Full Press Release Details
Tau Announces Cornerstone Interim Data Across Multiple Clinical Trials to be Shared at R&D Update Day
High disease control rate and strong interim safety results observed in pancreatic cancer patients across three trials exploring the
Ad-hoc analyses of pancreatic cancer population subgroups suggest meaningful improvement in median overall survival (OS) for patients
treated with Alpha DaRT after prior therapy, compared to previously published studies of alternative monotherapies, across all analyzed
Investigational Device Exemption (IDE) received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy
in patients with metastatic pancreatic cancer -
Approval received from France's Ministry of Health to commence French multicenter clinical trial of Alpha DaRT alongside capecitabine
for patients with locally advanced pancreatic cancer -
In the first eight patients of a combination trial of Alpha DaRT with a checkpoint inhibitor (pembrolizumab) for recurrent unresectable
or metastatic head and neck squamous cell carcinoma (HNSCC), a systemic objective response rate of 75% and systemic complete response
rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, observed for pembrolizumab alone in a similar
patient population in Merck's KEYNOTE-048 trial -
Alpha Tau is hosting a virtual R&D Update Day with Key Opinion Leaders at 11:00am ET today, January 27, 2025 -
Clinicians to share case studies of selected initial patient outcomes with the Alpha DaRT in treating liver metastases, lung cancer and
January 27th, 2025 -- Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW),
the developer of the innovative alpha-radiation cancer therapy Alpha DaRT ,
announced today positive interim data from multiple clinical trials, including safety and feasibility
studies treating patients with pancreatic cancer, a combination study with pembrolizumab in patients with recurrent unresectable or metastatic
HNSCC, and other clinical trials. The data will be shared during an R&D Update Day to be held today at 11am ET; registration for
the event and further information are available at https://alpha-tau-medical-2025-rd-day.open-exchange.net/registration.
Cancer Trials - Interim Data as of Jan 8, 2025
three ongoing feasibility and safety trials, two in Canada and one in Israel, 41 patients with pancreatic cancer had been treated with
Alpha DaRT in Canada (n=24) and Israel (n=17), including the first five patients for whom interim data was already released in late 2023.
A 100% success rate was achieved in delivering the Alpha DaRT sources (feasibility), and strong safety results were observed: 151 adverse
events were reported in total, of which 38 were possibly, probably or definitely associated with Alpha DaRT treatment, of which three
were deemed serious adverse events (SAEs). Two of three SAEs required brief hospitalizations and all patients were discharged or recovered.
the 41 patients across the three trials, 33 patients had a measured objective response and were examined for survival metrics.
best overall response (BOR) in patients with a measured response, the findings from a pooled analysis include:
Kaplan-Meier statistics for measurement of overall survival (OS), median OS across all 33 patients was 18.6 months after diagnosis or
initiation of the previous round of chemotherapy, or 10.9 months after treatment with Alpha DaRT.
analyses of key sub-populations evaluated in the Company's pancreatic cancer trials vs. results from relevant third-party clinical
studies illustrate the potential benefit of Alpha DaRT for patient populations with generally poor prognoses, though caution should be
exercised in comparing results from unrelated clinical studies due to differences in study designs, patient populations and other relevant
factors. Findings from the Company's ad-hoc analyses include:
today's presentation, the clinicians will discuss the clinician and patient experience with Alpha DaRT for pancreatic cancer, and
will also review the case study of a patient who was treated with Alpha DaRT concurrently with chemotherapy for pancreatic adenocarcinoma
with liver metastases and who had a complete resolution on PET scan at 90 days of both the primary tumor and the liver metastases.
for pancreatic cancer clinical trials in U.S. and France
Company has also announced the receipt of an IDE from the U.S. Food and Drug Administration (FDA), to conduct a clinical study examining
the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, as well as
the receipt of regulatory approval from France's Ministry of Health to initiate a French multi-center study examining the use of
Alpha DaRT alongside capecitabine in treating locally advanced pancreatic cancer in 40 patients who have responded or had stable disease
with first-line FOLFIRINOX.
combination trial in patients with HNSCC - Interim Data as of Jan 9, 2025
Company also announced interim data showing strong systemic responses in its safety and efficacy study combining Alpha DaRT treatment
with pembrolizumab in patients with recurrent unresectable or metastatic HNSCC, targeting a similar population as evaluated in Merck's
KEYNOTE-048 study9 and with a Combined Positive Score (CPS) of at least 1. As of Jan 9, 2025, eight patients were treated
with Alpha DaRT and pembrolizumab in the study. Of the eight patients treated, three demonstrated a systemic complete response, three
demonstrated a systemic partial response, and two patients died before being evaluated, demonstrating:
abstract entitled "Management of Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing Alpha-Emitter
Radiation Therapy in Combination with Pembrolizumab," with interim data from this clinical study, has been accepted for presentation
at the 11th European Congress on Head and Neck Oncology on March 26-29, 2025 in Amsterdam.
addition, no SAEs related to Alpha DaRT treatment were reported in these patients as of the data cutoff date of January 9, 2025.
today's presentation, the clinicians will also review the case of a patient with HNSCC in the alveolar ridge and lip as well as
dermal involvement, who underwent Alpha DaRT treatment of the neck alongside pembrolizumab, and has experienced a complete resolution
of all tumors and no measurable disease over two years since treatment.
these strong results, the Company intends to discuss with the FDA a potential U.S. trial exploring the combination of Alpha DaRT and
pembrolizumab in patients with head and neck cancer.
today's R&D Update Day, clinicians will also present case studies from the first patients treated with Alpha DaRT in a number
of other internal organs:
is truly a momentous day for Alpha Tau," noted Alpha Tau CEO Uzi Sofer. "With these fantastic clinical results observed across
a number of difficult cancers, we are now able to demonstrate the broader Alpha Tau vision: Beyond our historical activities treating
patients with localized and unresectable tumors, we are now expanding our focus on treating internal organ tumors of high unmet need,
as well as tumors in metastatic patients, by harnessing the potential systemic immune benefits of Alpha DaRT. We are incredibly excited
to pursue treatment of these cancers further across a number of future clinical trials, with increased attention to launching U.S. clinical
trials investigating Alpha DaRT treatment of the pancreas, the brain, and in combination with checkpoint inhibitors. We aim to continue
to generate incredible results and hope for these patients of high unmet need."
Tau Virtual R&D Update Day
Tau will host a Virtual R&D Update Day featuring Prof. Aron Popovtzer, MD (Hadassah Medical Center), Corey Miller, MD, MSc (McGill
University), Philip Blumenfeld, MD, MPH (Hadassah Medical Center), and Robert Den, MD (Alpha Tau) to discuss newly released data and
case studies on Monday, January 27th, 2025 at 11:00am ET. To register for the event, click here: https://alpha-tau-medical-2025-rd-day.open-exchange.net/registration. A live question and answer
session will follow the formal remarks.
Alpha Tau Medical Ltd.
in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization
of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and
Prof. Yona Keisari from Tel Aviv University.
DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation
of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released
from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting
atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around
press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of
1995. When used herein, words including "anticipate," "being," "will," "plan," "may,"
"continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information
that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances,
including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations
and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.
Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those
described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i)
Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates;
(ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's
need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery
and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure
of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early
clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its
clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates;
(xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations
applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes
in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's
annual report filed on form 20-F with the SEC on March 7, 2024, and other filings that Alpha Tau may make with the United States Securities
and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the