On September 30, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, and Evergreen Theragnostics, Inc. ("Evergreen"), a radiopharmaceutical contract manufacturer, reported that the companies have entered into a Targeted Copper Theranostics (TCTs) manufacturing agreement for Clarity’s US clinical trials (Press release, Clarity Pharmaceuticals, SEP 30, 2021, View Source [SID1234590524]).
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Evergreen will centrally manufacture and distribute a range of ready-to-use cGMP TCTs for Clarity’s expanding clinical programs across the US from its new state-of-the-art facility in Springfield, New Jersey, USA. These include:
Cu-67 SARTATE for Clarity’s theranostic neuroblastoma study which is currently underway at multiple sites across the US (NCT04023331); and
Cu-64 SAR-Bombesin for Clarity’s upcoming clinical trials for this pan-cancer product in the US.
The proximity of the manufacturing facility to major transportation hubs and the optimal half-lives of Cu-64 and Cu-67 will enable Evergreen to efficiently distribute TCTs to hospitals across North America as well as reach European markets.
Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We look forward to working together with Evergreen on Clarity’s products for our ongoing US-based clinical trial in neuroblastoma, an aggressive childhood cancer, and our highly anticipated clinical trial of our diagnostic pan-cancer product SAR-Bombesin in the US. Clarity’s TCT products hold great promise in the field of radiopharmaceuticals, including manufacturing, logistical and clinical benefits, underlying the key advantage of getting ready-to-use products to patients wherever they are located. The manufacturing agreement with Evergreen in the Springfield facility enables Clarity to take advantage of those benefits and strengthens our existing TCT manufacturing footprint in North America to ensure seamless clinical trial supply, reinforcing our focus on the US regulatory pathway for our TCT products as we head towards our ultimate goal of better treating children and adults with cancer."
Evergreen’s CEO, James Cook, commented, "We are pleased to be working together with Clarity on the manufacturing and supply of the TCT platform of products, helping Clarity to pave the way for the broader use of copper-64 and copper-67 based products. This pairing of isotopes is ideally suited for central manufacturing with optimal half-lives for distribution across North America. We look forward to working closely with Clarity and enhancing patient access to these innovative radiopharmaceuticals."
This announcement has been authorised for release by the Executive Chairman.
About CORAR
Evergreen Theragnostics was established in 2019 to be a leading US-based radiopharmaceutical Contract Development and Manufacturing Organization (CDMO). With a state-of-the-art global GMP facility opened in 2021, Evergreen provides highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals, from early development through commercialization. The company was founded by a team that brings a strong track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management.