DELFI Diagnostics Partners with Incendia Therapeutics for Phase 1 Clinical Trial Monitoring Test

Innovative Assay Aims to Enhance Patient Outcomes through Precision Medicine

Palo Alto, Calif. and Cambridge, Mass., Oct. 28, 2024 — DELFI Diagnostics, Inc., known for developing accessible blood-based tests that enhance cancer detection, has partnered with Incendia Therapeutics. Incendia will employ the DELFI-TF Monitoring assay as a part of their suite of tests to evaluate treatment response and disease progression in patients participating in their Phase I clinical trial (NCT05753722).

Incendia Therapeutics focuses on discovering and developing a new class of experimental therapeutics that reprogram the tumor microenvironment (TME). Susan Macdonald, PhD, SVP of Nonclinical Development & Strategy at Incendia Therapeutics, stated, "Incendia is dedicated to creating innovative precision medicines for patients in need. Products like those from DELFI will support the efficient advancement of these medicines through clinical phases."

Nicholas Dracopoli, Co-Founder and Chief Scientific Officer of DELFI Diagnostics, added, "The DELFI-TF assay offers a unique and cost-effective method for monitoring cfDNA in clinical research. This method provides early evidence of a New Molecular Entity's (NME) efficacy in initial clinical development stages. It will offer Incendia valuable insights to assist in managing their Phase 1 program."

A significant advantage of the DELFI-TF assay is its requirement of less than 1 mL of plasma, which is significantly lower than the volume needed for other cfDNA assays. This feature is particularly advantageous in early clinical studies that demand large blood volumes for other assessments, like pharmacokinetic (PK) analyses.

About DELFI Diagnostics

DELFI Diagnostics is at the forefront of developing next-generation, blood-based tests that are designed to be accurate, accessible, and transformative in cancer detection. Their tests are aimed at addressing significant population health issues, particularly in historically underserved demographics, with the potential to save lives globally. The FirstLook Lung test is their initial laboratory-developed screening test, designed for individuals eligible for lung cancer screening. It requires a simple blood draw and can be integrated with routine blood work. The test is based on the principle of fragmentomics, which notes that cancer cells exhibit more chaotic patterns than normal cells. When cancer cells die, they leave behind unique patterns of cell-free DNA (cfDNA) fragments in the blood. The DELFI platform uses advanced machine-learning techniques to analyze whole-genome sequencing data, comparing cfDNA fragments from individuals against those from populations with and without cancer. The FirstLook Lung test utilizes millions of data points to identify those who may have cancer detected through low-dose CT, including early-stage diseases, with a negative predictive value of 99.8 percent. It is important to note that this test has not been cleared or approved by the FDA.

About Incendia Therapeutics

Incendia Therapeutics is committed to discovering and developing a new class of experimental therapeutics focused on reprogramming the tumor microenvironment (TME). Their platform is built on cutting-edge research that involves spatial characterization of the TME, integration of multi-omics data, and extensive preclinical testing. The company's leading experimental molecule, PRTH-101, is currently undergoing a Phase 1 clinical trial for treating patients with advanced solid tumors.