I have been involved in healthcare innovation since 2003, for almost 18 years, as I concluded that the field would let me leverage my business experience to help patients around the globe. My feeling of shlichut (Hebrew term for personal mission) is very strong and it has guided me in the key choices I have made in my life. I’ve also found that I enjoy the process of taking an idea from an academic lab, then developing it into a product, moving it to production, and navigating a winding path through regulatory requirements, and finally the reimbursement and marketing world. In total, this is a very lengthy, difficult, and challenging process.
The world of healthcare therapeutics is a very dynamic and complicated one. Working in this world suits my character and provides me with a challenge. I am not afraid of challenges.
I got involved with Alpha Tau after I learned from Prof. Itzhak Kelson and Prof. Yona Keisari about the amazing technology of Alpha DaRT. I was very impressed by the two professors, their great minds and remarkable passion for helping humanity. Alpha Tau gives me a unique opportunity to bring hope to patients with diseases that have no cures or successful treatments today.
We have already produced superb outcomes in skin and oral cancer patients in Israel and Italy, and are working to replicate these results in other global locations and in other tumor types, all during a period in which coronavirus makes the clinical trial process more challenging.
Alpha DaRT has such great potential to save human life. Our animal studies show that the Alpha DaRT can destroy a solid tumor with minimal damage to surrounding tissue. Moreover, the extensive preclinical work that was done shows that the Alpha DaRT has a systemic immune effect, and when combined with different immunotherapies can destroy not only the primary tumor but also its metastases, while prolonging survival.
Our main challenge now is to fulfill the vast clinical potential of the Alpha DaRT across all possible indications.
What is the added value of Alpha DaRT?
Alpha DaRT is a highly focused and extremely potent anticancer treatment that spares the healthy tissue surrounding the tumor, while effectively killing the tumor itself. It is a unique device in the tool chest for surgeons and radiation oncologists who treat cancer patients who don’t respond to other treatments, or can’t bear the side effects. We believe it will be used both as a monotherapy and as combination therapy, when used before or after surgery or added to checkpoint inhibitors or other immunotherapies. It may be able to offer a solution for pancreatic cancer patients, for whom there are no good treatments today. The same is true for recurrent glioblastoma, cancer that has metastasized, and many other difficult-to-treat cancer types.
The most impressive thing about Alpha DaRT is its safety, especially compared to other cancer treatment modalities. We have now treated over 60 patients in clinical trials, and no serious adverse events have appeared at all, in any of them. This is an amazing thing in itself! Meanwhile, Alpha DaRT appears to produce local control of the cancer, with a durability of response.
What is so special about Alpha Tau?
The people! The most important ingredient in the success of Alpha Tau, I believe, is the team. A great technology — like Alpha DaRT
— without the right people, would not get very far. Because of my belief in the importance of quality staff, I am directly involved in the selection of employees at all levels. From the entry level worker to the top managers, we are all very committed to our mission – saving patients’ lives – globally.
Also, I appreciate our Board of Directors because it is comprised of members who have specialties in many different areas relevant to the company — production, financing, research, commercialization, and more. I am free to consult with them very honestly about the challenges facing the company and to get good advice. I don’t take this for granted, it is actually very unique to have a Board of Directors that adds so much value to the company.
Responses to Initial Clinical Achievements and Preclinical Research
There is no doubt that everything begins with preclinical research. Our presentations at conferences and publications in peer-reviewed literature gave us a lot of exposure to the marketplace, even before we started our first human clinical trial.
We are now expanding our preclinical laboratory. This will allow us to increase the extent of our preclinical research. We have collaborations with Tel Aviv University and Ben Gurion University in Israel. In addition, we are now also initiating research projects with top hospitals and cancer research centers around the world, in Canada (McGill University and Centre Hospitalier de l’Universite de Montreal - CHUM), and the United States (several prominent cancer research and treatment centers). We also support work in basic science research such as physics.
We trust the squamous cell carcinoma (SCC) and skin cancer trials that we are carrying out in the US, Japan, and Europe will validate the excellent results we have obtained from our 2 clinical studies in Israel and Italy. It is important for us to replicate these results elsewhere to confirm the success of Alpha DaRT and to aid us later with our commercialization plans.
The initial SCC clinical results that were published in The Red Journal, which is a prestigious journal for radiation oncologists, helped us recruit collaborators from top cancer research centers in the world, and aided in raising funds to continue to expand the company’s activities. I would say that these impressive initial results opened many doors for us.
We hope to achieve success with our pancreatic cancer trial in Montreal, which will soon start to take patients after being delayed by the coronavirus pandemic, and this will be very big news.
Current and Future Challenges Facing Alpha Tau
The period of the COVID-19 pandemic is challenging for all companies and organizations. However, at Alpha Tau not one employee was furloughed, unlike so many Israeli workers. Groups of workers were organized in capsules, working with 2 meters distance between them in the offices and production facility. We utilized this period, when some of our clinical trials were delayed, to accelerate the building of our factory in Jerusalem. When it is complete and fully ramped up, it will produce enough Alpha DaRT seeds to treat up to 10,000 patients per year. Soon, we will be ready to treat the accelerated inflow of patients from our growing list of clinical trials.
We are now working through the process required to win regulatory approval in the EU, to be followed by Japan, after achieving such approval in Israel. This is always a difficult process, but we are making progress. We have been successful in raising funds to expand our operations, which is always a challenge and especially so during a time of financial volatility.
Generally, the hurdles that must be overcome can be grouped into 3 categories:
Obtaining successful clinical trial outcomes, and then passing the regulatory barriers to get approval in many different countries and indications
Building the capacity of the company through recruiting a stellar work force, and building capacity of our production and logistics capabilities
Raising funds to allow us to bring the research, development, and production of Alpha DaRT to completion, at which point we can launch it in the market
Overview: Alpha Tau in Israel and the World
So far, during the COVID-19 pandemic, Alpha TAU recruited 17 new employees (a 30% growth in the workforce), in all departments of the company. We were able to raise significant funds during the January through April period — right up through the beginning of the first closure. Last Rosh Hashanah (the Jewish new year) we had 30 employees and this year we had 55 in Israel, 5 in the US, 2 in Japan, and 1 in Canada, for a total of 63, Baruch Hashem (thank G-d). And, I wouldn’t be surprised to see another big growth spurt over the next year.
Our goals for the next year?
We are hoping to start our first clinical study that combines Alpha DaRT and a Checkpoint Inhibitor, and will target locally advanced or metastatic cancers.
G-d willing, Alpha Tau will continue to grow globally through our clinical trial program, and we will continue to bring hope to cancer patients across the world. We will produce data that will confirm the excellent results we have already seen in Israel. We hope to show that we can provide a treatment option for advanced pancreatic cancer patients, for whom their cancer is essentially a death sentence.
Alpha Tau is building itself for the long haul. We are focusing on preclinical and clinical research, working to get approvals in indications for areas of unmet need, and building the capacity of the company. This year we are planning to start building a new factory in Japan.
I speak with investors, medical professionals, and patients from all over the world. They see Alpha Tau as a symbol of Start-Up Nation (i.e., Israel), and we are very proud of this. At the symbolic level, we are also proud to be making a medicine to treat a fatal disease from a product of radioactive decay of uranium, thus turning something potentially deadly into a life-saving treatment. These are the two symbols that most resonate with supporters of Alpha Tau with whom I meet. I would like to thank all of our supporters, investors, professional colleagues, and devoted staff, for a very good 2020, and I looking forward to even more progress in the upcoming year.