#Netherlands #Nijmegen #TGW101 #Tagworks Pharmaceuticals #Solid Tumors

Tagworks Pharmaceuticals Advances TGW101 Study to Third Dose Level

Tagworks Pharmaceuticals BV, a clinical-stage precision oncology company utilizing its proprietary Click-to-Release treatment platform, recently announced that the third dosage level in the ongoing Phase 1 study of TGW101 has commenced. TGW101 is a first-in-class antibody-drug conjugate (ADC) specifically targeting tumor-associated glycoprotein 72 (TAG-72) and is loaded with Monomethyl Auristatin E (MMAE). The company aims to establish a new standard of care for patients suffering from solid tumors.

The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of TGW101 among patients with advanced solid tumors. The initial phases have displayed a promising safety profile, which was underscored by the recent decision from the Safety Oversight Committee (SOC) to progress to this third dosing level. Ken Mills, CEO of Tagworks, expressed optimism about TGW101's potential to meet the significant unmet medical needs in this treatment area while addressing limitations associated with existing ADC therapies.

TGW101 has been developed using Tagworks' innovative Click-to-Release linker chemistry, making it the first bioorthogonal ADC that is activated in vivo through click chemistry. This technology allows for excellent control over the tumor payload activity, thereby maximizing therapeutic efficacy while minimizing off-target effects.

The ongoing Phase 1 study is a multicenter, open-label, dose-escalation trial, which will assess TGW101's application for patients who have recurrent or refractory solid tumors. The primary objectives include determining the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and the appropriate dosing schedule for cohort expansion. Thus far, three dosing levels have been introduced, and it's anticipated that the total could rise to seven, adjusted based on evolving clinical safety and pharmacokinetic data.

The company is recruiting up to 50 patients across different sites in the United States, with possibilities for expansion into other regions. With an eye toward future insights, Tagworks plans to release preliminary data regarding safety, pharmacokinetics, and initial clinical efficacy indicators by early to mid-2026.

What is TGW101?

TGW101 is designed as an ADC targeting TAG-72, a non-internalizing marker prevalent on the surface of many solid tumor cells. The ADC comprises a TAG-72 binding diabody conjugated with the cytotoxic agent Monomethyl Auristatin E (MMAE). TGW101 will initially be administered intravenously and is expected to bind to TAG-72 on tumor cells. Following administration, a small molecule given intravenously will trigger selective chemical cleavage of the linker on tumor-bound TGW101, releasing MMAE into the extracellular tumor microenvironment, allowing it to diffuse into surrounding cancer cells.

About Tagworks Pharmaceuticals

Founded with a mission to develop innovative cancer therapies, Tagworks Pharmaceuticals is a clinical-stage company focused on precision oncology. Their proprietary Click-to-Release treatment platform aims to set a new benchmark of care for solid tumor patients by targeting clinically validated tumor markers that were previously unreachable with existing therapies. The leading program, TGW101, aims to transform cancer treatment paradigms, combining ADCs with targeted radiopharmaceutical therapies. Tagworks operates from its headquarters in the Netherlands and has offices in the United States. For more information, visit Tagworks Pharmaceuticals.