Radiopharm Theranostics Limited announced 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 models¹, 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. Key terms of the Sublicense Agreement: Under the terms of the sublicense agreement, Radiopharm has secured the right to use the PTPµ-targeted agent conjugated to radiotherapy for the detection and treatment of human disease.

The sublicense agreement commences with an effective date of June 9, 2022 and extends to the expiration or abandonment of the applicable patent rights. The agreement sets out various development milestones commencing from IND approval. The cost of the sublicense agreement and various milestone payments are not material to the Company in its initial period and are allowed for in the Company's existing research budget.

No additional or new funding is required for commencement of the sublicense agreement. The sublicense agreement may be terminated by agreement, or according to common commercial termination provisions. The agreement includes industry standard, single digit percentage, royalty for future sales of products developed under the agreement.

The agreement sublicenses Radiopharm to develop products using PTPµ; however, CWRU retains ownership of the PTPµ-targeted agent.