Tagworks Pharmaceuticals BV (“Tagworks”), a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors, today 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. The Company also announced the appointment of Keith Orford, MD, PhD, as Chief Medical Officer (CMO).
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. The primary objectives of the study are to evaluate the safety and tolerability of TGW101 and identify the maximum tolerated dose, recommended dose, and regiment for cohort expansion. The study is currently recruiting in the U.S. and plans to enroll up to 50 patients.
“TAG-72 is a validated target with overexpression in many high unmet need solid tumors. However, due to its non-internalizing nature, this target has remained unreachable by current ADCs and other therapies which require uptake by tumor cells to activate their anti-tumor activity. TGW101’s highly differentiated profile enables controlled MMAE payload release and activation in the tumor microenvironment without internalization 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 favorable safety profile as well as effective and durable responses in preclinical solid tumor 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.”
Anthony Tolcher, MD, FRCPC, CEO, Founder, and Director of Clinical Research of NEXT Oncology San Antonio and the TGW101 Phase 1 Primary Investigator commented, “TGW101 represents an attractive new potential treatment option in advanced solid tumors with high unmet need, overcoming certain challenges and limitations of other ADC therapies. TGW101 has the potential to offer an improved anti-tumor effect and safety profile which may lead to better clinical outcomes. I am excited to collaborate with Tagworks’ team to evaluate TGW101 in patients with advanced solid tumors in the Phase 1 clinical trial.”
About TGW101
TGW101 is an antibody-drug conjugate (ADC) targeting TAG-72, a non-internalizing marker found on the surface of many solid tumor cells. TGW101 consists of a TAG-72-binding diabody conjugated with monomethyl auristatin E (MMAE) toxin. TGW101 is administered intravenous (IV) first and allowed to bind to TAG-72 in the tumor. Then a small molecule trigger is administered IV, resulting in selective chemical cleavage of the linker of the tumor-bound TGW101, release of the MMAE in the extracellular tumor microenvironment and diffusion into surrounding tumor cells. TGW101 is being studied in an open-label, multicenter, Phase 1 dose-escalation clinical trial designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors.
About Tagworks Pharmaceuticals
Tagworks Pharmaceuticals is a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors by targeting clinically validated tumor markers that so far have remained out of reach of current therapies. Its lead program, TGW101, is an antibody-drug conjugate (ADC) targeting TAG- 72, a non-internalizing marker found on the surface of many solid tumor cells. Tagworks is developing a pipeline of novel cancer treatments leveraging its Click-to-Release technology in a range of therapeutics modalities, including ADCs and targeted radiopharmaceutical therapies. The Company is headquartered in the Netherlands with operations in the U.S. For more information, visit us at www.tagworkspharma.com
About Gilde Healthcare
Gilde Healthcare is a transatlantic specialist investment firm managing over €2.6 billion across two fund strategies: Venture&Growth and Private Equity. The Venture&Growth fund of Gilde Healthcare invests in fast growing companies active in digital health, medtech and therapeutics, based in Europe and North America. The Private Equity fund of Gilde Healthcare participates in profitable lower mid-market healthcare companies based in North-Western Europe. For more information, visit the company’s website at www.gildehealthcare.com.
