Newsletter - Issue no. 5

Dear Colleagues and Friends, These are challenging times for all of us. The world is staggering between grief and economic shocks created by the coronavirus. Nevertheless, our work has continued throughout the pandemic, as you will read below.


Even during the near-complete shutdown here in Israel, which has since abated, we were able to continue operating at full speed. Our staff was split into organic teams, to minimize the risk of infection, while continuously developing the Alpha DaRT and maintaining its supply.


During the last few months, we were able to treat several new patients in Israel and around the world. Thanks to the tireless efforts of our logistics department, we successfully carried out a number of radioactive deliveries to Japan, both for patients as well as for preclinical study, even as passenger flights continued to dwindle. And thanks to swift efforts by our clinical research and training departments, we completed virtual training for a new clinical trial site in Japan, at Tohoku University, which has already treated its first patient.


The battle against coronavirus emphasizes the urgent need for a cancer treatment that can be provided in a one-time outpatient setting and minimizes the risk to cancer patients of contracting infectious diseases. We are striving to bring the therapeutic power of Alpha DaRT to a larger circle of patients through our expanding clinical trial program.


We are very happy to announce three very exciting pieces of news that demonstrate how the Alpha DaRT continues to advance in the world of medicine, investment, and business. The Red Journal (one of the premier journals in radiation oncology published by ASTRO) came out with an editorial written by influential thought leaders applauding the results of the SCC trial of the Alpha DaRT in human patients, and what it means for the future of cancer treatment. Read the details below.


At the same time, we have completed a new round of funding, raising $26 million for further research and development of Alpha DaRT. These funds have come from some of our original investors as well as new ones who have joined the family. And importantly, the company has just signed a distribution agreement with Medison Canada, which will allow us to enter the important Canadian market, once Alpha DaRT receives regulatory approval.

We have started construction on a production facility and new company headquarters in Jerusalem, in the Har Hotzvim hi-tech industrial park. We also just received our first order of Thorium-228 from Oak Ridge National Laboratory (US Department of Energy) for our new facility in Lawrence, Massachusetts. This will allow us to ramp up our capacity to produce Ra-224, just in time for the growth in our clinical trial program.


Regardless of the challenges that we are now facing and will face in the future, we continue to work hard to accomplish our mission - making the Alpha DaRT treatment available for millions of cancer patients all around the world. I hope that you will enjoy reading this newsletter, which provides more information on our operations over the last few months. Regards, Uzi Sofer CEO & Chairman

Outline

  • Company news

  • New round of funding just completed

  • Editorial in prestigious radiation oncology journal applauds Alpha DaRT technique and results of SCC trial

  • Exclusive Distribution Agreement with Medison Canada finalized

  • Blog

  • Dr. Robert Den: Alpha-emitting Radiation Therapy Could Create a Paradigm Shift in Cancer Treatment

  • Inspiring story of Lela, an Alpha DaRT patient

  • R & D

  • Patient recruitment has begun at Memorial Sloan Kettering in New York

  • Patient recruitment commenced at CHUM (Montreal) for pancreatic cancer trial

  • New Alpha DaRT clinical trials being organized in Thailand and Israel

  • Operations

  • Radioactive manufacturing license and Thorium-228 received at Lawrence facility

  • Construction started on facility in Jerusalem

  • First employee hired for new subsidiary in Canada

  • Regulatory Updates

  • MRI compatibility of DaRT seeds

Thank you for your continued support!

Company News

Successful new round of funding just announced


We are very happy to hear from CFO Raphi Levy that Alpha Tau has completed a Series B round of funding for $26 million. The funders in this round include a mix of existing investors (Shavit Capital, Medison Ventures, OurCrowd, among others) who are showing continued support, even during this time of financial instability in the global economy. New family office and high net-worth investors, primarily from North America and Israel, have also been added to the Alpha Tau investor group.

The money raised in this round will support the continuing clinical development of Alpha DaRT, the expansion of our global manufacturing facilities in Israel and Japan, and the initial steps we will be taking in preparation for commercialization.

A big thank you to all of our repeat and first-time investors! Read the full press release here


Editorial in prestigious radiation oncology journal applauds innovative Alpha DaRT technique and impressive results from the SCC trial



An editorial praising the innovative treatment approach taken with Alpha DaRT and its impressive results in the squamous cell carcinoma trial (Popovtzer, 2020), was just published in the International Journal of Radiation

Oncology, Biology, and Physics by Drs. Louis Harrison and George Yang. These eminent radiation oncologists are associated with one of the top cancer treatment centers in the US - the H. Lee Moffitt Cancer Center in Tampa, Florida.

The editorial was entitled, “A Hard Target Needs a Sharper DaRT,” and focuses on several impressive aspects of this clinical trial. The authors highlight how DaRT may fill an unmet need for less toxic radiation therapies for fragile patients with advanced or recurrent head & neck cancer. They also conclude that the SCC trial demonstrates the successful translation of preclinical results to tangible benefits in the clinic, and is an example of innovation in the field of radiation oncology. Read the entire editorial here.

The editorial was published in the official journal of the American Society for Radiation Oncology. Dr. Harrison is a former president of the society, and considered to be one of the global leaders in the field of radiation oncology. This is, therefore, a great honor to our company, to the principal investigators in this trial, and to our research team for their innovative and inspiring work!


Exclusive distribution agreement has been concluded with Medison Canada for Alpha DaRT


Uzi Sofer (CEO) and Raphi Levy (CFO) recently announcedthat Alpha Tau has concluded an exclusive distribution agreement with Medison Canada for its breakthrough cancer therapy Alpha DaRT. Medison is a specialized pharmaceutical and biotech company that licenses innovative, cutting edge therapeutics for patients in need of life-saving therapies. Medison has exclusive commercial distribution rights to Alpha DaRT in Israel, and now also in Canada.

Uzi Sofer commented, “This arrangement meaningfully furthers our important mission to bring our live-saving cancer therapy to thousands of cancer patients in Canada who may not have other treatment options remaining... Even in these challenging times, we continue to push forward our mission to help cancer patients around the world.”

With this agreement, Canada is emerging as a key hub for research and clinical trials on Alpha DaRT, and, after approval, its clinical use. At present, Alpha Tau is conducting a clinical trial with pancreatic cancer patients at CHUM (University of Montreal Hospital Center), and has initiated basic science with leading universities in Canada and Israel.

Read full press release here.

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Blog


Alpha-emitting radiation therapy could create a paradigm shift in cancer treatment

By Dr. Robert Den

Alpha Tau CMO, Dr. Robert Den, believes that alpha-emitting radiation therapy has the potential to make a profound impact on the field of radiation oncology by overcoming three major clinical challenges in radiation therapy. Read more…


Case study of Lela, Israeli skin cancer patient, shows the value of Alpha DaRT, through a heartwarming patient testimonial

When 78-year-old Israeli cancer patient Lela stumbled upon the Alpha DaRT treatment in 2017, with information from a friend of hers, she had just received her third diagnosis of cancer in multiple organs, as part of a long journey that had started in 2013. Read more about Lela’s journey here.


We would like to express our great appreciation and thanks to Prof. Aron Popovtzer and Dr. Eli Rosenfeld for their support and professional insights in producing Lela’s story and accompanying video.

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R&D

Patient recruitment underway at Memorial Sloan Kettering Cancer Center (MSKCC) in New York

Patient recruitment at MSKCC is ongoing for a clinical trial in malignant skin and superficial soft tissue tumors.

MSKCC is one of the leading cancer centers in the world for treatment and research.

Patient recruitment has begun at University of Montreal Hospital Center (CHUM) for a clinical trial of Alpha DaRT in pancreatic cancer.

A study in CHUM for advanced pancreatic cancer has started to recruit patients. The Principal Investigators Dr. David Donath and Dr. Anand Sahai at CHUM are aiming to recruit a small number of pancreatic cancer patients to establish the feasibility and safety of Alpha DaRT for patients with this aggressive form of cancer.

Dr. Robert Den adds, “We are moving ahead cautiously but hopefully with Alpha DaRT in patients with advanced pancreatic tumors. There is a real need for more effective and more tolerable therapies in this indication, and we look forward to receiving outcomes data for the initial patients in this trial.”



Progress in organizing new clinical trials for Alpha DaRT at Rambam Hospital in Haifa, Bumrungrad International Hospital in Bangkok, and Chiang Mai University in Chiang Mai

Progress is being made in establishing three new sites for Alpha DaRT clinical trials – at Rambam Hospital in Haifa, Bumrungrad International Hospital in Bangkok, and Chiang Mai University in Chiang Mai. At Bumrungrad, the IRB committee has given its approval for a trial, and at Rambam, all authorizations have been received.The trial at Rambam should be open for recruitment of patients starting in June.


In November-December of 2019, delegations of radiation oncologists and medical physicists from Bumrungrad, Chiang Mai and Rambam completed the Alpha DaRT clinical trial training program, led by Elad Flaisher, at the company’s offices.

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Operations

Radioactivity manufacturing license and first order of Thorium-228 received at Lawrence facility

We have recently received a radioactivity manufacturing license for our newly completed facility in Lawrence, Massachusetts.

The US team is now working hard on setting up the production line, as well as running the needed validations. Their goal is to start supplying Alpha DaRT for clinical trials as soon as possible. On May 21, we received our first delivery of Thorium-228 from Oak Ridge National Laboratory, run by the US Department of Energy. This will allow us to greatly expand our capacity to produce Ra-224, which is a daughter isotope of Th-228.

Alpha Tau is getting a lot of support from local Lawrence community leaders, and hopes to become an influential member of the community by creating local jobs and encouraging other high-tech and bio-tech companies to move to Lawrence.



Construction of Alpha Tau Medical headquarters and manufacturing facility in Jerusalem has begun

Construction of a new headquarters and enlarged manufacturing facility for Alpha Tau Medical has now begun in Jerusalem.

The site is located in the Har Hotzvim industrial park, which is one of the largest centers of hi-tech industry in Israel. The Jerusalem center will serve Alpha DaRT clinical sites in Europe, the Middle East, and Asia.

First Alpha Tau employee has been hired for researchcollaboration in Canada

Alpha Tau has hired its first employee in Montreal, Canada, to coordinate collaborative research projects among 4 leading academic institutions: University of Montreal (CHUM), McGill University, TAU, Ben Gurion University, and Rabin Medical Center in Petach Tikva.

The collaboration will focus on developing tools and models to provide a better understanding of the alpha radiation dosing requirements appropriate for patients at an individual level. This research will help to improve the accuracy of alpha radiotherapy. It 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.

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Regulatory Updates

MRI safety and compatibility tests are being carried out on Alpha DaRT seeds

Alpha DaRT seeds are undergoing testing by German company MR:comp, for safety and compatibility during MRI procedures. The first series of Alpha DaRT testing was completed and the final series of tests are now being conducted.

The MRI safety test ensures that the magnetic field utilized by the scan does not disturb the placement of the seeds in the tumor, and does not endanger patients who have been treated by Alpha DaRT and are in need of other diagnostics in parallel.


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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