Newsletter - Issue no. 6


Dear Colleagues and Friends, As we move towards the close of a challenging 2020, I am very pleased to announce many significant areas of progress that have been made by Alpha Tau since our last communication in June 2020.


Alpha Tau continues to grow, engaging new employees in all of our departments, especially Preclinical Research, Engineering Research & Development, and Production. We have inaugurated a new department of Patient Communications, which will project to a global audience the unique characteristics and clinical trial achievements of Alpha DaRT, while also providing a platform for personalized communication with our potential patient population. We have also started to build an animal lab in our Jerusalem facility, which will allow us to significantly expand our preclinical research capacity and accommodate our increased number of Alpha DaRT clinical studies, including in combination with leading immunotherapies such as checkpoint inhibitors.


I am also gratified to announce two outstanding accomplishments: first, Alpha DaRT has received approval by the Israeli Ministry of Health for use as a medical treatment for Squamous Cell Carcinoma of the skin and oral cavity; and second, our researchers have published a new paper in a respected oncology journal (Frontiers in Oncology), demonstrating promising pre-clinical results from combination therapy with very difficult-to-treat cancers, such as triple negative breast cancer and pancreatic cancer.


All of these impressive developments are taking place as we consolidate our Israel-based operations in our beautiful, modern office in Jerusalem – photographs included in this newsletter. Our teams in the United States, Japan, and Canada are also growing as our clinical trial program and Alpha DaRT production needs continuously expand. To that end, we recently signed a rental agreement for a new production facility in Togane, Japan. We are looking forward to beginning an extensive multi-center skin cancer trial in 6 leading cancer centers in France at the beginning of 2021. This will be our first large clinical trial in Europe, and we hope that it will confirm the excellent results, which we obtained in our pilot trial of Alpha DaRT with skin cancer that was completed in Israel and Italy in 2019.


We look forward, very hopefully, to a return to a more normal working and living environment with the expected release of COVID-19 vaccines. We anticipate an eventful upcoming year of continued growth and achievement on the preclinical, clinical, and production fronts. I would like to express my great appreciation for all the support and hard work we have received from our investors, staff, and professional colleagues who have allowed us to weather this storm while continuing to move forward toward our goals.

Regards, Uzi Sofer CEO & Chairman

Outline

  • Blog

  • Interview with Alpha Tau CEO Uzi Sofer on the greatest challenge of his professional life: building Alpha Tau from the ground up

  • R & D

  • New publication by Alpha Tau’s researchers

  • Clinical trials of Alpha DaRT are now ongoing in 5 countries with a sixth soon to come

  • Alpha Tau hosts French Clinical Trial Investigators’ Meeting by Zoom in preparation for launch of multi-center skin cancer trial in France in early 2021

  • Operations

  • Growth of Alpha Tau since last Rosh Hashanah, 2019

  • Rental agreement signed in Togane, Japan for new production facility

  • Opening of Alpha Tau’s new production facility in Lawrence, Massachusetts

  • New Marketing and Patient Communications department launched in Jerusalem office

  • Animal lab to be built in new Jerusalem office

  • New Alpha Tau headquarters in Jerusalem expanding

  • Regulatory Updates

  • Alpha DaRT has now received approval by AM”R, the Israeli Ministry of Health’s Department of Medical Devices and Accessories

  • Alpha Tau has passed the second requisite ISO audit

  • Conferences

  • Estro 2020, virtual meeting


Thank you for your continued support!


Blog


Building Alpha Tau has been the greatest experience of my professional life

By CEO Uzi Sofer

My feeling of shlichut (personal mission) is extremely strong and has guided me in the key choices I have made in my life. I enjoy the process of taking an idea from the academic lab, developing it into a product, navigating through the winding regulatory path, and finally to the world of the commercial market. In sum, it is a very lengthy and challenging process.


The world of healthcare innovation is quite a dynamic and complicated one. Working in this world suits my character and provides me with a challenge. I am not afraid of challenges. Certainly, it is fair to say that building Alpha Tau has been the greatest experience of my professional life Read more…


R&D

New publication by Alpha Tau’s researchers . in Frontiers in Oncology

A new scientific paper entitled “RIG-1-Like Receptor Activation Synergizes With Intratumoral Alpha Radiation to Induce Pancreatic Tumor Rejection, Triple-Negative Breast Metastases Clearance, and Antitumor Immune Memory in Mice” was published in July 2020 by the journal Frontiers in Oncology (Domankevich et al., 2020)

This paper is a follow-up to another preclinical study (Domankevich et al., 2019) published last November in which Alpha Tau scientists, led by Prof. Yona Keisari, confirmed that Alpha DaRT, combined with immunotherapy agents, induces systemic immune protection. That study showed that the combination treatment achieves impressive cure rates in mice with colon tumors, while establishing a tumor-cell-specific immunological memory.

In this recent paper, our scientists demonstrated that a different combination therapy regimen – Alpha DaRT plus polyIC(PEI) – caused pancreatic tumor rejection (i.e., complete disappearance of the tumor) in 3 out of 7 treated mice in a short-term response, and 2 out of 7 in a long-term response (see chart to the below).

These kinds of results are encouraging because to date there are no effective treatments for pancreatic cancer, which inevitably leads to early death in human patients. Moreover, animals that remained tumor-free survived for a long period, with no signs of illness, while control animals developed lung metastases, as expected. We hope that these promising animal studies will soon be translated into a trial with pancreatic cancer patients, and promote improved cancer treatment for human patients.


The other notable finding in this new paper was that Alpha DaRT plus polyIC(PEI) caused clearance of metastases from the lungs of most of the mice bearing triple-negative breast cancer (TNBC) tumor