FDA Approves Phase II Kidney Cancer Therapy Study

Telix Pharmaceuticals has announced that the FDA has accepted their Investigational New Drug Application to undertake a clinical study of TLX250, the company’s investigational kidney cancer therapy.

The STARLITE 2 study is a single arm, investigator-led Phase II study in patients with advanced clear cell renal cell carcinoma, the most common and aggressive form of kidney cancer. TLX250 targets a protein known as CA9 in the patient. This protein has been found to be highly expressed in patients that are likely to have a more limited response to cancer immunotherapy. Therefore, if TLX250 was to be successfully bought to market, it would be used in conjunction with already established immunotherapy to make it more effective.

The Principal Investigator for the STARLITE 2 study will be Darren R. Feldman, MD, Medical Oncologist at Memorial Sloan Kettering Cancer Center in New York. The study will look to evaluate TLX250-delivered radiation as an immune system “primer” in combination with the anti-PD-1 immunotherapy Opdivo (nivolumab). The effectiveness of the study will be based on the number of tumours responding to the Telix therapy versus the current standard of care alone (stand-alone immunotherapy). The study hopes to enrol 29 patients to take part. (MSK has institutional financial interests related to Telix.)

I have been following Telix for a little while now and they have been doing some really promising work in the medical field with several product avenues they are developing. They are focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation. Their lead product, Illuccix, used for prostate cancer imaging, has been accepted for filing by the FDA and is under priority evaluation by the Australian TGA. Telix is also progressing marketing authorisation applications for Illuccix in the European Union and Canada. However, none of Telix’s products have received a marketing authorisation in any jurisdiction as of yet.

DISC: not currently held.