Radiopharm Theranostics Ltd (ASX:RAD), which develops radiopharmaceutical products for diagnostic and therapeutic uses, has signed a deal with Dutch radionuclide production-focused company TerThera for the supply of Terbium-161 (Tb-161).
The agreement will provide supply for the company’s RAD 602 radiotherapeutic asset, a potential first-in-class radiopharmaceutical for the treatment of brain cancers.
Targeting cancer-associated protein
The Tb-161 isotope will be linked to a proprietary peptide to form RAD 602, which is being developed by Radiopharm to target protein tyrosine phosphatase mu (PTPμ).
PTPμ is expressed in cancer cells but has limited expression in healthy tissue.
Radiopharm will initiate a Phase 1 dose-escalating trial of RAD 602 for the treatment of patients with brain cancers during the fourth quarter of the year.
“We are excited to initiate our RAD 602 clinical trial, which is the first dose-escalating radiopharmaceutical study leveraging the strong therapeutic properties of Tb-161 in brain tumours,” said CEO and managing director Riccardo Canevari.
“This novel therapeutic isotope represents a potential first-in-class targeted radiotherapeutic that can expand treatment options for patients living with cancer.
“We believe that Radiopharm has achieved a strong competitive advantage from being the first company to do a Phase 1 trial using this isotope and securing supply of this relatively scarce isotope.”
Terbium-161 is a highly promising isotope for targeted cancer treatment due to its unique characteristics of radiation emitted, which includes both Auger electrons and short-range beta particles.
The beta radiation travels only a few millimetres and Auger electronic emission has a higher linear energy transfer that travels less than the width of a single cell.
Excellent bioequivalence
Tb‑161 has shown excellent bioequivalence, presenting a biodistribution comparable to currently used radiolanthanides and is potentially superior to Lutetium-177 (Lu-177) due to its Auger effect increasing potency and efficacy in selectively destroying tumour cells while leaving surrounding healthy tissue largely unaffected.
“TerThera is positioned to meet the growing global demand for radioisotopes in oncology by providing a highly sustainable and uninterrupted supply of Terbium-161,” said TerThera CEO Philippe van Overeem.
“We are proud to partner with Radiopharm Theranostics to supply their innovative radioligand pipeline and to help enable development of a new generation of therapeutic radiopharmaceuticals.”
RAD says the costs associated with the purchase of Tb-161 will be met from existing funds and will not be material to RAD’s annual budgeted expenditure.
The initial order for preclinical use is expected this month, with the first order for clinical use expected in October 2023.
The effective date of the supply agreement is April 17, 2023, and there are no material preconditions. The supply agreement is for an initial period of three years and may be extended for additional two years unless agreed otherwise by either party.
Radiopharm will own all data generated and all inventions and discoveries made or conceived from its clinical trials.
About TerThera
TerThera is building a global platform to meet the growing demand for radionuclides in oncology and nuclear medicine.
The founders and staff of the Netherlands-based TerThera have decades of experience in the nuclear medicine industry and are devoting their energies to the production of the radionuclide Terbium-161 (Tb-161).