JERUSALEM, Nov. 3, 2021 /PRNewswire/ -- Alpha Tau Medical
Ltd. ("Alpha Tau"), the developer of the innovative alpha-radiation
cancer therapy Alpha DaRT, announced today that it has enrolled its
first patient in the combination study of Alpha DaRT and
pembrolizumab (Keytruda®) at Hadassah Medical Center
in Jerusalem, Israel.
The clinical trial is designed to test the benefit of the Alpha
DaRT in combination with pembrolizumab, an immunotherapy drug, for
the treatment of recurrent unresectable or metastatic squamous cell
carcinoma of the head and neck. The primary objective of the study
is to evaluate efficacy of the combination, as measured by the
confirmed Best Overall Response rate determined by using the RECIST
criteria. Patients enrolled in the trial will receive pembrolizumab
cycles every three weeks both before and after receiving Alpha DaRT
treatment. The study uses a two-stage adaptive design and can
recruit up to 48 patients, with a planned interim analysis after
the first 18 patients have been treated.
"We are excited to begin our much-anticipated first human
clinical trial combining the Alpha DaRT with a checkpoint
inhibitor," said Alpha Tau CEO Uzi
Sofer. "This initiative is a major component of the vision
and future direction of Alpha Tau, as we look to evaluate our
locally administered Alpha DaRT therapy for its potential to
provide local treatment of tumors and also contribute to a systemic
response in untreated tumors throughout the body."
Alpha Tau CMO Dr. Robert Den
remarked, "The novel adaptive two-stage trial design will allow us
to determine very quickly whether we have observed an improved
systemic response from the combination of Alpha DaRT with
pembrolizumab, and at the same time allow for a meaningful enough
patient population to support decision-making with respect to our
clinical pathway. We are looking forward to seeing the data from
this trial, particularly in light of our pre-clinical data showing
that the combined use of Alpha DaRT with immunomodulators resulted
in decreased metastatic burden and improved survival in treated
animals, and that this activity was modulated by activation of the
immune system."
Prof. Aron Popovtzer, Head of the Sharett Institute of Oncology
at Hadassah Medical Center in Jerusalem, and principal investigator of the
study, commented, "We are excited to be leading this trial, the
first one to combine Alpha DaRT with an immunotherapy in humans. We
believe this patient population presents a serious unmet need, and
we are looking forward to seeing whether this combination can
provide a new source of relief for these patients."
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 source 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.
On July 8, 2021, Alpha Tau
announced that it had entered into a definitive merger agreement
(the "Merger Agreement") with Healthcare Capital Corp. (Nasdaq:
HCCC) ("HCCC"), a special purpose acquisition company, pursuant to
which Alpha Tau would consummate a business combination transaction
(the "Business Combination") with HCCC and become a Nasdaq-listed
public company.
Media Package: https://www.alphatau.com/media-package
Additional Information and Where to Find It
For additional information on the Business Combination, see
HCCC's Current Report on Form 8-K, which was filed with the
Securities and Exchange Commission ("SEC") on July 8, 2021.
In connection with the proposed transaction with HCCC, Alpha Tau
has filed a Registration Statement on Form F-4, which includes a
preliminary proxy statement/prospectus of HCCC.
Investors and security holders of HCCC are advised to read, when
available, the preliminary proxy statement, and amendments thereto,
and the definitive proxy statement in connection with HCCC's
solicitation of proxies for its special meeting of stockholders to
be held to approve the proposed Business Combination because the
proxy statement/prospectus will contain important information about
the proposed transaction and the parties to the proposed
transaction. The definitive proxy statement/prospectus will be
mailed to stockholders of HCCC as of a record date to be
established for voting on the proposed Business Combination.
Stockholders will also be able to obtain copies of the
Registration Statement, proxy statement/prospectus, and Form 8-K,
without charge at the SEC's website at www.sec.gov.
No Offer or Solicitation
This announcement is for informational purposes only and is
neither an offer to purchase, nor a solicitation of an offer to
sell, subscribe for or buy any securities or the solicitation of
any vote in any jurisdiction pursuant to the proposed Business
Combination or otherwise, nor shall there be any sale, issuance or
transfer or securities in any jurisdiction in contravention of
applicable law. No offer of securities shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Participants in the Solicitation
HCCC and Alpha Tau and their respective directors, executive
officers, other members of management, and employees, under SEC
rules, may be deemed to be participants in the solicitation of
proxies of HCCC's stockholders in connection with the proposed
Business Combination between HCCC and Alpha Tau. Investors and
security holders may obtain more detailed information regarding the
names and interests in the proposed transaction of HCCC's directors
and officers HCCC's and Alpha Tau's filings with the SEC, including
the Registration Statement.
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 and HCCC'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 occurrence of
any event, change or other circumstances that could give rise to
the termination of the Merger Agreement and the proposed Merger
contemplated thereby; (xiv) the inability to complete the
transactions contemplated by the Merger Agreement due to the
failure to obtain approval of the stockholders of HCCC or other
conditions to closing in the Merger Agreement; (xv) the inability
to meet the aggregate transaction proceeds requirements of the
Merger Agreement due to the inability to consummate the PIPE
Investment or the amount of cash available following any
redemptions by HCCC's stockholders; (xvi) the ability to meet
Nasdaq's listing standards following the consummation of the
transactions contemplated by the Merger Agreement; (xvii) the risk
that the proposed transactions disrupt current plans and operations
of Alpha Tau as a result of the announcement and consummation of
the transaction described herein; (xviii) the ability to recognize
the anticipated benefits of the proposed Merger, which may be
affected by, among other things, competition, the ability of the
combined company to grow and manage growth profitably, maintain
relationships with customers and suppliers and retain its
management and key employees; (xix) costs related to the proposed
Merger; (xx) changes in applicable laws or regulations; (xxi)
impacts from the COVID-19 pandemic; and the other important factors
discussed under the caption "Risk Factors" in Alpha Tau's
Registration Statement on Form F-4 originally filed with the SEC on
August 19, 2021, as amended, 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 our 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.
Contact:
Amnon Gat
+972-54-9746276
amnong@alphatau.com
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SOURCE Alpha Tau Medical