Study is designed to evaluate the potential
for a synergistic effect of CAR-M therapy in combination with
KEYTRUDA®
PHILADELPHIA, June 28,
2023 /PRNewswire/ -- Carisma Therapeutics Inc.
(Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage
biopharmaceutical company focused on discovering and developing
innovative immunotherapies, announced that the first patient has
been dosed in its Phase I clinical trial that will test the safety
and tolerability of the Company's lead product candidate, CT-0508,
a human epidermal growth factor receptor 2 (HER2) targeted chimeric
antigen receptor macrophage (CAR-M) in combination with Merck's
anti-PD1 therapy KEYTRUDA® (pembrolizumab) for the
treatment of HER2 overexpressing cancers.
Pre-clinical data presented at SITC in 2022 demonstrated that
the mice that received both therapies had improved tumor control,
overall survival, and tumor microenvironment (TME) activation as
compared to either treatment alone, indicating synergy and the
capacity for CAR-M to sensitize solid tumors to checkpoint
blockade.
This first patient's cells were manufactured at the Novartis
Cell Therapy Site in Morris Plains, New
Jersey, following the successful completion of the tech
transfer of CT-0508 to Novartis earlier this year. This is
Carisma's first clinical product to be manufactured and
administered from this collaboration.
"We are excited by the progress being made on our CT-0508
clinical program with the dosing of the first patient in the
combination study with KEYTRUDA®," said Michael Klichinsky, PharmD, PhD, Co-Founder and
Chief Scientific Officer at Carisma Therapeutics. "The CT-0508
monotherapy trial has demonstrated early clinical validation of the
CAR-M mechanism of action, and we are eager to explore this
sub-study to assess the potential synergistic effect of CAR-M
therapy in combination with KEYTRUDA®. The
initiation of clinical manufacturing at Novartis' GMP cell therapy
site is also a meaningful step forward in progressing our
overarching manufacturing strategy, and demonstrates our desire to
work alongside best-in-class companies."
In January 2023, Carisma appointed
nationally regarded cancer immunologist and oncologist, Dr.
Padmanee Sharma, MD, PhD, to the company's Scientific Advisory
Board. The Company expects that Dr. Sharma's scientific knowledge
in immunotherapy will provide valuable guidance in the studies of
CT-0508 and KEYTRUDA®.
The clinical trial sub-study of CT-0508 in combination with
KEYTRUDA® has been initiated at multiple site locations
in the U.S. and will enroll patients with different types of
recurrent or metastatic cancers with HER2 overexpressing solid
tumors. To learn more about this, please visit ClinicalTrials.gov
(NCT04660929) or Carisma's clinical trial website.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp, a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ, USA.
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 are not eligible for
treatment with currently available HER2-targeted therapies or who
do not respond to treatment. The trial is enrolling 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 is
first-of-its-kind, marking the first time that genetically
engineered macrophages are being studied in humans. The trial
continues to enroll patients at seven clinical sites in
the U.S., including (i) the University of
Pennsylvania 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 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. The first applications of the platform, developed in
collaboration with the University of
Pennsylvania, are autologous chimeric antigen receptor
(CAR)-macrophages for the treatment of solid tumors. 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
Therapeutics' business, strategy, future operations, cash runway,
the advancement of Carisma Therapeutics' product candidates and
product pipeline, and clinical development of Carisma Therapeutics'
product candidates, including expectations regarding timing of
initiation and results of clinical trials, and participation by
Carisma Therapeutics in future healthcare industry and investor
conferences. 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 May
11, 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-first-patient-dosed-in-phase-1-study-of-ct-0508-in-combination-with-keytruda-pembrolizumab-in-patients-with-her2-overexpressing-solid-tumors-301865175.html
SOURCE Carisma Therapeutics Inc.