Newsletter - Issue no. 4

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