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Topic
Alpha Tau Medical (DRTS)
Date & Time

Selected Sessions:

Sep 19, 2024 03:30 PM

Description
Alpha Tau Medical is the first company to develop a cancer therapy that releases an alpha radiating material for diffusion into solid tumors. Alpha DaRT utilizes alpha radiation for the local treatment of solid tumors, and is designed to release short-lived alpha-emitting atoms in the tumor, overcoming the traditional limitation of alpha radiation's short therapeutic range, and aiming to achieve the holy grail of delivering a high but conformal dose of radiation inside the tumor while sparing surrounding healthy tissue In its first US pilot study, a multi-center skin cancer study led by Memorial Sloan Kettering in NY and published in the JAMA Network journal in 2023, the company observed a 100% complete response rate at 12 and 24 weeks after treatment, with no product-related serious adverse events. The Company has launched its US pivotal study for FDA approval (in recurrent cutaneous squamous cell carcinoma), currently underway, as well as a feasibility study in pancreatic cancer, with fantastic interim safety and feasibility data read out in late 2023, and a trial in liver metastases, alongside a number of other indications. In pre-clinical research, Alpha DaRT has demonstrated success in controlled destruction of multiple tumor types, with >10 years of pre-clinical research generating >20 published peer-reviewed studies. The studies have also demonstrated signs of triggering a broader immune system effect and potential boost to immunotherapy treatments. The Alpha DaRT has already received two Breakthrough Device Designations from the FDA: one in skin SCC of the skin or oral cavity without curative standard of care, the other in recurrent GBM. The product is approved for marketing in Israel, for the treatment of squamous cell carcinoma of the skin or oral cavity, and has submitted an application in Japan for marketing authorization in head & neck cancers.