AlphaBreak is a Phase 2/3 registrational
program for FPI-2265 in patients with metastatic
castration-resistant prostate cancer
HAMILTON, ON and BOSTON, May 9, 2024
/PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a
clinical-stage oncology company focused on developing
next-generation radioconjugates (RCs) as precision medicines, today
announced that the first patient has been dosed in the Phase 2
portion of the AlphaBreak trial evaluating FPI-2265
(225Ac-PSMA I&T) in patients
with metastatic castration-resistant prostate cancer
(mCRPC).
"Actinium-based PSMA targeting RCs have demonstrated compelling
safety and clinical activity, which is supported by Fusion's
encouraging data from the Phase 2 TATCIST trial reported recently
at the AACR Annual Meeting. We believe FPI-2265 represents an
important potential new treatment option for patients with mCRPC,
and with the initiation of the AlphaBreak trial we are pleased to
move forward," said Chief Medical Officer Dmitri Bobilev, M.D.
"Despite recent advances in the field, we see many patients with
mCRPC still in need of additional treatment options, especially
after progressing on lutetium-based radiotherapy. It is encouraging
to see the promising clinical activity and good safety profile
demonstrated by FPI-2265. The initiation of the AlphaBreak trial
brings us a step closer to addressing the gap for patients and
providing this needed treatment option," said investigator
Luke Nordquist, M.D., FACP, XCancer
Chief Executive Officer.
The AlphaBreak trial is a Phase 2/3, randomized, open-label,
multicenter study to evaluate the safety and efficacy of FPI-2265
in patients with mCRPC previously treated with
177Lu-PSMA radiotherapy. The Phase 2 dose optimization
portion is designed to evaluate whether there are added safety
and/or efficacy benefits of two alternative dosing regimens in
comparison to the previously studied regimen of 100 kBq/kg every
eight weeks. The Phase 2 portion of the AlphaBreak trial is
expected to complete enrollment of approximately 60 patients by the
end of 2024. Following analysis of the Phase 2 data and an end of
Phase 2 meeting to determine the recommended Phase 3 dosing regimen
with the U.S. Food and Drug Administration (FDA), the Phase 3
global registration portion of the AlphaBreak trial will enroll
approximately 550 patients and is expected to begin in 2025.
About FPI-2265
FPI-2265 is an actinium-225 based PSMA targeting RC, for
mCRPC, currently in a Phase 2 trial. Actinium-225 emits alpha
particles and holds the promise of being a next-generation
radioisotope in cancer treatment. By delivering a greater radiation
dose over a shorter distance, alpha particles such as actinium-225
have the potential for more potent cancer cell killing, and
targeted delivery, thereby minimizing damage to surrounding healthy
tissue.
About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company
focused on developing next-generation RCs. Fusion conjugates alpha
particle emitting isotopes to various targeting molecules in order
to selectively deliver the alpha emitting payloads to tumors.
Fusion's clinical-stage development portfolio includes lead
program, FPI-2265, targeting PSMA for mCRPC and novel RCs targeting
solid tumors. Fusion has a fully operational Good Manufacturing
Practice compliant state-of-the-art radiopharmaceutical
manufacturing facility to meet supply demand for the Company's
growing pipeline of RCs. The Company has 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. 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 FPI-2265 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 trial evaluating
FPI-2265; 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
partners' ability to advance any technology relating to
actinium-225 to development. 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 March 31,
2024, 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.
Investors and others should note that Fusion communicates with
its investors and the public using the Fusion website,
www.fusionpharma.com, including, but not limited to, company
disclosures, investor presentations, SEC filings, and press
releases. The information that Fusion posts on this website could
be deemed to be material information. As a result, Fusion
encourages investors, media and others interested to review the
information that Fusion posts there on a regular basis.
Contact:
Amanda
Cray
Senior Director of Investor Relations & Corporate
Communications
(617) 967-0207
cray@fusionpharma.com
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SOURCE Fusion Pharmaceuticals