Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

MELBOURNE, Australia, April 11, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM).

The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The Phase I study is required to establish the safety profile of this therapeutic candidate in a Chinese patient population, thus enabling Chinese patients to be enrolled in Telix's planned global pivotal registration trial for TLX101. This is the first of Telix's investigational therapies to move into a clinical trial with Grand Pharma.

The IPAX-1 study of TLX101 (ClinicalTrials.gov Identifier: NCT03849105) met its primary objective demonstrating safety and tolerability profile of intravenous ¹³¹I-IPA administered concurrently with external beam radiation therapy (EBRT) in patients with recurrent GBM. The study also delivered encouraging preliminary efficacy data for further evaluation, demonstrating a median overall survival of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis.^[1][1]

Telix has now initiated the IPAX-2 study (ClinicalTrials.gov Identifier: NCT05450744^[2])  in Australian sites to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3. The IPAX-2 study will run concurrently to the study in Chinese patients in the same disease setting.

Mr Zhou Chao, CEO Grand Pharma said, "China is a rapid adopter of new radiopharmaceutical theranostics, and the Chinese regulator NMPA – a leading, competent global authority – is increasingly familiar with this class of drug. With over 30,000 patients diagnosed with GBM in China annually,^[2] there is very high unmet medical need for new therapeutic options for this disease, which makes studies like this one critical."

Dr David N Cade, CEO Telix Asia Pacific added, "Building on the successful IPAX-1 study of TLX101 therapy in patients with recurrent GBM, we are pleased to commence this follow-on study in newly diagnosed Chinese patients. Completion of this Phase I trial is critically important to the development of this asset, as it will enable Chinese patients to be included in the future global registration trial for TLX101 and potentially enable parallel regulatory submissions in Western markets and China. With our partner for Greater China, Grand Pharma, Telix's goal is to provide new treatment options for this aggressive cancer with significant unmet medical need as efficiently as possible in this large market."

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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 need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com^[3] 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 Twitter^[4] (@TelixPharma) and LinkedIn^[5].

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),^[3] and by the Australian Therapeutic Goods Administration (TGA),^[4] and by Health Canada.^[5] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom.^[6]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: 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. ^{^} NCT03849105 (www.clinicaltrials.gov)
2. ^{^} NCT05450744 (www.clinicaltrials.gov)
3. ^{^} www.telixpharma.com (www.telixpharma.com)
4. ^{^} Twitter (twitter.com)
5. ^{^} LinkedIn (www.linkedin.com)
6. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)