Angiex, a company focused on creating Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) treatments for solid tumors, has commenced patient dosing in their Phase 1 clinical trial of AGX101, an innovative TM4SF1-targeted Antibody-Drug Conjugate (ADC). To facilitate this trial, Angiex collaborated with Abzena, a premier end-to-end integrated CDMO specializing in complex biologics and bioconjugates, for the development, production, and supply of clinical trial materials.
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AGX101 is an ADC targeting TM4SF1, aimed at two tumor compartments: cancer cells and the tumor vasculature. It employs three action mechanisms: destroying tumor blood vessels, killing invasive and metastatic cancer cells, and engaging the immune system to attack the tumor. Abzena has facilitated the development of AGX101 through a comprehensive program that includes linker-payload design, bioconjugation, process development, and cGMP manufacturing for Angiex's Phase 1 clinical trial.
Paul Jaminet, Angiex's co-founder and CEO, expressed: “We are thrilled to have administered AGX101 to our first patient in this pioneering human trial of our TM4SF1 ADC. Abzena’s collaboration has been crucial in achieving successful cGMP manufacturing and quality assurance. We couldn't have reached this point without their expertise and cooperation. Both Angiex and Abzena possess deep expertise in their fields and share a mission-aligned partnership. We look forward to continuing our collaboration to ensure AGX101 meets clinical cancer patients' needs. We are pleased that Abzena shares our vision of ending cancer fatalities."
Matt Stober, Abzena's CEO, commented: “The Abzena team is extremely proud to have supported Angiex in reaching this critical milestone. Our distinctive ability to provide a fully integrated approach has enabled the rapid and safe advancement of AGX101 to clinical trials. We will persist in supporting Angiex with our extensive ADC expertise and comprehensive capabilities to accelerate AGX101’s development and deliver this transformative treatment to cancer patients swiftly.”
The Phase 1 trial of AGX101 is an open-label, dose-escalation and expansion study designed to evaluate AGX101 monotherapy's safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor efficacy. The dose escalation phase assesses doses up to 10 mg/kg in a diverse solid tumor patient group, while the dose expansion phase evaluates the Recommended Phase 2 Dose across multiple indications.
Abzena stands as a leading end-to-end bioconjugate and complex biologics CDMO and CRO. From discovery to commercial launch, we provide clients with fully integrated programs or bespoke services to mitigate risks and streamline the development of new therapies. Abzena tailors its strategies and customer experiences to each project, devising and executing innovative solutions that empower biotech and biopharma companies to maximize their molecules' potential and expedite medical advancements. With facilities for research, development, and cGMP manufacturing in San Diego, CA, Bristol, PA, and Cambridge, UK, Abzena is owned by Welsh, Carson, Anderson & Stowe, a premier private equity investor.
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According to the data provided by the Synapse Database, As of August 13, 2024, there are 1 investigational drug for the TM4SF1/Tubulin target, including 6 indications, 1 R&D institution involved, with related clinical trials reaching 1, and as many as 144 patents.
The Anti-TM4SF1 ADC (Angiex) is a type of drug known as an antibody-drug conjugate (ADC). This drug targets TM4SF1 and Tubulin and is used in the treatment of various therapeutic areas including neoplasms, digestive system disorders, endocrinology and metabolic disease, as well as skin and musculoskeletal diseases. The drug is primarily indicated for the treatment of advanced cancer, advanced malignant solid neoplasm, locally advanced urothelial carcinoma, metastatic solid tumor, pancreatic adenocarcinoma, and triple negative breast cancer.