TLX Telix Pharmaceuticals Ltd

Telix’s TLX66 in Phase II Academic Study of Pediatric Leukemia
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the London-based Great Ormond Street Hospital (GOSH) has received UK research ethics approval to commence a Phase II academic study of Telix’s investigational product, TLX66 (90Y-DTPA-besilesomab), in children with high-risk leukemia. Relevant approvals from the Medicines and Healthcare products Regulatory Agency (MHRA), and Administration of Radioactive Substances Advisory Committee (ARSAC) have also been received. The study is independently funded by the generosity of a philanthropic foundation, with GOSH as the sponsor.

The open label Phase II study is being carried out by GOSH to evaluate safety and efficacy of TLX66 as part of a reduced toxicity conditioning regimen in children and adolescents undergoing allogeneic haematopoietic stem cell (HSCT) transplantation. The independent trial will enroll 25 patients and follows the successful completion of a Phase I study1 of 10 patients with relapsed refractory leukemia. TLX66 targets CD662, a receptor expressed on specific types of immune/blood cells and has been granted orphan drug designation (ODD) status in Europe for bone marrow conditioning (BMC) for hematopoietic stem cell transplantation (HSCT), a broad clinical indication.

In addition to pediatric leukemia, prior Phase I3 and II4 clinical studies of TLX66 have demonstrated encouraging efficacy and safety data in multiple myeloma, and in patients with other hematological malignancies currently ineligible for stem cell transplant owing to toxicity. Telix recently reported positive topline results from the TRALA study5 of TLX66 at the University of Southampton (UK) for patients with systemic amyloid light chain amyloidosis (SALA), a rare disease with a poor prognosis characterised by abnormal protein deposition in the organs of the body.

Telix Chief Medical Officer, Dr. Colin Hayward stated, “We are pleased that Great Ormond Street Hospital, an international centre of excellence in child healthcare, has received ethics approval to use this investigational product in an important academic study of children and adolescents with high-risk leukemia. This disease currently has one of the poorest prognoses amongst pediatric cancers, and we will be closely monitoring progress by the team at GOSH, in line with Telix’s mission to help patients with cancer live longer, better quality lives.”

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix’s lead investigational product, illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,6 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).7 Telix is also progressing marketing authorisation applications for illuccix® in the European Union8 and Canada.9 None of Telix’s products have received a marketing authorisation in any jurisdiction.

Telix Media Contact

Dr. Stewart HolmstromTelix Pharmaceuticals LimitedDirector Corporate CommunicationsEmail: stewart.holmstrom@telixpharma.com

1 Full results from the Phase I study are expected to be published late 2021.2 Cluster of differentiation 66.3 ClinicalTrials.gov Identifier: NCT01521611.4 ClinicalTrials.gov Identifier: NCT00637767.5 ASX disclosure 25/05/21.6 ASX disclosure 24/11/20.7 ASX disclosure 14/04/21.8 ASX disclosure 1/05/20.9 ASX disclosure 16/12/20.