Nijmegen-based Tagworks has passed the investigational new drug (IND) review by the US Food and Drug Administration (FDA) for its antibody-drug conjugate TGW101, which targets tumour-associated glycoprotein 72 (TAG-72) in solid tumours. Approximately fifty patients will be enrolled in the Phase 1 clinical trial, which is now being initiated in the US.
TGW101 is the first antibody-drug conjugate to work via in vivo bio-orthogonal click chemistry. It consists of two parts: first, part 1 is administered, which binds specifically to TAG72 on the surface of tumour cells. Anything that is not bound is eliminated by the body. Then part 2 is administered, which clicks onto the bound part 1, causing the cytotoxic payload to fall off and immediately kill the tumour cells on the spot. This results in hyper-specific tumour control.
‘TAG-72 is a validated target with overexpression in many high unmet need solid tumors. However, due to its non-internalizing nature, this target has remained unreachable by current ADCs and other therapies which require uptake by tumor cells to activate their anti-tumor activity,’ said Marc Robillard, Chief Scientific Officer and Co-Founder of Tagworks.
‘TGW101’s highly differentiated profile enables controlled MMAE payload release and activation in the tumor microenvironment without internalization by tumor cells. This controlled drug release is achieved through a click reaction of the ADC linker with a trigger molecule, which is administered in a second step. TGW101 has demonstrated a favorable safety profile as well as effective and durable responses in preclinical solid tumor models. The IND clearance and initiation of our Phase 1 clinical trial is a significant milestone for our lead program and Tagworks, the pioneer of Click-to-Release chemistry.’
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