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Jerusalem-based Alpha Tau Medical Ltd. (Nasdaq: DRTS) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, has treated its first patient in a feasibility study evaluating the Alpha DaRT as neoadjuvant therapy in patients with prostate cancer at the Rambam Health Care Center in Haifa, Israel.

The primary objectives of this study are to assess the feasibility and safety of intratumoral Alpha DaRT source implantation for the treatment of local prostate cancer prior to surgery. Secondary objectives include assessing the radiological and pathological objective response rate of the tumor, and changes in quality-of-life measures. The study involves two separate procedures, with surgical resection of the prostate 50 days following Alpha DaRT source insertion, and can recruit up to 10 patients. The surgical resection will be performed at the Carmel Medical Center in Haifa, Israel using a da Vinci® surgical robot, and will be led by Dr. Yuval Freifeld and his senior team.

“This is a historic day for Alpha Tau,” said Alpha Tau CEO Uzi Sofer. “After gaining a wealth of experience in treating superficial cancers such as those of the skin, head & neck, and breast, we are thrilled to have treated the first prostate patient, our first internal organ treatment. Our pre-clinical data show that the Alpha DaRT technology may have the potential to address a very broad range of solid tumor types, and our strategy is to expand our clinical studies across multiple tumor types in order to evaluate the full potential of the Alpha DaRT. This study suggests our ability to deliver this promising treatment beyond superficial tumors and is an important milestone in executing this strategy.”

Alpha Tau CMO Dr. Robert Den remarked, “Since the prostate is surgically removed 50 days after the Alpha DaRT insertion, the neoadjuvant design of this trial will allow us to analyze the pathological response of tissues to the Alpha DaRT. This will hopefully provide very valuable information to our researchers and allow us to compare theoretical versus actual cell damage.”

Dr. Tomer Charas, head of the GU Radiotherapy Unit in the Oncology Division at Rambam Health Care Center in Haifa, Israel, and principal investigator of the study, commented, “We are excited to be leading this trial in collaboration with the Carmel Urology team and to be the first to evaluate Alpha Tau in prostate cancer in patients. Based on the results from preclinical studies, it is possible that neoadjuvant treatment with the Alpha DaRT may also trigger an immune response, which could help decrease the risk of tumor recurrence. In addition, a preferable safety profile has been observed to date in treatments of other tumor types.”

Cancers that trigger an immune response and which often respond better to immunotherapies such as checkpoint inhibitors are called “hot” tumors, while those that don’t respond well are called immunologically “cold” tumors. One of the goals of current cancer research is to find ways of making cold tumors hotter, that is, making them amenable to destruction by immune cells and more responsive to immunotherapy.

Dr. Gabriel Sawakuchi and Dr. Simona Shaitelman from MD Anderson, and Ronen Segal, CTO from Alpha Tau, have shown that radiation therapy to immunotherapy has been shown to increase tumor responsiveness to immunotherapy and are trying to determine which type of radiation does this best: photon (X-rays), proton beam, or alpha particle therapy.

Alpha radiation, with its high Linear Energy Transfer, has been shown to cause greater irreparable damage to the DNA of cancer cells than low Linear Energy Transfer photon radiation, and such damage correlates with prolonged and amplified inflammatory response, and, in turn, potential anti-tumor immune response.

Alpha Tau Medical  is currently exploring the relative impact of these different types of radiation on the responsiveness of immunologically “cold” breast tumor models in mice. This pre-clinical research will hopefully yield important data for AlphaDart regarding other poorly responsive cancers as well, such as pancreatic and soft tissue sarcomas, and then ultimately will be performed in human clinical trials.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor and spare the healthy tissue around it.

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is a Jerusalem-based medical device company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

The company, which is currently conducting trials to treat many other types of cancer including breast, oral cavity, pancreas, neck, and brain tumors, has 90 employees in Israel and operates a production line in Jerusalem. The company has several dozen more employees in the U.S. and Japan where its products are in the advanced stages of receiving approval. Alpha Tau is building plants in both countries.

Investor Relations Contact IR AT alphatau.com

Source: PR News Wire Jun 22, 2022, https://www.prnewswire.com/news-releases/alpha-tau-announces-treatment-of-first-prostate-cancer-patient-with-alpha-dart-301573470.html

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