Group 2 data available to date support primary
safety and feasibility endpoints of single-day bolus dosing of
CT-0508
New translational analyses combining group 1
& group 2 continue to support CAR-M mechanism of action,
demonstrating a correlation between biomarkers and best overall
response
PHILADELPHIA, Sept. 1,
2023 /PRNewswire/ -- Carisma Therapeutics Inc.
(Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage
biopharmaceutical company focused on discovering and developing
innovative immunotherapies, will present findings today at the
8th Annual CAR-TCR Summit from its Phase 1 clinical
trial of the Company's lead product candidate, CT-0508, a human
epidermal growth factor receptor 2 ("HER2") targeted chimeric
antigen receptor macrophage ("CAR-M") for the treatment of
advanced/metastatic HER2 overexpressing cancers.
The presentation includes data from group 1 (n=9) and group 2
(n=5). Patients in both groups received the same total dose (up to
5x109 CT-0508) either via a fractionated, multi-day
infusion regimen (group 1) or via a single-day bolus infusion
(group 2). The data are drawn from the ongoing clinical trial led
by Kim A. Reiss, MD, principal investigator of the Phase 1
clinical trial and an associate professor of Hematology-Oncology in
the Perelman School of Medicine at the University of Pennsylvania.
In the presentation, Michael
Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific
Officer at Carisma, will present data demonstrating that, in both
groups, CT-0508 was successfully manufactured for patients and that
the administration of CT-0508 was well-tolerated after infusion
with no dose-limiting toxicities reported to date.
"As the CT-0508 trial progresses, it is promising to see
consistent results supporting the safety profile, feasibility, and
mechanism of action of this first-in-class CAR-M investigational
therapy," commented Dr. Klichinsky. "We look forward to results
from the CT-0508 combination sub-study with pembrolizumab and
continued development of CAR-M and CAR-Monocyte therapies."
Previously, Carisma presented findings from group 1 showing that
CT-0508 remodeled and activated the tumor microenvironment ("TME")
and initiated anti-tumor T cell immunity. Translational analyses
combining group 1 and group 2 show that various biomarkers
including metrics of TME activation, T cell activation, and HER2
status correlate with best overall response ("BOR") of stable
disease, providing further evidence of the CT-0508 mechanism of
action.
The Phase 1 study translational analyses further demonstrate an
increase in exhausted CD8 T cells on treatment, supporting the
ongoing combination sub-study with Merck's anti-PD1 therapy
KEYTRUDA® (pembrolizumab). This latest data readout
follows the dosing of the first patient in the ongoing sub-study of
the Phase 1 clinical trial of CT-0508 in combination with
pembrolizumab for the treatment of HER2 overexpressing cancers.
The Company is filing a Current Report on Form 8-K today with
the U.S. Securities and Exchange Commission disclosing the new data
from its Phase 1 clinical trial of CT-0508, including an excerpt of
the presentation being made at the 8th Annual CAR-TCR
Summit.
Editor's Note: Carisma has licensed certain Penn-owned intellectual property from the
University of Pennsylvania, and
Penn's Perelman School of Medicine
receives sponsored research and clinical trial funding from the
company. Penn may be entitled to
receive additional financial benefits from technologies licensed
and optioned to Carisma. In addition, Penn is a co-founder of the company and holds
equity in Carisma.
About CT-0508
CT-0508 is a human epidermal growth factor receptor 2 (HER2)
targeted chimeric antigen receptor macrophage (CAR-M). It is being
evaluated in a landmark Phase 1 multi-center clinical trial that
focuses on patients with recurrent or metastatic
HER2-overexpressing solid tumors whose cancers do not have approved
HER2-targeted therapies or who do not respond to treatment. Carisma
is selecting participants who have tumors of any anatomical origin,
but with the commonality of overexpressing the HER2 receptor on the
cell surface, which is the target for our CAR-M. The Phase 1
clinical trial marks the first time that engineered macrophages are
being studied in humans. The trial continues to enroll patients at
seven clinical sites in the U.S., including (i) Penn Medicine's
Abramson Cancer Center, (ii) the University of
North Carolina Lineberger Comprehensive Cancer Center, (iii)
the City of Hope National Medical Center, (iv) the MD Anderson
Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi)
Oregon Health & Science University and (vii) Fred Hutchinson
Cancer Center.
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 and
ability to replicate in later clinical trials positive results
found in preclinical studies and early-stage clinical trials of its
product candidates. 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. 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 August
10, 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
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SOURCE Carisma Therapeutics Inc.