Telix Collaborates With Olivia Newton-John Cancer Research Institute On Brain Cancer Imaging Study

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MELBOURNE, Australia, December 22, 2021 (GLOBE NEWSWIRE) – Telix Pharmaceuticals Limited (ASX: TLX, Telix, the company) today announces that it has entered into a clinical data access agreement with the Olivia Newton-John Cancer Research Institute (ONJCRI) concerning a prospective clinical trial investigating the use of O- (2-[18F]fluoroethyl) -L-tyrosine or 18F-FET for imaging patients with glioblastoma with positron emission tomography (PET) (FET-PET). 18F-FET is under development by Telix (called TLX101-CDx) as a complementary diagnostic agent to its therapeutic candidate for glioblastoma TLX101.

The FET-PET in Glioblastoma (“FIG”) study (ANZCTR Trial ID: ACTRN12619001735145) is a prospective multicenter study which aims to definitively establish the role of FET-PET in the management of glioblastoma, a type of cancer of the brain.

Glioblastoma (GBM) is the most common primary brain cancer in adults, accounting for approximately 50% of brain tumors. Imaging plays a key role in diagnosing, planning radiation therapy, and monitoring response to treatment in GBM.

ONJCRI leads the FIG study with an Australian consortium1 and has secured more than $ 3 million in research grants from the Medical Research Future Fund (MRFF), Cure Brain Cancer Foundation and the MRFF-Australian Brain Cancer Mission. Telix is ​​participating in the FIG study as both a commercial collaborator and co-funder, in return for access to the final study data to support the development and registration of the TLX101-CDx. The Telix funding will specifically support an observational study (registry) that will collect data demonstrating the value of FET-PET imaging in brain cancer patients.

The FIG study, which will recruit up to 210 newly diagnosed adult GBM patients across Australia, examines the use of FET-PET imaging throughout a patient’s treatment journey as well as the standards current care. The primary endpoints are to assess the impact of FET-PET on radiotherapy planning and to understand the accuracy of FET-PET in assessing disease progression.

The Co-Chair of Clinical Trials for the FIG Study Professor Andrew Scott of ONJCRI and the Department of Molecular Imaging and Therapy at Austin Health said: Of vital importance in glioblastoma which is very aggressive and can be difficult to deal with. This groundbreaking study will use 18F-FET, a new PET tracer that can show us if tumor cells are active. It is a more functional imaging technique than magnetic resonance imaging (MRI), the current standard imaging tool, and could potentially provide a powerful imaging biomarker for the management of brain cancer. and improve survival rates.

Telix CEO Dr Christian Behrenbruch added: “We are delighted to have joined forces with ONJCRI and this Australian consortium evaluating FET-PET, which provides a superb example of the type of initiative we can pursue. through the Australian Federal Government Tax Credit for National R&D Activities. We hope that the clinical data will support Telix’s global regulatory submissions for TLX101-CDx, while also enabling the public release of the data in a way that can be robustly exploited for the benefit of patients with this disease with a prognosis. particularly dark.

About glioblastoma

Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive form of primary brain cancer, with approximately 11,000 new cases diagnosed each year in the United States.2 The basis of treatment for GBM usually includes surgical resection, followed by combined radiation therapy and chemotherapy. However, despite such treatment, most patients present with a recurrence, with an expected survival time of around 15 months from diagnosis.3

About TLX101-CDx (18F-FET)

18F-FET has been widely used in clinical research while recently new practice guidelines have been developed for imaging gliomas using PET with radiolabeled amino acids, including 18F-FET is a key radiopharmaceutical.418F-FET targets the L-amino acid transport system (LAT) and is therefore ideally suited for use as a complementary diagnostic agent to TLX101, Telix’s therapeutic drug candidate for glioblastoma. 18F-FET was used to screen patients and monitor disease response in Telix’s IPAX-1 Phase I / II clinical trial (ClinicalTrials.gov Identifier: NCT03849105), which recently completed recruitment in Europe. and Australia.5

About the Olivia Newton-John Cancer Research Institute

The Olivia Newton-John Cancer Research Institute (ONJCRI) is a leader in the development of experimental and breakthrough cancer treatments. ONJCRI studies and develops treatments for cancers of the breast, intestine, lung, melanoma, prostate, liver, gastrointestinal tract and brain. Its researchers and clinicians are actively involved in the conduct of clinical trials, providing patients with access to potential new treatments, including immunotherapies and personalized medicine. For more information, visit www.onjcri.org.au.

About Telix Pharmaceuticals Limited

Telix is ​​a biopharmaceutical company specializing in the development of diagnostic and therapeutic products using Targeted Molecular Radiation (MTR). Telix is ​​headquartered in Melbourne, Australia, with international operations in Belgium, Switzerland, Japan 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 Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communication and Investor Relations
Email: [email protected]

Important information

This announcement does not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States or any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not beenandwill benotto beregisteredbelowtheUnitedStatesSecuritiesActof1933(the“WESecuritiesAct”),Wherebelowthe titleslawsofanystateWhereotherjurisdictionoftheUnitedStatesandcannotto beFreeWheresoldintheUnited States,unlessthesecuritieshavesummerregisteredbelowtheweSecuritiesActWhereaexemptionfromthethe registration requirements of the US Securities Act isavailable. None of the technologies or products described in this document have received marketing authorization in any jurisdiction. The publication of this announcement has been authorized by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer.The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

1 Other members of the consortium: Australasian Radiopharmaceutical Trials Network (ARTnet); Collaborative Trials Group for Neuro-Oncology, University of New South Wales, University of Western Australia, University of Melbourne, University of Sydney and Study Sponsor Trans Tasman Radiation Oncology Group.
2 Ostrom QT et al. CBTRUS Statistical Report. 2013.
3 Ohgaki H et al. Acta Neuropathol. 2005.
4 Law I et al. Joint EANM / EANO / RANO / SNMMI procedural standards for imaging gliomas using PET with radiolabeled amino acids and [18F]FDG: version 1.0. Imaging Eur J Nucl Med Mol. 2019.
5 ASX Disclosure 06/17/21.

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