Telix to Add FAP-Targeting Candidates to Theranostic Pipeline
Telix Pharmaceuticals announces expansion of its theranostic pipeline with new FAP-targeting assets, focusing initially on bladder cancer treatment. The company has entered exclusive worldwide agreements for clinically validated FAP-targeting therapeutic and diagnostic radiopharmaceutical candidates developed at Johannes Gutenberg-Universität Mainz. The assets, tested in over 500 patients, feature enhanced tumor retention and reduced off-target uptake. The deal involves €7 million in initial cash payment, €3 million after 12 months, and up to €132 million in milestone payments, plus €20 million in commercial milestones and royalties.
Telix Pharmaceuticals annuncia l'espansione della sua pipeline teranostica con nuovi asset mirati al FAP, concentrandosi inizialmente sul trattamento del cancro alla vescica. L'azienda ha stipulato accordi esclusivi a livello mondiale per candidati radioterapeutici e diagnostici validati clinicamente, sviluppati presso la Johannes Gutenberg-Universität Mainz. Gli asset, testati su oltre 500 pazienti, presentano una maggiore ritenzione tumorale e una ridotta captazione non mirata. L'accordo prevede un pagamento iniziale in contante di 7 milioni di euro, 3 milioni dopo 12 mesi e fino a 132 milioni di euro in pagamenti legati ai traguardi, oltre a 20 milioni di euro in traguardi commerciali e royalties.
Telix Pharmaceuticals anuncia la expansión de su pipeline teranóstica con nuevos activos dirigidos al FAP, centrándose inicialmente en el tratamiento del cáncer de vejiga. La empresa ha firmado acuerdos exclusivos a nivel mundial para candidatos radioterapéuticos y de diagnóstico dirigidos al FAP que fueron desarrollados en la Johannes Gutenberg-Universität Mainz. Los activos, probados en más de 500 pacientes, presentan una mejor retención tumoral y una menor captación fuera del objetivo. El acuerdo incluye un pago inicial en efectivo de 7 millones de euros, 3 millones después de 12 meses y hasta 132 millones de euros en pagos por hitos, además de 20 millones de euros en hitos comerciales y regalías.
텔릭스 제약회사(Telix Pharmaceuticals)는 FAP 타겟 자산을 추가하여 테라노스틱 파이프라인 확장을 발표하며, 처음에는 방광암 치료에 집중합니다. 이 회사는 마인츠 요한네스 구텐베르크 대학교에서 개발된 임상적으로 검증된 FAP 타겟 치료 및 진단 방사성 의약품 후보에 대해 전 세계적으로 독점 계약을 체결했습니다. 이 자산은 500명 이상의 환자에서 테스트되었으며 종양 유지 시간이 증가하고 비특이적인 섭취가 감소하는 특징이 있습니다. 이번 거래는 초기 현금 지급금 700만 유로, 12개월 후 300만 유로, 최대 1억 3200만 유로의 이정표 지급 및 2000만 유로의 상업적 이정표 및 로열티를 포함합니다.
Telix Pharmaceuticals annonce l'expansion de son pipeline théranostique avec de nouveaux actifs ciblant le FAP, en se concentrant d'abord sur le traitement du cancer de la vessie. L'entreprise a signé des accords exclusifs à l'échelle mondiale pour des candidats radiopharmaceutiques thérapeutiques et diagnostiques ciblant le FAP, développés à l'université Johannes Gutenberg de Mayence. Ces actifs, testés sur plus de 500 patients, présentent une meilleure rétention tumorale et une réduction de l'absorption hors cible. L'accord inclut un paiement initial en espèces de 7 millions d'euros, 3 millions après 12 mois, et jusqu'à 132 millions d'euros en paiements d'étapes, ainsi que 20 millions d'euros en étapes commerciales et redevances.
Telix Pharmaceuticals gibt die Erweiterung seiner theranostischen Pipeline mit neuen FAP-zielgerichteten Assets bekannt, die zunächst auf die Behandlung von Blasenkrebs fokussiert sind. Das Unternehmen hat exklusive weltweite Vereinbarungen für klinisch validierte FAP-zielgerichtete therapeutische und diagnostische Radiopharmazeutika, die an der Johannes Gutenberg-Universität Mainz entwickelt wurden, getroffen. Die Assets, die an über 500 Patienten getestet wurden, zeichnen sich durch eine verbesserte Tumorrettung und eine reduzierte Off-Target-Aufnahme aus. Der Deal umfasst eine anfängliche Barauszahlung von 7 Millionen Euro, 3 Millionen Euro nach 12 Monaten und bis zu 132 Millionen Euro an Meilensteinzahlungen sowie 20 Millionen Euro an kommerziellen Meilensteinen und Lizenzgebühren.
- Assets already clinically validated in 500+ patients
- Next-generation therapeutics show improved tumor retention
- Expands pipeline into bladder cancer treatment
- Technology demonstrates pan-cancer targeting potential
- Significant upfront cash payment of €7 million required
- Additional €3 million payment due in 12 months
- Deal closing subject to regulatory approvals
- Future milestone payments up to €152 million plus royalties
Insights
This strategic acquisition significantly strengthens Telix's theranostic pipeline with clinically validated FAP-targeting assets. The deal structure, involving
The FAP-targeting platform's pan-cancer potential, particularly in bladder cancer, complements Telix's existing urology franchise. The novel structure claiming improved tumor retention and reduced off-target effects could provide a competitive advantage over first-generation compounds. The integration of both diagnostic and therapeutic capabilities aligns with the growing theranostic market trend.
The deal's value proposition is enhanced by the assets' extensive clinical validation and established safety profile, potentially accelerating the path to commercialization. However, investors should monitor the German FDI approval process and patent rights assignment as closing conditions.
The acquisition of FAP-targeting assets represents a significant scientific advancement in precision oncology. FAP's expression in the tumor microenvironment of epithelial cancers makes it an attractive pan-cancer target. The next-generation compounds' improved tumor retention and reduced off-target effects could potentially address key limitations in current radiopharmaceutical treatments.
The extensive clinical validation in 500+ patients across various solid tumors provides robust evidence of safety and efficacy. The dual diagnostic-therapeutic approach enables better patient selection and treatment monitoring. The focus on bladder cancer as the primary indication is strategic, given the unmet medical need and synergy with Telix's existing programs in prostate and kidney cancers.
MELBOURNE, Australia, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces it will expand its theranostic pipeline with new assets targeting Fibroblast Activation Protein (FAP), one of the most promising pan-cancer targets in nuclear medicine. Telix’s development program will initially focus on the treatment of bladder cancer, rounding out its urology franchise, which includes late-stage therapeutic programs for kidney and prostate cancers.
FAP is a pan-cancer marker expressed in the tumor microenvironment of epithelial cancers and on the surface of some specific cancer types, including sarcomas and mesotheliomas.
Telix has entered into asset purchase and exclusive worldwide in-licence agreements for a suite of clinically validated FAP-targeting therapeutic and precision medicine (diagnostic) radiopharmaceutical candidates developed by Professor Frank Roesch and his collaborators at the Institute of Nuclear Chemistry at the Johannes Gutenberg-Universität Mainz, Germany. The next-generation therapeutic assets are differentiated by a novel structure that drives extended tumor retention while minimizing off-target uptake, potentially overcoming the limitations seen with first-generation compounds. The diagnostic and therapeutic compounds have been clinically validated in over 500 patients across a variety of solid tumors and are the subject of multiple peer-review publications1.
Richard Valeix, Chief Executive Officer, Telix Therapeutics, said, “We are delighted to partner with Professor Roesch and his team on this exciting frontier of radiopharmaceuticals. Telix will gain access to assets that are already significantly de-risked, with clinically demonstrated safety profile and efficacy. We will develop these assets in bladder cancer as a primary indication, in line with our focus on urological cancers, and explore the potential of FAP as a pan-cancer target, adding significant value to our pipeline.”
Frank Roesch, professor emeritus, said, “Over the past two years, our FAP inhibitor-based theranostic candidates have seen extensive preclinical and clinical evaluation. Collaboration has been very important, and I am grateful to many colleagues around the world who have contributed to advancing the molecules to this point. We are excited to be working with Telix as a leader in radiopharmaceutical innovation, development and commercialization, to further develop and bring these drug candidates to regulatory approval. The ultimate goal is to improve the diagnostic precision and therapeutic outcomes of cancer patients in need.”
Visit the Telix corporate website to view an interactive explainer on FAP: Attack on Stroma
Deal terms and conditions
Under an exclusive worldwide licence agreement with a German company controlled by Professor Roesch, SCV GmbH, and a concurrently-signed asset purchase agreement with German company Medianezia GmbH, which collectively hold the intellectual property rights to the FAP assets, Telix will pay
Closing of the licence agreement and asset purchase agreement is expected to occur simultaneously and is subject to customary closing conditions including, with respect to the acquisition of assets, assignment of patents rights and foreign direct investment (FDI) approval of Germany’s Ministry for Economic Affairs and Climate Action. Telix cannot guarantee these transactions will close in any specific timeframe or upon the terms summarised herein, if at all.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. 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 significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: 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)2, by the Australian Therapeutic Goods Administration (TGA) 3, and by Health Canada4. No other Telix product has received a marketing authorization 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 X and LinkedIn.
Telix Investor Relations
Australia
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
United States
Lisa Wilson
In-Site Communications
Email: lwilson@insitecony.com
Telix Media Relations (U.S.)
Eliza Schleifstein
ES Media Relations
Email: eliza@schleifsteinpr.com
Phone: 917-763-8106
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
Legal Notices
You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, or on our website.
The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.
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©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
1 Ballal et al. Pharmaceuticals. 2021; Ballal et al. JNM. 2022; Ballal et al. JNM. 2023; Bal et al. JNM. 2024.
2 Telix ASX disclosure 20 December 2021.
3 Telix ASX disclosure 2 November 2021.
4 Telix ASX disclosure 14 October 2022.
FAQ
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