC BCG-Unresponsive and High-Risk NMIBC Incompletely Treated with BCG or BCG-Naïve
This study consists of two phases: a Phase 1 dose-escalation portion to establish safety and the recommended Phase 2 dose, followed by a Phase 2 portion to establish the effectiveness of EG-70. The study includes patients with NMIBC who have proven to be unresponsive to BCG therapy, as well as high-risk patients with NMIBC who are BCG-naïve or have received incomplete BCG treatment.
Additional information about the LEGEND clinical trial, including eligibility criteria, can be found on clinicaltrials.gov (identifier: NCT04752722).
EG-70 in Patients with NMIBC BCG-Unresponsive and High-Risk NMIBC Incompletely Treated with BCG or BCG-Naïve
This study consists of two phases: a Phase 1 dose-escalation portion to establish safety and the recommended Phase 2 dose, followed by a Phase 2 portion to establish the effectiveness of EG-70. The study includes patients with NMIBC who have proven to be unresponsive to BCG therapy, as well as high-risk patients with NMIBC who are BCG-naïve or have received incomplete BCG treatment.
Additional information about the LEGEND clinical trial, including eligibility criteria, can be found on clinicaltrials.gov (identifier: NCT04752722).