Fuzionaire Diagnostics, Inc. Announces Name Change to Fuzionaire Theranostics, Inc. and Preclinical Oncology Pipeline

2023-07-31

上市批准

New name reflects the company's pipeline of paired fluorine-18 PET diagnostics and radioligand therapies to find and treat cancer, led by a GRPR-targeting program for prostate cancer THE WOODLANDS, Texas--(BUSINESS WIRE)-- Fuzionaire Diagnostics, Inc. announced today that it has changed its name to Fuzionaire Theranostics, Inc. (“Fuzionaire Tx”). Originally directed to make diagnostic radiopharmaceuticals for PET scans, the company's HetSiFA® library has become a powerful theranostics platform that can also make radioligand therapies. HetSiFAs, or heteroaromatic silicon-fluoride acceptors, are modular radiolabeling moieties that enable rapid prototyping of peptide-based theranostics and the rapid manufacturing of fluorine-18 (18F) PET companions at large scale. HetSiFA-based radioligand therapies use leading alpha- and beta-emitting radionuclides. The HetSiFA® platform creates chemically identical diagnostic and therapeutic companions, a feature that enables a personalized therapeutic dose for each cancer patient. The name change marks a milestone in the company's growth plan and reflects a developing theranostic pipeline in oncology. Preclinical Oncology Pipeline Beginning With GRPR-Positive Prostate Cancer GRPR-Positive Prostate Cancer The company's first theranostic development program aims to improve the care of patients with metastatic prostate cancer by targeting the gastrin-releasing peptide receptor (GRPR) with a chemically identical and scalable 18F/ lutetium-177 (177Lu) theranostic pair. GRPR has emerged as a promising and validated target for prostate cancer to complement the widely utilized target prostate-specific membrane antigen (PSMA). In recent years, several PSMA-targeting radiopharmaceuticals have become available to patients worldwide. Novartis's PSMA-targeting radioligand therapy Pluvicto®, Lantheus's 18F PET imaging agent Pylarify®, Blue Earth Diagnostics' 18F PET imaging agent Posluma®, and ABX's PET imaging agent 18F-PSMA-1007 have been approved by regulatory agencies. Like Pylarify, Posluma, and 18F-PSMA-1007, Fuzionaire Tx's HetSiFA-based PET diagnostics use the nuclide 18F, which offers superior availability, production scalability, and image resolution as compared to gallium-68 (68Ga), often used in theranostics. Like Posluma, Fuzionaire Tx's HetSiFA-based radiopharmaceuticals are enabled by silicon. Posluma is the first drug approved by the FDA with a silicon-fluoride acceptor (SiFA) moiety. Fuzionaire Tx's patented HetSiFAs share the manufacturing advantages of SiFAs but with additional features, including an ability to create a more comprehensive array of theranostic candidates with different physicochemical and labeling properties. HetSiFAs are protected by a portfolio of issued and pending patents covering HetSiFAs and HetSiFA-containing candidates and the underlying silicon chemistry. In the context of the growth of PSMA radiopharmaceuticals and recent evidence that not all patients can benefit from them, GRPR has emerged as the most promising target to complement PSMA. The success of 18F/177Lu theranostics targeting PSMA underscores the need for an 18F/177Lu theranostic targeting GRPR. In this context, Fuzionaire Tx’s lead program targeting GRPR could occupy a key space in the portfolio of radiopharmaceuticals for prostate cancer. Additional Programs and Possibilities With origins in Robert Grubbs' lab at Caltech and the Crump Institute for Molecular Imaging at UCLA, the company's programs are advancing through a multi-party collaboration with McGill University, McMaster University, and Montreal-based contract research organization Paraza Pharma. The company is also advancing its programs in consultation with Prof. Mathias Schreckenberger, Director of the Nuclear Medicine Department at the University Medical Center Mainz in Germany, and the radiopharmaceutical contract development and manufacturing organization AtomVie Global Radiopharma Inc. The company's pipeline can expand further. The modularity of the HetSiFA platform enables the company to expand its pipeline rapidly with existing collaborators and new partners. In addition to the GRPR program, the company has discovery-stage programs for lung cancer and PSMA/GRPR-positive prostate cancer GRPR-positive prostate cancer. Initial preclinical data from the GRPR program will be presented by Alexey Kostikov, PhD, Associate Professor at McGill University, at the American Chemical Society Fall Conference in August 2023. “We are motivated to continue to innovate in how we collaborate with new partners to expand the use of HetSiFAs and the ecosystem supporting these important new labeling moieties, and to advance our GRPR and other programs through clinical trials,” said Nick Slavin, CEO of Fuzionaire Tx. “By doing so, we can create new ways to treat cancer and make new theranostic medicines more accessible.” About Fuzionaire Theranostics Fuzionaire Theranostics Fuzionaire Theranostics Fuzionaire Theranostics is a radiopharmaceutical company on a mission to make theranostic treatments more accessible to people with cancer. With origins in Nobel laureate Robert Grubbs' lab at Caltech, the company's patented HetSiFA® platform offers manufacturing advantages in a clinical setting and enables a personalized therapeutic dose for each cancer patient. Current development plans address pressing clinical needs in prostate and lung cancer. For more, visit us at: