Unlocking New Possibilities: First Patient Dosed in Phase II STARBURST Study of TLX250-CDx

Telix Pharmaceuticals Limited (ASX: TLX, Telix) is pleased to announce that the first patient has been dosed in the groundbreaking clinical trial of TLX250-CDx (89Zr-DFO-girentuximab), an innovative PET/CT imaging agent targeting carbonic anhydrase- (CAIX). This Phase II study will explore the potential of TLX250-CDx across a wide range of cancer indications, providing an exciting opportunity to advance cancer treatment.

The STARBURST study (ClinicalTrials.gov Identifier: NCT05563272) is your chance to be part of a revolutionary Phase II “basket” study that is looking into the use of CAIX expression to diagnose and treat a broad range of solid tumours. These include breast, cervix, colorectal, gastric, esophageal, head and neck, lung, ovarian, pancreatic and vulval cancers and is a highly anticipated project with potential to revolutionize the field!

CAIX, a protein overexpressed on the surface of clear cell renal cell carcinoma (ccRCC), has been the cancer target of Telix’s highly successful Phase III ZIRCON study. It is also highly expressed among other advanced-stage solid tumors with poor prognostic outlooks. Tumors that express CAIX are typically more aggressive and feature a TME that can prove to be resistant to common immunotherapies, due to increased levels of hypoxia in the surrounding environment.

STARBURST is exploring different types of tumours to see if they can be targeted similarly for diagnosis and treatment. Results from two studies on triple-negative breast cancer and non-muscle-invasive bladder cancer seem to indicate the potential of using TLX250-CDx in these areas, which are in desperate need of new treatments. 89Zr’s longer half-life makes it especially helpful in this context, as it can act as a “scouting” study for future attempts to use radionuclides for therapeutic purposes.

Dr. Jackson Kiser, Medical Director of Molecular Imaging at Carilion Clinic in Roanoke, Virginia (U.S.), is excited to expand the potential of a new investigational agent already proven in the ZIRCON study of ccRCC to a series of other tumour types known to express the cancer target CAIX. As Principal Investigator for the STARBURST study, Dr. Kiser believes this agent has the potential to improve patient outcomes for many forms of cancer.

Telix’s Chief Medical Officer, Dr Colin Hayward, is delighted to announce the dosing of the first patient in the innovative STARBURST study, which has the potential to assess the effectiveness of CAIX as a biomarker beyond renal cancer.

Following the success of ZIRCON and preliminary promising results from TLX250-CDx in bladder and breast cancer, this step is a strategically important milestone. We are immensely grateful to Dr Kiser and his team at Carilion Clinic for their involvement, and also thank those patients who are contributing to the study.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical leader with a passion for providing innovative diagnostic and therapeutic radiopharmaceuticals to patients, and their families, around the globe. With operations in Australia: Melbourne USA, Europe: Belgium and Switzerland and Japan, the Melbourne-based company is remarkable for its Australian Stock Exchange listing, and its determined commitment to developing a comprehensive portfolio of clinical-stage products that passionately address and serve an unmet medical need in oncology and rare diseases.

Telix’s breakthrough lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection has been granted a green light for use in the United States, Australia, and Canada, and is paving the way for broader marketing applications in the United Kingdom and the European Union. Its approval by the FDA, TGA, and Health Canada have unlocked new possibilities for the treatment and diagnosis of cancers and other complex medical conditions.

Telix Investor Relations

Telix is announcing an exciting new development that could have a transformative effect on its business and operations. Through this announcement forward-looking statements can be identified pertaining to the progress, timing, results and success of the Company’s preclinical and clinical studies, research and development programs, regulatory filings and approvals, manufacturing activities, product marketing activities, commercialisation of products if or when approved, estimates of future revenues and capital requirements and more.

It is important to note however, that Telix’s actual results, performance or achievements may differ from those which are expressed or implied by such statements. Therefore, it is essential to keep this in mind when considering the potential of the immense opportunities provided by Telix.

Leave a Comment