Centre For Probe Development & Commercialization

A Canadian manufacturer of radiopharmaceuticals is building a new site in Ontario after netting a major investment. AtomVie Global Radiopharma, which launched and secured a $40 million Series A in the latter half of last year, is currently building a new 64,000-square-foot manufacturing facility in the city of Hamilton in Ontario, Canada. The company’s origins can be traced back to 2008, with the Centres of Excellence for Commercialization and Research (CECR) program, AtomVie CEO Bruno Paquin said, in an interview with Endpoints News. The program, run by the Canadian government, was aimed at commercializing academic research and resulted in the Hamilton-based Center for Probe Development and Commercialization (CPDC), aimed at bringing radiopharmaceuticals to Ontario. The CPDC started offering contract manufacturing services which quickly grew, Paquin said, and in 2020, he became the CEO. However, CDPC was then based on the campus of McMaster University in Hamilton, and the space became too small, so Paquin decided to create a spinoff company. In 2021, AtomVie was incorporated with the manufacturer and officially launched in August of 2022, eventually closing on a $40 million Series A. However, Paquin said, the company was still operating in a 15,000 square-foot space at McMaster University and was “scattered” over four different buildings. Paquin said the space at McMaster University is limited in terms of growth, and there were other factors, such as the electrical and HVAC systems, that were not controlled by the company. “There was several drivers for us to go out, seek that money and build the facility. One of them was that the demand was way over what we could offer in the current facility. The second is that the current facility (at) McMaster University is very good, but it’s limited in terms of infrastructure, and it’s very limited in terms of growth for space,” Paquin said. AtomVie’s new space is located near Hamilton’s airport and about 50 miles from the US border. The shell of the facility is already built, and Paquin said the buildout of the interior will start soon. The new build will allow the manufacturer to attract more clients who have commercial needs in the radiopharmaceutical space and allow it to handle around 30 products, Paquin said. The facility’s exact cost was not disclosed, but Paquin said the funding for the facility’s buildout all came from private investment in the US, and no funding came from the Canadian government. AtomVie, which currently has 110 employees, plans to increase its headcount to 200 by 2027. The facility’s full build-out is expected to be finished in the second half of 2024, with Paquin estimating that production will start in 2025.

HAMILTON, ON, Feb. 24, 2021 /PRNewswire/ - The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, is announcing today that the first patient has been dosed and imaged in a Phase 3 trial for [18F]PSMA-1007. This diagnostic imaging product is a positron-emitting tomography (PET) agent that targets Prostate Specific Membrane Antigen (PSMA), a protein that is overexpressed in prostate cancer. Prostate cancer is the most common malignancy in Canadian men, accounting for over 23,000 new cases per year and 4,000 deaths annually. Men with recurrent or persistent prostate cancer have poor outcomes, and there is an unmet need to accurately define the location and overall spread of disease in this population to help plan effective treatment. "We are excited to bring [18F]PSMA-1007 to Canadian patients as we believe that improved detection of disease in the pelvic region and areas of metastases by [18F]PSMA-1007 will lead to better outcomes in prostate cancer patient treatments." said CPDC's Interim CEO, Bruno Paquin. "We also express our appreciation to Drs. Joseph Chin (Professor of Urology and Oncology at Western University), Glenn Bauman (Chair/Chief, Cancer Care, London Health Sciences Centre), and Ur Metser (Division Head Molecular Imaging, Joint Department Of Medical Imaging at UHN) for their contributions to this program and look forward to working with them as investigators in this trial". "Imaging prostate cancer with PET imaging agents directed towards PSMA is an extremely exciting advance for the personalized care of men with prostate cancer. This Phase III trial will be crucial in providing information regarding the safety and accuracy of [18F]PSMA-1007 PET imaging and will pave the way to establishing this type of imaging as an approved standard of care imaging test in Canada for men with prostate cancer." said Dr. Glenn Bauman About [18F]PSMA-1007 [18F]PSMA-1007 is a positron emission tomography (PET) imaging agent that binds to PSMA. Published clinical data suggest that [18F]PSMA-1007 PET has the potential to improve the detection of recurrent prostate cancer with earlier detection and better localization of disease, thereby improving patient management. In addition, the lipophilic characteristics and hepatobiliary excretion of [18F]PSMA-1007 allow for improved imaging of local recurrence and pelvic lymph node metastases in the prostatic bed versus other [18F]PSMA-targeting agents. CPDC has licensed [18F]PSMA-1007 from ABX- advanced biochemical compounds GmbH (Radeberg, Germany) and holds the exclusive license to develop, manufacture, and distribute the imaging agent in Canada. About the Clinical Trial The Phase 3 clinical trial is a prospective, single arm, non-randomized, open label study that will enroll 100 men with suspected persistent or recurrent prostate cancer based on detectable levels of prostate serum antigen (PSA) and having negative or equivocal detection of disease by conventional imaging. The primary objective of the clinical trial is to evaluate the diagnostic performance of [18F]PSMA-1007 PET, by comparing the PET imaging results to a composite of clinical outcome information. Other objectives include assessing the safety of [18F]PSMA-1007 and the impact of [18F]PSMA-1007 PET on management of patients with recurrent prostate cancer. For additional information about the clinical trial, visit (NCT NCT04644822). About Centre for Probe Development and Commercialization (CPDC) The Centre for Probe Development and Commercialization (CPDC) is a Centre of Excellence for Commercialization and Research (CECR) located at McMaster University in Hamilton, Ontario, Canada. CPDC is a private, not-for-profit company and global leader in the discovery, development and commercialization of next-generation radiopharmaceuticals that was created with the support of multiple stakeholders, including the Networks of Centres of Excellence (NCE), McMaster University and the Ontario Institute for Cancer Research (OICR). Since its foundation in 2008, CPDC has established a pipeline of products along with a robust and reliable global supply of innovative diagnostic and therapeutic radiopharmaceuticals used daily for the detection and treatment of human diseases such as cancer. For more information about CPDC, please visit: or contact info@imagingprobes.ca