89Zr-DFO-MSTP2109A

BURNABY, British Columbia--(BUSINESS WIRE)-- ARTMS Inc. (ARTMS) is pleased to announce the submission of a Drug Master File (DMF) to the FDA for the high-volume production of Gallium-68 (68Ga) with ARTMS’ solid target technology in combination with a medical cyclotron. ARTMS’ proprietary QUANTM Irradiation system (QISTM) demonstrated world record production of over 10 Ci 68Ga in 2019 on a low energy cyclotron. These low energy cyclotrons are installed in hundreds of sites globally where the QIS can be installed for daily use. “This submission to the FDA demonstrates how the team at ARTMS is executing our strategy. The molecular imaging community has and will continue to develop a number of innovative agents that are labeled with 68Ga. Unfortunately, the current supply chain of germanium/gallium generators is not robust enough to meet projected demand for these products. The action taken today by ARTMS marks a significant step toward solving the forthcoming supply issues for this critical isotope. ARTMS has spent the last 18 months solidifying partnerships with drug developers and building a network of cyclotron operators with the intention of changing the way isotopes are delivered to patients in greatest need of these imaging studies. The ARTMS platform goes far beyond 68Ga production, expanding our client’s reach to other high demand diagnostic and therapeutic isotopes. I am extremely excited about the opportunity that is in front of ARTMS and our partners,” says Charles S. Conroy, Chief Executive Officer of ARTMS. The use of 68Ga labelled products is among the most important innovations in the history of nuclear medicine. Currently, 68Ga radiopharmaceuticals are used to identify and stage a variety of oncology conditions, including neuroendocrine tumors and prostate cancer. This isotope has been traditionally supplied by generators which have limited output capabilities and are logistically and economically burdensome. While generators will continue to be a part of the 68Ga supply chain, ARTMS’ technology will alleviate widespread shortages as demand increases for 68Ga labelled diagnostic agents. “It is our strategy to work alongside the radiopharmaceutical innovator community to allow the ARTMS solution and associated regulatory filings to be included in the innovator’s investigational new drug and new drug applications,” said Dr. Michael Cross, Chief Operating Officer and project lead at ARTMS. “Moving forward, ARTMS will continue to expand collaboration efforts with the radiopharmaceutical innovators to validate ARTMS’ 68Ga with these important medical products.” With a focus on optimizing production potential, ARTMS will continue the development of cyclotron-produced 68Ga and other vitally important medical isotopes, while also pursuing multiple regulatory approvals. ARTMS has a variety of solid targets commercially available used in combination with ARTMS’ QUANTM Irradiation System (QIS™). About ARTMS Based in Vancouver, British Columbia, Canada, ARTMS Inc. is a global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world’s most-used diagnostic imaging isotopes. ARTMS’ flagship product, the QUANTM Irradiation SystemTM (QISTM), enables decentralized, cost-effective, large-scale production of important medical isotopes such as gallium-68 (68Ga), zirconium-89 (89Zr), technetium‐99m (99mTc) and copper-64 (64Cu) using pharmaceutical distributor and hospital-based medical cyclotrons, empowering users to control their supply chain. ARTMS commercializes these award-winning and proprietary Canadian inventions on a global basis and has the prospect of revolutionizing the nuclear medicine industry. For more information on the QUANTM Irradiation System™ and ARTMS, please follow us on Twitter @Quantm99 and LinkedIn and visit

LOS ANGELES and SAN DIEGO, Jan. 28, 2021 /PRNewswire/ -- ImaginAb Inc, a leading global provider of immuno-oncology imaging agents and NEUVOGEN, an immuno-oncology company developing next generation therapeutic whole cell cancer vaccines, announced they have signed a multi-year non-exclusive licensing agreement. Under the terms of the agreement, ImaginAb will work with NEUVOGEN to implement clinical doses of 89Zr CD8 Immuno-PET imaging agents into their therapeutic vaccine clinical trials, and provide technical and clinical support to NEUVOGEN's development teams. ImaginAb will receive license fees and other contingent payments. No other terms were disclosed. ImaginAb's PET imaging technology enables tracking and quantitative imaging of CD8 T cells in cancer patients, enabling confirmation of drug mechanism and indication of the cancer immunotherapies' efficacy. Previous clinical studies have shown the clinical relevance of ImaginAb's 89Zr CD8 Immuno-PET imaging agent, and the use of these imaging data sets potentially contributes to improving the standard of care in immune-oncology therapies. The company's goal is to enable widespread use and adoption of 89Zr CD8 Immuno-PET technology. ImaginAb's CEO, Ian Wilson, commented: "We are delighted and very excited to work with NEUVOGEN and support the clinical development of their novel therapeutic cancer vaccine candidates. CD8 T cells play a pivotal role in cancer immunotherapy and our clinical studies have shown our 89Zr CD8 Immuno-PET imaging agent tracks and quantifies CD8 T cells in patients. We believe combining CD8 imaging with NEUVOGEN's whole cell cancer vaccines will enable more robust clinical data sets and accelerate the development of novel treatment protocols for solid tumors." NEUVOGEN's next-generation whole cell cancer vaccines are designed to simultaneously prime the broadest array of tumor targets, impacting multiple biologic pathways with the goal of directing an immune response against overlapping targets on every cell within a tumor. ImaginAb's T Cell specific PET imaging technology allows the NEUVOGEN team to visualize Tumor Infiltrating Lymphocytes, and monitor the dynamics of CD8 T cells in response to its novel cancer vaccine therapies, without the need for multiple tumor biopsies. "This agreement provides NEUVOGEN access to highly specific and precise imaging of the presence of CD8 T Cells in solid tumors over time." said Todd Binder, Chief Executive Officer, NEUVOGEN. "ImaginAb's 89Zr CD8 Immuno-PET imaging agent will help our development teams determine changes in CD8 T cell tumor infiltrates induced by NEUVOGEN's therapies, an important indicator of a patient's successful immune response to our vaccine therapy." About ImaginAb ImaginAb Inc. is a market leading biotechnology company focused on developing radiopharmaceutical imaging and therapy agents. ImaginAb engineers antibody fragments called minibodies that maintain the exquisite specificity of full-length antibodies while remaining biologically inert in the body. Used with widely available PET scan technology, these novel minibodies illuminate high-value molecular targets, providing physicians with a whole-body picture of immune activity. ImaginAb is advancing a pipeline of minibodies against oncology and immunology targets including the 89Zr CD8 ImmunoPET targeting CD8 T cells. ImaginAb's products have the potential to improve patient care and lower healthcare costs. The Company is backed by top tier venture capital firms and strategic corporate firms including, Adage Capital, The Cycad Group, Norgine ventures Jim Pallotta of the Raptor Group, The Parker Institute for Cancer Immunotherapy, and Merck (MSD) Pharma. For more information about ImaginAb's pipeline and technology, visit . About CD8 Immuno-PET The 89Zr CD8 Immuno-PET agent ([89Zr]-Df-IAB22M2C) is a Zirconium-89 labelled minibody that binds the CD8 receptor on human T cells and is used for quantitative, non-invasive PET imaging of CD8 T cells in patients. CD8 T cells are the main effector cells involved in the immune response against tumor cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases. As such, quantitative imaging of CD8 T cells can be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and predict patient outcomes. About NEUVOGEN NEUVOGEN, Inc. is an immune-oncology company focused on whole cell cancer vaccine therapies. NEUVOGEN believes its cancer vaccines have the broadest combination of tumor associated antigens and tumor specific antigens ever delivered in a cancer vaccine and as a result can directly target a greater percentage of cancer cells in a solid tumor than any previous cancer vaccine. Based in San Diego, California, NEUVOGEN's goal is to develop therapeutic cancer vaccines that activate the body's immune system to eradicate solid tumors and meaningfully extend the lives of patients while limiting side effects. To learn more, visit . For further information please contact: ImaginAb Ian Wilson info@imaginab.com NEUVOGEN Cyrus Arman partnering@neuvogen.com Christine Dusek media@neuvogen.com View original content to download multimedia: SOURCE ImaginAb, Inc.