What is the LEGEND study drug?

The investigational* study drug, called detalimogene voraplasmid, is a type of gene therapy that provides your body with a blueprint for how to recognize and fight the cancer.

The study drug does this by delivering small, code-carrying DNA molecules, that occur naturally in our bodies. Once your bladder cells receive the study drug (1), the code-carrying molecules teach your bladder cells how to produce small proteins (2) that tell your immune system its attention is needed in the bladder to fight the cancer (3). The immune system then launches an attack against the cancer cells (4). The study drug is quickly shed when you urinate, but the blueprint for how to recognize and fight the cancer is remembered by your immune system so that it can protect your bladder against the cancer if it tries to come back.

Unlike many other gene therapies, the study drug is non-viral, which means it does not use a modified virus to get into cells and deliver the therapy. The study drug is not infectious, and is not made with  virus or bacteria, instead, the study drug is comprised of tiny droplets that contain the instructions for your body to recognize, fight, and remember the cancer.

Study participants receive the study drug as a liquid solution that is delivered directly to the bladder through a temporary tube called a catheter, similar to the instillation method used for BCG.

Detalimogene:
Designed to eradicate tumors via synergistic stimulation of bladder-specific innate and adaptive immune responses.

Will I receive the study drug if I join?

All LEGEND study participants will receive study drug for the first 12-week cycle and may receive access to the study drug for up to 48 weeks (about 1 year) under study treatment period.  The length of time depends on the response to EG-70 study treatment.  Participants who remain with a good response at this time can continue to maintenance treatments with detalimogene.

*Investigational means the study drug has not been approved by the US Food and Drug Administration (FDA), or the regulatory authority in any country, to be used outside of clinical research.