Data presented at the 2023 AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics
FPI-2068 demonstrates anti-tumor activity
in colorectal and lung tumor xenograft mouse models
FPI-2068, developed as part of
collaboration agreement with AstraZeneca, received IND clearance in
2Q 2023
HAMILTON, ON and BOSTON, Oct. 12,
2023 /PRNewswire/ -- Fusion Pharmaceuticals Inc.
(Nasdaq: FUSN), a clinical-stage oncology company focused on
developing next-generation radiopharmaceuticals as precision
medicines, today announced the presentation of preclinical data for
FPI-2068, a clinical stage bispecific IgG-based targeted alpha
therapy (TAT) designed to deliver actinium-225 to various solid
tumors that co-express EGFR-cMET. Fusion is jointly developing
FPI-2068 with AstraZeneca (LSE/STO/Nasdaq: AZN) under the
companies' multi-asset collaboration agreement. The data are being
presented in a poster presentation at the 2023 AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics, being held October
11-15 in Boston,
Massachusetts.
"We are pleased to share preclinical data demonstrating potent
anti-tumor activity and evidence of mechanism of action of
FPI-2068. EGFR and cMET are each validated targets, widely
expressed in multiple solid tumor types. FPI-2068 combines the
potency of an alpha-emitting isotope with the dual antigen
targeting capability of the bispecific antibody to deliver a
differentiated mechanism of action molecule that we believe has the
potential to enhance therapeutic index, said Fusion Pharmaceuticals
Chief Scientific Officer Christopher
Leamon, Ph.D. "Following the IND clearance obtained earlier
this year, we look forward to advancing FPI-2068 into clinical
trials given the substantial unmet need for patients with non-small
cell lung cancer and other cancer types that are known to
co-express EGFR-cMET."
Data from a preclinical study of FPI-2068 are being presented in
a poster presentation titled, "FPI-2068: A novel anti-EGFR/cMET,
alpha-particle emitting, radioimmunoconjugate for cancer
therapy."
In the preclinical study, FPI-2068 demonstrated anti-tumor
efficacy in colorectal and lung tumor xenograft mouse models, and
single dose administration of FPI-2068 led to prolonged tumor
regression. Further, FPI-2068 caused activation of the DNA damage
response (DDR) pathway as well as apoptosis, suggesting an
inability of the cellular machinery to repair the DNA damage
induced by the alpha radiation, consistent with the proposed
primary mechanism of action.
These data provide further evidence supporting the clinical
development of FPI-2068, which is expected to enter a Phase 1 study
for the treatment of solid tumors co-expressing EGFR-cMET. EGFR and
cMET are both validated targets that are co-expressed in multiple
tumor types, including head and neck squamous cell carcinoma,
non-small cell lung cancer, colorectal cancer, and pancreatic
ductal adenocarcinoma.
Copies of the poster presentation can be found
at: https://fusionpharma.com/fusion-scientific-presentations/ following the
conclusion of the AACR-NCI-EORTC Annual Meeting.
About FPI-2068
[225Ac]-FPI-2068 (FPI-2068) is a targeted alpha
therapy (TAT) designed to deliver actinium-225 to various solid
tumors that co-express EGFR and cMET. EGFR and cMET are validated
cancer targets that are co-expressed in multiple tumor types,
including head and neck squamous cell carcinoma, non-small cell
lung cancer, colorectal cancer, and pancreatic ductal
adenocarcinoma.
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 to selectively deliver the
alpha emitting payloads to tumors. Fusion's clinical portfolio
includes: FPI-2265 targeting prostate specific membrane antigen
(PSMA) 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 trial; and
FPI-2059, a small molecule targeting neurotensin receptor 1
(NTSR1), 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 (DDRis) and immuno-oncology agents. The
Company recently 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. To support Fusion's
growing pipeline of TATs, the Company has signed strategic actinium
supply agreements with TRIUMF, 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 Fusion
Pharmaceuticals Inc.'s (the "Company") future business. 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 potential drug candidates,
including any expressed or implied statements regarding the
successful development of its product candidates. 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 or other
component of its potential pipeline to the clinic, to the
regulatory process or to commercialization; management's
expectations could be affected by unexpected patient recruitment
delays, regulatory actions or delays, or changes in the competitive
landscape; uncertainties relating to, or unsuccessful results of,
clinical trials, including additional data relating to the ongoing
clinical trials evaluating its product candidates; and competition
in general. 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 year ended June 30, 2023, as
filed with 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