The FDA accepts the new drug application and grants priority review

MELBOURNE, Australia, October 24, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the U.S. Food and Drug Administration (FDA) has accepted its new drug application (NDA) for TLX101-CDx (Pixclara®¹), an agent for imaging gliomas. The application was granted priority consideration and was designated a PDUFA² The target date is April 26, 2025, paving the way for a U.S. commercial launch in 2025³.

Pixclara (¹⁸F-Floretyrosine or ¹⁸F-FET) is a PET agent used to characterize progressive or recurrent gliomas due to treatment-related changes in adult and pediatric patients. FET-PET is already included in international clinical practice guidelines for imaging gliomas⁴However, there is currently no FDA-approved targeted amino acid PET agent for brain tumor imaging in adults and children that is commercially available in the United States. Due to its potential to address significant unmet medical needs, Pixclara was designated an orphan drug⁵ and received fast track status⁶ from the FDA.

There is an urgent unmet need to improve the diagnosis and treatment of gliomas, the most common primary brain tumors of the central nervous system, particularly after treatment. Conventional MRI⁷ Imaging techniques have several limitations, including lack of biological specificity, dependence on disruption of the blood-brain barrier, and the inherent inability to distinguish between tumor progression and treatment-related causes. This can lead to inconclusive results and delay time-critical treatment decisions⁸.

Given low survival rates and the need to make rapid decisions, accurate imaging is of utmost importance. Pixclara, pending regulatory approval, has the potential to address this need and provide patients in the U.S. with greater clarity in their diagnosis and treatment decisions. Telix is ​​also exploring the potential use of Pixclara as a “companion” diagnostic agent to TLX101-Tx, the investigational neuro-oncology drug currently in development that targets the same amino acid transport mechanism with therapeutic targeted radiation.

Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, said: “Telix believes that the FDA approval of Pixclara will be a step change in brain tumor imaging in the US, aligning it with a more advanced standard of care currently in use will.” in other markets. There is currently an urgent need for better imaging of brain tumors, and Telix is ​​committed to providing precision medicine solutions that address patient needs and improve both cancer imaging and treatment outcomes.”

About TLX101-CDx

TLX101-CDx (Pixclara) is a PET imaging agent that has received fast track and orphan drug designation from the FDA as an imaging agent for the characterization of gliomas. TLX101-CDx targets membrane transport proteins known as LAT and LAT2⁹. This allows for the potential use of Pixclara as a companion diagnostic for TLX101 (¹³¹I-iodofalan, or ¹³¹I-IPA), Telix's LAT1-targeting investigational therapy for glioblastoma (GBM), currently being investigated in Telix's IPAX-2¹⁰ and IPAX Linz¹¹ Studies.

About gliomas in the USA

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasms arising from glial cells and account for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors¹². In the United States, six cases of gliomas are diagnosed per 100,000 people each year. GBM is a high-grade glioma and the most common and aggressive form of primary brain tumor. Approximately 22,000 new cases are diagnosed in the United States each year¹³. The main treatment for GBM is surgical resection followed by combined radiation therapy and chemotherapy. Despite such treatment, almost all patients experience a recurrence¹⁴with an expected survival time of 12-15 months from diagnosis¹⁵.

Um Telix Pharmaceuticals Limited

Telix is ​​a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and related medical devices. Telix is ​​headquartered in Melbourne, Australia, with international offices in the United States, Europe (Belgium and Switzerland) and Japan. Telix is ​​developing a portfolio of clinical and commercial stage products aimed at addressing significant unmet medical needs in oncology and rare diseases. Telix is ​​listed on the Australian Securities Exchange (ASX: TLX).

Telix's leading 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 US Food and Drug Administration (FDA).¹⁶from the Australian Therapeutic Goods Administration (TGA) ¹⁷and from Health Canada¹⁸. No other Telix product has received marketing approval in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including current share price details, ASX announcements, investor and analyst presentations, press 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: [email protected]

This announcement has been approved for publication by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board of Directors.

Legal Notice

You should read this announcement together with our risk factors as disclosed in our most recent reports filed with the Australian Securities Exchange (ASX) or on our website.

The information contained in this communication does not constitute an offer to subscribe, invitation or recommendation with respect to the securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this communication are subject to change without notice . To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this release, including any forward-looking statements (as set forth below), whether as a result of new information or future developments, a change in expectations or assumptions or anything else. No representation or warranty, express or implied, is made as to the accuracy or completeness of the information contained or opinions expressed in this announcement.

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©2024 Telix Pharmaceuticals Limited. The names and logos of Telix Pharmaceuticals®, Illuccix® and Pixclara® are trademarks of Telix Pharmaceuticals Limited and its affiliated companies – all rights reserved. The Pixclara trade name is subject to final regulatory approval.

¹ The brand name is subject to final regulatory approval.
² Prescription Drug Fee Act.
³ Subject to FDA approval.
⁴ 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.
⁵ Telix ASX disclosure dated October 6, 2020.
⁶ Telix ASX Disclosure April 16, 2024 Fast Track is a process designed to facilitate the development and accelerate testing of medicines to treat serious diseases and address unmet medical needs. The goal is to bring important new medications to patients earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
⁷ Magnetic resonance imaging.
⁸ Smith NJ et al. J Nucl Med. 2023.
⁹ Large amino acid transporters 1 and 2.
¹⁰ Telix media release dated August 8, 2023. ClinicalTrials.gov ID: NCT05450744.
¹¹ Telix media release from November 22, 2022.
¹² Goodenberger et al. Cancer Genet. 2012.
¹³ Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
¹⁴ Park et al. Journal of Clinical Oncology. 2010.
¹⁵ Ostrom et al. Neuro Oncol. 2018.
¹⁶ Telix ASX disclosure dated December 20, 2021.
¹⁷ Telix ASX disclosure dated November 2, 2021.
¹⁸ Telix ASX disclosure dated October 14, 2022.