Newsletter - Issue no. 2
We are delighted to share with you our first quarterly newsletter of 2019. Beyond the great operational progress, our most important advancement this quarter has been the highly promising clinical results from the cancer centers, Rabin Medical Center (RMC) in Israel and IRST in Italy. In 26 patients treated at RMC and 5 patients at IRST, over 70% of the tumors were entirely destroyed. Patients also showed no negative systemic side effects and minimal local toxicity when compared to surgery or radiotherapy. Alongside our ongoing squamous cell carcinoma (SCC) trial, we have recently launched a new clinical trial to treat all types of skin and oral cavity cancer at RMC. We are thrilled that 3 patients have already been treated successfully. Meanwhile, we are continuing to expand our clinical trials with the opening of new sites. In Russia, we have signed an agreement to treat inoperable breast cancer – the new site will open in the next few months – and in the U.S., we have established new collaborations to treat lung tumors. Other clinical studies planned to open include pancreatic cancer, prostate cancer, gynecological cancer as well as tumors in the skin and oral cavity. Please follow us on social media to stay up to date on our upcoming events and progress.
Enjoy the read! Uzi Sofer, CEO and Chairman, Alpha Tau Medical
Turning Alpha Radiation into a High-precision Cancer Therapy Prof. Itzhak Kelson uncovers the story about Alpha DaRT Discover how Alpha DaRT delivers
on the huge clinical promise of alpha radiation. Read our co-inventor and Chief Physics Officer, Professor Itzhak Kelson, explain how his initial physics research was transformed into a ground-breaking treatment for solid tumors. Learn more
Global Clinical Experts Discussing the Need for the Alpha DaRT Treatment
We were proud to reveal our new video at the Biotech Showcase event in January showing our worldwide collaborations with the clinical community. Watch the full video to see key opinion leaders share their insights on the Alpha DaRT technology for solid tumor treatment. A special thank you to all our clinical experts for taking part.
Alpha Tau CEO, Uzi Sofer, Presents at the Biotech Showcase during JP Morgan Annual Healthcare Conference We were glad to be selected and have the opportunity to present Alpha Tau’s latest progress at the Biotech Showcase during the 37th Annual J.P. Morgan Healthcare Conference. "It was a fantastic conference that garnered further interest and excitement for our breakthrough Alpha DaRT technology", said Mr. Sofer. "Thank you to everyone for coming to listen and meet with us." The Biotech Showcase, is part of the J.P. Morgan Healthcare Conference, the industry’s largest annual healthcare investor conference. Learn more
Nominated as one of the top “100 Companies That Will Change the World"!
We were excited to be nominated by Nikkei Business Publications of Japan as one of the top 100 innovative companies that will change the world! Alpha Tau was chosen as one out of 3 companies from Israel - “An Israeli company that develops medical equipment using radiation for patients with solid cancers such as breast cancer and skin cancer. Clinical development has started in Japan, the U.S. and in Europe.”
Expanding Operations to Asia and China
Michael Tolub was chosen to present our Alpha DaRT cancer treatment at the IPIEC Global start-up competition in China. “IPIEC GLOBAL 2018 is accredited as part of the Maker in China contest series guided by the Ministry of Industry and Information Technology of the People’s Republic of China (MIIT).” The participation was an important part of our efforts to make our treatment available in China. Across all industry sectors, we were delighted to be voted as one of the “Top 30 Tech Projects of IPIEC GLOBAL 2018”.
Numerous Patients Contacted us to Participate in Clinical Trials We are grateful for the huge interest and support we received following key articles in the UK Sunday Express, NoCamels, Israel21c and The Times of Israel with more than 500 patient inquiries in the last 2 months to participate in clinical trials. As we are committed to enabling patients to find the best care possible, we have expanded our clinical department to support this increased demand. We have also launched a self-assessment online test to help patients quickly know if Alpha DaRT can be suitable for them and how we can help.
Alpha Tau Japanese PMDA Approval Getting Closer We are happy to announce that we have agreed with the PMDA (the Pharmaceuticals and Medical Devices Agency of Japan, similar to the U.S. FDA) on the terms of the clinical study that will lead to a multi-indication approval and reimbursement in Japan. This will enable Alpha Tau to initiate a clinical trial that will test several cancer indications at the same time. We have also received safety confirmations that the Alpha DaRT will be exempt from special handling and facility requirements. This means that Japan will be a leading region for making this ground-breaking treatment widely available to doctors, patients and their families. "The strong partnership and support we have received from the Ministry of Health, Labor and Welfare (MHLW) and the PMDA mean that we are able to proceed quickly with a very efficient clinical trial program. We are on track to enroll and begin treating patients in Q2 of this year, and success in this study will yield a broad Shonin Approval (medical device regulatory pathway) for solid tumors.” --Rob Claar, CEO, Alpha Tau Medical K.K.
New Study Shows 4X Shorter Distribution Length of Alpha-Emitters in Healthy Tissue Compared to SCC Tissue The company’s team conducted a recent study in pigs examining the distribution of the alpha-emitting daughter isotopes of Radium-224 in healthy tissue of several different organs. Regardless of the tissue, toxicity stayed extremely low. The animals remained healthy and with no systemic side effects. Distribution measurements in the ear showed a diffusion length that was 4x smaller than in tumor tissue (SCC). “The higher distribution of alpha-emitting atoms in cancer tissue compared to normal tissue, accentuates the potential of this treatment for tumors located near critical organs and for organ-saving procedures", said Prof. Yona Keisari, Alpha DaRT co-inventor and Chief Biomedical Officer. These results are most important for e.g., tumors in the pancreas which are often inoperable due to their proximity to critical surrounding organs. The Alpha DaRT seeds can be placed as close as 5 millimeters to critical organs and blood vessels while maintaining high safety of the treatment.
New Plans to Initiate Huge Research Collaboration with 5 Leading Universities We welcomed earlier this year a huge Canadian delegation to Alpha Tau from top universities in Canada: the University of Montreal and McGill University. We are now pleased to announce a groundbreaking Canadian-Israel research collaboration, that partners with leading Israeli research facilities; Tel Aviv University (TAU), Ben-Gurion University of the Negev and Rabin Medical Center, to investigate further the clinical potential of Alpha DaRT. The collaboration will focus on developing tools and models to provide a better understanding of the alpha radiation dose on micro and macro levels, from a single cell to the entire tumor, the surrounding tissue and the body as a whole. This collaboration will not only help to improve the accuracy of alpha irradiation but will also enable a better understanding of the alpha particles' effect on a single cell and how the alpha-emitting atoms diffuse inside the tumor over time. Alpha Tau to Continue Research Cooperation with Ben Gurion University of the Negev In addition to the Canada-Israel research collaboration, the company has signed a new research agreement with Ben Gurion University. The research agreement will enable effective cooperation with the leading scientists, Lior Arazi, Ph.D., and Tomer Cooks, Ph.D., who have contributed major efforts to the expansive preclinical research of the Alpha DaRT treatment, completing their Ph.D.’s with Alpha Tau’s co-inventors, Prof. Yona Keisari and Prof. Itzhak Kelson.
Applications Submitted for New Patents To further strengthen the intellectual property of the Alpha DaRT treatment, Alpha Tau has submitted applications for two new patents. The first patent covers the production of the radiotherapy seeds and applicators, while the second patent covers combination cancer treatment using viral mimic intratumoral cytoplasmic delivery and tumor ablation.
Alpha Tau Welcomes New Team Members to Support Company Expansion Activities Following the great success of 2018, the company has grown with the addition of 15 new team members to the clinical, manufacturing, engineering and medical research departments. Alpha Tau is delighted to welcome to the management team, Yaniv Sagie (QA/RA Director), Yael Zeiger (Corporate Controller) and Ronen Segal (CTO), who will devote their expertise in medical devices and corporate
business strategy to the company’s progress. Expecting
further rapid growth in 2019, the company is currently
expanding its offices in Tel Aviv.
Establishment of Scientific Advisory Board Alpha Tau has established a Scientific Advisory Board, consisting of global key opinion leaders in the physics, biomedical and radiation therapy fields, Prof. Itzhak Kelson (TAU), Prof. Yona Keisari (TAU), Prof. Michael J. Zelefsky M.D. (Memorial Sloan Kettering Cancer Center), and Prof. Aron Popovtzer M.D. (RMC). Prof. Kelson is the co-inventor of the Alpha DaRT technology and Chief Physics Officer and is currently a retired Chairman of the TAU Physics Department. He has
held research and teaching positions at the Weizmann Institute, Yale University, Lawrence Livermore National Laboratory, University of Wisconsin, Brookhaven National Laboratory, and other institutions. Prof. Keisari is a member of the Human Microbiology Department and Professor of Immunology at TAU. Prof. Keisari co-invented the DaRT technology. He has held a variety of faculty management positions at the TAU Faculty of Medicine and was a Postdoctoral Fellow at the Tumor Biology Department, National Cancer Institute of the NIH, Bethesda, USA. Prof. Zelefsky M.D. is a Professor of Radiation Oncology, Chief of Brachytherapy and co-leader of the Genitourinary Disease Management Team at Memorial Sloan Kettering Cancer Center
in New York. He is a former President and Chairman of the Board at the American Brachytherapy Society and currently Editor in Chief of Brachytherapy. Dr. Zelefsky has published over 400 articles in the oncology literature and has received numerous awards for his research and work in the field. Prof. Popovtzer M.D. is a Professor of Radiation Oncology and head of the Head and Neck Tumor Unit at Rabin Medical Center, Israel. Dr. Popovtzer has authored and co-authored several national and international publications and has received several awards for his contributions to the scientific community.
Exploring the Veterinary Market Potential with VCA We welcomed earlier this month a delegation from the largest veterinary chain in the USA, the VCA, to explore the option of providing Alpha DaRT to treat cancer in dogs. The VCA (previously known as the Veterinary Centers of America) is an operator of more than 750 animal hospitals in the USA and Canada, and owner of more than 50 veterinary diagnostic laboratories.
New Production Facility is Showing Further Progress Alpha Tau’s U.S. subsidiary has submitted an application for manufacturing of the Alpha DaRT at the new production facility in Massachusetts. The facility is expected to supply the first seeds by the beginning of the second half of 2019. By the end of the year, the facility will reach a volume equal to 3x the current capacity in Israel and later will be increased to 12x the capacity of the Israeli production site.
Join us at Upcoming Conferences
Where Medical and Radiation Oncology Meet: Integrating State of the Art Strategies", February 27 - March 01, Tel Aviv, Israel Contact us to schedule a meeting.
2019 OurCrowd Global Investor Summit, March 07, Jerusalem, Israel Contact us to schedule a meeting.
TAT11 International Symposium, April 1 - 4, Ottawa, Canada Contact us to schedule a meeting.
ESTRO 38, 2019, April 26 - 30, Milan, Italy Contact us to schedule a meeting.
Thank you for your continued support!
Stay tuned and don't forget to follow us on Linkedin, Twitter and Facebook. Until next time, The Alpha Tau Team