#Netherlands #Nijmegen #Tagworks Pharmaceuticals #HER2+ Cancer #TGW211

Tagworks Pharmaceuticals Announces Clinical Study Approval for TGW211

Tagworks Pharmaceuticals, a company specializing in precision oncology, recently announced that it has received approval from Dutch regulatory authorities for a clinical Phase 0/1 study (referred to as the CleavHER study) of TGW211, a sophisticated radiopharmaceutical aimed at treating HER2-positive tumors. This innovative approach marks a significant step forward in cancer treatment, utilizing the proprietary Click-to-Release linker platform developed by Tagworks.

Innovative Technology

TGW211 represents a new generation of radioimmunoconjugates that leverages advanced bioorthogonal in vivo click chemistry to achieve enhanced tumor uptake. Unlike traditional methods, TGW211 is designed to focus on effective tumor targeting while minimizing unnecessary radiation exposure to healthy tissues, which is a common issue with existing treatments.

Dr. Marc Robillard, the Chief Scientific Officer and co-founder of Tagworks, emphasized the importance of this development, stating, "Approval of the CTA and the commencement of our second clinical study this year is a crucial milestone for Tagworks, confirming the potential of our Click-to-Release platform." He pointed out that traditional radio-marked monoclonal antibodies often lead to high radiation doses in the kidneys, which limit their clinical applications. In contrast, TGW211 aims to improve therapeutic windows by targeting the tumor while enabling rapid clearance of the radionuclide from the body, enhancing treatment efficacy.

Clinical Study Details

The CleavHER study, sponsored by Radboud University Medical Center in the Netherlands, aims to recruit up to 18 patients who have HER2-positive solid tumors. The primary objectives will evaluate the safety and tolerability of Indium-111 (111In)-labeled TGW211. Secondary endpoints include analyzing pharmacokinetics and dosimetry in both tumor and healthy tissue.

"The Click-to-Release platform has the potential to redefine the therapeutic window of antibodies as vectors for radioactivity," explained Prof. Dr. James Nagarajah, the study's principal investigator at Radboudumc. "This marks a paradigm shift in cancer treatment by enabling selective elimination of circulating radioactivity after targeting the tumor, improving the tumor-to-blood dose ratio while simultaneously reducing damage to healthy tissue."

Preclinical data presented at the recent Congress of the European Association of Nuclear Medicine indicated that 111In-TGW211 has shown promising results in in vitro function tests and in vivo animal models. These findings suggest that TGW211 could significantly reduce adverse radiation exposure for patients undergoing targeted therapies and improve imaging by decreasing background noise.

The initial patient enrollment is projected by the end of 2025, with preliminary safety and dosimetry data expected in 2026, which could lead to the transition into a therapeutic Phase-1 study utilizing Actinium-225 or Lutetium-177 labeled TGW211.

About TGW211

TGW211 targets the human epidermal growth factor receptor 2 (HER2), a well-validated molecular target for various solid tumors. This antibody-radioimmunoconjugate (trastuzumab) is bound via Tagworks’ proprietary Click-to-Release linker platform. Once administered intravenously, TGW211 binds to HER2 and enters the tumor, followed by the administration of a non-cell permeable small-molecule trigger that selectively cleaves the linker from circulating TGW211, allowing for rapid excretion of the radionuclide through the kidneys.

Company Background

Tagworks Pharmaceuticals is based in the Netherlands and operates in the US, focusing on developing new standards of care for patients with solid tumors through innovative treatments. Apart from TGW211, Tagworks is also advancing other promising programs, such as TGW101, which targets TAG-72, a non-internalizing marker found on many solid tumors. For more details, visit www.tagworkspharma.com.