First Patient Dosed in Phase II Renal Cancer Theranostics Study

MELBOURNE, Australia and INDIANAPOLIS, May 5, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that a first patient has been dosed in the 'STARLITE 2' Phase II study of the Company's investigational renal cancer therapy, TLX250 (¹⁷⁷Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in New York.

STARLITE 2 (NCT05239533) will assess the efficacy of TLX250 targeted radiation in combination with immunotherapy for clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. TLX250 targets carbonic anhydrase IX (CA9),^[1] a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy.^[2] The concept is that low doses of targeted radiation can potentially overcome immune resistance – or "immune prime" a tumour and therefore make it more responsive to cancer immunotherapy.

This Phase II study, in patients who have progressed following prior immunotherapy, will evaluate TLX250-delivered radiation in combination with the anti-PD-1^[3] immunotherapy Opdivo®^[4] (nivolumab). The primary endpoint is to determine the safety and efficacy of combination therapy with TLX250 as assessed by the tumours responding to the Telix therapy versus the current standard of care alone. Telix's investigational companion imaging agent TLX250-CDx (⁸⁹Zr-DFO-girentuximab) will also be used in the study to image CA9 expression. The single-arm investigator-led study is expected to enrol approximately 30 patients.

Telix Chief Medical Officer, Dr. Colin Hayward noted, "The integration of precision nuclear medicine and medical oncology is underway and Telix is at the forefront of this movement to develop personalised products and patient-friendly regimens. We wish to express our gratitude to Dr. Darren Feldman and his clinical team, as well as the patients who will contribute to this ground-breaking study."

Disclosure: MSK has institutional financial interests related to Telix.

About TLX250

TLX250 (¹⁷⁷Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets carbonic anhydrase IX (CA9), a cell surface protein that is highly expressed in several human cancers including ccRCC. High CA9 tumour expression is generally correlated with poor prognosis. Telix's companion investigational diagnostic imaging agent TLX250-CDx (⁸⁹Zr-DFO-girentuximab) is currently the subject of a global Phase III trial (ZIRCON trial, NCT03849118).

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, 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 product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),^[5] and by the Australian Therapeutic Goods Administration (TGA).^[6] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^[7] and Canada.^[8]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com 

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

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