Regulatory Advances for Prostate and Kidney Cancer Imaging

Melbourne, Australia, August 1, 2022 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today reports regulatory progress for the Company’s leading prostate and kidney cancer imaging programs in the Asia Pacific (APAC) Region of operation, including progress in the main market of China with its strategic partner Grand Pharmaceutical Group Limited (Grand Pharma).

TLX591-CDx (Iluccix®) for prostate cancer imaging

  • China: An Investigational New Drug (IND) application was filed by Telix’s partner in Greater ChinaGrand Pharma, at the National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) – and accepted for review – for a pivotal Phase III registrational study that will link to the approval of Illuccix by the United States Food and Drug Administration (FDA).
  • South Korea: As previously reported, an imported New Drug Application (NDA) was submitted by Telix’s partner in South KoreaDuChemBio Co, Ltd. (DuChemBio), to the Ministry of Food and Drug Safety (MFDS) for TLX591-CDx (Illuccix®Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).1

TLX250-CDx for Kidney Cancer Imaging

  • China: An IND application has been submitted by Grand Pharma to the NMPA CDE (and accepted for review) for a pivotal Phase III registrational study that will link to Telix’s global Phase III “ZIRCON” trial in the TLX250-CDx (89Zr-girentuximab), for imaging renal cell carcinoma (RCC) with positional emission tomography.

Phase III bridging studies of TLX591-CDx and TLX250-CDx must provide “additional” data in a Chinese-only population to establish that the efficacy of these investigational products is equivalent in Chinese and Western populations. Both studies are planned to be multicentre, enrolling approximately 100 patients.

“Together with our partners, we are pleased to announce the achievement of these important regulatory milestones, including the submission of a first NDA for PSMA imaging in Asia. Additionally, we have made significant progress in China, following an extensive consultation process with the NMPA, and have filed our first IND applications in this important market. The expertise and strong support of our partners Grand Pharma and DuChemBio enabled an efficient process and the achievement of these milestones on time,” said Dr. David N Cade, CEO of Telix Asia Pacific. “The Asia Pacific The region represents a major market opportunity, driven by rising cancer incidence rates and investment in the installation of PET/CT cameras in markets such as China and India. We are committed to bringing targeted imaging and radiation therapy to patients in need throughout the region. »

About prostate and kidney cancer in the Asia Pacific Region

The Asia Pacific The region contains about one-third of the world’s male population and includes many countries whose populations are aging or increasingly adopting more affluent “Western-style” lifestyles, with the two main demographic trends leading to rising rates of cancer incidence. Consequently, the incidence of prostate cancer is increasing in many parts of the region.

In South Koreamore than 13,000 men are diagnosed with prostate cancer each year.2

In China, 115,000 men are diagnosed with prostate cancer each year, increasing by approx. 6% each year and 73,000 people are diagnosed with renal cell carcinoma each year.

In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China should reach 1,110 at the end of 2022, compared to 133 in 2010.3

About Iluccix® (TLX591-CDx)

Illuccix (TLX591-CDx) is a preparation for positron emission tomography (PET) imaging of prostate cancer, targeting prostate-specific membrane antigen (PSMA), a protein overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix allows PSMA-11 to be labeled with the radionuclide Ga-68 directly before injection by healthcare professionals. After preparation of the radiopharmaceutical and injection into the patient, the PSMA-positive lesions are localized by PET imaging.

Illuccix has been approved by the United States Food and Drug Administration (FDA),4 and by the Australian Therapeutic Goods Administration (TGA).5 Telix is ​​also pursuing marketing authorization applications for this experimental candidate in Europe6 and Canada.seven

About the TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is an investigational product developed by Telix with the aim of non-invasively detecting clear cell kidney cancer in patients with “undetermined renal masses” (IDMR), usually identified on the basis of CT scan (CT) or magnetic resonance imaging. (MRI) and are a growing medical dilemma as more tests are performed and more MDRIs are identified.

Grentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CA9), a cell surface target highly expressed in several human cancers, including kidney, lung and esophageal cancers. In July 2020the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy (BT) designation to TLX250-CDx,8 reflecting the significant unmet clinical need to improve the diagnosis and staging of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

About Telix Pharmaceuticals Limited

Telix is ​​a biopharmaceutical company specializing in the development and marketing of diagnostic and therapeutic products using targeted molecular radiation (MTR). Telix is ​​headquartered in Melbourne, Australia with international operations in Belgium, Japan, Swissand United States. Telix is ​​developing a portfolio of clinical-stage products that address significant unmet medical needs 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 Investor Relations

Ms Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
E-mail: [email protected]

This announcement has been authorized for publication by Dr. Christian BehrenbruchManaging Director and Group Chief Executive.

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To the fullest extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.

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

1 ASX Disclosure July 21, 2022.
2 Globocan 2021.
3 Search Goetz Partners 2020.
4 ASX Disclosure December 20, 2021.
5 ASX Disclosure November 2, 2021.
6 ASX Disclosure December 10, 2021.
seven ASX Disclosure December 16, 2020.
8 ASX Disclosure July 1, 2020.

SOURCE Telix Pharmaceuticals Limited

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