FPI-2265 positioned to be the first
approved PSMA targeted alpha therapy
HAMILTON, ON and BOSTON,
Feb. 16,
2024 /CNW/ -- Fusion Pharmaceuticals Inc. (Nasdaq:
FUSN), a clinical-stage oncology company focused on developing
next-generation radiopharmaceuticals as precision medicines, today
announced that it has entered into an exclusive worldwide license
agreement with Heidelberg
University and Euratom represented by the European
Commission, Joint Research Centre (together, the "Licensors"). The
license agreement grants Fusion exclusive worldwide rights to
utilize, develop, manufacture and commercialize compounds covered
by the patent, which includes 225Ac-PSMA I&T
("FPI-2265") for the treatment of prostate specific membrane
antigen (PSMA)-expressing cancers. In addition, Fusion and the
Licensors have signed an agreement to settle the parties' dispute
related to an inter partes review ("IPR") of a
U.S. patent owned by the Licensors which was instituted in
August 2023 by the United States
Patent and Trademark Board.
Fusion President and Chief Business Officer Mohit Rawat said, "We are pleased to enter into
this exclusive license agreement with Heidelberg University and Euratom
for their existing patent as we progress FPI-2265, the most
advanced actinium-based PSMA targeted radiotherapy currently in
development. With Fusion's expertise in the development and
manufacturing of alpha-emitting radiopharmaceuticals, an
operational radiopharmaceutical manufacturing facility, and our
advantageous actinium supply, we are well positioned to execute
this program. We look forward to providing updates as we reach
anticipated upcoming milestones in 2024, including data from the
TATCIST study in April and the initiation of our Phase
2/3 registrational study in the second quarter."
As announced in January 2024,
Fusion and the U.S. Food and Drug Administration reached alignment
on Fusion's Phase 2/3 protocol for FPI-2265 in patients with mCRPC
who have progressed following treatment with lutetium-based
radiopharmaceuticals. The updated development plan includes a Phase
2 dose optimization lead-in, expected to complete enrollment by the
end of 2024, and a Phase 3 registrational trial expected to begin
in 2025.
Under the terms of the license agreement, Fusion will pay the
Licensors an aggregate upfront fee of €1.0 million, in addition to
certain regulatory milestones upon potential approval and low
single-digit royalties on future net sales of applicable
products.
About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company
focused on developing next-generation radiopharmaceuticals as
precision medicines. Fusion connects alpha particle emitting
isotopes to various targeting molecules in order to selectively
deliver the alpha emitting payloads to tumors. Fusion's clinical
portfolio includes: FPI-2265 targeting prostate specific membrane
antigen for metastatic castration resistant prostate cancer
currently in a Phase 2 trial; FPI-1434 targeting insulin-like
growth factor 1 receptor currently in a Phase 1 clinical trial; and
FPI-2059, a small molecule targeting neurotensin receptor 1,
currently in a Phase 1 trial. In addition to a robust proprietary
pipeline, Fusion has a collaboration with AstraZeneca to jointly
develop novel targeted alpha therapies (TATs) and combination
programs between Fusion's TATs and AstraZeneca's DNA Damage
Response Inhibitors and immuno-oncology agents. The Company
received IND clearance for FPI-2068, the first novel TAT under the
collaboration, which targets EGFR-cMET. Fusion has also entered
into a collaboration with Merck to evaluate FPI-1434 in combination
with Merck's KEYTRUDA® (pembrolizumab) in patients with
solid tumors expressing IGF-1R. Fusion has a Good Manufacturing
Practice compliant radiopharmaceutical manufacturing facility
designed to support manufacturing of the Company's growing pipeline
of TATs. The Company has signed strategic actinium supply
agreements with Niowave, Inc. and BWXT Medical.
Forward-Looking Statements
This press release contains "forward-looking statements" for
purposes of the safe harbor provisions of The Private Securities
Litigation Reform Act of 1995, including but not limited to the
statements regarding the future business and financial performance
of Fusion Pharmaceuticals Inc. (the "Company"). For this purpose,
any statements contained herein that are not statements of
historical fact may be deemed forward-looking statements. Without
limiting the foregoing, the words "expect," "plans," "anticipates,"
"intends," "will," and similar expressions are also intended to
identify forward-looking statements, as are expressed or implied
statements with respect to the Company's financial condition,
liquidity, and potential drug candidates, including any expressed
or implied statements regarding the successful development of
FPI-2265 or timing of updates. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of risks and uncertainties, including but not limited to the
following: there can be no guarantees that the Company will advance
any clinical product candidate in the clinic, to the regulatory
process or to commercialization; management's expectations could be
affected by unexpected patient recruitment delays or regulatory
actions or delays; uncertainties relating to, or unsuccessful
results of, clinical trials, including additional data relating to
the ongoing clinical trials evaluating its product candidates; the
Company's ability to obtain additional funding required to conduct
its research, development and commercialization activities; changes
in the Company's business plan or objectives; competition in
general; the Company's ability to obtain, maintain and enforce
patent and other intellectual property protection for its product
candidates and its discoveries; and the Company ability to secure
sufficient amounts of actinium-225 for its clinical and commercial
activities. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results,
performance or achievements expressed or implied by such
statements. These and other risks which may impact management's
expectations are described in greater detail under the heading
"Risk Factors" in the Company's quarterly report on Form 10-Q for
the period ended September 30, 2023,
as filed with the Securities and Exchange Commission (the "SEC")
and in any subsequent periodic or current report that the Company
files with the SEC. All forward-looking statements reflect the
Company's estimates only as of the date of this release (unless
another date is indicated) and should not be relied upon as
reflecting the Company's views, expectations, or beliefs at any
date subsequent to the date of this release. While Fusion may elect
to update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so, even if
the Company's estimates change.
Contact:
Amanda
Cray
Senior Director of Investor Relations & Corporate
Communications
(617) 967-0207
cray@fusionpharma.com
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SOURCE Fusion Pharmaceuticals