First Patient Dosed in IPAX-2 Study of TLX101 Brain Cancer Therapy Candidate in Patients with Newly Diagnosed Glioblastoma

MELBOURNE, Australia, Aug. 8, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that a first patient has been dosed in a Phase I study of the Company's investigational therapy TLX101 (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer.

IPAX-2 (ClinicalTrials.gov Identifier: NCT05450744^[1]) is a Phase I dose escalation study to confirm safety profile of TLX101 in combination with external beam radiation therapy (EBRT) and temozolomide in front-line glioblastoma. Twelve patients are expected to be recruited to evaluate whether the observed safety and drug interaction profile remains suitable in this setting before progressing to a proof-of-concept Phase II study.

IPAX-2 is being conducted at six sites across Australia, New Zealand and Europe. The study will build on data generated in IPAX-1 (ClinicalTrials.gov Identifier NCT03849105^[2]), which reported final results in September 2022.^[1] The IPAX-1 study met its primary objective demonstrating safety and tolerability profile of intravenous ¹³¹I-IPA administered concurrently with second line EBRT. The study also delivered encouraging preliminary therapeutic effect, demonstrating a median overall survival of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis.

Professor Josef Pichler, Kepler University Hospital, Austria and Principal Investigator in the IPAX-2 study said, "Promising efficacy data observed in IPAX-1 clearly warrants further investigation in an earlier setting. We are therefore pleased to be exploring Telix's glioblastoma therapy candidate in newly diagnosed patients, to accelerate development in this underserved disease area with few effective treatment options."

Dr. Colin Hayward, Telix Chief Medical Officer added, "Commencing this study supports Telix's goal to expedite new radiopharmaceutical therapies in areas of unmet need. With IPAX-2, we are taking the development of TLX101 into front-line glioblastoma for the first time, and excited to see the potential impact of targeted radiation in patients after initial surgery."

Telix's investigational positron emission tomography (PET) agent TLX101-CDx (¹⁸F-FET) will be used for imaging in the study to identify participants with over-expressed LAT-1 as suitable candidates for ¹³¹I-IPA therapy, and to provide baseline and follow up information on tumour response and progression.

In parallel to IPAX-2, TLX101 is being further investigated in the recurrent setting in the investigator-initiated Phase II IPAX-Linz study, which dosed a first patient in November 2022^[2] and has now exceeded 70% of the patient enrolment target.

About TLX101

TLX101 (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) is one of Telix's lead therapeutic clinical programs and has been granted orphan drug designation in the United States and Europe for glioblastoma therapy. TLX101 targets a membrane transport protein called L-type amino acid transporter 1 (LAT-1) that is typically highly expressed in glioblastoma. TLX101 is a novel approach that is readily able to pass through the blood-brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain.

About TLX101-CDx (¹⁸F-FET)

¹⁸F-FET has been widely used in clinical research settings while recently, new practice guidelines have been developed for the imaging of gliomas using PET with radiolabelled amino acids, of which ¹⁸F-FET is a key enabling radiopharmaceutical.^[3]18F-FET targets the amino acid transport system L (LAT) and is therefore highly suitable for use as a complementary diagnostic agent to TLX101. Telix is preparing to file a new drug application for TLX101-CDx with the United States Food and Drug Administration (FDA) during 2023, in preparation for U.S. commercial launch in 2024, pending regulatory approval.

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].

TLX101 and TLX101-CDx have not received a marketing authorisation in any jurisdiction. Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the FDA,^[4] and by the Australian Therapeutic Goods Administration (TGA),^[5] and by Health Canada.^[6] Telix is also progressing marketing authorisation applications for this investigational candidate in the United Kingdom and the European Union.^[7]

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. ^{^} NCT05450744 (clinicaltrials.gov)
2. ^{^} NCT03849105 (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)