Blue Earth Diagnostics Expands Oncology Portfolio with Exclusive, Worldwide Licensing of Investigational Radiohybrid PSMA-targeted Agents for Prostate Cancer from Scintomics
OXFORD, England & Munich, Germany--Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced that it has signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in radiopharmaceuticals and radiopharmaceutical technologies. Under the terms of the agreement, Blue Earth Diagnostics has acquired the exclusive worldwide rights to a broad family of Prostate Specific Membrane Antigen (PSMA)-targeted radiohybrid (“rh”) agents for cancer imaging, together with an exclusive option to explore therapeutic applications
“This agreement supports our strategic focus and is the next step in advancing our mission to develop and deliver products that address unmet medical needs in prostate cancer,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “Blue Earth Diagnostics is working to assemble a world-leading prostate cancer imaging portfolio. To that end, 18F rhPSMA and Axumin® have unique mechanisms of action which we believe may ultimately allow physicians and their patients to select the diagnostic agent most appropriate to each specific clinical situation. 18F rhPSMA is an ideal strategic expansion of our imaging portfolio that also enables us to broaden into therapeutic applications of this technology.”
The agreement expands Blue Earth Diagnostics’ oncology portfolio and builds on the company’s proven track record and depth of expertise in the rapid development and global commercialization of radiopharmaceuticals for cancer. Blue Earth Diagnostics will drive development of a lead 18F rhPSMA imaging compound and collaborate with Scintomics to identify optimized therapeutic candidates for future development. Acquisition of the rights to this advanced technology provides strong synergies with Axumin® (fluciclovine F 18), Blue Earth Diagnostics’ approved and commercially available PET/CT imaging agent for use in patients with a rising PSA after prior prostate cancer treatment.
Scintomics’ theranostic “radiohybrid” technology allows for the efficient labelling of PSMA-targeted agents with imaging radioisotopes, such as 18F, or therapeutic radioisotopes such as 177Lu, providing the ability to potentially be used either as a prostate cancer imaging agent or as a therapeutic agent. If approved, these innovative compounds offer the possibility of “precision medicine” for men with prostate cancer.
“We are very pleased to enter into this license agreement with Blue Earth Diagnostics, as their experience in the successful rapid development, approval and commercialization of Axumin will accelerate this first class of exciting “rh” technology based agents towards routine clinical use worldwide,” said Prof. Hans-Jürgen Wester, PhD, Founder of Scintomics and Chair, for Pharmaceutical Radiochemistry at the Technical University of Munich (TUM), Germany. “Our early clinical experience with 18F-rhPSMA-7 has been very encouraging and justifies advancing an “rh” candidate into formal clinical development,” added Matthias Eiber, MD, attending physician at the Department of Nuclear Medicine, Klinikum rechts der Isar, TUM.
“As evidenced by its recent inclusion in the National Comprehensive Cancer Network® guidelines, 18F-fluciclovine has become established as a standard-of-care PET imaging agent in the United States for men with recurrent prostate cancer,” said Judd Moul, MD, Professor of Surgery and Director, Duke Prostate Center, Duke University Medical Center, Durham, NC. “It is clear that PSMA-targeted PET imaging agents will play an important role in the future management of prostate cancer patients. However, there is a wide array of these agents in development, and some have more promising attributes than others. Optimally, a PSMA-targeted diagnostic agent for routine clinical use should be labeled with the radioisotope 18F for its durability and possess favorable clinical attributes that facilitate broad applicability and utility in men with prostate cancer.”
rhPSMA was invented by Hans-J Wester and Alexander Wurzer at the Department of Pharmaceutical Radiochemistry of the Technical University of Munich, Germany, where it has been utilized clinically under German legislation by Matthias Eiber at the Department of Nuclear Medicine for the diagnostic imaging of men with both primary and recurrent prostate cancer. Bayerische Patentallianz (BayPAT), the technology transfer office of Bavarian Universities and Universities of Applied Sciences out-licensed the Radiohybrid (“rh”) PSMA-targeted technology to Scintomics in 2017. 18F rhPSMA consists of a prostate-specific membrane antigen (PSMA) receptor ligand, which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with the radioisotope 177Lu for therapeutic use. 18F rhPSMA and 177Lu rhPSMA have not received regulatory approval.