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
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
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
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
Estro 2020, virtual meeting
Thank you for your continued support!
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…
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) tumors.
The combined treatment showed better results than Alpha DaRT alone or polyIC(PEI) alone in reducing the incidence of lung metastases-related death (as shown in the chart to the right), thus showing the synergistic potency of the combined therapy.
Clinical trial sites for Alpha DaRT
Clinical trials of Alpha DaRT are now ongoing in the following locations:
· New York (MSKCC, skin cancer)
· Montreal (CHUM, advanced pancreatic cancer)
· Tokyo (Tokyo Medical and Dental University, National Cancer Center in Tokyo, and Tohoku University Hospital; skin or head & neck, and recurrent breast cancer)
· Russia (metastatic breast cancer)
· Israel (Rabin Medical Center and Rambam Healthcare Campus, skin cancer)
New clinical trial sites are expected to open soon in the following locations:
· Israel (Hadassah Medical Center, skin cancer)
· French Multi-Center (Lyon, Nice, Neuilly -Paris, Nancy, Toulouse, and Grenoble; skin cancer)
Alpha Tau hosts France Multi-Center Study Investigators’ Meeting
On October 19th, 2020, Alpha Tau hosted a virtual, five-hour Zoom meeting from our Jerusalem office, with over 30 participants: principal investigators, physicists, and study coordinators from France. The purpose of the session was to introduce the science, technology, and clinical results supporting Alpha DaRT to the scientists and clinicians who will be managing a French multi-center clinical skin cancer trial scheduled for launch at the beginning of 2021. This clinical trial will be carried out at 6 sites in France: Lyon, Grenoble, Neuilly (Paris), Nice, Nancy, and Toulouse.
The meeting began with introductions by Dr. Pascal Pommier from the Leon Berard Center in Lyon and CEO Uzi Sofer, and a review of the medical and physics fundamentals by Dr. Robert Den and Prof. Itzhak Kelson.
Next, Naama Barel reviewed the Alpha DaRT clinical trial program, and Ofer Magen and Elad Flaisher demonstrated the Alpha DaRT applicators for skin cancer. The program concluded with a discussion by Dr. Den and Prof. Aron Popovtzer of the clinical experience and medical outcomes thus far achieved, a preview of anticipated process upgrades by COO Amnon Gat, and a lively discussion by the participants.
We would like to thank our French colleagues for a successful session, and for the beginning of a fruitful collaboration in launching this innovative cancer treatment technique in Europe. The French Multi-Center Trial will be a critical step towards Alpha DaRT’s penetration of the European market, given its size, strategic location, and significance. This is the first large-scale trial planned for the European market.
Rapid growth of Alpha Tau since last Rosh Hashanah
At the time of Rosh Hashanah 2019 (September), Alpha Tau employment in Israel was 30, with another 2 employees at our office in Massachusetts. This year at the Jewish new year, employment has more than doubled, with new employees in:
· Unites States
· Montreal, Canada
· Tokyo, Japan
CEO Uzi Sofer predicts that there will be another burst of hiring over the next year, due to expansion in our preclinical and clinical research, production, and development departments.
Rental agreement signed in Togane, Japan for third Alpha DaRT production facility
In September 2020, Alpha Tau management signed a rental agreement for its third production facility in Togane, Japan.
Togane is a town near Tokyo, located approximately 30 km from Narita International Airport. At present, this new production facility will serve our clinical trial activity in Japan for Alpha DaRT. We have 3 clinical trial sites ongoing, at National Cancer Center of Japan, Tokyo Medical and Dental University, and Tohoku University Hospital. Ultimately, the facility will also supply Alpha DaRT for the Japanese patient population being treated for various cancer types. Soon, the design and buildup of the facility will begin. We would like to wish a hearty congratulations and good luck for future success to Rob Claar (in the photo) Benjamin Pratt and Takashi Yagyu, all from our partner company in Japan – HekaBio. Also, much appreciation to CFO Raphi Levy and COO Amnon Gat, for concluding this agreement.
Kicking off the opening of Alpha Tau’s new production facility in Lawrence, Massachusetts
Alpha Tau staff located at our Massachusetts office are preparing to kick off the opening of the new production facility in the city of Lawrence.
This facility will supply Alpha DaRT for all clinical trials planned for the US and Canada in the near future. After completing all the required validations, the facility will start supplying Alpha DaRT treatments (seeds and applicators) for clinical trials in North American for various cancer indications.
New Marketing and Patient Communications Department Launched in Jerusalem office
In August 2020, Alpha Tau inaugurated a Marketing and Patient Communications Department in its new Jerusalem office led by Michael Tolub, Marketing and BizDev Manager.
This department is responsible for online recruiting of patients at our clinical trial sites, and managing company communications and events. In addition, department members will respond to information and treatment requests from prospective patients, caregivers, healthcare professionals, and business partners who reach out to us.
Thanks to Erol Azuz for bringing his IT magic to Alpha Tau, and to Yael Mimoun for her special touch with patient communications.
Recruitment of patients for the skin and head & neck cancer trials at Rabin Medical Center has been very successful, and we are now starting to receive patients for treatment at Rambam Healthcare Campus, as well. All patient information is handled with the highest degree of confidentiality.
Animal lab to be built in new Jerusalem facility to facilitate preclinical research
Alpha Tau is preparing to build an animal lab in our Jerusalem facility that will enable the expansion of our research program, as well as facilitating extensive preclinical studies on combination therapy involving Alpha DaRT plus immunotherapy. Treatment regimens combining radiation therapy with various types of immunotherapy, including checkpoint inhibitors, are now viewed as one of the most promising approaches to treating metastatic and recurrent cancer.
Alpha Tau scientists have published two scientific papers in the last year (Domankevich, 2019 and 2020) providing evidence that Alpha DaRT plus immunomodulators CpG and PolyIC (in addition to a cocktail of other immunostimulants) can reduce the growth of the primary tumor, slow down metastatic spread, and prolong lifespan of mice with various types of cancer. Our goal is to continue this research using checkpoint inhibitors that are approved for human use, in preparation for future clinical trials in human patients.
Alpha Tau headquarters in Jerusalem expanding with new departments and additional employees
The new headquarters of Alpha Tau is rapidly filling up with new departments, more employees, and expanded activities.
Since the initial move was made on July 1, construction of the main office floor has been completed, and furnishings and interior design have been added. As mentioned above, a new Marketing and Patient Communications Department has been inaugurated with additional staff hired. Recently, the Finance Department welcomed attorney Rebecca Becker, VP Legal, to work with CFO Raphi Levy. Additional staff have been added to the Department of Clinical Operations to handle the growing list of clinical trials being planned and executed.
Soon, we hope to finalize the move of our Research and Development and Production Departments, and complete our Animal Lab, which will enable an expansion of our production of Alpha DaRT to support our clinical trial needs and our preclinical research program, respectively.
Alpha DaRT receives approval by AM”R (Israel Ministry of Health’s Department of Medical Devices and Accessories)
In September, Alpha Tau was notified by Israel’s Ministry of Health Department of Medical Devices and Accessories that Alpha DaRT has received approval for use in Israel in Squamous Cell Carcinoma of the skin and oral cavity. This includes for treatment purposes, in addition to use in clinical trials.
Alpha Tau passed the second required ISO audit
In September, Alpha Tau passed its second audit by the ISO (International Organization for Standardization).
This second audit was required because the company’s employment, range of activities, and planned production at its multiple facilities has grown so much since the first audit in March 2020.
Among the subjects reviewed were:
· Management review processes
· Measurability of company quality objectives
· Training framework
· Final inspection and product release
· Regulatory compliance
Passing a successful ISO audit means that consumers can have confidence that Alpha Tau’s products are safe, reliable, and of good quality.
A big thank you to employees of the company for the high standards of their work, and in particular, to the Production, R&D, and Quality Assurance teams who worked hard to ensure that we meet the appropriate standards of quality.
ESTRO 2020, Virtual Meeting Nov. 28 - Dec. 1, 2020
Poster presentation: Lior Arazi, PhD. Ben Gurion University (presented by Mirta Dumancic, post-doctoral fellow)
Diffusing Alpha-Emitters Radiation Therapy: Theoretical Modeling.
Outline of a model that describes the diffusion of alpha-emitting atoms from their Alpha DaRT source throughout the volume of a tumor.
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
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