TLX101-CDx (Pixclara) Granted FDA Fast Track Designation - Seite 2

David N. Cade, MD, Group Chief Medical Officer at Telix, stated, “This unique collaboration between Dr. Hope’s team at UCSF and Telix will enable us to utilise our collective clinical data and expertise to facilitate nationwide access to FET PET in the United States while fostering ongoing research and development with the objective 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 supply finished unit doses of TLX101-CDx to the U.S. market.

Steven Chilinski, President and CEO at Pharmalogic, added, “Telix has quickly grown into a global theranostics leader with an impressive product pipeline. Through this partnership, we’re delighted to bring this imaging agent to glioma patients in the U.S. upon regulatory approval.” 

Richard Valeix, Group Chief Commercial Officer at Telix, continued, “These milestones represent significant progress as we bring this investigational product closer to market in the U.S. and commercial launch. PharmaLogic has rapidly developed an excellent reputation for manufacturing radiopharmaceuticals to rigorous quality standards and will deliver 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 (Pixclara²) 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 glioma⁶. TLX101-CDx targets membrane transport proteins known as LAT1 and LAT2⁷. 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 and IPAX-2⁸ and IPAX-Linz⁹ 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 tumours¹⁰. 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.¹¹. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients¹², with an expected survival duration of 12-15 months from diagnosis¹³.