On May 10, 2022 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has reported that the first patient has been dosed in the ‘STARLITE 2’ Phase II study of Telix Pharmaceuticals Limited (Telix) investigational renal cancer therapy product, TLX250 (177Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in New York (Press release, Eczacıbaşı-Monrol Nuclear Products, MAY 10, 2022, View Source [SID1234614128]). Monrol supplied Lutetium (Lu-177 n.c.a) to Telix Pharmaceuticals to manufacture clinical doses of TLX250 for STARLITE 2 Phase II study. This collaboration may offer significant opportunities for clear cell renal cell carcinoma (ccRCC) patients in the future.

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The STARLITE 2 Phase II study (NCT05239533) will assess the efficacy of TLX250 targeted radiation in combination with the anti-PD-11 immunotherapy Opdivo2 (nivolumab) for ccRCC, the most common and aggressive form of kidney cancer. The primary endpoint is to determine the safety and efficacy of combination therapy with TLX250 as assessed by the tumours responding to the Telix therapy versus the current standard of care alone. TLX250 targets carbonic anhydrase IX (CA9),3 a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy.4 The concept is that low doses of targeted radiation can potentially overcome immune resistance – or "immune prime" a tumour and therefore make it more responsive to cancer immunotherapy. Telix’s investigational companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) will also be used in the study to image CA9 expression.

Clinical doses of Telix’s investigational renal cancer companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is also produced by Eczacıbası Monrol in its Istanbul facility for the Phase III ZIRCON clinical trial.

ZIRCON Phase III study ("Zirconium Imaging in Renal Cancer Oncology") is an international multi-centre study at 34 sites in Europe, Australia, Turkey, Canada, and the United States. The study enrolled 30 patients in Turkey. The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth.

Monrol is a company developing, manufacturing, and distributing world-class radiopharmaceutical products, radioisotopes to improve quality of life of cancer patients globally and one of the few producers of Lutetium-177 n.c.a, having uninterrupted worldwide supply capabilities. Monrol Lu-177 n.c.a production process is an exclusive processing technology having cleaner and safer production method with stable isotope enrichment capability.

"Lu-177 n.c.a contributes to our mission to improve quality of life of cancer patients globally. Our new GMP certified facility exclusively designed for theranostic R&D and production with cutting edge technology will enable us to maximize supply of high-quality Lutetium worldwide. We are committed to working closely with Telix to potentially bring new therapeutic radiopharmaceutical agents into market soon to improve patients’ lives having life threatening diseases" said Monrol General Manager Aydin Kucuk".

Telix Chief Medical Officer, Dr. Colin Hayward noted, "The integration of precision nuclear medicine and medical oncology is underway and Telix is at the forefront of this movement to develop personalised products and patient-friendly regimens. We wish to express our gratitude to Dr. Darren Feldman and his clinical team, as well as the patients who will contribute to this ground-breaking study STARLITE 2".

Disclosure: MSK has institutional financial interests related to Telix.

About Lutetium-177 n.c.a

Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients today. Unique properties of Lutetium-177 n.c.a makes it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like Neuro Endocrine Tumors (NET), Prostate cancer and many other clinical development programs are ongoing for other cancers like ccRCC.

In line with the company mission to create hope for a better life for cancer patients, Monrol is establishing strategic partnerships with multinational pharmaceutical companies and constructing a new production facility compliant with FDA 21 CFR Part 211 quality standards which will have an annual production capacity of 60 thousand doses. With its location close to Istanbul, a major transportation hub, the new facility will benefit from a worldwide logistics network and agreements with cargo services to 320 destinations worldwide.

About TLX250

TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets carbonic anhydrase IX (CA9), a cell surface protein that is highly expressed in several human cancers including ccRCC. High CA9 tumour expression is generally correlated with poor prognosis.

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is being developed by Telix for the purpose of determining whether "indeterminate renal masses", typically identified based on CT or MRI imaging, are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer. Telix’s companion investigational diagnostic imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is the subject of a global Phase III trial recruiting (ZIRCON trial, NCT03849118).