Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 139

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 139
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 ad hoc compassionate
use treatments, we have initiated a clinical study at Hadassah Medical Center, Jerusalem, Israel, for any patients with malignant tumors
of up to 7 centimeters in the longest dimension. The study objectives are to collect data on the general safety and efficacy of Alpha
DaRT among patients who do not fit the entry criteria of existing investigational trials. The primary endpoint of the study is to assess
the frequency, severity and causality of acute AEs related to the Alpha DaRT treatment, according to CTCAE version 5.0. The secondary
endpoint is to assess the tumor response to Alpha DaRT treatment assessed using RECIST version 1.1, approximately 3 months after Alpha
DaRT treatment.

Additional Pipeline Indications

In addition to the trials
and clinical pathways described above, we are currently planning a number of other clinical studies, both to generate additional data
from the tumor types we are already exploring in humans, as well as to test the use of Alpha DaRT in additional tumor types, including
breast cancer, glioblastoma multiforme, and rectal cancer.

We are seeking to secure IDE approval to commence a U. S. early feasibility
study exploring the use of Alpha DaRT to treat glioblastoma multiforme. In preclinical experiments, clinicians have successfully demonstrated
the ability to deliver Alpha DaRT sources into the brain cortex and subcortex using our radial applicator. No unexpected abnormalities
were detected in blood or cerebral spinal floor samples, and MRI and CT scans revealed no evidence of major bleeding or infection. Minimal
spatial and temporal movements of the sources were noted. Histopathological analysis demonstrated locally confined findings in brain
parenchyma in a very close proximity to the sources.

Exploration of Potential Systemic Immune Benefit

Combination study: Alpha DaRT +
checkpoint inhibitor (recruiting)

In November 2021, we initiated
a combination study of the Alpha DaRT and pembrolizumab (Keytruda) for the treatment of HNSCC, in Israel. We chose to evaluate the Alpha
DaRT in combination with pembrolizumab for the treatment of HNSCC because in our pre-clinical studies (discussed below), the combined
use of Alpha DaRT with immunomodulators resulted in decreased metastatic burden and improved survival in treated animals. Further, the
results indicated that this activity was modulated by activation of the immune system. Both