Abzena Supplies Material for Angiex's AGX101 Phase I Study

SAN DIEGO, CA, USA I August 8, 2024 I Angiex, a developer specializing in Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies aimed at treating solid cancers, has officially started patient dosing in its Phase 1 clinical trial for AGX101. This innovative therapy is a first-in-class TM4SF1-directed Antibody-Drug Conjugate (ADC). Angiex collaborates with Abzena, a leading integrated contract development and manufacturing organization (CDMO) for complex biologics and bioconjugates, to facilitate the development, production, and supply of clinical trial material required for this study.

AGX101, the centerpiece of this trial, is designed to target two critical components of tumors: the cancer cells and the tumor vasculature. Its mechanisms include the elimination of tumor blood vessels, the destruction of tumor cells that have the potential to invade and metastasize, and the activation of the immune system to target the cancer. Abzena has been instrumental in the development of AGX101, providing services that encompass linker-payload design and synthesis, bioconjugation, process development, and cGMP manufacturing.

Paul Jaminet, co-founder and CEO of Angiex, expressed enthusiasm regarding this milestone, stating, “We are thrilled to have administered our first dose in the initial human trial of our innovative TM4SF1 ADC, AGX101. The close collaboration with Abzena has been crucial in achieving successful GMP manufacturing and quality control. Their expertise and support have been invaluable in reaching this point. Both Angiex and Abzena bring extensive expertise and a shared mission to the table, and we look forward to continuing this partnership to ensure AGX101 meets the clinical needs of cancer patients. We are proud to share a vision where no one succumbs to cancer."

Echoing Jaminet's sentiments, Matt Stober, CEO of Abzena, remarked, “The Abzena team is immensely proud to have supported Angiex in reaching this significant milestone. Our fully integrated approach has enabled us to de-risk and expedite AGX101's progression into clinical stages for patient dosing. We remain committed to leveraging our extensive ADC expertise and integrated capabilities to accelerate AGX101’s development timeline, ultimately bringing this transformative treatment to cancer patients more swiftly.”

The Phase 1 clinical trial of AGX101 is structured as an open-label, dose-escalation, and expansion study. Its main objectives are to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and initial anti-tumor efficacy of AGX101 as a standalone therapy. The dose escalation phase will assess doses up to 10 mg/kg in a diverse population of patients with solid tumors. Following this, the dose expansion phase will aim to determine the Recommended Phase 2 Dose across multiple indications.

Abzena stands out as a leader in the bioconjugate and complex biologics sector, providing end-to-end solutions from discovery through to commercial launch. They offer fully integrated programs or individual services tailored to mitigate risks and streamline the development of new treatments. With research, development, and cGMP facilities in San Diego, CA, Bristol, PA, and Cambridge, UK, Abzena is positioned to provide comprehensive support to biotech and biopharma companies.

Angiex, Inc., a biotech startup based in Cambridge, Massachusetts, focuses on leveraging newly identified biological transport mechanisms to develop drugs with significant efficacy against cancer. Founded by leading experts in angiogenesis, vascular biology, and oncology, Angiex is pioneering a range of Nuclear-Delivered Antibody-Drug Conjugates™ (ND-ADCs). These novel drugs are designed to deliver therapeutic payloads directly to the nucleus or cytosol, enhancing the effectiveness and therapeutic margin of conventional ADCs. AGX101, their flagship product, has progressed from pre-clinical development to Phase 1 clinical trials, marking a significant advancement in cancer therapy.