ARTIBIO and SpectronRx Enter Partnership Agreement to Manufacture Key Components of ARTIBIO's AlphaDirect™ Technology
Tuesday, July 25, 2023
ARTBIO, Inc. a clinical-stage radiopharmaceutical company developing a new class of alpha radioligand (ART) targeted therapies, and SpectronRx, a leading radiopharmaceutical developer and manufacturer, today announced a global strategic partnership agreement to support the manufacture of alpha radioligand technology components. ARTBIO's AlphaDirect™ isotopic isolation.
Under this agreement, SpectronRx will manufacture a key component of ARTBIO's proprietary AlphaDirect™ technology. AlphaDirect™ is a novel system that provides highly pure Pb212 from widely available raw materials. The multi-year agreement covers an initial phase of technology transfer and development, followed by the qualification and provision of technical components.
"We have a long history of managing complex technology projects involving radioactive materials," said John Zehner , co-founder and CEO of SpectronRx. “We understand the importance of collaboration for companies developing new technologies aimed at creating radioligand-based therapies. SpectronRx is fully equipped and proud to partner with ARTBIO to develop and supply the key components of AlphaDirect™. »
ARTBIO pioneered the AlphaDirect™ technology by creating an optimized and patented Pb212 isotope isolation technology that has unique advantages, including:
- A workbench, which can be operated in facilities of any size.
- A simple process, without separation of fluids, which makes it possible to obtain a purity of more than 99.9%.
- A streamlined supply chain with source materials from accessible nuclear industry stocks that minimizes uncertainty and costs.
SpectronRx will leverage its expertise in the handling and production of rare medical radioisotopes such as Ac-225 (actinium- 225) and Pb-212, as well as its radiopharmaceutical contract development (rCDMO) and radiopharmaceutical contract manufacturing (rCMO) infrastructure. This unique combination and deep regulatory experiences will allow ARTBIO to effectively improve and validate its manufacturing processes so that they are ready for review by the FDA and EMA.
“We are pleased to partner with SpectronRx, a company that has extensive experience and skills in managing nuclear chemistry projects,” said Dr. Emanuele Ostuni, CEO of ARTBIO. “Handling high doses of radioactivity is an extremely complex process, and it was essential that we worked with a partner who understood the specific requirements needed and who could create a custom solution for our proprietary AlphaDirect™ technology. Thanks to the expertise of SpectronRx, we are one step closer to setting up an ARTBIO manufacturing network. »
"ARTBIO's technology has the potential to revolutionize the cancer treatment industry," added Anwer Rizvi , President of SpectronRx. “We are delighted to accompany them on this incredible adventure. »
About ARTBIO
ARTBIO is a clinical-stage radiopharmaceutical company that is redefining cancer treatment by creating a new class of radioligand alpha (ART) therapies. ARTBIO's unique approach selects the optimal alpha -emitting isotope (Pb212) and tumor-specific targets to create highly targeted therapies. The company's AlphaDirect™ technology , a novel method of Pb212 isolation, enables a distributed manufacturing approach for safe ART production and delivery. ARTBIOdevelops three programs currently in development, the main one of which, AB001, is currently undergoing a first phase of human trials. ARTBIO benefits from a long scientific heritage, with almost a century of pioneering work in radiotherapy carried out at the University of Oslo and the Norwegian Radium Hospital. To learn more, visit www.artbio.com and follow us on LinkedIn (@ artbio-inc ) and Twitter (@artbio_inc ) .
About SpectronRx
SpectronRx is a developer and manufacturer of radiopharmaceuticals for diagnostic and therapeutic use, with three distinct specialties: Contract Radiopharmaceutical Development (RCDMO), Contract Radiopharmaceutical Manufacturing (RCMO), and Isotope Production. The company carries out all stages of development, from initial combinations to commercial distribution and scale-up. It also has the ability to conduct clinical trials. Additionally, SpectronRx's deep industry knowledge, technical prowess and state-of-the-art facilities allow the company to dramatically shorten the time to market for new drugs,
With a large staff of radiochemists, radiopharmacists, scientists, and engineers, dozens of qualified laboratories, and more than 150,000 square feet of production space in Indiana, plus additional facilities in Danbury, Connecticut, and Europe, SpectronRx today supplies therapeutic and diagnostic radiopharmaceuticals to 29 countries . The company which has been inspected by the EMA and the FDA is able to produce and acquire all the radioisotopes currently in use, including actinium-225. For more information, visit SpectronRx.com , or follow the company on LinkedIn .
Source:prnewswire.com
