CT-0525 is the first CAR-Monocyte to be
evaluated in humans in the solid tumor setting
Initial data expected by year-end 2024
PHILADELPHIA, May 16, 2024
/PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM)
("Carisma" or the "Company"), a clinical stage
biopharmaceutical company focused on discovering and developing
innovative immunotherapies, today announced that the first patient
was dosed in its Phase 1 clinical trial evaluating CT-0525, an
ex vivo gene-modified autologous chimeric antigen
receptor-monocyte (CAR-Monocyte) cellular therapy, for the
treatment of patients with solid tumors that overexpress human
epidermal growth factor receptor 2 (HER2).
"Dosing of the first patient in the CT-0525 Phase 1 trial is a
significant step in the development of engineered myeloid cells,
marking the first time a CAR-Monocyte is tested in humans in the
solid tumor setting," said Eugene P.
Kennedy, M.D., Chief Medical Officer of Carisma. "Our
pre-clinical data leads us to believe that this next-generation
approach of our CAR-M platform has the potential to have a greater
impact on patients than our initial CAR-Macrophage program,
particularly through faster manufacturing, higher dosing, and
increased potency, persistence, and tumor infiltration. We look
forward to progressing this trial and expect to report initial data
by the end of 2024."
"Patients battling HER2-overexpressing solid tumors face an
urgent need for new therapeutic options, as disease progression is
a common challenge," commented Davendra
Sohal, M.D., M.P.H., Professor of Medicine at the
University of Cincinnati Cancer Center.
"CT-0525 introduces a differentiated approach to potentially
address this shortcoming, offering hope for HER2-positive cancer
patients. We are proud to be the first site to treat a patient with
CT-0525 and look forward to continuing to collaborate with Carisma
and other cancer centers to rapidly enroll patients in the Phase 1
trial."
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 study will consist of two dose escalation
cohorts. Further details of the trial can be found at
www.clinicaltrials.gov under NCT identifier: NCT06254807.
Carisma will present a Trial in Progress poster outlining the
design of the CT-0525 Phase 1 trial at the American Society of
Clinical Oncology (ASCO) 2024 Annual Meeting, scheduled to take
place from May 31 to June 4, 2024, in
Chicago, IL.
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 obtain,
maintain and protect its intellectual property rights related to
its product candidates; (ii) 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; (iii) Carisma's ability to
replicate in later clinical trials positive results found in
preclinical studies and early-stage clinical trials of its product
candidates; (iv) 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; (v) 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; (vi) changes to
clinical trial designs and regulatory pathways; (vii) risks
associated with Carisma's ability to manage expenses; (viii)
changes in capital resource requirements; (ix) risks related to the
inability of Carisma to obtain sufficient additional capital to
continue to advance its product candidates and its preclinical
programs; and (x) 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, its Quarterly Reports on Form
10-Q, 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.