Newsletter - Issue no. 3

July 2, 2019

 

Dear Colleagues and Friends, 

 

I am thrilled to share with you our newest developments achieved in the past months - whether it comes to new collaborations, approvals, research or operational developments, Alpha Tau is rapidly progressing!

 

In the last several weeks, we have seen tremendous interest from the medical community in our Alpha DaRT treatment. Committees at the most prestigious industry meetings, including the American Societies for Radiation Oncology (ASTRO) and Brachytherapy (ABS), selected our scientists to present their latest results from our preclinical and clinical studies.

 

I am even more excited to report that Prof. Keisari, the co-inventor of the Alpha DaRT technology, won the Best Oral Presentation Award at this year’s annual ABS meeting for his talk on immunomodulation of the antitumor response induced by Alpha DaRT.

 

In parallel, leading experts worldwide are now developing a broad array of studies that will investigate the Alpha DaRT from the cellular level to the entire system and across a variety of indications.

 

Yet all of this would not be possible if it wasn’t for your support! A big thank you to every single one of our team members and collaborators - employees, scientists, investors, patients and caregivers - for your interest, motivation, hard work and your investment into making Alpha DaRT available to cancer patients worldwide.

 

Regards,

Uzi Sofer
CEO & Chairman


 

Outline
 
  • Operations

    • Welcome to our new CFO Raphi Levy!

    • Increased production capacity in Israel

    • New larger offices

    • Initial steps towards production and distribution in Asia

  • Regulatory Updates

    • ISO - Getting closer to CE

    • Regulatory Milestones in Canada

  • R&D

    • First clinical trial completed!

    • Japan pivotal trial launched

    • Clinical trial launched for metastatic breast cancer

    • International research collaboration - final steps before initiation

    • New agreements with Israeli Innovation Authority

  • Conferences

    • Prof. Keisari wins Best Oral Presentation Award at ABS Annual Meeting

    • ESTRO Meeting - News and highlights

    • Outstanding presence at TAT11

  • Set a Meeting at Upcoming Conferences

    • American Association for Physics Meeting (AAPM), July 14 - 18, San Antonio, US

    • ICRR (International Congress for Radiation Research), August 25 - 29, Manchester, UK

    • ASTRO Annual Meeting, September 15 - 18, Chicago, US

    • GEC ESTRO Workshop, November 21 - 22, Budapest, Hungary

Operations

Welcome to our new CFO Raphi Levy!

We are excited to welcome our new CFO, Raphi Levy. Leveraging his unique experience and long-standing international relationships, Raphi will contribute to driving business growth and to securing long-term fundraising that will support our extensive R&D strategy.

"I am thrilled to join Alpha Tau and take part in a revolutionary new therapy for cancer patients. I look forward to being part of this outstanding team and to helping drive the company's strategy and commercial relationships in the future," commented Raphi.

Raphi has spent the past 13 years working in the Investment Banking Division at the leading financial institution
Goldman Sachs in New York and Tel Aviv, most recently serving as Executive Director in charge of healthcare banking in Israel. 

 

Read more

Increased production capacity in Israel

After months of detailed planning, our engineering and production teams have successfully upgraded our production facility in Israel. By implementing new manufacturing technologies, the facility will now allow us to increase the capacity dramatically, by more than 4x. This upgrade will also enable the supply of seeds for clinical studies to remote sites in the Far East and Europe.

New larger offices

As our team keeps growing we have now expanded into new office space at Campus Broshim next to Tel Aviv University. It is only a matter of time until even further space will be needed for the continuous flow of new recruits!

A big thanks to Eliran Ron and Or Nahum for the amazing space design and construction!

Initial steps towards production and distribution in Asia

After a productive visit in Japan, our team has started first preparations towards commercialization in Asia, with Japan in focus. We are currently in the first stages of planning and building a Japanese manufacturing facility. In parallel, we are in initial discussions with pharmaceutical and medical device companies who might help distribute our products in Japan.

 

 

Regulatory Updates

ISO - Getting closer to CE

Recently, we officially announced that Alpha Tau obtained ISO 13485:2016 certification*.

This certification represents an important milestone that enables our team to continue development of the Alpha DaRT in compliance with the highest standards for safety, efficacy and product performance. Together with the CE approval, it will make our Alpha DaRT treatment available to European patients as a standard treatment.

"This official recognition demonstrates our dedication to ensuring that the infrastructure to develop, manufacture and distribute our therapy is safe, effective and reliable,“ said Yaniv Sagie, Quality Assurance and Regulatory Affairs Director.

*ISO 13485:2016 is the internationally-recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes

 

Read more

Regulatory Milestones in Canada

We are glad to announce that we have received two major regulatory approvals issued by the Canadian Nuclear Safety Commission (CNSC) and Health Canada that will enable us to initiate our clinical program in Canada imminently.

 

Certificate of Radiation Devices

The certificate approves the Alpha DaRT as a radiation device in Canada, regulated by the Canadian Nuclear Safety Commission (CNSC) in accordance with the Nuclear Safety and Control Act (NSCA). The Alpha DaRT is now licensed for possession, use, transfer, import, export, servicing, abandonment and storage.

 

Health Canada Investigational Testing Authorization (ITA) for CMN Trial

Equivalent to the FDA’s IDE (Investigational Device Exemption), the ITA gives authorization from Health Canada to provide a device to a qualified investigator for investigational testing.

 

 

R&D

First clinical trial completed!

We have submitted the outstanding results of our first clinical study for publication! The study investigated the safety and efficacy of Alpha DaRT for the treatment of Squamous Cell Carcinoma (SCC) of the head & neck and skin. The outcomes were achieved in patients who in most of the cases suffered from recurrent disease post radiation treatment. The final long-term results show data at 6 months follow-up and after a maximum of 24 months. The paper is currently being peer-reviewed and will be officially released once approved.

Japan pivotal trial launched

Our team in Japan is currently launching a local clinical trial and has already recruited its first patient!

“We are excited to start treating patients in Japan with our revolutionary treatment. The pivotal trial for solid tumor cancer in Japan will be conducted at two centers, the National Cancer Center and the Tokyo Medical and Dental University. The trial will involve patients with recurrent breast cancer as well as recurrent head and neck cancer, with a total enrollment of 18 patients”, said Rob Claar, CEO of HekaBio, a partner of Alpha Tau.

Clinical trial launched for metastatic breast cancer

We are excited to announce the launch of our first clinical trial for metastatic breast cancer. Led by principal investigator Dr. Alexander Obukhov, the study will take place at the A. Tsyb Medical Radiological Research Center, Obninsk, Russia and will investigate the safety and efficacy of Alpha DaRT for patients who suffer from newly diagnosed metastatic breast cancer with an active primary lesion.

International research collaboration - final steps before initiation

A new research collaboration has been established with leading universities and cancer centers worldwide (CHUM, McGill, Jewish General Hospital, MSKCC, BGU, TAU).

Following a major gathering in Montreal, we have now determined the specifics of both the research subject and the budget.

The collaboration will include an extensive and long-term study of DaRT physics, in particular, cell-level microdosimetry and the effect of a single alpha particle on the DNA.

We are also discussing some exciting potential deeper collaboration ideas with Dr. Bruce Mazer, Executive Director/Chief Scientific Officer (CSO) of the Research Institute of the McGill University Health Centre.

New agreements with Israeli Innovation Authority

After an important visit of the Israeli Innovation Authority, we are looking forward to new approvals of our plans for the next year, including government grants for studies of the DaRT’s safety and efficacy in combination with various chemical and biological cancer treatment modalities, including chemotherapy and immunotherapy.

 

 

Conferences

Prof. Keisari wins Best Oral Presentation Award at ABS Annual Meeting

We are very excited that at this year’s American Brachytherapy Society (ABS) Meeting, Prof. Keisari was awarded the Best Oral Presentation Award at the Breast Plenary Session!

 

Prof. Keisari presented his results on “Immunomodulation of the Antitumor Response Induced by Alpha Radiation-Based Brachytherapy - Results in the Elimination of Spontaneous Lung Metastases in a Triple Negative Breast Cancer Mice Model and in the Cure of Colon Cancer Bearing Mice".

 

Furthermore, the scientific committee invited two additional researchers to present their Alpha DaRT studies: Prof. Popovtzer, MD, and Lior Arazi, PhD. 

 

The Alpha DaRT received immense recognition and several experts pointed out the great potential of DaRT to create an abscopal effect and to become a game changer in the field of brachytherapy!

 

Read more

ESTRO Meeting - News and highlights

This year, our team participated for the third time at the European Society of Radiation Oncology Annual Meeting - one of the most successful and important conferences so far.

As scientists from all over Europe visited our booth to discuss their research ideas, it was inspiring to see the excitement that arose in light of the variety of research opportunities and potential benefits for patients.

We hope and strive to soon make available our treatment to thousands of patients around the world with various cases, from tumors in the prostate, breast, vulvar, pancreas, skin and head & neck.

Outstanding presence at TAT11

DaRT physicist and Ben-Gurion University (BGU) scientist Lior Arazi delivered a significant presentation at TAT11 discussing the mechanism of action, production, treatment planning and dosimetry of Alpha DaRT. The local alpha therapy has drawn specific attention when compared to targeted alpha therapies (TAT). The DaRT’s focal mechanism of action has shown vast benefits for the treatment of solid tumors compared to targeted alpha therapies, which are limited to single cells and micro-lesions.

 

 

Upcoming Conferences

We are looking forward to learning about new ideas and developments in upcoming conferences. Please schedule a meeting in advance of the following events:

  • American Association for Physics Meeting (AAPM), July 14 - 18, San Antonio, US

  •  ICRR (International Congress for Radiation Research), August 25 - 29, Manchester, UK

  • ASTRO Annual Meeting, September 15 - 18, Chicago, US

  •  GEC ESTRO Workshop, November 21 - 22, Budapest, Hungary

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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