MONROL
10.5.2022 06:02:14 CEST | Business Wire | Press release
Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has today announced 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 (177 Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in New York. 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.
The STARLITE 2 Phase II study (NCT05239533 ) will assess the efficacy of TLX250 targeted radiation in combination with the anti-PD-11 immunotherapy Opdivo®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 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 (89 Zr-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 (89 Zr-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 (177 Lu-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 (89 Zr-DFO-girentuximab) is the subject of a global Phase III trial recruiting (ZIRCON trial, NCT03849118 ).
About Monrol
Monrol is one of the world’s largest nuclear medicine companies leading innovation for the development and manufacturing of GMP grade radioisotopes and radiopharmaceuticals having headquarters in Istanbul. Monrol is distributing its world-class radiopharmaceutical products portfolio with excellence in global markets. Monrol is a CDMO, providing early development support to its customers as well as offering fully integrated services for today’s nimble, lean, virtual companies effectively taking new product concepts into clinical trials, demonstrating proof of concept and going into first-in-human studies. Monrol is committed to transform and improve patient journey in cancer treatment with its radiopharmaceutical products portfolio distributing to more than 50 countries around the globe. To learn more, visit www.monrol.com and LinkedIn .
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted 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 need 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 lead product, gallium-68 (68 Ga) gozetotide (also known as 68 Ga PSMA-11) injection for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),5 and by the Australian Therapeutic Goods Administration (TGA).6 Telix is also progressing marketing authorisation applications for this investigational candidate in Europe7 and Canada.8
1
Programmed cell death protein 1.
2
Opdivo is a registered trade mark of Bristol Myers Squibb.
3
Carbonic anhydrase IX.
4
Giatromanolaki et al. British Journal of Cancer
. 2020.
5
ASX disclosure 20 December 2021.
6
ASX disclosure 2 November 2021.
7
ASX disclosure 10 December 2021.
8
ASX disclosure 16 December 2020.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220505005820/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Dubai Launches Global Create AI Agents Championship with Prize Pool Exceeding AED 2.5 Million8.10.2026 19:05:00 CEST | Press release
Dubai has launched the Create AI Agents Championship, a global competition inviting innovators to develop practical and scalable AI-agent solutions that address real-world challenges, with a total prize pool exceeding AED 2.5 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008883373/en/ Dubai has launched the Create AI Agents Championship as part of its efforts to accelerate the adoption and development of Agentic AI (Photo: AETOSWire) The launch of the championship was announced by H.H. Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister and Minister of Defence of the UAE, and Chairman of The Executive Council of Dubai, who encouraged innovators from around the world to participate. Led by Dubai Chamber of Digital Economy, the championship aims to accelerate the adoption of Agentic AI and support the development of innovative AI-agent solutions with strong potential for
Seiden Law LLP issues statement: Prosecuted by Press Conference: Declared Guilty Without a Charge, Yim Leak Family Asks UN Human Rights Experts to Hold Thailand to Its Own Treaty Commitments8.10.2026 18:26:00 CEST | Press release
Urgent appeal to UN Special Rapporteurs cites the presumption of innocence, due process and protection of a child. The key facts are the Thai government's own words and files. Seiden Law LLP, chief global counsel to Cambodian businessman Yim Leak, announced today that Jared Genser, international counsel to Mr. Yim and his wife, has asked two UN Special Rapporteurs to send an urgent appeal to the Thai government. The request is made on behalf of the couple and their seven-year-old son. It says Thailand violated its international human rights commitments by announcing the family’s guilt before any court had tried them, and by freezing their assets, including their minor son’s savings, without a hearing. Six Official Statements in Nine Months. No Charge Filed in Any Court. Between December 2025 and September 2026, Thai officials described Mr. Yim as the center of a criminal network on six occasions: at two press conferences chaired by the head of the Thai government, in the House of Repre
Sam Altman-Backed Meanwhile Raises $37.5M as Families Across Asia, Europe and the Middle East Turn to Bitcoin Life Insurance8.10.2026 18:12:00 CEST | Press release
Existing investors, led by Bain Capital Crypto, back the first licensed Bitcoin life insurer after its single-premium policy for international clients drives a record year Meanwhile, the first life insurer licensed to operate entirely in Bitcoin, today announced $37.5 million in new funding from its existing investors. Bain Capital Crypto led the round, alongside Haun Ventures, Framework Ventures, Pantera Capital, Apollo, Northwestern Mutual Future Ventures, and Morgan Creek Digital. Meanwhile, whose backers also include Sam Altman, has now raised more than $180 million. The round follows a surge in international demand for Meanwhile’s Bitcoin life insurance policies, particularly in Asia, Europe and the Middle East amid broader macro instability. In early 2026, Meanwhile launched BTC Life 1-Pay, a single-premium whole life policy built for high-net-worth clients outside the United States. It is the company's second product line after BTC 10-Pay, which is purposely designed for US taxp
Toluna Announces Planned CEO Transition After 25 Years; Founder Frédéric Charles Petit to remain as Board Member, Senior Advisor and Shareholder8.10.2026 16:20:00 CEST | Press release
Toluna, a global leader in consumer insights and market research technology, today announces a planned leadership transition. After 25 years leading the company he founded, Frédéric Charles Petit, Founder and Chief Executive Officer, intends to transition from his role as CEO following the appointment of his successor as part of a carefully planned succession process designed to ensure continuity for clients, employees and partners. Following the transition, Mr. Petit will continue to serve on Toluna's Board of Directors, will remain a significant shareholder of the company, and will take on an ongoing strategic advisory role for areas central to Toluna's next phase of growth. The Board, in close consultation with Mr. Petit, has initiated a structured succession process. A comprehensive transition plan is in place, including a defined handover with Mr. Petit, to ensure continuity for the company’s clients, employees, and partners. The Board expects to confirm the appointment of the com
CSC Wins for Threat Intelligence Innovation in 2026 CyberSecurity Breakthrough Awards8.10.2026 16:00:00 CEST | Press release
3D Domain Security and Global Enforcement recognized for excellence in an information security product CSC, an enterprise-class domain registrar and world leader in detecting and mitigating brand, fraud, domain, and Domain Name System (DNS) threat vectors, today announced that its 3D Domain Security and Global Enforcement solution won for Threat Intelligence Innovation in the 10th annual CyberSecurity Breakthrough Awards. The awards recognize the most innovative companies, products, and technologies driving progress in the global information security industry. CSC’s 3D Domain Security and Global Enforcement solution for the enterprise domain ecosystem combines advanced AI machine learning technology, proprietary domain threat intelligence, expert analysis, and integrated global enforcement. With this technology, organizations can detect, understand, and act on external cyber threats targeting their brand online across social media, search engines, email, and e-commerce websites. By unc
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom