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MELBOURNE, Australia and NANTES, France, Aug. 24, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and Nantes-based ATONCO S.A.S. ('ATONCO') today announced that the final patient has been dosed in a Phase I study of TLX250-CDx in patients with non-muscle invasive bladder cancer (NMIBC) at the Institut de Cancérologie de l'Ouest (ICO) in St Herblain, France.
The objective of 'PERTINENCE' (NCT04897763), an investigator-led, open-label, proof of concept study, which has reached target enrolment of six patients, is to evaluate safety, biodistribution and dosing properties of TLX250-CDx (89Zr-DFO-girentuximab) given directly into the bladder in patients with NMIBC and establish CAIX as a potential therapeutic target in this condition. Should the trial prove successful, the next stage will be to commence therapeutic studies with astatine-211 (211At) for targeted alpha therapy (TAT). This is aligned with Telix's strategy to both develop alpha therapeutics and expand potential indications for radiolabelled girentuximab (TLX250), targeting carbonic anhydrase IX (CAIX), a cell surface protein that is highly expressed in several human cancers including renal, bladder, lung and oesophageal cancers.
Alpha emitters such as 211At have the potential to deliver very high amounts of energy to cancer tissue whilst the short path length can decrease the risk of damage to surrounding healthy cells, increasing the selectivity and potency of the radiation treatment. Alpha emitters have the potential to be complementary to beta-emitters in different stages of disease.
Lutetium-labelled TLX250 (177Lu-DOTA-girentuximab) is currently being evaluated in clear cell renal cell carcinoma (ccRCC) in Phase II therapeutic studies in combination with checkpoint inhibitors (STARLITE 1 and 2),[1] and the Company's pivotal Phase III imaging study (ZIRCON) of TLX250-CDx (89Zr-DFO-girentuximab) also in ccRCC, has recently completed enrolment.[2]
Principal Investigator for the PERTINENCE study, sponsored by ICO, Dr. Caroline Rousseau said, "We are pleased to have successfully completed enrolment in this proof-of-concept study, which we hope will improve our understanding of the imaging properties of TLX250-CDx in NMIBC and pave the way for studying astatine-labelled girentuximab as a targeted alpha therapy."
Telix Chief Medical Officer, Dr Colin Hayward added, "We would like to congratulate Dr. Caroline Rousseau and her clinical team at ICO for recruiting this trial ahead of time, and extend our gratitude to all study participants for their commitment to exploring innovative treatment options for patients living with NMIBC. Subject to positive outcomes, we look forward to Atonco proceeding to therapeutic studies with astatine-211 and exploring targeted alpha therapy in bladder cancer, as part of Telix's and Atonco's drive to establish category leadership in urologic oncology."
About Bladder Cancer
Bladder cancer is the sixth most commonly occurring cancer in men, and the tenth most common cancer overall worldwide.[3] In 2020, 573,278 people worldwide were diagnosed with bladder cancer and 212,536 people died from their disease.[4] NMIBC is found in the tissue that lines the inner surface of the bladder and is responsible for approximately 75–85% of newly diagnosed bladder cancers.[5]
About ATONCO
ATONCO is a privately held French company that develops molecularly targeted radiopharmaceuticals for oncology applications. Originating from the world-class nuclear medicine cluster in Nantes, France, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, in particular astatine-211 (²¹¹At).
For more information contact: info@atonco-pharma.com
About the Institut de Cancérologie de l'Ouest (ICO)
ICO is a 1,400 professional strong not-for-profit center fighting against cancer. It welcomes close to 48,000 patients per year, and conducts the mission and service of a public hospital. Strengthened by its 4 missions – Prevention, Care, Research and Teaching – ICO offers broad, state-of-the-art expertise that is exclusively dedicated to cancerology.
The integration of care, research and innovation is integral to ICO. Research activities, which are a specific mission at ICO, are undertaken from concept all the way through to clinical trials. Research is conducted in all disciplines of cancerology: medical oncology, radiotherapy, surgery, anaesthesia, nuclear medicine, medical imagery, support care, and human sciences. Patients who are cared for at ICO receive privileged access to cutting edge clinical trials in cancerology. The Innovation Centre, opened in 2021, is dedicated to accompanying innovation in oncology, and thus supports internal and external projects, from concept, all the way to operational deployment.
For more information contact: promotionrc@ico.unicancer.fr
About TLX250-CDx
TLX250-CDx (89Zr-girentuximab) is an investigational product being developed by Telix for the purpose of non-invasive detection of clear cell renal cancer in patients with "indeterminate renal masses" (IDRMs) are, typically identified based on CT or MRI imaging and are an increasing medical dilemma as more scans are performed and more IDRMs are identified. 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,[6] reflecting the significant unmet clinical need to improve the characterization of indeterminate renal masses previously identified on CT or MRI as ccRCC or non-ccRCC. ccRCC is the most common and aggressive form of kidney cancer.
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 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[7] and by the Australian Therapeutic Goods Administration (TGA).[8] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe[9] and Canada.[10]
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.
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This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.
To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.
The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).
[1] Media release 4 May 2022. |
[2] ASX disclosure 11 July 2022. |
[3] World Cancer Research Fund (WCRF). |
[4] Globocan 2021. |
[5] Somuncu et al. Nature. 2020. |
[6] ASX disclosure 1 July 2020. |
[7] ASX disclosure 20 December 2021. |
[8] ASX disclosure 2 November 2021. |
[9] ASX disclosure 10 December 2021. |
[10] ASX disclosure 16 December 2020. |
