Alpha Tau Announces the Acceptance in Major Peer-Reviewed Journals (International Journal of Radiation Oncology, Biology, Physics, and Frontiers in Oncology) of Two Landmark Pre-Clinical Studies Demonstrating Significant Potential Synergies Between the Alp
09 September 2022 - 6:05AM
Alpha Tau Medical Ltd. ("Alpha Tau") (Nasdaq: DRTS and DRTSW), the
developer of the innovative alpha-radiation cancer therapy Alpha
DaRT™, announced today the acceptance of two landmark pre-clinical
studies in major peer-reviewed journals, both demonstrating the
significant potential synergies between Alpha DaRT therapy and
standard-of-care solid tumor therapies used today.
“We are very excited to have these fantastic
results recognized by two leading journals in our field,” said
Alpha Tau CEO Uzi Sofer. “The potential synergy between Alpha DaRT
and immunotherapies continues to be a strong area of focus for
Alpha Tau, both in our ongoing pre-clinical work as well as in our
endeavors to run multiple human clinical trials examining such
combinations, including the trial currently underway combining
Alpha DaRT with pembrolizumab in recurrent unresectable or
metastatic head & neck squamous cell carcinoma patients.
Similarly, the promising results for GBM patients are a key
priority for Alpha Tau, as we continue to focus on advancing our
solution for this deadly disease as quickly as possible. Armed with
our Breakthrough Device Designation from the FDA in recurrent GBM,
we have been progressing swiftly in large animal studies using our
specially designed radial applicator for use in the brain, with the
intent to begin a human clinical study in the near future.”
Ronen Segal, CTO at Alpha Tau, added, “These two
significant studies continue to build on the ever-growing body of
evidence that the Alpha DaRT may offer not only a compelling local
radiation therapy solution, but also provide a broader systemic
benefit through interaction with the immune system, and our
incorporation of more advanced immunological analyses has improved
our understanding of these amazing mechanisms. We also are
impressed by the synergies we see with other mechanisms such as
anti-angiogenesis and continue to explore those in parallel as
well.”
The first study, published in the International
Journal of Radiation Oncology, Biology, Physics (known as the Red
Journal) examines the transcriptional profile activated by Alpha
DaRT, and its potential to enhance responsiveness to immune
checkpoint inhibition of the programmed cell death protein 1 (PD-1)
blockade. These results demonstrate potential synergies with immune
stimulation in mice and support the further exploration of the
Alpha DaRT as a compelling local radiation therapy with the
potential to induce antitumor immunity.
In this pre-clinical study, Squamous Cell
Carcinoma (“SCC”) tumor-bearing mice were treated with Alpha DaRT
in combination with an anti-PD1 therapy (“aPD-1”). This group was
compared to groups of mice treated with either Alpha DaRT or aPD-1
as a monotherapy, as well as to a control group. The efficacy of
the treatment was evaluated over time, and the immune level of
activation was analyzed through immunophenotyping and
immunohistochemical staining sixteen days after Alpha DaRT source
insertion.
The group treated with Alpha DaRT in combination
with aPD-1 demonstrated delayed tumor development, higher
T-effector cell infiltration with enhanced cytotoxic potential, and
reduced systemic Myeloid-Derived Suppressor Cells (“MDSCs”) than
either monotherapy alone. Gene expression and gene set enrichment
analysis of mRNA levels seven days after Alpha DaRT insertion
indicated that Alpha DaRT upregulated indicators of cell death,
interferon signaling and myeloid related transcription, while
downregulating indicators of DNA repair and cell proliferation.
Moreover, immunophenotyping analysis at this timepoint showed that
Alpha DaRT induced dendritic cell activation and affected the
distribution of MDSC populations. Altogether, those findings
demonstrated that the Alpha DaRT may offer tumor cell destruction
via additional pathways beyond the immediate local impact of
generating double-strand DNA breaks in tumor cells.
This study’s authors conclude that Alpha DaRT
can promote a “hot” tumor microenvironment and changes in immune
suppression that lead to a potentiation of aPD-1 blockade-induced
effector T-cell function and improved treatment efficacy. The
authors observe that this study provides a rationale for
investigating the combination of Alpha DaRT and aPD-1 clinically in
SCC patients.
The full publication can be seen here:
https://www.sciencedirect.com/science/article/pii/S0360301622031881
The second study, accepted for publication by
Frontiers in Oncology in its Radiation Oncology section, examines
the use of Alpha DaRT in treating human glioblastoma multiforme
(“GBM”) xenografts, together with Temozolomide (“TMZ”), a
standard-of-care chemotherapy, or Bevacizumab, a standard-of-care
antiangiogenic therapy, both commonly used in treating GBM.
The results demonstrated that the combination of
alpha radiation with TMZ doubled the cytotoxic effect of each of
the treatments alone, and the surviving fraction of cancer cells
treated by TMZ in combination with alpha irradiation was lower than
alpha- or x-ray irradiation as monotherapies, or than by x-ray
combined with TMZ. In addition, the treatment of GBM-bearing mice
with Alpha DaRT and TMZ delayed tumor development more efficiently
than the monotherapies. The studies further confirmed that, unlike
other radiation types, alpha radiation did not increase the
secretion of VEGF, a potent angiogenic factor that promotes tumor
growth.
With respect to the combination of Alpha DaRT
with anti-angiogenic therapy, Bevacizumab treatment introduced
several days after Alpha DaRT implantation improved tumor control,
compared to Bevacizumab or Alpha DaRT as monotherapies. The
combination was also shown to be superior when starting Bevacizumab
administration prior to Alpha DaRT implantation in large tumors
relative to the size of the Alpha DaRT source. Bevacizumab induced
a decrease in the endothelial cell marker CD31 staining in
conjunction with the Alpha DaRT treatment, and increased the
diffusive spread of Radium-224 daughter atoms in the tumor tissue,
while decreasing their clearance from the tumor through the
blood.
A summary abstract of the publication can be seen
here:https://www.frontiersin.org/articles/10.3389/fonc.2022.888100/abstract
About Alpha DaRT™
Alpha 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
it.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli medical device 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.
Forward-Looking Statements
This 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; (xix)
impacts from the COVID-19 pandemic; 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 28, 2022, 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 forward-looking statements made in this press release. Any such
forward-looking statements represent management's estimates as of
the date of this press release. While Alpha Tau may elect to update
such forward-looking statements at some point in the future, except
as required by law, it disclaims any obligation to do so, even if
subsequent events cause its views to change. These forward-looking
statements should not be relied upon as representing Alpha Tau's
views as of any date subsequent to the date of this press
release.
Investor Relations Contact
IR@alphatau.com
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