#Netherlands #ADC technology #Nijmegen #Tagworks #TGW101

Tagworks Pharmaceuticals Advances TGW101 Clinical Trials

Tagworks Pharmaceuticals, a leading clinical-stage precision oncology company, has announced the commencement of the third dosing level in their Phase 1 clinical trial for TGW101. This innovative treatment targets solid tumors and is designed as an Antibody-Drug Conjugate (ADC) with cutting-edge capabilities.

TGW101 specifically targets TAG-72, a glycoprotein associated with various solid tumors, employing a unique payload of Monomethyl Auristatin E (MMAE). Utilizing Tagworks' proprietary Click-to-Release chemistry, TGW101 represents the first bioorthogonal ADC that activates in vivo, offering significant potential for improved therapeutic efficacy.

According to Ken Mills, CEO of Tagworks, "We are pleased to announce the ongoing progress in our Phase 1 trial, a testament to our operational excellence and commitment to advancing our innovative Click-to-Release technology. The decision by the Safety Oversight Committee to proceed with the third dose underscores TGW101’s favorable safety profile observed to date."

The trial aims to uncover TGW101’s potential to meet significant unmet needs in the treatment of advanced solid tumors, particularly by addressing limitations faced by existing ADC therapies. Tagworks anticipates sharing preliminary data regarding safety, pharmacokinetics, and potential early signs of clinical activity in early to mid-2026.

Overview of the Phase 1 Trial

The current Phase 1 trial is an open-label, multicenter, dose-escalating study aimed at evaluating the safety, tolerability, pharmacokinetics, and early antitumor activity of TGW101 in patients with relapsed or refractory solid tumors. The primary objectives include determining the maximum tolerated dose (MTD), the recommended dose for Phase 2 (RP2D), and the dosing regimen for cohort expansion.

Three dosing levels have been initiated thus far, following favorable safety evaluations by the Safety Oversight Committee. The trial plans to test up to seven dosing levels, with the possibility of increasing the maximum dose based on ongoing clinical safety and pharmacokinetic data. The objective is to enroll up to 50 patients across various centers in the United States, with potential expansion to other regions.

Patients participating in this trial are provided with TGW101 intravenously to bind to TAG-72 on the tumor tissue. This is followed by the intravenous administration of a small triggering molecule, which selectively cleaves the linked payload and releases MMAE in the tumor microenvironment, allowing it to diffuse toward surrounding tumor cells.

Tagworks believes that TGW101 may play a crucial role in setting new standards of care for solid tumor patients, especially by targeting previously unattainable clinical markers. The development of this treatment could represent a significant step forward in the quest to enhance cancer therapy precision and effectiveness.

About TGW101

TGW101 is a novel ADC that targets TAG-72, an external non-internalizing marker found on the surface of many solid tumor cells. Its dual-action approach, combining the specificity of antibodies with the potent cytotoxicity of MMAE, positions it as a promising candidate in oncology. The drug's mechanism relies heavily on the innovative Click-to-Release technology, which enhances the precision of drug delivery directly to tumor cells, potentially improving patient outcomes.

About Tagworks Pharmaceuticals

Tagworks Pharmaceuticals is dedicated to evolving cancer treatment through its proprietary Click-to-Release platform, laying the groundwork for new standards in the management of solid tumors. The company's primary focus is on clinically validated tumor markers, seeking to create innovative therapies that surpass the capabilities of existing options. With headquarters in the Netherlands and operational activities in the United States, Tagworks is poised to advance a portfolio of therapeutic solutions leveraging its unique technology across various treatment modalities, including ADCs and targeted radiotherapies.

For further information, visit www.tagworkspharma.com.