Tagworks Pharmaceuticals BV, a Netherlands-based clinical-stage precision oncology company, announced on Tuesday that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for a Phase 1 clinical trial evaluating TGW101, a first-in-class antibody drug-conjugate (ADC) targeting tumour associated glycoprotein 72 (TAG-72) with an monomethyl auristatin E (MMAE) payload, in patients with advanced solid tumours.

The company has initiated first-in-human Phase 1 clinical development of TGW101 in a multicentre, open-label, dose-escalation trial in patients with advanced solid tumours. The primary objectives of the study are to evaluate the safety and tolerability of TGW101 and identify the maximum tolerated dose, recommended dose, and regiment for cohort expansion. The study is currently recruiting in the United States and is planned to enrol up to 50 patients.

"TAG-72 is a validated target with overexpression in many high unmet need solid tumours. However, due to its non-internalising nature, this target has remained unreachable by current ADCs and other therapies which require uptake by tumour cells to activate their anti-tumour activity," said Marc Robillard, Tagworks chief scientific officer and co-founder. "TGW101's highly differentiated profile enables controlled MMAE payload release and activation in the tumour microenvironment without internalisation by tumour 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 favourable safety profile as well as effective and durable responses in preclinical solid tumour 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."

Tagworks also announced the appointment of Keith Orford, MD, PhD, as chief medical officer. Dr. Orford has served as a physician, scientist, and executive leader at several biotechnology companies.