Newsletter - Issue no. 4

December 1, 2019

 

Dear Colleagues and Friends,

Our fourth Alpha Tau Newsletter is full of fantastic updates that I am very excited to share with you.
 
I am thrilled to inform you that our first clinical trial results have been published! The exceptional results were presented in the International Journal of Radiation Oncology (the “Red Journal”), the prestigious peer-reviewed journal of the American Society of Radiation Oncology.
 
I would like to thank Prof. Aron Popovtzer from Rabin Medical Center, Israel and Dr. Salvatore Roberto Bellia from the IRST, Italy, and their teams. A special thanks also to our clinical, research, development and production teams. The publication in the Red Journal, is the best recognition for your hard work on delivering Alpha DaRT as an effective and safe treatment for challenging cancer cases. Congratulations!
On top of that, our scientific teams have made significant progress in researching the use of Alpha DaRT in combination with immunotherapy, with several new publications demonstrating its vast potential for the clinical world.
 
To further support our global scientific and clinical collaborations, Alpha Tau continues to grow. Accordingly, we are thrilled to welcome Dr. Robert Den from Thomas Jefferson University in Philadelphia, who has joined the company as Chief Medical Officer (CMO). In addition, we wish a warm congratulations to Prof. Yona Keisari, who has been appointed Chief Scientific Officer (CSO) in recognition of his ground-breaking work and scientific accomplishments.
 
We are looking forward to new insights and developments in the upcoming year of 2020 - a year expected to bring significant milestones to Alpha Tau.
 
Regards,
Uzi Sofer
CEO & Chairman

 

Outline

  • R & D

    • First clinical paper on Alpha DaRT published in the International Journal of Radiation Oncology, Biology and Physics

    • Intriguing case report published from SCC clinical trial suggests that the Alpha DaRT might activate the immune system and generate anti-tumor immune response against metastatic tumors

    • New scientific paper on Alpha DaRT combination with immunotherapy published in Cancer Immunology, Immunotherapy.

    • Physics paper accepted for publication: Dr. Lior Arazi constructs a model for Alpha DaRT dosimetry, to improve treatment planning for patients

    • Last steps towards trial initiation at Memorial Sloan Kettering Cancer Center (MSKCC)

    • Patient recruitment and treatment with Alpha DaRT have begun in Japan

  • Operations

    • Welcome to our new CMO Dr. Robert Den, MD!

    • Congratulations to Prof. Yona Keisari on his appointment to Chief Scientific Officer!

    • Significant progress made at our US office and production site

    • Canadian government approves comprehensive Alpha DaRT physics research collaboration

  • Regulatory Updates

    • Technical files submitted for EU registration and CE mark

    • All biocompatibility tests for Alpha DaRT successfully completed

  • Conferences

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

    • Three successful presentations at ASTRO19

    • Encouraging feedback at first Oral and Head & Neck Surgery meeting, the IAOO

    • Dr. Lior Arazi discusses potential benefits of Alpha DaRT seed technology at AAPM in San Antonio, Texas

  • Set a Meeting at Upcoming Conferences

    • ESTRO meets Asia, December 6-8, Singapore

    • Biotech Showcase, JP Morgan Healthcare Week, January 13–15, 2020, San Francisco

    • ESTRO 2020, April 3-7, 2020, Vienna

    • World Congress of Brachytherapy 2020, April 2-4, Vienna

 
R&D
 
First clinical paper on Alpha DaRT published in the International Journal of Radiation Oncology, Biology and Physics


Alpha DaRT™ achieves a 78.6% complete response rate in management of challenging squamous cell carcinoma tumors
 

 The objectives of the trial, conducted in Israel and in Italy, were to establish the feasibility, safety and efficacy of Alpha DaRT for management of patients with squamous cell carcinoma of the skin and head and neck region. All 28 evaluable treated lesions underwent successful placement of the Alpha DaRT™ seeds, and there were no severe (Grade 3 or higher) toxicities noted. Common toxicities observed included local pain, redness at the implantation site – frequently followed by swelling, and mild skin ulceration. There were no systemic toxicities noted. All toxicities were mild to moderate and resolved within 3-5 weeks.
 
Efficacy endpoints demonstrated a 100% overall response rate with a 78.6% complete tumor response rate. This is quite noteworthy given that over 40% of the patients had undergone prior radiation therapy to the affected area, and 61% of patients overall had received some form of prior therapy.
 
The principal investigator of the Israeli arm of the trial, radiation oncologist Prof. Aron Popovtzer, MD, from Rabin Medical Center in Israel, explained, “The results we obtained from our first clinical trial in human squamous cell carcinoma patients confirm the promising findings from preclinical studies. The observed tumor response rates and survival metrics seem especially impressive given this elderly (median age 80.5 years) and heavily pretreated patient sample. Overall, these impressive outcomes serve as an excellent basis for future trials in other tumor types.” The Italian arm of the trial was led by Dr. Salvatore Roberto Bellia from the IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori). Future clinical trials will also investigate Alpha DaRT in other oncology indications, as a monotherapy or in combination with various systemic therapies.
 
As the official journal of the American Society for Radiation Oncology, the Red Journal’s detailed peer review of our work represents an important validation of the outstanding outcome. Congratulations to our research team on their inspiring work!

Read more

 

 
Intriguing case report published from SCC clinical trial suggests that the Alpha DaRT might activate the immune system and generate anti-tumor immune response against metastatic tumors

 

Dr. Salvatore Roberto Bellia and his radiation therapy team at IRST in Italy recently published an intriguing case report of a 65-year old woman who participated in the  Alpha DaRT clinical trial. The patient was diagnosed with several SCC lesions. One of these lesions was treated with Alpha DaRT, but the other two were not.
 
Within three months after treatment completion, the treated lesion had undergone complete remission, and surprisingly, spontaneous regression was observed for the two untreated distant lesions, which remained in complete remission a year later. One of the explanations offered by Dr. Bellia for this unexpected result was that Alpha DaRT may be stimulating an “awakening” of the immune system. This enhanced immune responsiveness may then lead to an attack not only on the lesion that was treated, but on other distant ones as well, through the creation of a systemic anti-tumor immunity.
 
This result has also been observed by Alpha DaRT scientists in multiple preclinical trials with mice. These findings encourage us to expand our investigations of Alpha DaRT combined with immunotherapy agents to examine the potential for a systemic anti-tumor immune response against metastatic cancer.

 

 
New scientific paper on Alpha DaRT combination with immunotherapy published in Cancer Immunology, Immunotherapy


Alpha Tau scientists working with Chief Scientific Officer Prof. Yona Keisari received with enthusiasm the notice that their most recent research paper on Alpha DaRT combined with immunotherapy was published on October 22, 2019, by the respected journal, Cancer Immunology, Immunotherapy.
 
In this study on colon tumors in mice, the scientists confirmed that Alpha DaRT combined with immunotherapy agents induces a systemic immune protection. The study showed that the combination treatment achieves high complete response rates in mice with colon tumors while establishing a tumor-cell-specific immunological memory.  
 
The mortality of cancer patients is mainly caused by the growth of metastases, and the Alpha DaRT - immunotherapy combination has shown to be effective in lowering the metastatic tumor burden. Based on these promising newly published results, Alpha Tau is planning clinical trials of Alpha DaRT combined with different immunomodulators. We envision that patients suffering from metastatic cancer may soon be able to benefit from a treatment that can both prolong their survival and potentially completely eradicate their disease.
 
Congratulations to Dr. Vered Domankevich, Adi Cohen, Margalit Efrati, Dr. Michael Schmidt, Hans-Georg Rammensee, Dr. Sujit S. Nair MD, Dr. Ashutosh Tewari MD, Prof. Itzhak Kelson and Prof. Yona Keisari.

 

 
Physics paper accepted for publication: Dr. Lior Arazi constructs a model for Alpha DaRT dosimetry, to improve treatment planning for patients


Dr. Lior Arazi from Ben-Gurion University has developed a physical model for calculating the radiation dose in Alpha DaRT treatments. The paper discussing his work has recently been accepted for publication in Physics in Medicine and Biology, one of the leading journals of the field. The model is based on several practical and physical assumptions and quantitative predictions, and has been used to select the Alpha DaRT seed activity and spacing in clinical trials.

 

 
Last steps towards trial initiation at Memorial Sloan Kettering Cancer Center (MSKCC)


We are glad to say that the team from MSKCC recently completed training in Israel, for its clinical trial investigating Alpha DaRT for the management of malignant skin tumors. MSKCC is one of the leading cancer research and treatment centers in the world. This trial will be a significant milestone in the development of Alpha DaRT in the US market.

 

 
Patient recruitment and treatment with Alpha DaRT have begun in Japan


We are happy to say that patient enrollment has begun in Japan for the management of patients suffering from recurrent breast cancer as well as recurrent head and neck cancer.

The trial is being led by principal investigators Dr. Igaki from the National Cancer Center of Japan, and by Dr. Toda from the Tokyo Medical and Dental University.

The trial’s results will accelerate the regulatory approval for Alpha DaRT in Japan.

 

 


 

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Operations
 
Welcome to our new CMO Dr. Robert Den, MD!


We are very pleased to announce the appointment of Dr. Robert Den as Alpha Tau’s Chief Medical Officer (CMO). Dr. Den will provide leadership in further expanding the clinical development of Alpha DaRT. 

"I envision alpha-emitting radiation-based therapy being employed across multiple malignancies, either as primary therapy or in conjunction with immuno-oncology treatments. We have only scratched the surface of the potential indications for this technology. I am privileged to join the Alpha Tau team and take part in this exciting revolution in radiation oncology," commented Dr. Den.

Dr. Den’s research spans the spectrum of basic, clinical, and translational science, with vast experience in radiotherapy, and includes over 120 publications in peer-reviewed journals.
Read More

 

 
Congratulations to Prof. Yona Keisari on his appointment to Chief Scientific Officer!


We wish warm congratulations to Prof. Yona Keisari on his appointment as Chief Scientific Officer (CSO) of Alpha Tau. Prof. Keisari is a co-inventor of the Alpha DaRT technology, and until his recent appointment, was the Chief Biomedical Officer of the company. He has led the company’s basic science preclinical research activities, with the goal of utilizing the potential of Alpha DaRT to treat cancer.

“It is my honor to assume the duty of Chief Scientific Officer of Alpha Tau Medical," said Prof. Keisari, "our alpha radiation-based treatment has already demonstrated its potential to treat tumorous lesions in humans, and I see it as my mission to take this treatment modality to a higher level of effectiveness and examine a potential comprehensive solution for metastatic disease by combining it with immunotherapy.”

Prof. Keisari has been a Professor in the Department of Clinical Microbiology and Immunology, Faculty of Medicine, at Tel Aviv University in Israel since 1979. His ongoing studies focus on the activation of anti-tumoral immune reactivity through in-situ destruction of solid tumors with DaRT and developing means to improved eradication of metastases. During his career, he has co-authored 90 peer-reviewed scientific papers. Read More

 

 
Significant progress made at our US office and production site


Significant progress has been made at the new US office and production site in Lawrence, MA, north of Boston. The clean rooms have been built, and the facility is planned to be operational by the end of the first quarter of 2020.

This means that Alpha DaRT seeds for our North American clinical trials and patients will soon be produced within the United States.

 

 
Canadian government approves comprehensive Alpha DaRT physics research collaboration


Ronen Segal, our CTO, is happy to share with you that the Quebec government has officially granted approval for a highly comprehensive research program of medical physics related to the Alpha DaRT technology. The program will be funded by four different agencies in Quebec and Montreal as well as by Alpha Tau Medical. The research collaboration will be led by top physics groups at McGill University, University of Montreal (CHUM), Ben Gurion University, Tel Aviv University and Memorial Sloan Kettering, all working together on developing simulations, models, and alpha-detection technologies using a variety of modalities.

We are looking forward to interesting results and developments fruiting from this new and promising collaboration.


 

 

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Regulatory Updates
 
Technical files submitted for EU registration and CE mark 


Yaniv Sagie, the Quality and Regulatory Director at Alpha Tau, is excited to report that we are now at the last stage in the approval process for EU registration and CE mark. All three steps in the audit process (stage I, II, and microbiology) have been completed. The technical files have now been submitted to the BSI (British Standards Institute) for assessment and approval. Once we receive this approval, Alpha DaRT may be marketed to treat superficial squamous cell carcinoma patients in the European market.

 

 
All biocompatibility tests for Alpha DaRT successfully completed


North American Science Associates, Inc. (NAMSA) has successfully completed biocompatibility tests for the Alpha DaRT seeds and applicator, in accordance with ISO-10993 standards. The device was confirmed to be completely safe and biocompatible for up to 29 days’ use after insertion. The following specific tests were included in the certification:

  • Cytotoxicity testing                                  

  • Intracutaneous (irritation) testing

  • Sensitization testing

  • Acute systemic toxicity testing

  • Pyrogenicity testing

  • Genotoxicity testing

  • 4-week acute systemic toxicity testing

 


 

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Conferences
 
Successful GEC ESTRO Workshop, November 21 - 22, Budapest


We would like to thank GEC ESTRO for an outstanding and highly interesting workshop in Budapest on Nov. 21-22.

We wish a warm congratulations to Prof. Yona Keisari who gave a fabulous presentation on alpha particle-mediated treatment for solid tumors using Alpha DaRT. He specifically discussed the results of a preclinical study of colon cancer in which an Alpha DaRT and immunotherapy combination reduced both primary and metastatic tumor burdens.

We also enjoyed wonderful company at our Alpha Tau Dinner Party, celebrating with colleagues and friends. Thank you for joining us!

 

 
Three successful presentations at ASTRO19 


In September, Alpha Tau made an astonishing presence in Chicago at the ASTRO Annual Meeting 2019, one of the leading radiation oncology conferences in the world. Three of our scientists were chosen to present their new preclinical results and clinical study. 

  1. Prof. Aron Popovtzer reviewed the follow-up data for their first-in-human clinical trial of Alpha DaRT in patients with squamous cell carcinoma of the skin and oral cavity. (See above for more information on newest clinical publication)
     

  2. Prof. Yona Keisari presented data from a study demonstrating the effective treatment of triple-negative breast cancer (TNBC) in mice by treatment with Alpha DaRT in combination with PolyIC. TNBC is an aggressive and malignant cancer with few successful treatment options. Read More
     

  3. Prof. Zvi Symon presented critical histopathology data from a study on animal tissue. The results showed no major toxicity of Alpha DaRT in healthy tissue of various locations and therefore confirmed the technology’s high safety profile. Read More
     

 
Encouraging feedback at first Oral and Head & Neck Surgery meeting, the IAOO


We were excited to report on very positive impressions of Alpha DaRT, along with a successful presentation by Dr. Aviram Mizrachi, at the IAOO (International Association of Oral Oncologists) meeting, August 31-Sept 3, in Rome. 

The IAOO was the first surgery conference that Alpha Tau has attended. Our goal for the IAOO meeting was to test the perceptions and responses of oral surgeons from around the world to Alpha DaRT, as a new treatment modality in this field.

Dr. Mizrachi, a leading head and neck surgeon and sub-investigator of the Rabin Medical Center clinical trials, was chosen to present the promising initial SCC clinical results. In conversations with Dr. Mizrachi, many conference participants expressed the view that Alpha DaRT could potentially be used as first-line therapy for advanced H&N cancer that is inoperable by standard surgical techniques. 

 

 
Dr. Lior Arazi discusses potential benefits of Alpha DaRT seed technology at AAPM in San Antonio, Texas


The American Association of Physicists in Medicine (AAPM) is an organization for medical physicists who work to ensure the accuracy and safety of radiation in medical procedures, such as medical imaging and radiation therapy. 

At the meeting (July 14-19), Dr. Arazi (one of the developers of Alpha DaRT) explained how the Alpha DaRT technology works to a curious audience of physicists. He described how high-dose alpha particles can kill cancer cells even when placed close to critical organ structures, without causing collateral damage to healthy tissue. 
Watch Interview


 

 

 

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Set a Meeting at Upcoming Conferences

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

ESTRO meets Asia, December 6-8, Singapore
Contact us to schedule a meeting 

 

 

 

Biotech Showcase, JP Morgan Healthcare Week, January 13–15, 2020, San Francisco
Contact us to schedule a meeting

 

 

 

ESTRO 2020, April 3-7, Vienna

World Congress of Brachytherapy 2020, April 2-4, Vienna
Contact us to schedule a meeting

 

 

 

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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Copyright © 2019 Alpha Tau Medical LTD., All rights reserved.


 

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