CT-0525 is the first CAR-Monocyte to be
evaluated in humans in the solid tumor setting
First patient expected to be treated in the
first half of 2024
PHILADELPHIA, Nov. 28,
2023 /PRNewswire/ -- Carisma Therapeutics Inc.
(Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage
biopharmaceutical company focused on discovering and developing
innovative immunotherapies, today announced the clearance of its
Investigational New Drug application (IND) by the U.S. Food and
Drug Administration (FDA) 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). Having received a
Study May Proceed notification from the FDA, Carisma expects to
initiate a Phase 1 study in the coming months and to treat the
first patient in the first half of 2024.
"Clearance of the IND for CT-0525 is a significant milestone in
Carisma's mission to develop innovative myeloid cell therapies for
metastatic solid tumors," said Steven
Kelly, President and Chief Executive Officer of Carisma.
"Through this Phase 1 study, we aim to advance our understanding of
safety, tolerability, manufacturing feasibility and mechanism of
action of CT-0525."
Monocytes are the precursor cells to macrophages, and there are
numerous potential benefits to a CAR-Monocyte approach to help
overcome certain challenges of treating solid tumors. The
CAR-Monocyte manufacturing platform enables the ability to
manufacture up to 10 billion cells from a single apheresis and
utilizes a rapid, single-day manufacturing process. This
manufacturing process holds the potential to significantly reduce
the future cost of goods and manufacturing turnaround time
associated with this autologous cell therapy. Pre-clinical
data presented at The Society for Immunotherapy of Cancer's
Annual Meeting in November 2022
demonstrate that CT-0525 therapy reduced tumor growth in multiple
pre-clinical solid tumor models.
"CT-0525 is the first CAR-Monocyte to be evaluated in the solid
tumor setting. With a CAR-Monocyte's in vivo persistence, ability
to differentiate into pro-inflammatory CAR macrophages, and
multi-modal anti-tumor mechanism of action, along with its high
cell yield, CT-0525 has the potential to improve the treatment
paradigm for patients with HER2 overexpressing metastatic solid
tumors," said Michael Klichinsky,
PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma.
"We look forward to the clinical development of CT-0525."
The Phase 1 study for CT-0525 is designed to assess the safety,
tolerability, and the manufacturing feasibility of CT-0525. This
study 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 cohorts: Cohort 1 will receive IV administration of up to 3
billion CAR-positive cells, while Cohort 2 will receive IV
administration of CT-0525 of up to 10 billion CAR-positive
cells.
About CT-0525
CT-0525 is 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 CAR-Monocyte approach has the potential to
address the challenges of treating solid tumors with cell
therapies, including tumor infiltration, immunosuppression within
the tumor microenvironment, and antigen heterogeneity.
About Carisma
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; (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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on November 9,
2023, 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.
Media Contact:
Julia
Stern
(763) 350-5223
jstern@realchemistry.com
Investor Contact:
investors@carismatx.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/carisma-therapeutics-announces-fda-clearance-of-ind-application-for-ct-0525-a-novel-her2-targeting-car-monocyte-301998422.html
SOURCE Carisma Therapeutics Inc.