Expanded Access Program Opens in the U.S. for TLX101-CDx, Telix’s Investigational Glioma (Brain Cancer) Imaging Agent

/EIN News/ -- MELBOURNE, Australia, July 29, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the opening of an expanded access program (EAP) in the United States (U.S.) for TLX101-CDx (Pixclara™¹, ¹⁸F-floretyrosine or ¹⁸F-FET) an investigational positron emission tomography (PET) agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration (FDA) agreement to proceed.        

Amino acid PET is included in U.S. and European clinical practice guidelines for the imaging of gliomas², however there is no FDA-approved targeted amino acid PET agent for brain cancer imaging currently available in the U.S. Telix’s goal is to make this product commercially available in the U.S., significantly increasing patient access to this important imaging agent for both adult and paediatric patients. The Company expects to file its New Drug Application (NDA) for TLX101-CDx with the FDA during Q3 2024.

Patrick Wen, MD, Professor, Neurology, Harvard Medical School and Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, said, “Amino acid PET imaging of the brain is increasingly used to supplement conventional imaging by MRI³, which for many years has been the primary clinical imaging modality in patients with glioma at all stages of disease. After treatment, MRI has several limitations, including the lack of biological specificity, dependency on blood-brain barrier disruption, and an inability to differentiate between tumour progression or recurrence from treatment-related changes. TLX101-CDx (FET-PET) shows potential to provide a more rapid and conclusive diagnosis, inform treatment decisions and deliver a new standard for the management of gliomas in the U.S.”

David N. Cade, MD, Telix Chief Medical Officer, added, “As we finalise the submission of our NDA for TLX101-CDx, the opening of this expanded access program will enable us to provide continued access to this investigational agent, where there is significant unmet medical need in the U.S. Glioma is the most common and aggressive form of primary brain cancer and we believe TLX101-CDx has the potential to make an important difference for U.S. glioma patients who deserve greater reliability in their diagnosis and treatment decision making.”

Under its EAPs – sometimes also called ‘compassionate use’ – the FDA works with companies to allow access to investigational products, outside of a clinical trial, to patients with serious or life-threatening illnesses, for whom there are no comparable or satisfactory alternate options.

U.S. patients, or physicians who may have eligible patients in the U.S. can e-mail eap-americas@telixpharma.com or complete the form here for further information about the TLX101-CDx EAP.

Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.

About TLX101-CDx
TLX101-CDx (Pixclara™¹) is a PET imaging agent, which has been granted fast track⁴ and orphan drug⁵ designations by the FDA as an imaging agent for the characterisation of glioma. TLX101-CDx targets membrane transport proteins known as LAT1 and LAT2⁶. This enables TLX101-CDx to be potentially utilised as a companion diagnostic agent to TLX101 (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA), Telix’s LAT1-targeting investigational glioblastoma (GBM) therapy, currently under investigation in the IPAX-2⁷ and IPAX-Linz⁸ studies. 

About gliomas in the U.S.
Gliomas are very diffusely infiltrative tumours that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumours and 80% of all malignant brain tumours⁹. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.¹⁰. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients¹¹, with an expected survival duration of 12-15 months from diagnosis¹². 

About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).  

Telix’s lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the FDA⁸, by the Australian Therapeutic Goods Administration (TGA) ⁹, and by Health Canada¹⁰. No other Telix product has received a marketing authorisation in any jurisdiction. 

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. 

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Legal Notices

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. The information contained in this announcement is subject to change without notification. 

This announcement may contain 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. 

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Pixclara™¹ names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

________________________
¹ Brand name subject to final regulatory approval.
² Joint European Association of Nuclear Medicine//European Association of Neurooncology/Response Assessment in Neurooncology practice guidelines/Society for Nuclear Medicine and Molecular Imaging procedure standards for the clinical use of PET imaging in gliomas.
³ Magnetic resonance imaging.
⁴ Telix ASX disclosure 16 April 2024.
⁵ Telix ASX disclosure 6 October 2020.
⁶ Large amino acid transporters 1 and 2.
⁷ Telix media release 8 August 2023. ClinicalTrials.gov ID: NCT05450744.
⁸ Telix media release 22 November 2022.
⁹ Goodenberger et al. Cancer Genet. 2012.
¹⁰ Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
¹¹ Park et al. Journal of Clinical Oncology. 2010.
¹² Ostrom et al. Neuro Oncol. 2018.