Tagworks Pharmaceuticals Initiates Phase 1 Trial For TGW101 With FDA Approval And Appoints Dr. Keith Orford As Chief Medical Officer

​Tagworks Pharmaceuticals is a clinical-stage precision oncology company using its proprietary treatment platform to manufacture new standard treatments for patients suffering from solid tumours. The company has received FDA clearance to initiate a Phase 1 clinical trial for TGW101, a first-in-class antibody-drug conjugate (ADC) targeting TAG-72 in patients with advanced solid tumours. TGW101 utilises Tagworks' proprietary Click-to-Release linker chemistry, enabling controlled activation of the MMAE payload within the tumour microenvironment. This bioorthogonal, in vivo click chemistry-activated ADC represents a novel approach to targeting non-internalising tumour antigens.​

“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 tumor cells to activate their anti-tumour activity. TGW101’s highly differentiated profile enables controlled MMAE payload release and activation in the tumor microenvironment without internalisation 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,” said Marc Robillard, Chief Scientific Officer and Co-Founder of Tagworks. “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.” 

The multicenter, open-label, dose-escalation trial aims to enroll up to 50 patients in the U.S. Primary objectives include evaluating the safety and tolerability of TGW101 and determining the maximum tolerated dose and recommended dose for cohort expansion. Preclinical studies have demonstrated a favourable safety profile and effective, durable responses in solid tumour models.​ 

“We are pleased to welcome Keith and look forward to his contributions to the clinical development of our pipeline of innovative ADCs and targeted radiopharmaceuticals. As we enter into clinical development, Keith’s development expertise, strategic insights, and leadership in the oncology community will be critical in positioning Tagworks for long-term success,” said Ken Mills, Chief Executive Officer of Tagworks.

Keith Orford, MD, PhD, CMO of Tagworks, commented, “I am thrilled to join the experienced team at Tagworks to develop and expand on the transformative potential of the Click-to-Release technology with the clear goal of providing safe and efficacious new therapies for patients with cancer. I look forward to immediately working closely with all of our investigators to evaluate the therapeutic utility of TGW101 in multiple advanced solid tumor indications.” 

In addition to the trial initiation, Tagworks has appointed Keith Orford, MD, PhD, as Chief Medical Officer. Dr. Orford brings over three decades of experience in oncology research and clinical drug development, having held leadership roles at companies including Parabilis Medicines, Calithera Biosciences, GlaxoSmithKline, and Merck. He will oversee the clinical development of Tagworks' pipeline, which includes innovative ADCs and targeted radiopharmaceuticals leveraging Click-to-Release technology.