RAD Adds Brain Tumor Technology to Portfolio

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a world-class developer of cutting-edge radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to announce that it has signed an exclusive sublicensing agreement with NeoIndicate, LLC (“NeoIndicate”) to a PTPµ-targeted radiopharmaceutical agent, which was developed at CWRU in Ohio, USA.

The sublicensing agreement gives Radiopharm the rights to develop the PTPµ-targeted agent as an imaging diagnostic and as a targeted radiopharmaceutical theranostic as part of its clinical development pipeline.

Highly specific, targeted agents for the detection, imaging and treatment of tumors are the future of precision medicine. When combined with low level radiation, the PTPµ-targeted agent functions as a highly specific Positron Emission Tomography (PET) imaging agent. When combined with high energy radiation, the PTPµ-targeted agent works as a radiopharmaceutical theranostic to destroy tumors.

The PTPµ-targeted agent labels invading tumor cells far away from the main tumor mass, achieving specific recognition of the full extent of an invasive tumor. It also recognizes this fragment in multiple tumor types including brain tumors and gynecological cancers.

The technology has shown encouraging pre-clinical data in human glioblastoma (GBM) tumor models¹ˉ⁶, the focus of Radiopharm’s initial studies and the most common and devastating form of brain cancer with a median survival of one year from diagnosis. The current standard of care is surgery followed by nonspecific radiation and chemotherapy. Due to the limited treatment options and poor prognosis, there is an immediate need for targeted therapies with high sensitivity and specificity.

Manufacturing of PTPµ is scheduled to commence in December 2022.

Dr. Susann Brady-Kalnay PhD, Professor in the Department of Molecular Biology and Microbiology at the CWRU School of Medicine, created the PTPµ-targeted agent. Her work spans 30 years of research into the cell adhesion molecules that regulate cancer cell progression and metastasis. Development of agents to improve tumor detection, imaging and treatment led Dr. Brady-Kalnay to found NeoIndicate, a woman-owned and operated biotech company in Wellington, Ohio, United States.

Radiopharm’s CEO & Managing Director Riccardo Canevari said:

“We are eager to bring the highly sensitive and tumor specific PTPµ-targeted agent to our clinical development pipeline and plan to enter Phase 1 studies in approximately 12 months. The sublicensing agreement with NeoIndicate, who licensed the technology from CWRU, will build upon our portfolio of targeted radiopharmaceutical therapies. A number of tumor types can be detected with this novel PTPµ-targeted agent. Due to the limited treatment options and immediate need for therapies, we are focused on detecting and treating aggressive brain tumors with the PTPµ-targeted agents.

“From a cash perspective the commercial terms are very attractive and can be absorbed into our existing cash flow forecasts.”

A Research Agreement will provide Radiopharm with access to the inventor & NeoIndicate.

The technology is protected by a broad, long life patent portfolio to 2037.