MELBOURNE,Australia,Aug. 28,2024 --Telix Pharmaceuticals Limited (ASX: TLX,Telix,the Company) today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx,(Pixclara®[1],18F-floretyrosine or 18F-FET),an investigational PET[2] agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients.
Given the potential to address significant unmet medical need,Pixclara®1 has been granted Orphan Drug[3] and Fast Track[4] designation by the FDA,which facilitates expedited review and closer consultation with the agency during the review process. FETPET (Pixclara®1)is already included in international clinical practice guidelines for the imaging of gliomas[5],however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.
There is a critical unmet need to improve the diagnosis and management of glioma,particularly in the post-treatment setting. With low survival rates and the need to make rapid decisions,precision imaging is paramount. Subject to regulatory approval,Pixclara®1 has the potential to address this need,enabling patients to receive greater clarity in their diagnosis and treatment decision making. Pixclara®1 is also being developed as the "companion" theranostic imaging agent for TLX101,Telix's investigational neuro-oncology drug candidate,which targets the same amino acid transporter mechanism with therapeutic targeted radiation.
Kevin Richardson,Chief Executive Officer,Telix Precision Medicine,stated,"Gliomas are the most common primary brain tumours of the central nervous system. Conventional imaging with MRI[6] often yields inconclusive results in characterising recurrent disease and therefore delays time-sensitive decision making4. Limitations of conventional imaging techniques include the lack of biological specificity,dependency on blood-brain barrier disruption,and an inherent inability to differentiate between tumour progression or treatment-related causes[7]. Telix's filing of this NDA for Pixclara®1 is an important milestone,reflecting our commitment to improved and accessible neuro-oncology imaging in the U.S.,and taking us one step closer to commercial availability in 2025,subject to FDA approval."
About TLX101-CDx
TLX101-CDx (Pixclara®1) is a PET imaging agent,which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterisation of glioma. TLX101-CDx targets membrane transport proteins known as LAT1 and LAT2[8]. 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-2[9] and IPAX-Linz[10] 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 tumours[11]. 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.[12].The mainstay of treatment for GBM comprises surgical resection,followed by combined radiotherapy and chemotherapy. Despite such treatment,recurrence occurs in almost all patients[13],with an expected survival duration of 12-15 months from diagnosis[14].
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne,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 U.S. Food and Drug Administration (FDA)[15],by the Australian Therapeutic Goods Administration (TGA)[16],and by Health Canada[17]. 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 XandLinkedIn.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®,Illuccix® and Pixclara® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Pixclara trade name is subject to final regulatory approval.
[1] Brand name subject to final regulatory approval.
[2]Positron emission tomography.
[3]Telix ASX disclosure 6 October 2020.
[4]Telix ASX disclosure 16 April 2024. Fast Track is a process designed to facilitate the development,and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
[5]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.
[6]Magnetic resonance imaging.
[7]Smith NJ et al. J Nucl Med. 2023.
[8]Large amino acid transporters 1 and 2.
[9]Telix media release 8 August 2023. ClinicalTrials.gov ID:NCT05450744.
[10]Telix media release 22 November 2022.
[11]Goodenberger et al. Cancer Genet. 2012.
[12]Ostrom 2022,CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
[13]Park et al.Journal of Clinical Oncology.2010.
[14]Ostrom et al.Neuro Oncol.2018.
[15]Telix ASX disclosure 20 December 2021.
[16]Telix ASX disclosure 2 November 2021.
[17]Telix ASX disclosure 14 October 2022.
