Turning cancer on itself. Finally.
While RefleXion’s approach is designed to better treat patients with any stage of cancer, RefleXion believes that its impact will be most significant in metastatic cancer where locally ablative therapies are not applied as standard-of-care today. In metastatic cancer patients, modern systemic therapy, even in combination, has very low response rates and typically leads to only small improvements in overall survival of patients. Although external-beam radiotherapy is a well-established locally ablative therapy, approximately 90% of metastatic disease patients will die from their disease, which equates to over 600K deaths annually in the U.S. RefleXion’s BgRT is designed to one day target bulky disease in the oligometastatic disease setting--a type of metastasis in which cancer cells from the original (primary) tumor travel through the body and form a small number of new tumors (metastatic tumors) in one or two other parts of the body, and in the polymetastatic disease setting, or widespread disease, in combination with systemic therapy. BgRT aims to overcome current limitations by reducing the volume of tissue treated with radiation, and therefore cumulative toxicity, to enable treatment of oligometastatic and polymetastatic disease, in parallel, in one session. BgRT incorporates PET imaging data to enable tumors to continuously signal their location and is being designed to synchronize these data with the linear accelerator (LINAC) to direct radiotherapy to tumors with subsecond latency. By using the tumor’s own emissions to guide radiation delivery, treatment
We developed BgRT to reimagine radiotherapy. Our novel technology innovation in BgRT allows a LINAC, the source of a radiotherapy beam, to directly communicate with a tumor embedded deep inside a patient’s body. By tracking and detecting changes in the position and orientation of its target, RefleXion’s X1 LINAC can change the trajectory of its beam in milliseconds, leading to millimeter precision within the patient. Whereas physicians today aim LINACs using conventional images, already stale by the time the beam is turned on, the BgRT closed-loop feedback system integrates active automation into the targeting process using a tumor’s own biological signals. We believe our technology can unlock unique clinical opportunities and transform the cancer care paradigm. Active beam guidance using PET tracer signals via BgRT means that the X1 has the potential to aim and dose-track one tumor with biological precision and also tackle multiple tumors with scalable accuracy to enhance efficiency in the clinic and unlock a large new cohort of patients. We believe our BgRT technology could have profound implications for cancer patients. Biological precision means more targeted, potentially less toxicity for the millions of patients treated today with radiotherapy for early-stage cancers, including nonmetastatic breast, prostate, lung and rectal cancer. Scalable accuracy unleashes the possibility of completely eradicating all visible sites of disease for patients with late-stage, metastatic cancer, which is a vast unmet opportunity for a condition that affects millions more globally. Together, our precision and accuracy could result in unmatched confidence for physicians and patients.
By turning cancer on itself, RefleXion is pioneering a novel modality for the treatment of all stages of all solid tumor malignancies. This scope is larger and more complex than any one company alone could address. Therefore, RefleXion is building an “External Innovation Ecosystem” to complement the internal, engineering-focused R&D efforts with technologies and products derived from the radiopharmaceutical, biopharmaceutical, and clinical informatics industries. Besides a number of research collaborations with academic centers, RefleXion entered into the following partnerships: • In collaboration with Merck, we plan to test the combination of BgRT and Merck’s PD-1 inhibitor pembrolizumab in randomized clinical trials of patients with metastatic cancers to test the hypothesis that BgRT serves as force-multiplier for pembrolizumab and thereby increases response rates and overall survival outcome, all without significantly impacting the safety profile. • With Telix Pharmaceuticals, one of the leading radiopharmaceutical companies, we are evaluating several novel and cancer-specific PET tracers for their ability to serve as fiducial for BgRT. Such ability would improve upon the real-time delivery guidance provided by FDG. • In our partnership with HealthMyne, a Madison, WI-based clinical informatics company, we are evaluating the utility of CT and PET imaging information derived from our BgRT device as input to HealthMyne’s radiomics discovery engine. Radiomics, the ability to extract information that is not accessible to the human eye from imaging data, holds the promise to develop imaging biomarkers for the selection of patients most suitable for BgRT, and for early assessment of response to BgRT.