ISTANBUL–(BUSINESS WIRE)–Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) today announced that the first patient received a dose in the “STARLITE 2” Phase II study of the investigational kidney cancer treatment product of Telix Pharmaceuticals Limited (Telix), TLX250 (177Lu-DOTA-girentuximab), at the Memorial Sloan Kettering Cancer Center (MSK) in New York. Monrol has provided lutetium (Lu-177 nec) to Telix Pharmaceuticals to manufacture clinical doses of TLX250 for the Phase II STARLITE 2 study. This collaboration could provide important opportunities for patients with clear cell renal cell carcinoma ( ccRCC) in the future.
Phase II STARLITE 2 study (NCT05239533) will evaluate the efficacy of targeted radiation TLX250 in combination with anti-PD-11 Opdivo immunotherapy®2 (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 tumors responding to Telix therapy compared to current standard of care alone. TLX250 targets carbonic anhydrase IX (CA9),3 a highly expressed protein in patients likely to show a more limited response to cancer immunotherapy.4 The concept is that low doses of targeted radiation can potentially overcome immune resistance – or “immunize” a tumor and therefore make it more responsive to cancer immunotherapy. Telix’s experimental companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) will also be used in the study to image CA9 expression.
Clinical doses of TLX250-CDx, Telix’s investigational companion kidney cancer imaging agent (89Zr-DFO-girentuximab) is also produced by Eczacıbası Monrol at its Istanbul plant for the ZIRCON phase III clinical trial.
The phase III ZIRCON (“Zirconium Imaging in Renal Cancer Oncology”) study is an international multicenter study at 34 sites in Europe, Australia, Turkey, Canada and the United States. The study recruited 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 noninvasively detect ccRCC in patients with indeterminate renal masses compared to surgical resection. (histology), as the standard of truth.
Monrol is a company developing, manufacturing and distributing world-class radiopharmaceuticals, radioisotopes to improve the quality of life of cancer patients worldwide and one of the few producers of Lutetium-177 nec, with capabilities uninterrupted global supply chain. The Monrol Lu-177 nec production process is a proprietary processing technology having a cleaner and safer production method with stable isotopic enrichment capability.
“Lu-177 nca contributes to our mission to improve the quality of life for cancer patients worldwide. Our new GMP certified facility exclusively designed for theranostic R&D and production with state-of-the-art technology will allow us to maximize the supply of high-quality lutetium worldwide. We are committed to working closely with Telix to potentially commercialize new therapeutic radiopharmaceutical agents in the near future to improve the lives of patients with life-threatening diseases,” said Aydin Kucuk, Managing Director of Monrol”.
Telix’s Chief Medical Officer, Dr. Colin Hayward, said: “The integration of precision nuclear medicine and medical oncology is underway and Telix is at the forefront of this movement to develop products personalized and patient-specific diets. We would like to express our gratitude to Dr. Darren Feldman and his clinical team, and to the patients who will contribute to this groundbreaking STARLITE 2 study.”
Disclosure: MSK has institutional financial interests related to Telix.
About Lutetium-177 nec
Lutetium-177 nec is a radioisotope of choice for targeted radiotherapy. The Lu-177 nca production process enables treatment options that have the potential to improve treatment outcomes for some cancer patients today. The unique properties of Lutetium-177 nec make it a theranostically desirable radioisotope for Peptide Receptor Radionuclide Therapy (PRRT) to treat certain cancers like Neuroendocrine Tumors (NETs), Prostate Cancer and many other cancer programs. clinical development are underway for other cancers such as ccRCC.
In line with the company’s mission to create hope for a better life for cancer patients, Monrol establishes strategic partnerships with multinational pharmaceutical companies and builds a new production facility that meets FDA 21 CFR quality standards. Part 211 which will have an annual production capacity of 60 thousand doses. Located close to Istanbul, a major transport hub, the new facility will benefit from a global logistics network and agreements with freight services to 320 destinations worldwide.
About the TLX250
TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets carbonic anhydrase IX (CA9), a cell surface protein highly expressed in several human cancers including ccRCC. High tumor expression of CA9 is generally correlated with a poor prognosis.
About the TLX250-CDx
TLX250-CDx (89Zr-girentuximab) is being developed by Telix with the aim of determining whether “undetermined renal masses”, usually identified on the basis of CT or MRI imaging, are either clear cell renal cell cancer ( ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging. Grentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target highly expressed in several human cancers, including kidney, lung and esophageal cancers. In July 2020, the United States Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation to 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 TLX250-CDx Companion Investigational Diagnostic Imaging Agent (89Zr-DFO-girentuximab) is in global Phase III trial enrollment (ZIRCON trial, NCT03849118).
Monrol is one of the world’s largest nuclear medicine companies at the forefront of innovation for the development and manufacture of GMP-grade radioisotopes and radiopharmaceuticals, headquartered in Istanbul. Monrol distributes its portfolio of world-class radiopharmaceuticals with excellence in global markets. Monrol is a CDMO, providing early development support to its customers along with a fully integrated service offering for today’s agile, lean and virtual businesses, effectively taking new product concepts into clinical trials, demonstrating proof of concept and embarking on first-in-human studies. Monrol is committed to transforming and improving the patient journey in cancer treatment with its portfolio of radiopharmaceuticals distributed in more than 50 countries around the world. To learn more, visit www.monrol.com and LinkedIn.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company specializing in the development and marketing of diagnostic and therapeutic products using targeted molecular radiation (MTR). Telix is headquartered in Melbourne, Australia, with international operations in Belgium, Japan, Switzerland and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information, visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix’s flagship product, gallium-68 (68Ga) gozetotide (also called 68Ga PSMA-11) injectable for prostate cancer imaging, has been approved by the United States Food and Drug Administration (FDA),5 and by the Australian Therapeutic Goods Administration (TGA).6 Telix is also advancing marketing authorization applications for this experimental candidate in Europe7 and Canada.8
1 Programmed cell death protein 1.
2 Opdivo is a registered trademark of Bristol Myers Squibb.
3 Carbonic anhydrase IX.
4 Giatromanolaki et al. British Journal of Cancer. 2020.
5 ASX disclosure December 20, 2021.
6 ASX disclosure November 2, 2021.
7 ASX disclosure December 10, 2021.
8 ASX Disclosure December 16, 2020.