Radiopharm (ASX:RAD) shares welcome portfolio boost with brain tumor technology

Highlights

• Radiopharm has gained access to a promising imaging & therapeutic radiopharmaceutical.
• The agreement with leading US university CWRU entails attractive commercial terms.
• The PTPµ – targeting agent holds the potential of first-in-class therapy in a range of tumor types.
• The agent will be first tested in glioblastoma, with the Phase 1 study expected in nearly 12 months.

Shares of Radiopharm Theranostics (ASX:RAD) soared 11.428% to AU$0.195 midday on 9 June 2022 following a significant update on a sublicensing agreement with NeoIndicate, LLC.

The company has signed an exclusive sublicensing agreement with NeoIndicate to a PTPµ-targeted radiopharmaceutical agent, developed at Case Western Reserve University, Ohio, US. PTPµ is a unique biomarker present only in tumor cells but not in healthy cells, and the radionuclide carrying PTPµ – targeting agent holds the potential of first-in-class therapy in various tumor types.

Under the agreement, RAD holds the right to develop the PTPµ-targeted agent as an imaging diagnostic and as a targeted radiopharmaceutical theranostic under its clinical development pipeline. The technology has patent protection till 2037.

The manufacturing of PTPµ is set to begin in late-2022, with Phase I studies expected to commence in nearly 12 months.

Glioblastoma – the first indication under clinical development plan

The PTPµ – targeted agent will be first tested in glioblastoma (GBM), the most prevalent and aggressive form of brain cancer. GBM has very limited treatment options and poor prognosis, leading to an immediate need for highly sensitive and specific targeted therapies.

The technology has delivered encouraging pre-clinical data in human GBM tumor models.

Image source: RAD investor presentation

Market prospect – In the US alone, 13,500 new cases of GBM are diagnosed each year, accounting.

GBM accounts for 48% of all primary malignant brain tumors. The indication has no targeted diagnostic imaging and no targeted radiopharmaceutical agents. Further, PET imaging agents in development report high non-specific binding.

GBM also has an Orphan indication, implying a fast regulatory process.

What does the development mean for RAD?

The future of precision medicine lies in highly specific and targeted agents for tumor detection, imaging, and treatment. The PTPµ – targeted agent functions as a highly specific Positron Emission Tomography (PET) imaging agent in combination with low level radiation, and it works as a radiopharmaceutical theranostic for tumor destruction when combined with high energy radiation.

The PTPµ – targeting agent specifically recognises an invasive tumor by invading tumor cells distantly located from the main tumor mass. Further, it identifies the fragment in multiple tumor types, including brain tumors and gynaecological cancers.  

Major terms of the pact

The PTPµ – targeted agent was developed by Dr. Susann Brady-Kalnay PhD, Professor in the Department of Molecular Biology and Microbiology at the CWRU School of Medicine.

With the sub-licensing agreement, RAD can now use the PTPµ – targeted agent coupled with radiotherapy for detecting and treating human disease. It can develop products using PTPµ; however, CWRU holds ownership of the PTPµ – targeted agent.

The agreement sets out different development milestones initiating from Investigational New Drug (IND) approval. The agreement cost 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.

The agreement includes industry standard, single digit percentage, royalty for future sales of products.   

RAD shares closed the day’s trade at AU$0.190 on 9 June 2022.