TLX101-CDx (Pixclara™) Granted FDA Breakthrough Device Designation, Alternate Records

• FDA Like a flash Video display designation granted for TLX101-CDx for glioma (mind most cancers) imaging
• Collaboration agreement launched for joint development and commercialisation with UCSF
• PharmaLogic launched as commercial manufacturing and pharmacy distribution partner

/PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation^[1] for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™^[2], ¹⁸F-floretyrosine or ¹⁸F-FET).

The granted Like a flash Video display designation is for the characterisation of innovative or recurrent glioma utilizing positron emission tomography (PET). Concurrently, Telix is within the final stages of developing willing its U.S. Aloof Drug Utility (NDA) for TLX101-CDx on this preliminary indication, in both grownup and paediatric patients. This designation permits expedited review and closer session with the FDA within the course of the review project.

Amino acid PET is currently included in U.S. and European guidelines for glioma imaging^[3], although there is currently no FDA-approved targeted PET agent for brain cancer imaging in the U.S. Telix aims to make this product commercially available in the U.S., significantly increasing patient access to this important imaging agent.

Collaboration with the University of California, San Francisco

Telix has an ongoing research collaboration and data license agreement with the University of California, San Francisco (UCSF). UCSF is one of the leading academic centers conducting clinical research on the use of FET PET^[4] in a range of neurological malignancies. This academic-industry collaboration supporting joint development and commercialization will enable Telix to provide TLX101-CDx as a commercial product in the U.S., subject to regulatory approval.

Thomas A. HopeMD, Professor of Radiology at UCSF, said, “There is serious unmet need to improve the prognosis and management of glioma, particularly in the post-treatment setting, and we are eager to leverage the clinical expertise at UCSF to help make this investigational agent more widely available. ¹⁸F-FET has the potential to help determine whether a glioma is truly progressing or undergoing a treatment-induced change, known as pseudoprogression, where MRI^[5] — the standard of care — can often be inconclusive.”

David N. CadeMD, Chief Clinical Officer at Telix, said, “This unique collaboration between Dr. Hope’s team at UCSF and Telix will enable us to utilize our combined clinical data and expertise to facilitate nationwide access to FET PET in the United States while fostering ongoing research and development with the goal of expanding the clinical utility of this advanced imaging agent for the benefit of patients.”

Commercial Partnership: PharmaLogic Holdings Corp

Telix has selected PharmaLogic Holdings Corp (PharmaLogic) as its commercial manufacturing and pharmacy distribution partner, to provide unit doses of TLX101-CDx to the U.S. market.

Steven ChilinskiPresident and CEO at Pharmalogic, added, “Telix has rapidly grown into an international theranostics leader with an ambitious product pipeline. Through this partnership, we’re pleased to deliver this imaging agent to glioma patients in the U.S. upon regulatory approval.” 

Richard Valeix, Team Chief Commercial Officer at Telix, continued, “These milestones indicate necessary growth as we advance this investigational product toward market in the U.S. and commercial launch. PharmaLogic has developed a strong reputation for manufacturing radiopharmaceuticals to rigorous quality standards and can reliably supply a key component of Telix’s supply chain strategy for TLX101-CDx in the U.S., subject to regulatory approval.”

About TLX101-CDx

TLX101-CDx (Pixclara™^[2]) is a PET imaging agent, which has been previously granted orphan drug designation (ODD) in the U.S. as an imaging agent for the management of glioma^[6]. TLX101-CDx targets membrane transport proteins known as LAT1 and LAT2^[7]. This enables TLX101-CDx to be potentially used as a companion diagnostic agent to TLX101 (4-L-[[[[¹³¹I]iodo-phenylalanine, or ¹³¹I-IPA), Telix’s LAT1-targeted investigational glioblastoma (GBM) therapy, currently under investigation in the IPAX-2^[8] and IPAX-Linz^[9] trials.

About gliomas in the U.S.

Gliomas are highly diffusely infiltrative tumours that affect the surrounding brain tissue. They are the most common type 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^[10]. In the U.S., there are six cases of gliomas diagnosed per 100,000 people each 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.^[11]. The standard treatment for GBM involves surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in nearly all patients^[12] with an expected survival duration of 12-15 months from diagnosis^[13].

About PharmaLogic

PharmaLogic is a world-class contract pattern and manufacturing organisation specialising in unique diagnostic imaging and therapeutic radiopharmaceuticals for the drugs of cancers and other malignancies. In addition to an established and legit community of radiopharmacies, PharmaLogic has a long time of journey in drug pattern from discovery, thru manufacturing and commercialisation. The Firm seeks to plot conclude the lead within the pattern of radiopharmaceutical technology for the again of patients worldwide. For added knowledge, seek recommendation from: www.radiopharmacy.com.

About Telix Prescribed capsules Diminutive

Telix is a biopharmaceutical firm focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated clinical 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 necessary unmet clinical 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 acknowledged as ⁶⁸Ga PSMA-11 and marketed below the logo name Illuccix®), has been well-liked by the FDA^[14]by the Australian Therapeutic Goods Administration (TGA)^[15]and by Health Canada^[16]. No other Telix product has purchased a marketing authorisation in any jurisdiction.

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

Telix Investor Kinfolk

Ms. Kyahn Williamson
Telix Prescribed capsules Diminutive
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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