Telix, ANMI to Jointly Develop, Commercialize Prostate Cancer Imaging Agent

Telix, ANMI to Jointly Develop, Commercialize Prostate Cancer Imaging Agent

Australia’s Telix Pharmaceuticals has entered a partnership with Belgium’s Advanced Nuclear Medicine Ingredients (ANMI) to commercialize ANMI’s 68Ga-HBED-CC-PSMA (68Ga-PSMA-11) kit, used for prostate cancer imaging, in the United States.

“Prostate cancer affects one in eight men in the U.S. and the market opportunity is very significant,” ANMI co-founder and CEO Ludovic Wouters said in a press release. “We are pleased to be working with Telix to deliver our solution to patients in the U.S.”

ANMI’s 68Ga-PSMA-11 kit is composed of a small molecule, called PSMA-11, that binds to the prostate-specific membrane antigen (PSMA). PSMA is found in all types of prostatic tissues, but is more prevalent in metastatic prostate cancer, including castrate-resistant prostate cancer.

The PSMA-11 in ANMI’s kit is attached to 68Ga (gallium), a radioactive chemical element that positron emission tomography (PET) scans can detect, providing improved spatial resolution and easier quantitation.

As a result, the 68Ga-PSMA-11 kit allows for a better imaging of the patients’ primary tumor and metastasis.

“ANMI’s ‘shake and inject’ kit allows for the rapid, room-temperature labelling of the PSMA-11 ligand with gallium. This has become a well-proven approach for imaging prostate cancer and ANMI’s technology makes the process extremely efficient in the clinical setting,” said Telix’s co-founder and CEO, Dr. Christian Behrenbruch. “ANMI’s radiochemists are the best and brightest in the industry and we are pleased to be working with the team to tackle prostate cancer.”

ANMI’s partnership with Telix will also allow the kit to be commercialized on a worldwide basis as a companion diagnostic imaging agent to the Telix’s prostate cancer therapeutic (TLX- 591). This is an anti-PSMA antibody bound to a radioactive agent, Lutetium-177 (177Lu). After binding to PSMA, the antibody delivers the payload to cancer cells, killing them.

As part of the agreement, the companies will have to fill the kits’ Drug Master File, and complete the necessary clinical trials to receive marketing authorization from the U.S. Food and Drug Administration.

“Telix is building a portfolio of diagnostic and therapeutic urology products that we believe will help to drive physician interest and market share for our products,” said Dr. Sam Voccia, ANMI’s co-founder and chief scientific officer.

Both companies will establish a joint-venture entity that allows ANMI to sell kits on an exclusive basis for the U.S. market; Telix will be the sales and marketing partner.

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One comment

  1. Stephen B. Strum, MD, FACP says:

    The concept of imaging and therapy (I & T) aka theranostics, is a long time in the coming. In fact, as a medical oncologist that is particularly interested not only in prostate cancer (PC) but very much involved in imaging of PC & other tumors, I am at the same time puzzled and distressed that the USA consistently lags behind other countries in imaging updates (refined imaging). When TRUSP (transrectal ultrasound of the prostate) was being used in Europe it was an unknown in the USA. When contrast-enhanced ultrasound was written about in Europe starting ≈ 2000, it was not adopted in the USA. A PubMed search just done a few minutes ago revealed 61 articles on contrast-enhanced ultrasound (CEUS) and only 1 came from the USA and it included a key radiologist from Europe (Ethan Halpern). Now many of the publications are coming not only from Europe but also from China and S. Korea & Japan. In fact, of 15 articles published between 2015 & 2017, 8 came from Asia.
    The same is true with articles on theranostics in the case of PSMA I&T. The work emanates from Germany and starts ≈ ten years ago. The results are excellent & yet just recently we here in the USA are engaged in trials. Why this lag? Is it the FDA and the Oncology Drug Advisory Committee (ODAC) which seems to be mired in the NIH (not invented here) syndrome?
    The same has happened with what I would regard as the most important advance in the imaging of just about all solid tumors — the use of contrast nanoparticles combined with MRI to ascertain nodal involvement. The images are striking but again, our “wonderful” FDA panel rejected Combidex-Enhanced MRI (CEM) despite that it was purely an issue of the contrast agent (Combidex)– which was already in use to treat iron deficient anemia in end-stage renal disease.
    We have become a 3rd world country in comparison to Europe and Asia with so much of our medicine. Something is rotten and it ain’t Denmark!

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