RefleXion, Telix Expand Prostate Cancer Treatment Partnership

A co-development and commercialization agreement between Telix Pharmaceuticals Limited and RefleXion Medical, Inc. will expand the use of Telix’s prostate cancer imaging agent, Illuccix (kit for preparation of gallium (⁶⁸Ga) gozetotide) with the RefleXion biology-guided radiotherapy (BgRT) platform to guide external-beam radiotherapy in real-time. The RefleXion X1 is cleared for SBRT/SRS/IMRT, however, BgRT is pending regulatory review and is not commercially available.

BgRT is the first and only cancer treatment designed to integrate PET technology as part of external-beam radiotherapy delivery. It uses PET tracers as biological guides to signal the location of cancer and guide the delivery of radiotherapy to tumors in real-time. BgRT has the potential to offer significant advantages over conventional radiotherapy as it may one day enable treatment of multiple tumors per session for metastatic disease, increase the conformality of radiotherapy delivery, and reduce toxicity to healthy tissue. This approach may facilitate treatment of later stage cancers than is currently practical for hospitals or tolerable by patients.

Under the agreement, which builds on an existing strategic collaboration between the companies, Telix and RefleXion will conduct and co-fund a BgRT clinical program using Illuccix as a biological guide, seek regulatory approval and jointly pursue commercialization, initially in the United States. The parties will share in any upside generated if successfully commercialized. The clinical program is expected to commence in 2023.  RefleXion is exclusively partnering with Telix for⁶⁸Ga PSMA-PET imaging agents for use with BgRT.  The agreement also includes the potential to expand the exclusive relationship beyond the US, in countries where both Illuccix and BgRT are intending to be commercialized.

If approved, Illuccix for BgRT could potentially open a broad new market opportunity for Illuccix as a therapy guidance agent. More than 60,000 men undergo external-beam radiotherapy for prostate cancer every year in the U.S. alone.  Illuccix for BgRT would require up to five doses per patient (one for each session of external-beam radiotherapy), potentially expanding the volume of Illuccix used in the U.S. significantly. The scheduling flexibility of Gallium-based compounds such as Illuccix may provide additional advantages for patients and caregivers using BgRT technology.

Dr. Christian Behrenbruch, Group CEO of Telix Pharmaceuticals said, “Following a successful evaluation period, we are pleased to expand our relationship with RefleXion and move ahead with a clinical program with the objective of regulatory approval of Illuccix for BgRT. This partnership demonstrates the potential for Illuccix and other molecularly-targeted imaging agents in our pipeline to be used as a tool to both detect the presence of metastatic disease and guide treatment using innovative complementary technologies such as BgRT.”

Dr. Thorsten Melcher, Chief Business Officer at RefleXion added, “With PSMA-PET quickly being established as a standard of care in prostate cancer imaging, the clinical program aims to determine whether Telix’s gallium-based tracer can provide a complete and robust signal to guide BgRT to treat all stages of prostate cancer, eventually including metastatic disease. Illuccix offers great accessibility and scheduling flexibility, factors which we believe will be well-suited to the treatment regimen with our BgRT system.”

Reflexion has received marketing clearance from the US FDA for its X1 machine that combines high quality computed tomography (CT) imaging with stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT).