TGW101 / Tagworks - LARVOL DELTA

Phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TGW101 in patients with advanced solid tumors. (ASCO 2026) - P1 | "The trial began in May 2025 and 7 sites, all within the United States, are open for enrollment. Clinical trial information: NCT06959706."

Clinical • First-in-human • Metastases • P1 data • PK/PD data • Colon Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TAG-72

Characterization of TAG-72, a glycan-based ADC target and its pan-tumor expression profile (AACR 2026) - P1 | "TGW101, a novel antibody-drug conjugate (ADC) targeting non-internalizing TAG-72, incorporates a CC49-derived diabody and a DAR4 MMAE payload linked via a trans-cyclooctene-based linker that enables controlled cleavage following administration of a tetrazine small-molecule trigger... TAG-72 is a tumor-associated glycoepitope consisting of STn and Tn glycans present on multiple mucin proteins. It is widely expressed in epithelial cancers, while almost entirely absent in normal tissues, making it an attractive therapeutic target. Current commercially available antibodies show excellent specificity using modern IHC techniques and could facilitate biomarker-driven clinical development for TAG-72-targeted therapies."

ADC • Pan tumor • Oncology • Solid Tumor • MUC1 • TAG-72

Preclinical development of TGW101, a first in class click-cleavable ADC with MMAE against non-internalizing pan-carcinoma marker TAG72 (AACR 2025) - "In conclusion, TGW101 demonstrated potent and specific in vitro and in vivo anti-tumor activity, while it was well tolerated in rats and NHPs at doses at or higher than current MMAE ADCs. This warrants clinical development of this promising click-cleavable ADC with the aim to expand the ADC target scope."

ADC • Preclinical • Oncology • Solid Tumor • TAG-72

Tagworks Pharmaceuticals Announces Initiation of Third Dose Level in Ongoing Phase 1 Clinical Trial of TGW101 for the Treatment of Solid Tumors (Canada Newswire) - "The ongoing Phase 1 trial is a multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TGW101 in patients with relapsed or refractory solid tumors....Tagworks expects to share preliminary safety and pharmacokinetic data, along with any early signals of efficacy, in early to mid-2026."

P1 data • Trial status • Solid Tumor

Tagworks Pharmaceuticals Announces FDA Clearance of IND Application and Initiation of Phase 1 Clinical Trial for TGW101… (Canada Newswire) - "Tagworks Pharmaceuticals BV...announced the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for a Phase 1 clinical trial evaluating TGW101, a first-in-class antibody drug-conjugate (ADC) targeting tumor associated glycoprotein 72 (TAG-72) with an monomethyl auristatin E (MMAE) payload, in patients with advanced solid tumors....Tagworks initiated first-in-human Phase 1 clinical development of TGW101 in a multicenter, open-label, dose-escalation trial in patients with advanced solid tumors."

IND • New P1 trial • Oncology • Solid Tumor

Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Tagworks Pharmaceuticals BV

New P1 trial • Solid Tumor

Tagworks Pharmaceuticals Announces $65 Million in Series A Financing to Advance Click-to-Release Therapeutics (PRNewswire-Asia) - "Tagworks Pharmaceuticals BV...announced a $65 million Series A financing led by Ysios Capital and Gilde Healthcare with participation from Novartis Venture Fund, New Enterprise Associates (NEA), and Lightstone Ventures....The financing will support the advancement of TGW101, Tagworks' lead click-cleavable ADC program, and the company's proprietary Click-to-Release platform....The company's lead program, TGW101, is a click-cleavable ADC targeting tumor-associated glycoprotein 72 (TAG72), a clinically validated non-internalizing target widely expressed in solid tumors."

Financing • Oncology • Solid Tumor