Alpha Tau Announces Multiple Corporate Updates Ahead of 2022 Annual Meeting of the American Society for Radiation Oncology

– Medicines and Healthcare products Regulatory Agency of the United Kingdom approves clinical trial in squamous cell carcinoma of the vulva at Addenbrookes Hospital in Cambridge –

– Health Canada approves the addition of Jewish General Hospital in Montreal as a second site in the Company’s clinical trial in advanced pancreatic cancer –

– Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center will be delivering a presentation at the ASTRO 2022 Annual Meeting regarding results of the Company’s U.S. pilot feasibility study completed earlier in 2022 –

– Investigators at The University of Texas MD Anderson Cancer Center presented a poster at the Radiation Research Society’s 2022 Annual Meeting on tumor growth delay and immune stimulation using the Alpha DaRT in treating 4T1 murine triple-negative breast cancer tumors –

JERUSALEM, Oct. 21, 2022 (GLOBE NEWSWIRE) — Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”)  (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today its participation in the upcoming 2022 Annual Meeting of the American Society for Radiation Oncology (“ASTRO”), being held October 23 – 25, 2022 in San Antonio, TX, where the Company will be at Booth #3719. Ahead of the conference, the Company is pleased to announce a number of recent developments:

• The Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom has approved the Company’s request to initiate a clinical trial for the treatment of primary and recurrent Squamous Cell Carcinoma of the vulva using the Alpha DaRT. The trial is expected to be conducted with 10 patients, and will be led by Dr. Li Tee Tan of Addenbrooke’s Hospital of the Cambridge University Hospitals NHS Trust. The trial seeks to measure the feasibility, safety, efficacy and immunological response associated with treatment with the Alpha DaRT.
• Health Canada has approved the Company’s request to revise its Investigational Testing Authorization for the Company’s clinical trial testing the feasibility and safety of the Alpha DaRT treatment in patients with advanced pancreatic cancer. The revision allows the Company to add Jewish General Hospital in Montreal, Canada as a second site to the trial, alongside Centre Hospitalier de l’Université de Montréal (CHUM).
• Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center in New York will deliver a presentation at the ASTRO 2022 Annual Meeting, on Wednesday, October 26, 2022 at 8:20am in the Henry B. Gonzalez Convention Center, Room 303, entitled “A Multicenter Prospective Trial of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or Unresectable Cutaneous Cancers: Early Results from a Pilot Feasibility Study in the United States,” providing further detail on the results of the Company’s U.S. pilot feasibility study that was conducted in 2021, the initial results of which were reported earlier in 2022, including a 100% complete response rate observed at 12 and 24 weeks after treatment with the Alpha DaRT.
• Following the Company’s announcement in January 2022 that it had signed a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center, the investigators presented a poster at the Radiation Research Society’s 2022 Annual Meeting, held October 16 – 19, 2022 in Waikoloa Village, Hawaii. The poster detailed results of the investigators’ pre-clinical study using the Alpha DaRT to treat mice with 4T1 triple-negative breast cancer tumors, demonstrating significantly smaller tumor volume as well as a significant two-fold increase in CD8⁺ cell populations in the spleens of mice when treated with the Alpha DaRT vs. those treated with inert sources. The investigators concluded that, “[Alpha] DaRT seeds were effective in delaying tumor growth with activation of the immune system…The magnitude of increase in CD8+ populations in the irradiated spleens of mice suggests systemic activation of the immune system.”

Alpha Tau CEO Uzi Sofer commented, “Following the completion of our U.S. pilot study earlier this year, we are laser-focused on initiating our U.S. multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma using the Alpha DaRT, which we expect to occur before the end of the year, as we are currently progressing on the associated preparatory logistics such as IRB approvals and site initiations. At the same time, we continue to forge ahead in our strategy to broaden the application of the Alpha DaRT to other indications, and are very excited to see continued meaningful progress across three different indications: cancer of the vulva, pancreas and breast. We look forward to further advances in these and other indications, as we continue to explore ways that the Alpha DaRT can help patients around the world.”