Phase II OPALESCENCE Study of TLX250-CDx in Triple Negative Breast Cancer to be Presented at SABCS

MELBOURNE, Australia, Nov. 30, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today advises that the completed Phase II OPALESCENCE investigator-initiated trial (IIT) of its carbonic anhydrase IX (CAIX)-targeting positron emission tomography (PET) imaging candidate, TLX250-CDx (⁸⁹Zr-DFO-girentuximab), in patients with triple-negative breast cancer (TNBC), will be presented at the 2023 San Antonio Breast Cancer Symposium® (SABCS) taking place from December 5-9, 2023.

Dr. Caroline Rousseau, Principal Investigator for the OPALESCENCE study (ClinicalTrials.gov ID NCT04758780^[1]) at the Institut de Cancérologie de l'Ouest (ICO) in St Herblain (France), will deliver top-line results as a poster presentation at 5pm CT on Wednesday December 6.

The primary objective of the OPALESCENCE study was to evaluate how CAIX-targeted imaging with PET can be utilised for the diagnosis and staging of TNBC and to develop a deeper understanding of CAIX as a potential therapeutic target in this patient population with a significant unmet medical need. 

SABCS is the largest and most prestigious scientific gathering on breast cancer research worldwide. Visit http://www.sabcs.org/^[2] for more information on the congress.

About the Institut de Cancérologie de l'Ouest (ICO)

ICO is a 1,400 professional strong not-for-profit center fighting against cancer. It welcomes close to 48,000 patients per year, and conducts the mission and service of a public hospital. Strengthened by its 4 missions – Prevention, Care, Research and Teaching – ICO offers broad, state-of-the-art expertise that is exclusively dedicated to cancerology. 

Advanced medicine at the service of patients: specialising in oncology, ICO professionals provide patients with personalised, innovative and multidisciplinary care at every stage of their treatment. From rapid diagnosis to surgery, chemotherapy and radiotherapy, care also extends to supportive care, which is highly developed at ICO.

The integration of care, research and innovation is integral to ICO. Research activities, which are a specific mission at ICO, are undertaken from concept all the way through to clinical trials. Research is conducted in all disciplines of cancerology: medical oncology, radiotherapy, surgery, anaesthesia, nuclear medicine, medical imagery, support care, and human sciences. Patients who are cared for at ICO receive privileged access to cutting edge clinical trials in cancerology. The mission of the Innovation Unit is to support innovation in oncology by assisting both internal and external project leaders from the initial idea to the operational implementation of the innovation. Through its teaching mission and academic expertise, ICO contributes to the training of tomorrow's cancer professionals. For more information contact: promotionrc@ico.unicancer.fr^[3]

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. 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-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).

Visit www.telixpharma.com^[4] 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 LinkedIn^[5].

TLX250-CDx has not received a marketing authorisation in any jurisdiction. 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),^[1] by the Australian Therapeutic Goods Administration (TGA),^[2] and by Health Canada.^[3]

Telix's SENSEI® ultra-miniaturised robotic gamma probe is registered as a Class 1 device with the FDA, and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area for intra-operative detection of sentinel lymph nodes.^[4]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com^[6]

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments.  Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

References

1. ^{^} NCT04758780 (clinicaltrials.gov)
2. ^{^} http://www.sabcs.org/ (www.sabcs.org)
3. ^{^} promotionrc@ico.unicancer.fr (www.prnasia.com)
4. ^{^} www.telixpharma.com (www.telixpharma.com)
5. ^{^} LinkedIn (www.linkedin.com)
6. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)