Austin, Texas – August 27, 2026
Natera and Angiex have entered a new collaboration to assess treatment response to AGX101, an investigational Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC), using Natera’s Signatera circulating tumor DNA (ctDNA) test. The collaboration will evaluate whether longitudinal molecular monitoring can provide additional information on response during treatment with AGX101 in patients with advanced solid tumors. Angiex is currently conducting a Phase 1 clinical trial of AGX101 in patients with unresectable, locally advanced or metastatic solid tumors. Under the collaboration, patients receiving the investigational ADC will undergo longitudinal Signatera testing to explore changes in ctDNA levels during treatment. The partnership connects an emerging ADC therapeutic approach with a personalized molecular monitoring technology, creating an opportunity to examine treatment response beyond conventional imaging. For cGxP.wire, the development is particularly relevant to the growing intersection of ADC therapy, precision oncology and molecular response monitoring, as pharmaceutical developers increasingly evaluate biomarkers that may provide earlier insight into treatment activity.
Signatera to Monitor Molecular Treatment Response
The collaboration will use Signatera to track patient-specific ctDNA during AGX101 treatment. Signatera is designed to provide a personalized molecular measure of residual or circulating tumor DNA and may complement conventional radiologic assessments. In the AGX101 study, longitudinal testing is intended to investigate whether changes in ctDNA can help characterize treatment response over time. This approach may be particularly relevant when imaging results are difficult to interpret because structural or metabolic changes do not always clearly indicate whether viable tumor remains. By adding molecular measurements to the clinical assessment, investigators will be able to explore whether ctDNA dynamics provide additional information about the biological response to the investigational therapy. The collaboration is exploratory and is intended to generate data that could help inform the development of AGX101 and future clinical studies. It does not establish that Signatera can improve outcomes or that ctDNA monitoring will ultimately serve as a validated response endpoint for AGX101.
AGX101 Uses TM4SF1-Directed ND-ADC Approach
AGX101 is Angiex’s investigational TM4SF1-directed ND-ADC being evaluated in a Phase 1 clinical trial. The candidate is designed to bind TM4SF1, a target expressed on tumor cells and tumor-associated endothelial cells, and deliver a cytotoxic payload to these cells. Angiex’s approach is intended to provide dual targeting of tumor cells and tumor vasculature, potentially addressing two components that contribute to solid tumor growth. The Phase 1 study is currently enrolling patients with unresectable, locally advanced or metastatic solid tumors and is evaluating AGX101 in the clinical setting for the first time. The program represents an emerging approach within the broader antibody-drug conjugate field, where researchers are developing increasingly specialized targeting strategies and payload technologies. Angiex is developing AGX101 as part of its portfolio of Nuclear-Delivered Antibody-Drug Conjugates, with the company aiming to use its platform to deliver cytotoxic agents to cancer cells and associated tumor biology. As an investigational therapy, the safety and efficacy of AGX101 have not yet been established.
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Collaboration Supports Precision Oncology Development
The Natera-Angiex collaboration adds a molecular monitoring component to the clinical development of AGX101 and reflects increasing interest in integrating ctDNA analysis into oncology drug development. For Angiex, longitudinal molecular data could provide an additional method for evaluating biological activity as the company advances its Phase 1 program. For Natera, the collaboration expands the application of Signatera in the development of an investigational ADC therapy and provides an opportunity to assess ctDNA dynamics alongside clinical and imaging assessments. The companies will use the collaboration to investigate whether molecular response measurements can complement existing approaches to evaluating patients receiving AGX101. The work remains at an early clinical stage, with the immediate objective focused on generating evidence rather than establishing a new treatment standard. If molecular response patterns correlate with clinical outcomes in future studies, such findings could potentially support more informed development decisions for AGX101 and other novel solid-tumor therapies. The collaboration therefore highlights a growing trend toward combining innovative therapeutic platforms with precision molecular monitoring throughout clinical development.
Source:Natera, press relese
