Abzena and Angiex Partners as AGX101 Enters Phase 1 Clinical Trials

• Angiex has initiated patient dosing in its Phase 1 trial for AGX101, a TM4SF1-directed Antibody-Drug Conjugate (ADC).

• Abzena supported the development and manufacturing of AGX101 for the clinical trial through its comprehensive CDMO services.

Angiex, a biopharmaceutical company focused on developing innovative therapies for solid cancers, has begun patient dosing for its Phase 1 clinical trial of AGX101, a TM4SF1-directed Antibody-Drug Conjugate (ADC). The trial, which marks the first-in-human study for AGX101, is supported by Abzena, a integrated CDMO specializing in complex biologics and bioconjugates.

The Phase 1 study is designed as an open-label, dose-escalation, and expansion trial to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of AGX101 monotherapy. The dose escalation portion of the study will explore doses up to 10 mg/kg across a solid tumor patient population, with the dose expansion phase focusing on multiple indications at the Recommended Phase 2 Dose.

AGX101 is unique in its dual-target approach, aiming to eliminate tumor blood vessels, destroy invasive and metastatic tumor cells, and activate the immune system against the cancer. Abzena has been instrumental in advancing AGX101 to this stage, providing a fully integrated program that included linker-payload design and synthesis, bioconjugation, process development, and cGMP manufacturing.

Paul Jaminet, co-founder and CEO of Angiex, expressed appreciation for Abzena’s role, stating, “Throughout the development of AGX101, Abzena has worked closely with us to achieve successful GMP manufacturing and quality control. We could not have reached this milestone without Abzena’s expertise, cooperation, and support.”

Matt Stober, CEO of Abzena, added, “Our unique ability to support Angiex with a fully integrated approach allowed us to de-risk and rapidly progress AGX101 into the clinic for patient dosing. We will continue supporting Angiex to accelerate the development timeline of AGX101.”