Radiopharm Theranostics has negotiated an expanded agreement with TerThera for the supply of the terbium-161 (Tb-161) isotope to continue its fight against prostate cancer.
The crucial isotope will be linked to a proprietary monoclonal antibody to form “RAD 402”, a radiotherapeutic being developed by Radiopharm to target KLK3, a clinical cancer biomarker. The company says the novel radiopharmaceutical has the potential to become the first KLK-based theranostic option for patients with advanced prostate cancer.
KLK3, which is abbreviated from kallikrein-related peptidase 3, is a gene which contains the information necessary to build the prostate-specific antigen (PSA) protein produced by the cells of the prostate gland in males. PSA is commonly used as a biomarker for various prostate conditions, including prostate cancer and benign prostatic hyperplasia (BPH).
Elevated PSA levels can indicate potential issues with the prostate, such as inflammation, infection, BPH, or prostate cancer. The KLK3 gene and the PSA test play a significant role in prostate health monitoring and in the early detection of prostate-related issues, as KLK3 is highly expressed in prostate cancer cells but has limited expression in healthy tissue.
Management will initiate a phase-one dose trial during the second half of next year to evaluate the safety and efficacy of RAD 402 in patients with advanced prostate cancer.
Radiopharm Theranostics managing director and chief executive officer Riccardo Canevari said: “We are excited about bringing this highly differentiated technology (Tb161-RAD402) to patients with advanced prostate cancer. Until now, Prostate-Specific Membrane Antigen (PSMA) targeting agents represent the only theranostic option in the market or in development. RAD has decided to leverage a different mechanism of action by targeting KLK3, and the combination with Tb-161 is unique and highly promising.”
According to the company, Tb-161 has shown far better preclinical results in comparison with the isotope Lutetium-177 (Lu-177) that is commonly used in targeted radionuclide therapy. It believes that may translate into higher absorbed doses in micrometastatic disease and cause less harm to the kidneys.
An earlier agreement with TerThera was finalised in April this year for the development of “RAD 602” for brain cancer treatment. Radiopharm is the first company with access to Tb-161 for the clinical development of two different molecules, which is viewed as an exciting innovation in the field of radio pharmacy.
The company says Tb-161 looks promising for treating cancer in a special way as it gives off two kinds of radiation. One is like small bullets that only travel a short distance and the other is like energy sparks that are even smaller and stay close to where they start.
It means Tb-161 can better target cancer cells because its radiation travels only a few millimetres and the energy sparks it gives off can damage cancer cells without adversely affecting nearby healthy cells.
TerThera chief executive officer Philippe van Overeem said the company was positioning itself to meet the growing global demand for radioisotopes in oncology, by providing a highly-sustainable and uninterrupted supply of Terbium-161.
“The properties of Tb-161 should make it one of the radionuclides of choice within the current and future theranostic landscape,” Mr van Overeem said. “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.”
The costs associated with the purchase of Tb-161 will be met from existing funds and the initial order with TerThera is expected to occur during this year’s fourth quarter. The supply agreement, which triggers on Monday, is set for an initial period of three years, with the possibility of extension for additional two years.
Radiopharm will own all data generated and all inventions and discoveries made or conceived from its clinical trials.
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By Steve Butler
