Australian biopharmaceutical company Telix Pharmaceuticals (ASX: TLX) has completed an in-licensing agremeent with Mexico’s Instituto Nacional de Investigaciones Nucleares (ININ) for a clinical-stage radiopharmaceutical product used in the imaging of prostate cancer.
The product – known as 99m-technetium-EDDA/HYNIC-Lys(NaI)-Urea-Glu, or 99m-Tc-iPSMA – will be used as a prostate imaging solution for use with Telix’s single photon emission computed tomography (SPECT) technology.
SPECT is a nuclear medicine imaging procedure widely used in the management of cancer and is an alternative to the positron emission tomography (PET) approach already in development by the Telix-ANMI partnership formed in November for the illumet/68-Ga-PSMA (prostate-specific membrane antigen) testing kit.
PSMA is a cell surface target which is highly expressed by nearly all prostate cancers, with enhanced expression levels found in poorly-differentiated, aggressive tumours, metastatic and hormone-refractory carcinomas.
SPECT is similar to PET in its use of radioactive tracer material and detection of gamma rays (or gamma imaging).
It is more readily available for use worldwide and remains the dominant nuclear imaging modality for cancer management.
Telix’s partnership with ININ takes the form of a royalty-bearing licence agreement and manufacturing access to existing clinical-grade production of the 99m-Tc-PSMA kit.
It is a worldwide agreement and includes a manufacturing partnership for the product.
It will enable Telix to rapidly add a second commercially-ready prostate imaging product to its urologic oncology portfolio.
The development of 99m-Tc-iPSMA is the result of world-class research by ININ’s nuclear medicine experts who maintain national and international collaborations through a scientific association with the Mexican National Institute of Cancerology and the National Laboratories of the National Council of Science and Technology.
Telix chief executive officer Dr Christian Behrenbruch said the addition of ININ’s 99m-Tc-PSMA kit to Telix’s product portfolio considerably extends Telix’s global reach in the development of prostate cancer solutions.
“The clinical and commercial potential of 99m-Tc-iPSMA to evaluate primary disease and metastases in regions that don’t have extensive PET infrastructure at this time is significant,” he said.
The delivery of 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,” he said.
Most common cancer
Prostate cancer – which develops when abnormal cells in the prostate gland grow to form a malignant tumour – is the second most common cancer diagnosed in men in Australia and the third most common cause of cancer death.
According to Cancer Council Australia statistics, one in seven men will be diagnosed with prostate cancer by the age of 85.
In the US, it has emerged as the most commonly-occurring cancer amongst males, with approximately 160,000 new cases diagnosed annually and 3 million males living with the condition.
The US prostate imaging market is estimated to be worth nearly $700 million and is presently dominated by the use of PET and imaging agents targeting PSMA.
In March, Telix submitted a Drug Master File to the US Food and Drug Administration for the illumet kit, marking an important step in the development of a commercial PSMA prostate imaging solution for the US.
At midday, shares in Telex Pharmaceuticals were steady at $0.755.