In order to provide its investigational positron emission tomography (PET) imaging radiotracers, TLX250-CDx (Zr-DFO-girentuximab) and [18F]-FLac (F-3-fluoro-2-hydroxypropionate) for use in third-party clinical research and development activities, Telix Pharmaceuticals Limited has announced a collaborative development and reseller agreement with GE Healthcare. These cutting-edge tracers have the potential to reveal crucial details about the metabolic surroundings of tumours, which could assist in guiding and improving therapy choice. During the European Association of Nuclear Medicine (EANM) Congress in Barcelona, Spain, the agreement was disclosed.
In the recently finished Phase III ZIRCON research for clear cell renal cell cancer, TLX250-CDx targets the carbonic anhydrase IX antigen (CAIX). Since CAIX is expressed in a wide variety of solid tumour types, it is possible to utilise it to detect hypoxic tumors—tumor cells that haven’t had access to oxygen—which are associated with disease progression and resistance to treatment, including immunotherapy. When such tumours are found, treatment options may be changed, ranging from immune checkpoint inhibitor (ICI) monotherapy to combinations of therapies that cross the hypoxic barrier.
It has been demonstrated that [18F]-FLac, which Telix in-licensed in 2021, can be used to image lactate metabolism in oxygenated tumours. High lactate levels in tumours may inhibit ICI responses and damage patients undergoing ICI treatments. Understanding the lactate metabolic condition of the tumour may help clinicians choose immunotherapy combinations that can get over this obstacle.
With the ability to predict and track immunotherapy response, TLX250-CDx and [18F]-FLac are an addition to GE Healthcare Pharmaceutical Diagnostics’ pipeline of investigational non-invasive [18F]-CD8 and [18F]-Granzyme-B imaging tracers. Only 20 to 40 percent of patients currently react to immunotherapies on average, and tumour samples are often used to assess a patient’s eligibility.
“This partnership will see our investigational imaging agents used more widely in third-party clinical trials. Excitingly, it will also help to expedite the development of [18F]-FLac, while expanding the utility of our TLX250-CDx imaging candidate.”
Jonathan Barlow, SVP Global Business Development & Alliance Management, Telix
“This partnership expands our pharmaceutical services offering, including our toolbox of investigational PET imaging diagnostics. These aim to enrich clinical trials for pharmaceutical companies with the possibility of determining the metabolic environment and immune status of tumours, and if successful, help to improve speed to market for potential therapies. Ultimately, these PET imaging diagnostics could assist in delivering effective oncology therapies to patients.”
Sanka Thiru, Global Business Leader, Immuno-Oncology, GE Healthcare’s Pharmaceutical Diagnostics business
According to the agreement, Telix will be in charge of manufacturing and continued product development, and GE Healthcare will be in charge of sales and marketing of Telix’s imaging agents to pharmaceutical companies, working closely with Telix. The validation of [18F]-FLac for usage in GE Healthcare’s FASTlabTM, an automated PET radiochemistry synthesiser that is frequently used for on-site manufacture of FDG and other PET tracers, will be investigated by Telix and GE Healthcare.
The initial length of the agreement is five years, but after three years, it is subject to review and termination rights based on performance.
- New agreement adds two Telix investigational PET imaging radiotracers to GE Healthcare’s immuno-diagnostic portfolio, to enable patient selection and monitoring in immunotherapy trials
- Telix tracers evaluate levels of carbonic anhydrase IX and lactate in tumours to inform and improve therapy selection
- GE Healthcare’s Pharmaceutical Diagnostics business is an established global supplier of PET imaging tracers to the global clinical research market
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