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Telix Pharmaceuticals Ltd — Capital/Financing Update 2020
Dec 13, 2020
31324_rns_2020-12-13_7349daa2-1a8c-4978-bd9a-377ad9b3ef73.pdf
Capital/Financing Update
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Telix Pharmaceuticals Limited ACN 616 620 369 Suite 401, 55 Flemington Road North Melbourne Victoria, 3051 Australia
Telix Completes IP Agreement with the University of Southampton (UK) Granting Exclusive Access to TRALA Clinical Trial Data
Melbourne (Australia) – 14[th] December 2020 . Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that its wholly-owned subsidiary TheraPharm GmbH[1] has completed an Intellectual Property (IP) agreement (‘Agreement’) with the University of Southampton, UK thereby granting Telix exclusive access to a key clinical data package relating to[90] Y-besilesomab, a therapeutic product Telix intends to develop for bone marrow conditioning (BMC) in patients undergoing hematopoietic stem cell transplant (HSCT) for the treatment of blood cancers (hematologic malignancies) and various related conditions.
The Agreement specifically provides Telix the exclusive rights to clinical data generated in the University of Southampton’s Targeted Radiotherapy for AL Amyloidosis (‘TRALA’) clinical trial, led by Dr. Kim Orchard, Senior Lecturer and Consultant Hematologist at the University Hospital Southampton. The Phase I TRALA trial, which has completed patient recruitment, evaluated the safety and toxicity of[90] Y-besilesomab as the sole bone marrow conditioning agent in patients undergoing hematopoietic stem cell transplant for the treatment of systemic amyloid light chain amyloidosis (‘SALA’).
Under the terms of the Agreement, subject to successful clinical development of[90] Y-besilesomab, Telix will pay the University of Southampton approximately GBP £0.875M in future clinical, regulatory and commercial milestones, and a low single-digit royalty on net sales of commercial products.
Early observations from the TRALA study have demonstrated promising safety and efficacy results for[90] Y-besilesomab as a BMC agent in patients with SALA[2] , with final results from the TRALA trial expected to be reported in January 2021.[90] Y-besilesomab has been granted orphan drug designation (ODD) status in Europe for the broad indication of BMC for HSCT and has significant potential for fast-track development for the treatment of SALA.
Dr. Kim Orchard, from the University Hospital Southampton stated, “This approach represents a step change in the way we deliver HSCT transplants, and we have yet to explore the full potential of this technology. It will be a very positive development for patients receiving bone marrow transplants, particularly if we are able to avoid long term toxicity that current treatment causes, especially in younger patients.”
Telix CEO, Dr. Christian Behrenbruch said, “Telix is committed to extending and improving the lives of patients with serious diseases. We are delighted to be entering into collaboration with Dr. Kim Orchard and the University of Southampton, and look forward to efficiently moving[90] Y-besilesomab into the next stage of development for the treatment of patients with SALA, following appropriate consultation with European regulatory authorities.”
About Systemic Amyloid Light-Chain Amyloidosis (SALA)
SALA is a rare, but serious protein deposition disease, caused by a protein known as ‘amyloid’ that is produced by abnormal plasma cells residing in the bone marrow. As amyloid accumulates in the
1 See ASX disclosures 14th December 2020 and 30th November 2020.
2 Orchard K, Bosslet K. Antibody Targeted Radio Therapy (ATRT) for Conditioning before Hematopoietic Stem Cell Transplantation (HSCT). Presented at the 35[th] International Conference on Advances in the Application of Monoclonal Antibodies in Clinical Oncology, June 2018.
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organs of the body, organ function will eventually deteriorate, ultimately causing organ failure. SALA has an estimated prevalence of 30,000 and 45,000 in United States and Europe, respectively and while a rare disease, SALA portends a very poor prognosis, with a median survival from diagnosis of ~11 months if untreated.
The current standard of care comprises of induction therapy (typically cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC, followed by HSCT. This approach is typically only accessible to a small proportion of patients (<20%) who are able to tolerate induction therapy and melphalan BMC.
About Telix Pharmaceuticals Limited
Telix is a clinical-stage 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 oncology products that address significant unmet medical needs in prostate, kidney, brain and hematological cancers. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.
Telix Corporate Contact Dr. Christian Behrenbruch Telix Pharmaceuticals Limited CEO Email: [email protected]
Telix Investor Relations
Dr. David N. Cade Telix Pharmaceuticals Limited CBO and Head of Investor Relations Email: [email protected]
Important Information
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “U.S. Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the U.S. Securities Act or an exemption from the registration requirements of the U.S. Securities Act is available. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer.
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