Program relevance: TLX591 (Therapy) / TLX591-CDx (Imaging)
Telix is developing prostate cancer imaging technology as part of its “theranostic” (diagnostic+therapeutic) strategy for prostate therapy. High quality imaging is a vitally important part of delivering prostate cancer therapy. Through the partnership (and subsequent acquisition of ANMI SA), Telix has focused on the development of 68Ga-PSMA (the illumetTM kit – illumet.com) for use with Positron Emission Tomography (PET) imaging, with commercial emphasis on US and European markets. However outside of major markets, the adoption of PET is growing but still somewhat limited. The in-licensing of the ININ 99mTc-PSMA kit enables Telix to offer a similar prostate imaging solution for use with Single Photon Emission Computed Tomography (SPECT) - an imaging approach and radiopharmaceutical supply chain that is far more widely available in MENA, Latin America and Asia.
Key points for investors:
The addition of the ININ 99mTc-PSMA kit to the exiting 68Ga-PSMA (illumetTM) solution is highly complementary and considerably extends Telix’s global reach in prostate cancer.
Prostate cancer (PCa) is the second most common cancer (after skin cancer) and the sixth leading cause of cancer death among men worldwide. The prostate cancer mortality rate is decreasing in high income countries. However, the incidence and burden of disease are steadily increasing globally, resulting in further challenges in the allocation of limited health care resources, underscoring the need for high quality and cost-effective patient management tools as 99mTc-PSMA.
The partnership with ININ takes the form of a royalty-bearing license agreement and manufacturing access to existing clinical-grade production of the 99mTc-PSMA kit, enabling Telix to rapidly add a second commercially-ready prostate imaging product to its urologic oncology portfolio.
Telix Group Expands Prostate Imaging Capability through ININ Technology Partnership
Liège (Belgium) – 24 January 2019. Advanced Nuclear Medicine Ingredients SA (“ANMI”), a wholly- owned subsidiary of Telix Pharmaceuticals Limited (ASX:TLX, “Telix”) today announced that it has completed the in-licensing of 99mtechnetium-EDDA/HYNIC-Lys(NaI)-Urea-Glu (99mTc-iPSMA), a novel clinical-stage radiopharmaceutical for the imaging of prostate cancer, from the Mexican Instituto Nacional de Investigaciones Nucleares (“ININ”).
Single Photon Emission Computed Tomography or “SPECT” is a nuclear medicine imaging procedure widely used especially in the management of cancer and is an alternative to the Positron Emission Tomography (PET) approach already under development by ANMI/Telix (the illumetTM / 68Ga-PSMA kit). SPECT is similar to PET in its use of radioactive tracer material and detection of gamma rays (and it is often generically referred to as “gamma imaging”). However, in much of the world PET/CT technology is not yet widely available, and therefore SPECT remains the dominant nuclear imaging modality for cancer management.
The ININ team and collaborators have clinically evaluated 99mTc-iPSMA with SPECT/CT and the acquired results demonstrate highly sensitive detection of prostate cancer lesions. The clinical and commercial potential of 99mTc-iPSMA to evaluate both primary disease and metastases in regions that do not have extensive PET infrastructure (at this time), is significant. The images obtained with 9mTc-iPSMA are qualitatively and semi-quantitatively similar to 68Ga-PSMA-11 with 99m PET/CT. Tc-iPSMA has robust international patent protection in relevant commercial markets.
Telix Group CEO Dr. Christian Behrenbruch stated, “In the US and EU where PET infrastructure is well-developed, PET-based nuclear medicine dominates due to superior image quality, the quantitative nature of PET and higher reimbursement for PET-based procedures compared to traditional SPECT-based nuclear medicine procedures. However, we believe that the availability of PSMA imaging is fundamental to enabling patient access to 177Lu-PSMA therapy on a global basis and therefore a kit-based approach based on 99mTc-iPSMA is a powerful addition to the product portfolio and complements our existing development of the 68Ga-PSMA illumetTM kit.”
ANMI Co-Founder and CSO Dr. Sam Voccia noted, “Delivering SPECT PSMA to patients in countries where PET is not accessible or has limited availability will contribute to better management of prostate cancer globally. This is particularly the case for key Asian and Latin American growth markets where there is major demand for prostate imaging and where a product like this can ensure that we ‘leave no patient behind’ in terms of access to prostate imaging technology.”
The development of the 99mTc-iPSMA product is the result of world-class research conducted by the highly innovative ININ research group of the National Laboratory on Research and Development of Radiopharmaceuticals (LANIDER), who have vast experience in the field of nuclear medicine. The LADINDER group maintains various national and international collaborations through a scientific association with the Mexican National Institute of Cancerology (INCan) and the National Laboratories of the National Council of Science and Technology (CONACyT). The license agreement with ININ is a worldwide agreement3 and includes a manufacturing partnership for the product.
About Telix Pharmaceuticals
Telix Pharmaceuticals Limited (“Telix”) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (Japan) and Indianapolis (USA). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information visit www.telixpharma.com.
About Advanced Nuclear Medicine Ingredients (ANMI) SA
ANMI SA is an innovative pharmaceutical company developing novel radiopharmaceutical solutions, located in Liège, Belgium. ANMI has developed innovative solutions to facilitate the scalable synthesis of “theranostic” radiopharmaceuticals and to streamline routine production in hospitals and radiopharmacies. ANMI's mission is to increase patient access to new highly specific theranostic radiopharmaceuticals through efficient and cost-effective production processes. ANMI is a wholly- owned subsidiary of Telix Pharmaceuticals. For more information visit www.anmi.be.
About Instituto Nacional de Investigaciones Nucleares (ININ)
ININ was established by the Mexican Government to contribute to the objectives of a competitive national economy, establishment of high-value technology-based employment, sustainability of the environment and energy security. ININ achieves this mission through excellence in the research and development of nuclear science and technology. ININ is an internationally recognized innovator in the field of nuclear medicine.
About Prostate-Specific Membrane Antigen (PSMA)
PSMA is a cancer target (cell surface antigen) that is highly upregulated in prostate cancer cells and is a highly validated and promising target for a range of diagnostic and therapeutic strategies in prostate cancer.
About iPSMA (99mTc-EDDA/HYNIC-iPSMA)
99mTc-EDDA/HYNIC-iPSMA (99Tc-iPSMA) is a small molecule (ligand) that targets and binds to PSMA and enables metastatic prostate cancer can be imaged using Single-Photon Emission Computed Tomography (SPECT). SPECT is a highly effective and widely used imaging modality in the management of cancer. Tc-iPSMA is a development stage radiopharmaceutical imaging agent that is designed to facilitate the visualization of subtle changes in biochemical and biological processes associated with disease progression. The expression of distinct proteins by diseased cells offers the opportunity to "visualize cancer", potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available. None of the products described in this release have obtained a marketing authorization in any jurisdiction, including the United States and Europe.