RAD adds brain tumor technology to the portfolio

• Sub-licensing of promising therapeutic and imaging radiopharmaceuticals from leading US university, Case Western Reserve University (CWRU), Ohio
• PTPµ (PTPmu), the target, is a unique biomarker present only in cancer cells but not in healthy cells
• The radionuclide carrying the target agent PTPµ holds the potential of first in class therapy in different types of cancer
• The phase 1 brain tumor imaging study will begin in approx. 12 months
• Attractive business terms with modest cash requirements and low single-digit royalties

Melbourne, Australia, June 9, 2022 / PRNewswire / – Radiopharm Theranostics (ASX: RAD, “Radiopharm” or “Company”), a world-class developer of state-of-the-art radiopharmaceuticals for both diagnostic and therapeutic uses, is pleased to announce that it has signed an exclusive contract sublicense with NeoIndicate, LLC (“NeoIndicate”) to a PTPµ targeted radiopharmaceutical agent, developed at CWRU in Ohio, United States.

The sublicense agreement grants Radiopharm the rights to develop the PTPµ Targeted Agent as diagnostic imaging and as a targeted theranostic radiopharmaceutical as part of its clinical development pipeline.

Highly specific and targeted agents for tumor detection, imaging and treatment 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 targeting agent functions as a theranostic radiopharmaceutical to destroy tumors.

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

The technology has shown encouraging preclinical data in tumor models of human glioblastoma (GBM) ¹ˉ⁶, 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 radiotherapy and chemotherapy. Due to limited therapeutic options and poor prognosis, there is an immediate need for targeted therapies with high sensitivity and specificity.

PTPµ production is expected to start at December 2022.

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

CEO and CEO of Radiopharm Riccardo Canevari She said:

“We look forward to bringing the highly sensitive and tumor-specific PTPµ targeted agent into our clinical development pipeline and expect to enter Phase 1 trials in approximately 12 months. The sublicense agreement with NeoIndicate, which has granted in licensed technology from CWRU, it will be based on our portfolio of targeted radiopharmaceutical therapies. With this new targeted PTPµ agent it is possible to detect a number of tumor types. Due to limited treatment options and immediate need for therapies, we focus on the detection and treatment of aggressive brain tumors with PTPµ-targeted agents.

“From a liquidity point of view, the trading conditions are very attractive and can be absorbed by our forecasts on existing cash flows.”

A research agreement will provide Radiopharm with access to the inventor and NeoIndicate.

The technology is protected by a large portfolio of long-lasting patents up to 2037.

Key Terms of the Sublicense Agreement

Under the terms of the sub-license agreement, Radiopharm has secured the right to use the targeted agent for PTPµ conjugated to radiotherapy for the detection and treatment of human diseases. The sub-license agreement runs from June 9, 2022 and extends to the expiration or abandonment of applicable patent rights.

The agreement sets several development milestones since the approval of the IND.

The cost of the sub-license agreement and various interim payments are not relevant to the Company in its initial term and are permitted in the Company’s existing research budget. No additional or new funding is required for the initiation of the sub-license agreement. The sub-license agreement can be terminated by mutual agreement or based on the common commercial termination provisions.

The agreement includes industry standards, single digit percentage, royalties for future sales of products developed under the agreement.

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

Authorized on behalf of the Board of Directors of Radiopharm Theranostics by the Executive President Paolo Hopper.

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SOURCE Theranostic radiopharmaceuticals