ASX-listed Radiopharm Theranostics is moving quickly to add another cancer-fighting weapon to its diagnostic armoury after penning a sub-licensing agreement for a promising radiopharmaceutical agent with a US biotech company.
The agent targets a unique biomarker, PTPmu, that is present only in tumour cells.
The exclusive sublicensing agreement has been penned with NeoIndicate, a biotechnology company based in Wellington, Ohio.
Radiopharm believes the agent can target several tumour types, including gynaecological cancers however the company is focusing first on its possibilities for detecting and treatment of aggressive brain tumours.
The agent has shown encouraging pre-clinical data in human glioblastoma, or “GBM”.
GBM is the most common and devastating form of brain cancer. It resists treatment and the median prospect of survival after diagnosis is one year and the five-year survival rate is just 6.8 per cent.
Treatment options currently are limited to surgery, followed by radiation and chemotherapy. No targeted radiopharmaceutical therapy has been approved for GBM.
Radiopharm is keen to get to work on testing the agent amid tight rules on targeted therapies with high sensitivity and specificity.
The PTPmu biomarker labels invading tumour cells far away from the main tumour mass, enabling specific recognition of the full extent of the tumour.
The company claims its agent distinguishes the tumour from normal, inflamed and necrotic tissue. When used with high-energy radiation, it could destroy tumours.
Radiopharm Theranostic CEO and Managing Director, Riccardo Canevari said:“We are eager to bring the highly sensitive and tumour specific PTPµ-targeted agent to our clinical development pipeline and plan to enter phase 1 studies in approximately 12 months.”
A phase 1 imaging study will be followed by therapeutic research. Isotope supply has been secured and peptide manufacturing is scheduled to be completed by December.
NeoIndicate was founded by the creator of the PTPmu agent, Dr Susann Brady-Kalnay, Professor in the Department of Molecular Biology and Microbiology at the Case Western Reserve University, School of Medicine in Ohio, USA.
CWRU retains ownership of the technology however has licensed PTPmu to NeoIndicate.
The sublicensing agreement allows Radiopharm to develop products using PTPmu and a research agreement will provide the company assess to NeoIndicate and Brady-Kalnay.
Management says the costs of the sublicense agreement and its various milestone payments are allowed for in its existing research budget.
“From a cash perspective, the commercial terms are very attractive and can be absorbed into our existing cashflow forecasts,” Canevari says.
The biotech firm has had a busy few weeks.
Its sublicensing deal with NeoIndicate comes after a licensing agreement in April with the University of California Los Angeles Technology Development Group for a tumour-killing antibody DUNP19.
Earlier this month, Radiopharm announced the appointment of a pharmaceutical and medical devices industry veteran Vittorio Puppo to the newly created role of Chief Operating Officer. Puppo will be based in New York City.
And on Monday, Dr Leila Alland was appointed to the board as a non-executive director.
Alland is Chief Medical Officer of PMV Pharmaceuticals, a clinical stage precision oncology company.
Canevari says Alland’s scientific and clinical expertise along with her impressive background in pharmaceutical drug development make her a valuable addition to the board as Radiopharm steers through a pivotal period of innovation and growth.
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