AB-001 (AKSO)

ARTBIO has secured $132 million in fresh funding to accelerate development of its lead-212 (Pb212)-based alpha radioligand therapy (ART), while building out a decentralised supply chain aimed at addressing one of the field's biggest bottlenecks: reliable access to radioisotopes.The series B will primarily support clinical development of ARTBIO's lead candidate, AB001, currently in early development for metastatic castration resistant prostate cancer (mCRPC). "Prostate-specific membrane antigen (PSMA) imaging shows AB001 to be well-tolerated in scans of a patient who recently received AB001 through a compassionate use request (publication here)," CEO Emanuele Ostuni told FirstWord, adding that an IND submission is "imminent."Promising substitute Traditional radioligand therapies tend to rely on beta emitters like lutetium-177, but the field has increasingly turned to alpha emitters, such as actinium-225, given the potential for greater safety and efficacy. However, global shortages of actinium — causing even programmes like Bristol Myers Squibb's Phase III trial of RYZ101 to pause enrolment last year — have prompted companies to explore alternatives, with Pb212 seen as a promising substitute (see – Spotlight On: Pb212 emerges as alternative isotope for radiopharmaceuticals)."Pb212 is highly stable in the carrier molecules we develop," said Ostuni. "Following the emission of the first and only alpha from Pb212, the low rate of recoil of the isotope avoids any unintended radiation toxicity in non-tumour areas." He added that the 10.6-hour half-life of Pb212 "matches the properties of the small-molecule carriers we use thereby delivering most of its energy (80-90% transfer) into the tumour." Meanwhile, unlike other ARTs in which the alpha isotopes are made in nuclear reactors or centralised facilities with rigid production schedules, ARTBIO is pioneering what it touts as a more efficient method to isolate the isotopes it needs.Discrete manufacturing sitesThe company's "first-of-its-kind" AlphaDirect system offers several advantages, including its benchtop format that allows it to be operated in different manufacturing facilities, and a simple separation-free process that yields isotopes with over 99.9% purity. Further, in order to minimise uncertainty and cost, the supply chain starts with materials derived from accessible nuclear industry stockpiles, reducing reliance on reactors or cyclotrons."Through strategic partnerships spanning the US, Europe and Asia, ARTBIO can maximise patient access through a network of discrete manufacturing sites," Ostuni said. "This approach mitigates single point of failure concerns."Maha Katabi, general partner at Sofinnova Investments, which co-led the series B along with B Capital, called ARTBIO's technology "a game-changer for navigating around supply and production challenges for radioisotopes in today's complex environment."The round also included participation from existing investors F-Prime, Omega Funds and Third Rock Ventures, along with new backers Qatar Investment Authority and Alexandria Venture Investments.

INDIANAPOLIS & CAMBRIDGE, Mass.--( BUSINESS WIRE )-- SpectronRx , a leading radiopharmaceutical developer and manufacturer, has entered into a new partnership agreement with ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), to produce a novel prostate cancer therapy known as AB001. SpectronRx will utilize its expertise and state-of-the-art facilities in Indiana to be a contract developer and manufacturer for the groundbreaking treatment currently undergoing first-in-human trials. The manufacturing processes will start with ARTBIO’s proprietary AlphaDirect TM technology for isolation of Pb212. "We are excited to be working with ARTBIO to bring their targeted alpha radioligand therapy to patients in need," said SpectronRx co-founder and CEO John Zehner. "As part of their distributed manufacturing network, we will tap into our expertise in handling and producing medical radioisotopes, such as Pb212, along with our infrastructure for radiopharmaceutical contract development and manufacturing to validate the manufacturing process and produce clinical supplies of AB001.” AB001 is a promising therapy for prostate cancer, as it targets and destroys cancer cells while minimizing damage to healthy tissue. SpectronRx’s state-of-the-art equipment, industry experience and extensive regulatory track record will enable ARTBIO to strengthen and validate its manufacturing processes. Upon validation, SpectronRx will design, develop and implement the customized manufacturing line and processes required to scale up production to meet clinical supply requirements. “We are pleased to be partnering with SpectronRx once again,” said Daniel Rossetto, Head and Senior Vice President, Supply Chain and External Manufacturing of ARTBIO. “Their expertise and capabilities in radiopharmaceutical development and manufacturing make them an ideal partner for us. With SpectronRx as part of our distributed manufacturing network, we are confident that the clinical supply of AB001 will be made available to patients safely and reliably in Indiana and neighboring states. This is an important milestone as we continue to advance our lead program, AB001, and our entire pipeline.” This is the second partnership that SpectronRx and ARTBIO have entered. The news comes just months after SpectronRx revealed it is manufacturing a critical component of ARTBIO’s proprietary AlphaDirect TM isolation technology, which delivers highly pure Pb212 from widely available raw materials. With the additional support from SpectronRx, ARTBIO hopes to bring its novel therapy to market efficiently and make a significant impact in the fight against prostate cancer. “ARTBIO’s groundbreaking therapy has the potential to change the landscape of cancer treatment,” added SpectronRx President Anwer Rizvi. “Our team at SpectronRx is dedicated to ensuring the highest quality and safety standards in the production of AB001.” About SpectronRx SpectronRx is a diagnostic and therapeutic radiopharmaceutical developer and manufacturer with three distinct specialties: Radiopharmaceutical Contract Development (RCDMO), Radiopharmaceutical Contract Manufacturing (RCMO), and Isotope Production. The company performs all scales of development, from initial conjugations through scale-up and commercial distribution. It also has the capacity to run clinical trials. With a large staff of radiochemists, radiopharmacists, scientists and engineers, dozens of qualified clean rooms, and over 150,000 sq. ft. of production space in Indiana, with additional facilities in Danbury, Connecticut and Europe, SpectronRx now supplies therapeutic and diagnostic radiopharmaceuticals to 29 countries. The company has been EMA and FDA inspected and can produce and procure any currently used radioisotopes. For more information visit SpectronRx.com , or follow the company on LinkedIn . About ARTBIO ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (Pb212) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company's AlphaDirect TM technology, a first-of-its-kind Pb212 isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing three pipeline programs with lead program AB001 currently in first in human trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway's Radium Hospital. For more information, visit www.artbio.com , and follow us on LinkedIn (@artbio-inc) and Twitter (@artbio_inc).