Fusion Pharmaceuticals Inc. | June 13, 2022
Fusion Pharmaceuticals Inc. a clinical-stage oncology company focused on developing next-generation radio pharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of medical radioisotopes from radium and uranium, today announced that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225. Under the agreement, Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave's capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion's needs.
"As excitement for the tumor-killing potential of alpha-emitting radio pharmaceuticals increases, we intend to stay at the forefront of actinium development and supply to support our growing pipeline of targeted alpha therapies. We continue to prioritize manufacturing and access to actinium as a critical component of Fusion's platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we advance multiple actinium-based radio pharmaceuticals in the clinic."
Fusion Chief Executive Officer John Valliant, Ph.D
"The Niowave team has worked hard to scale up our actinium-225 production to the millicurie level and this has allowed us to start working with oncology community partners," said Niowave Chief Executive Officer/Senior Scientist Terry Grimm, Ph.D. "We have been watching Fusion's progress in the development of their pipeline of targeted alpha therapies and we are very excited to partner with them on this journey."
Fusion is developing actinium-based TATs leveraging the potency and precision offered by alpha particles. Actinium-225 decay gives off four alpha emissions in relatively rapid succession, maximizing the damage to the DNA of tumor cells, with a 10-day half life that allows for central manufacturing and distribution of products to clinical sites in a ready-to-use form.
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.
Niowave manufactures radioisotopes to cure cancer and save lives. Niowave builds and operates superconducting electron linear accelerators and is using that expertise to produce various radioisotopes for nuclear medicine. Niowave is a Cooperative Agreement partner with the National Nuclear Security Administration to develop a domestic supply of molybdenum-99 and currently produces yttrium-90 for use in cancer therapy. Niowave is licensed by the NRC to manufacture radioisotopes from uranium and radium and has partnerships with several universities and national laboratories focused on production and purification of radioisotopes for use in cancer therapy. By using radium targets and electron beams, Niowave is able to produce ultra pure and carrier-free actinium-225. Niowave's R&D facility is currently supplying actinium-225 samples to partners. Production-scale operations are ramping up at a second, FDA-compliant facility capable of meeting the growing actinium-225 market.
Labcorp | July 04, 2022
Labcorp a leading global life sciences company, announced that it is enhancing its central laboratory presence and drug development capabilities in Japan through an expansion of CB Trial Laboratory, the central laboratory co-managed by Labcorp Drug Development and BML, a leading Japanese provider of clinical laboratory testing services.
Extending their strategic relationship that dates back more than a decade, Labcorp Drug Development and BML will begin work on a new laboratory facility in the city of Kawagoe, Saitama, expanding capacity and services for pharmaceutical and biotechnology clients. This will bolster Labcorp Drug Development’s central laboratory services offerings in Japan and sets the stage for a continued acceleration of companion diagnostic capabilities.
“Labcorp Drug Development remains committed to growing its Japanese operations and services through continued expansion and partnerships. Broadening our work with BML and increasing our laboratory footprint means we will be able to offer shorter turnaround times, superior in-country sample management and full lab testing services for global clinical trials in Japan. This will benefit patients, clients and health care providers by providing them with the information needed to make key decisions.”
Honggang Bi, senior vice president and head of Asia-Pacific for Labcorp Drug Development
The new facility will be located near BML’s General Laboratory in Kawagoe where the current CB Trial Laboratory is located, providing over 4,000 square meters of dedicated space for global clinical trials managed by Labcorp Drug Development. The new space will be greater than five times the size of the current facility, with additional capabilities such as genomics, microbiology and companion diagnostics in addition to expanded offerings in current lab capabilities including flow cytometry, immunology, and anatomical pathology and histology. Completion of the expanded laboratory is expected by early 2025.
Through the planned laboratory expansion, Labcorp will advance biomarker and esoteric testing services, expand its companion diagnostics portfolio and deepen the integration with its clinical development services. In addition, the company will be able to intensify its focus on cell and gene therapy research and development, part of a broader commitment to precision medicine and fortifying the company’s position as an oncology leader.
“In collaborating with Labcorp, we are able to offer our pharmaceutical and biotechnology clients access to both comprehensive clinical laboratory testing and drug development opportunities,” said Dr. Kensuke Kondo, president of BML. “The laboratory expansion provides additional capabilities and capacity and opens the door to enriched services, more resources and better outcomes for our clients and patients.”
Labcorp and BML have successfully provided central laboratory services for global clinical trials in Japan since 2010 through kit production, sample logistics and laboratory operations at CB Trial Laboratory. Their partnership agreement was renewed in 2020.
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp reported revenue of $16 billion in FY2021.
On Demand Pharmaceuticals, Azzur Group | June 02, 2022
On Demand Pharmaceuticals, Inc. an innovative technology company transforming the way medicines are made, announced that it has signed a Preferred Supplier agreement with Azzur Group through 2024. The transformation of ODP's Rockville Headquarters into a State-of-the-Art cGMP Medicine Manufacturing facility began with Azzur in the fall of 2020.
Azzur collaborated in designing ODP's GMP Roadmap and helped develop the strategy and execution plan for ushering in this latest addition to Maryland's Biotech Hub. Building on the strategy, Azzur worked alongside ODP to initiate a Managed Services approach to execution, providing a single source for Commissioning services, Equipment rentals, Technology subscriptions, and a series of outsourced packages covering Environmental Monitoring, Training, and Documentation.
"The flexibility Azzur demonstrated to accommodate the fluid nature of a startup and the challenges we all faced during the COVID-19 pandemic was remarkable. Having the ability to pull on a variety of resources and expertise, when we needed it, is the reason we entered this relationship."
Dr. John Lewin, ODP's Chief Medical Officer
Tita Tavares, the Director of Azzur Washington, D.C., said "Enabling ODP to implement their innovative approaches required beginning with compliance in mind. Our unique approach to the Compliance Services world parallels ODP's strengths for innovation and delivering value to customers. At Azzur Group, we deliver the cGMP solutions required to address the greatest challenges life science companies face at every stage of their life cycle. ODP is on their way to filing their first regulatory submission and we look forward to our future efforts together."
About On Demand Pharmaceuticals
On Demand Pharmaceuticals™ is an innovative technology company transforming how medicines are made so they can be produced on demand—whenever and wherever medicines are needed. Our breakthrough manufacturing technology platform, Pharmacy on Demand (PoD)™, can be quickly customized to produce anything from key starting materials to active pharmaceutical ingredients (API) and final formulated drugs and was recently named by the World Economic Forum and published in Scientific American as one of the top 10 emerging technologies of 2021. With this technology, we're on a mission to provide an adequate, safe, and reliable supply of medicines to every community across the world.
About Azzur Group
From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers, and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.