Fast Track designation highlights potential
for CT-0525 to address unmet need for patients with solid
tumors
Initial Phase 1 data expected by year-end
2024
PHILADELPHIA, June 25,
2024 /PRNewswire/ -- Carisma Therapeutics Inc.
(Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage
biopharmaceutical company focused on discovering and developing
innovative immunotherapies, announced today that the U.S. Food and
Drug Administration (FDA) has granted Fast Track designation for
CT-0525, an ex vivo gene-modified autologous chimeric
antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended
to treat solid tumors that overexpress human epidermal growth
factor receptor 2 (HER2).
The FDA's Fast Track program is aimed to facilitate the
development, and expedite the review, of novel potential therapies
that are designed to treat serious conditions and have the
potential to address significant unmet medical need.
"Receiving Fast Track designation for CT-0525 from the FDA marks
a significant milestone for Carisma, highlighting the FDA's
recognition of the serious and life-threatening nature of these
malignancies and the potential of CT-0525 to meet this critical
medical need," said Eugene P.
Kennedy, M.D., Chief Medical Officer of Carisma. "We are
committed to working closely with the FDA to accelerate the
development of CT-0525. Currently, we are enrolling patients in the
Phase 1 clinical trial and remain on track to report initial
clinical data by the end of 2024."
The Phase 1 clinical trial for CT-0525 is an open-label study
designed to assess the safety, tolerability, and manufacturing
feasibility of CT-0525. This trial will enroll participants with
locally advanced (unresectable) or metastatic solid tumors
overexpressing HER2 whose disease has progressed on standard
approved therapies. The initial study design will consist of two
dose escalation cohorts. Further details of the trial can be found
at www.clinicaltrials.gov under NCT identifier: NCT06254807.
About CT-0525
CT-0525 is a first-in-class, ex
vivo gene-modified autologous chimeric antigen
receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat
solid tumors that overexpress human epidermal growth factor
receptor 2 (HER2). It is being studied in a multi-center, open
label, Phase 1 clinical trial for patients with advanced/metastatic
HER2-overexpressing solid tumors that have progressed on available
therapies. The CAR-Monocyte approach has the potential to address
some of the challenges of treating solid tumors with cell
therapies, including tumor infiltration, immunosuppression within
the tumor microenvironment, and antigen heterogeneity. CT-0525 has
the potential to enable significant dose escalation, enhance tumor
infiltration, increase persistence, and reduce manufacturing time
compared to macrophage therapy.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical stage biopharmaceutical
company focused on utilizing our proprietary macrophage and
monocyte cell engineering platform to develop transformative
immunotherapies to treat cancer and other serious diseases. We have
created a comprehensive, differentiated proprietary cell therapy
platform focused on engineered macrophages and monocytes, cells
that play a crucial role in both the innate and adaptive immune
response. Carisma is headquartered in Philadelphia, PA. For more information, please
visit www.carismatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
"forward-looking statements" within the meaning of The Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, statements relating to Carisma's business,
strategy, future operations, cash runway, the advancement of
Carisma's product candidates and product pipeline, and clinical
development of Carisma's product candidates, including expectations
regarding timing of initiation and results of clinical trials. The
words "anticipate," "believe," "contemplate," "continue," "could,"
"estimate," "expect," "goals," "intend," "may," "might," "outlook,"
"plan," "project," "potential," "predict," "target," "possible,"
"will," "would," "could," "should," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements are based on management's current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in, or implied by,
such forward-looking statements. These risks and uncertainties
include, but are not limited to, (i) Carisma's ability to realize
the anticipated benefits of its pipeline reprioritization and
corporate restructuring, (ii) Carisma's ability to obtain, maintain
and protect its intellectual property rights related to its product
candidates; (iii) Carisma's ability to advance the development of
its product candidates under the timelines it anticipates in
planned and future clinical trials and with its current financial
and human resources; (iv) Carisma's ability to replicate in later
clinical trials positive results found in preclinical studies and
early-stage clinical trials of its product candidates; (v)
Carisma's ability to realize the anticipated benefits of its
research and development programs, strategic partnerships, research
and licensing programs and academic and other collaborations; (vi)
regulatory requirements or developments and Carisma's ability to
obtain and maintain necessary approvals from the U.S. Food and Drug
Administration and other regulatory authorities related to its
product candidates; (vii) changes to clinical trial designs and
regulatory pathways; (viii) risks associated with Carisma's ability
to manage expenses; (ix) changes in capital resource requirements;
(x) risks related to the inability of Carisma to obtain sufficient
additional capital to continue to advance its product candidates
and its preclinical programs; and (xi) legislative, regulatory,
political and economic developments.
For a discussion of these risks and uncertainties, and other
important factors, any of which could cause Carisma's actual
results to differ from those contained in the forward-looking
statements, see the "Risk Factors" set forth in the Company's
Annual Report on Form 10-K for the year ended December 31, 2023, the Company's Quarterly Report
on Form 10-Q for the Quarter ended March 31,
2024, as well as discussions of potential risks,
uncertainties, and other important factors in Carisma's other
recent filings with the Securities and Exchange Commission. Any
forward-looking statements that are made in this press release
speak as of the date of this press release. Carisma undertakes no
obligation to revise the forward-looking statements or to update
them to reflect events or circumstances occurring after the date of
this press release, whether as a result of new information, future
developments or otherwise, except as required by the federal
securities laws.
Investors:
Shveta
Dighe
Head of Investor Relations
investors@carismatx.com
Media Contact:
Julia
Stern
(763) 350-5223
jstern@realchemistry.com
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SOURCE Carisma Therapeutics Inc.