Incendia Therapeutics, Inc.

Innovative Assay Aims to Enhance Patient Outcomes through Precision Medicine PALO ALTO, Calif. and CAMBRIDGE, Mass., Oct. 28, 2024 /PRNewswire/ -- DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, today announced that Incendia Therapeutics will use the DELFI-TF Monitoring assay as part of their suite of assays for evaluation of treatment response and disease progression in patients enrolled in their Phase I clinical trial (NCT05753722). Continue Reading Incendia Therapeutics is discovering and developing a novel class of experimental therapeutics that reprogram the tumor microenvironment (TME). "Incendia is committed to the development of novel, precision medicines for patients in need. Innovative products, such as those being developed by DELFI, will aid in the efficient progress of those medicines through the clinic," said Susan Macdonald, PhD, SVP Nonclinical Development & Strategy at Incendia Therapeutics, commenting on how the relationship leverages the strengths of both companies to bring a state-of-the-art detection tool to scientific researchers looking to develop precise treatment monitoring. "The DELFI-TF assay provides a unique, cost-effective approach to monitoring cfDNA from patients in clinical research studies, providing evidence of the efficacy of a New Molecular Entity (NME) in the earliest phases of clinical development," said DELFI Diagnostics Co-Founder and Chief Scientific Officer, Nicholas Dracopoli. "The DELFI-TF assay will provide Incendia with valuable insights to help them manage their Phase 1 program." One key advantage of the DELFI TF assay is that it requires under 1 mL of plasma — considerably less than the volume needed for other cfDNA assays. This low volume is particularly beneficial in early clinical studies that require large volumes of blood for other assessments, such as pharmacokinetic (PK) analyses. About DELFI Diagnostics DELFI Diagnostics is developing next-generation, blood-based tests that are accurate, accessible, and deliver a new way to help detect cancer. DELFI tests are built to solve the highest-burden population health issues, including in historically underserved demographics, and have the potential to save lives on a global scale. FirstLook Lung, for individuals eligible for lung cancer screening, is our first laboratory-developed screening test and requires a simple blood draw that can be incorporated with routine blood work. The test is based on fragmentomics, the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments in the blood. The DELFI platform applies advanced machine-learning technology to whole-genome sequencing data to assess individuals' cfDNA fragments against populations with and without cancer. FirstLook Lung uses these millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early-stage disease, with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. To learn more about the FirstLook Lung test, visit or . About Incendia Therapeutics Incendia Therapeutics is discovering and developing a novel class of experimental therapeutics that reprogram the tumor microenvironment (TME). Incendia's platform is based on rigorous, groundbreaking research involving spatial characterization of the tumor microenvironment, multi-omics data integration, and extensive preclinical testing. The Company's most advanced experimental molecule, PRTH-101, is in a Phase 1 clinical trial for the treatment of patients with advanced solid tumors. For more information visit incendiatx.com and LinkedIn. SOURCE DELFI Diagnostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1c study of PRTH-101 alone or in combination with KEYTRUDA® in patients with advanced or metastatic solid tumors will inform optimal design of the Phase 2/3 study PRTH-101 demonstrated favorable safety profile in Phase 1a and 1b studies CAMBRIDGE, MA, USA I September 10, 2024 I Incendia Therapeutics , a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), today announced that the first patient has been enrolled in the Phase 1c study of PRTH-101 for the treatment of patients with advanced or metastatic solid tumors. “In our Phase 1a and 1b studies, we were able to select an optimal dose and identify potential biomarkers to carry forward” said Irena Webster, SVP Development and Operations of Incendia. “The data from this study will inform the design of the Phase 2/3 program, for which planning and global feasibility are currently underway.” Dr. Joseph Paul Eder, CMO, added “Incendia, with its outstanding team of investigators and investigative sites, has determined a recommended Phase 2 dose of PRTH 101. PRTH 101 has shown consistent safety as a single agent and in combination with pembrolizumab. We will now focus on tumor types that have demonstrated signs of clinical activity and patient benefits.” The Phase 1c study will evaluate the safety, tolerability and anti-tumor activity of PRTH-101 as both a monotherapy and in combination with KEYTRUDA® (pembrolizumab). About PRTH-101 PRTH-101 is a therapeutic antibody that targets DDR1, a collagen binding protein and kinase present on epithelial cells. Some tumor cells are believed to co-opt DDR1 – collagen binding to build an impenetrable barrier around the tumor. By allosterically disabling DDR1, PRTH-101 disrupts tumor associated collagen alignment to permit immune cell access into the tumor core. In preclinical experiments, PRTH-101 mediated DDR1 blockade has demonstrated both single agent anti-tumor activity as well as marked augmentation of checkpoint inhibitor function. Tumor types that express high levels of DDR1-associated collagen barriers include thymic, colorectal, pancreatic, ovarian, glioma, and non-small cell lung cancer. Currently, there are no approved drugs that target DDR1. About the Phase 1 Trial The Phase 1 trial ( NCT05753722 ) is a multi-center, open-label, dose escalation and dose expansion study that is expected to enroll up to 270 patients in the US with advanced or metastatic solid tumors. The goals of the study are to assess safety and tolerability of PRTH-101, evaluate anti-tumor activity in select indications alone and in combination with anti-PD-1 inhibitors, and determine dosing regimens for the Phase 2 clinical program. In addition to examining the clinical profile of PRTH-101, the trial will evaluate DDR1 and pathway-related proteins as predictive biomarkers for patients whose tumors respond to treatment. About Incendia Therapeutics Incendia Therapeutics is discovering and developing a novel class of experimental therapeutics that reprogram the tumor microenvironment (TME). Incendia’s platform is based on rigorous, groundbreaking research involving spatial characterization of the tumor microenvironment, multi-omics data integration, and extensive preclinical testing. The Company’s most advanced experimental molecule, PRTH-101, is in a Phase 1c clinical trial for the treatment of patients with advanced solid tumors. For more information visit incendia.com and LinkedIn . SOURCE: Incendia Therapeutics

SAN DIEGO and RESEARCH TRIANGLE PARK, N.C., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Creyon Bio, Inc. ("Creyon"), a clinical-stage leader in AI/machine learning-enabled engineering of oligonucleotide-based medicines (OBMs), has appointed two prominent venture capitalists, Serge Messerlian, Operating Partner at DCVC Bio, and Shaquille Vayda, Principal at Lux Capital to serve on its Board of Directors. “We are excited to welcome Serge and Shaq officially to our Board of Directors, and their extensive experience in life sciences and technology aligns with Creyon’s mission to reimagine drug development through AI-enabled engineering of oligonucleotide-based medicines,” said Chris Hart, Ph.D., Co-Founder, Chief Executive Officer, and President of Creyon Bio. “Their insight and strategic guidance has been immensely valuable to date as observers and will be instrumental as Creyon advances best-in-class clinical assets created with its pioneering platform of oligonucleotide-based medicines.” Mr. Messerlian brings extensive leadership experience in the life science industry, across various therapeutic areas including hematology, oncology, immunology, and rare diseases. He is Operating Partner at DCVC Bio and currently serves on the boards of Auron Therapeutics and Plexium. He previously served as CEO of Teon Therapeutics, an immuno-oncology biotech, and President of Janssen Oncology, a Johnson & Johnson company. Mr. Messerlian has also held executive leadership positions at Johnson & Johnson's Actelion, Baxalta, and Baxter International. He holds a B.S. in Physiology & Biotechnology and an M.S. in Molecular Genetics from McGill University, as well as an MBA from the Rotman School of Management at the University of Toronto. “The potential applications of Creyon’s foundational technology are vast,” said Mr. Messerlian. “I look forward to working with the Creyon team as they transform the industry standard paradigm from drug discovery to drug engineering.” Mr. Vayda brings diverse experience spanning technology, aerospace, and life sciences, with a focus on discovery and delivery platforms; molecular, phenotypic and computational tools; synthetic biology; and data infrastructure. He is currently Principal at Lux Capital and serves on the boards of several companies including Anagenex, Atavistik, Enveda Biosciences, Gandeeva Therapeutics, LabGenius, Nomic Bio, and Rivet. Prior to joining Lux Capital, Mr. Vayda worked at Parthenon in San Francisco, where he advised private equity and growth equity firms on enterprise technology and healthcare investments. His experience in the life sciences industry includes a position at Illumina, seeing firsthand the impact DNA sequencing has had on ending human suffering. Mr. Vayda's career also spans the aerospace and defense sector with prior roles at NASA and Northrop Grumman. He holds a B.S. in mechanical engineering from the University of Florida. “Creyon is at the forefront of creating the future of medicine by developing the fundamental building blocks that will revolutionize how oligonucleotides are engineered for both safety and targeted delivery to the right cells and tissues,” said Mr. Vayda. “This aligns well with my passion for investing at the intersection of technology and natural sciences. I look forward to being part of Creyon’s growth journey.” About Creyon Bio, Inc.Creyon Bio is a clinical stage biotechnology company developing best-in-class precision medicines with industry-leading efficiency through molecular engineering of Oligonucleotide-Based Medicines (OBMs). These include antisense oligonucleotides, siRNAs, and aptamers. The company is changing how novel OBMs are created, transforming the process from drug discovery to drug engineering. Creyon has built the first and only platform capable of engineering for safety first, translating new target discoveries to OBMs with optimal pharmacological properties. Coupled with our aptamer-based delivery technologies, Creyon is unlocking the full potential of OBMs for common and rare diseases alike. Our platform has already demonstrated promising results in a n-of-1 clinical trial, rapidly progressing from concept to patient treatment in just 13 months. To learn more, visit creyonbio.com. Media Contact Jon YuCreyonPR@westwicke.com