MONROL
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
Andersen Consulting udvider sit udbud af humankapital med tilføjelsen af Jakarta Consulting Group16.1.2026 21:09:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer gennem en samarbejdsaftale med Jakarta Consulting Group (JCG), der er et rådgivningsfirma, som er kendt for sin ekspertise inden for organisatorisk transformation, humankapitalstrategi og ledelsesudvikling. Med hovedsæde i Indonesien har JCG rådgivet virksomheder inden for brancher som ejendom, minedrift og produktion gennem strategisk og kulturel transformation. Med kerneydelser, der omfatter virksomheds- og administrationsrådgivning, hr-rådgivning, vurdering samt virksomheds- og ledelsestræning, er virksomheden kendt for sin evne til at transformere virksomheder og ledere med agilitet, kulturel intelligens og handlingsorienterede løsninger. "Vi har altid ment, at bæredygtig transformation begynder med mennesker – når ledere udvikler sig, følger organisationer med," siger Patricia Susanto, CEO for Jakarta Consulting Group. "Ved at kombinere Andersen Consultings globale perspektiv med vores regionale indsigt kan vi tilbyde kunderne mere helh
ClickHouse Raises $400M Series D Led by Dragoneer to Accelerate Expansion Across Analytics and AI Infrastructure16.1.2026 15:30:00 CET | Press release
Company acquires Langfuse to enter LLM observability and introduces a native Postgres service to unify transactional and analytical workloads ClickHouse, a leader in real-time analytics, data warehousing, observability, and AI/ML, announced today the close of its Series D financing, raising $400 million. The round was led by Dragoneer Investment Group, with participation from Bessemer Venture Partners, GIC, Index Ventures, Khosla Ventures, Lightspeed Venture Partners, accounts advised by T. Rowe Price Associates, Inc., and WCM Investment Management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260116008883/en/ ClickHouse Co-Founders (left to right): Yury Izrailevsky, Aaron Katz, Alexey Milovidov The financing follows a period of sustained, accelerating growth for ClickHouse. The company now serves more than 3,000 customers on its fully managed service, ClickHouse Cloud, with ARR growing more than 250 percent year over year
Qualcomm Announces Quarterly Cash Dividend16.1.2026 15:00:00 CET | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on March 26, 2026, to stockholders of record at the close of business on March 5, 2026. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing busine
Nominations open for The MIDORI Prize for Biodiversity 2026 by AEON Environmental Foundation and the Secretariat of the Convention on Biological Diversity16.1.2026 09:00:00 CET | Press release
The MIDORI Prize recognizes outstanding individual contributions to the conservation and sustainable use of biodiversityThe unique prize contributes to raising public awareness of the essential role biodiversity plays for human well-being and in addressing global challenges such as climate changeThe Award Ceremony and Award Winners Forum will be held on 27 August 2026 in Tokyo, Japan The call for nominations for The MIDORI Prize for Biodiversity 2026 is open from 2 February to 31 March 2026. Nominations are invited from members of the public through the AEON Environmental Foundation website at https://www.aeonkankyozaidan.or.jp/en/prize/. The Award Ceremony and Award Winners Forum of the 2026 edition of the Prize will be held on 27 August in Tokyo, Japan. These events will contribute to the global mobilization around COP 17 of the Convention on Biological Diversity (CBD), which will take place in Yerevan (Armenia) under the theme of “Taking action for Nature”. Co-organized by the AEON
Tigo Energy and Weco Certify MLPE-Inverter Compatibility to Simplify PV System Design16.1.2026 06:00:00 CET | Press release
Tigo MLPE technology and hybrid inverters of Italian manufacturer Weco are now certified to work together to enhance design flexibility, system performance, and seamless integration. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced the Company has signed a certificate of compatibility with Weco S.r.l., documenting the compatibility between Tigo Flex MLPE products and hybrid solar inverters from Weco. The certification covers certain single-phase and three-phase Weco products and members of the Tigo TS4-A and TS4-X product families, when properly designed and installed. Together, these products are designed to deliver high-quality, enhanced value through a system that generates and manages solar energy more efficiently and delivers the features residential energy customers demand. “The compatibility between our inverter solutions and Tigo optimizers represents a significant step forward for the
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