First patient dosed with ADC therapy designed to disrupt tumor blood supply

Biotechnology company Angiex has dosed the first patient in a phase 1 trial of AGX101, an ADC drug candidate designed to target multiple types of solid tumors with a dual mechanism of action that starves tumors and stops them from spreading. 

Antibody-drug conjugates​ (ADCs) consist of an antibody that is chemically linked to a chemotherapy payload. This construct allows the antibody to guide the chemotherapy drug to a specific target, with the goal of causing fewer side effects when compared to traditional chemotherapy, which is delivered systemically. 

“Antibody drug conjugates are an exciting drug modality that seek to improve the safety and efficacy of chemotherapies by targeting the therapies to tumors and keeping them away from normal tissue,” said Ildefonso Ismael Rodriguez Rivera, site principal investigator for the phase 1 study at NEXT Oncology. “AGX101 with its novel and differentiated mechanisms of action represents a first-in-class drug with potential to address high unmet medical needs.”

AGX101 targets TM4SF1, a protein involved in the process of angiogenesis, where tumors stimulate the growth of new blood vessels, as well as the process of metastasis, where cancerous cells migrate and invade other organs and tissues. By attacking the cancer cells involved in angiogenesis, AGX101 is designed to cut off the blood supply to the tumor, killing the cancer by starving it of oxygen and nutrients.

Data from preclinical studies has shown that the treatment resulted in increased survival and tumor shrinkage. The main goal of the phase 1 trial is to evaluate the safety and tolerability of AGX101, as well as obtain preliminary efficacy data in humans.

“Building upon 20 years of biological research and through 12 years of drug development, Angiex has tailored AGX101 design to TM4SF1 biology. Preclinical studies have supported AGX101’s ability to attack cancers by multiple mechanisms of action, and demonstrated a broad therapeutic margin in animals. We believe AGX101 has potential to help clinical cancer patients, especially in indications with high unmet need,” said Paul Jaminet, co-founder and CEO of Angiex.

Angiex partnered with Abzena, a CDMO specializing in complex biologics and bioconjugates, to provide support for key activities including the design and development, current good manufacturing practice (cGMP) and the supply of materials for the clinical trial.