CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage
biotechnology company positioned to advance next generation,
potentially curative cell therapies for cancer patients, today
announced that The Lancet has published favorable data from a Phase
1, single-center clinical study (NCT04088890) by Stanford Medicine
(Stanford), evaluating firi-cel, a CD22 CAR T-cell therapy CARGO
in-licensed for patients with LBCL whose disease is R/R to CD19 CAR
T-cell therapy. The clinical data presented in the publication is
as of May 22, 2023.
“This first peer-reviewed publication of Stanford’s Phase 1
study data in The Lancet further validates firi-cel’s clinically
transformative potential in addressing the high unmet needs of LBCL
patients. Currently, approximately 60% of these patients treated
with a CD19 CAR T-cell therapy experience disease relapse or
progression and have a median survival of less than six months,”
said Gina Chapman, President and Chief Executive Officer of CARGO
Therapeutics. “We congratulate Stanford and the study’s
investigators on these impactful findings, demonstrating the
achievement of favorable complete response rate and long-term
durability of response in this heavily pretreated, advanced-disease
patient population, many of whom were refractory to all prior lines
of therapy. We believe that the patient subset analyses further
support the study design of our potentially pivotal Phase 2
program, which continues to progress as planned and is on track for
interim analysis in first half 2025.”
The Lancet publication titled “CD22-Directed CAR T-Cell Therapy
for Large B-Cell Lymphomas Progressing After CD19-Directed CAR
T-cell Therapy: A dose-finding Phase 1 study,” demonstrated for all
patients treated (n=38), an Overall Response Rate (ORR) and CR rate
of 68% and 53%, respectively, at a median follow-up of 23.3 months.
Notably, there were no significant differences observed between ORR
and CR across subgroups, and of the patients with a history of
refractory disease to all prior therapies, 36% (4 of 11) achieved
CR.
For Dose Level 1 (DL1), the selected dose for the potentially
pivotal Phase 2 study FIRCE-1, the ORR and CR rates were 66% and
52%, respectively. The estimated one- and two-year survival at DL1
was 57% and 52%, respectively. Further for DL1, firi-cel was
generally well-tolerated with no episodes of >grade 3 cytokine
release syndrome (CRS), immune effector cell-associated
neurotoxicity syndrome (ICANS) and immune effector cell-associated
HLH-like syndrome (IEC-HS).
Key baseline and clinical characteristics of the Phase 1 patient
population are outlined, including:
- Median age of 65 years; 50% >65 years of age
- Median of 4 lines of priory therapies
- 26 (68%) advanced stage III or IV
- 32 (84%) had elevated pre-treatment lactate dehydrogenase
(LDH), or high tumor burden
- 11 (29%) had history of refractory disease to all prior
therapies
- 37 (97%) had relapsed after CAR T-cell therapy
As reported by CARGO on May 14, 2024, a subsequent abstract and
poster were shared at the 2024 European Hematology Association
(EHA) Congress reflecting a data cutoff as of February 1, 2024,
with a median follow up of 31.4 months. ORR and CR rates for all
patients treated were 68% and 53%, respectively. New data for DL1
(n=29) at a median follow-up of 29.8 months include median overall
survival (mOS) of 25.7 months (95% CI: 9.2, NE) and estimated
2-year survival remains at 52%. The median PFS, duration of
response, and OS have not been reached for patients who achieved a
CR. Of the 20 patients achieving CR, there have been no additional
patient relapses since the last data cut in November of 2023.
Further, no grade 3 or higher cytokine release syndrome (CRS) or
immune effector cell-associated neurotoxicity syndrome (ICANS)
events occurred at DL1.
Stanford received Breakthrough Therapy Designation for firi-cel
from the FDA for the treatment of adult patients with LBCL whose
disease is R/R after CD19-directed CAR T-cell therapy.
The Lancet publication can be viewed by clicking this
link.
About Large B-Cell Lymphoma (LBCL)Lymphoma that
affects B lymphocytes are called B-cell lymphomas. B-cells make
antibodies to fight infections and are an important part of the
human immune system. B-cell lymphomas account for approximately 85%
of non-Hodgkin lymphomas (NHL) in the United States. LBCL is an
aggressive (fast-growing) lymphoma increasing in prevalence that
occurs most commonly in people over the age of 60, though it can
occur in childhood.
About Firi-cel
Firicabtagene autoleucel (firi-cel) is CARGO's investigational
cell therapy composed of autologous T-cells transduced with a
lentiviral vector (m971-BBZ) expressing a CD22-targeting chimeric
antigen receptor or CAR. CD22 is a transmembrane protein expressed
on normal B-cells and B-cell malignancies. Results of a fully
enrolled, ongoing Phase 1 clinical trial conducted by Stanford
Medicine (Stanford) in adults demonstrate the safety and antitumor
activity of CD22 CAR T-cell therapy in patients with LBCL whose
disease is relapsed or refractory (R/R) to CD19 CAR T-cell therapy.
Based on initial Phase 1 data, Stanford was granted Breakthrough
Therapy Designation from the FDA for the treatment of adult LBCL
patients whose disease is R/R after CD19-directed CAR T-cell
therapy. CARGO Therapeutics exclusively in-licensed the CD22 CAR
T-cell technology from the National Cancer Institute to develop
firi-cel. Its unique design is associated with efficacy in the
clinic that has not been seen with other CD22 CAR Ts. CARGO
believes that firi-cel has the potential to safely and effectively
treat LBCL, including patients for whom prior CD19 CAR T-cell
therapies have failed.
About CARGO Therapeutics
CARGO Therapeutics, Inc. is a clinical-stage
biotechnology company positioned to advance next- generation,
potentially curative cell therapies for cancer patients. CARGO’s
programs, platform technologies, and manufacturing strategy are
designed to directly address the limitations of approved cell
therapies, including limited durability of effect, safety concerns
and unreliable supply. CARGO is currently evaluating its lead
program, firicabtagene autoleucel (firi-cel) (CRG-022), an
autologous CD22 chimeric antigen receptor (CAR) T-cell therapy
candidate, in a potentially pivotal Phase 2 clinical study in
patients with large B-cell lymphoma (LBCL) whose disease relapsed
or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also
plans to evaluate firi-cel in patients at earlier stages of
disease, including LBCL and other hematologic malignancies. Beyond
its lead program, CARGO is leveraging its proprietary cell
engineering platform technologies to develop a pipeline of programs
that incorporate multiple transgene therapeutic “cargo” designed to
enhance CAR T-cell persistence and trafficking to tumor lesions, as
well as to help safeguard against tumor resistance and T-cell
exhaustion. This includes the CRG-023 program, which incorporates a
tri-specific CAR T with CD2 co-stimulation. CARGO’s founders are
pioneers and world-class experts in CAR T-cell therapy, and its
team has significant experience and success in developing,
manufacturing, launching and commercializing oncology and cell
therapy products. For more information, please visit the CARGO
Therapeutics website at https://cargo-tx.com/.Follow us on
LinkedIn: CARGO TherapeuticsFollow us on X (Twitter): @CARGOTx
1 Firicabtagene autoleucel (firi-cel) is CARGO
Therapeutics' autologous CD22 CAR T-cell product candidate. The
underlying CAR of which CARGO exclusively in-licensed from the
National Cancer Institute was the construct evaluated by Stanford
Medicine in a Phase 1 clinical trial in patients with large B-cell
lymphoma whose disease relapsed or was refractory to CD19 CAR
T-cell therapy. CARGO’s firi-cel Investigational New Drug
application included a comprehensive package in which CARGO
performed and demonstrated analytical comparability of CRG-022
produced using the intended commercial process to the CRG-022
produced using the process used for the Stanford Phase 1 clinical
trials. CARGO cannot assure that the FDA will agree with its claim
of comparability and the sufficiency of the data to support it when
it files its Biologics License Application.
Cautionary Note Regarding
Forward-Looking StatementsThis press release contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. In some cases, you can
identify forward-looking statements by terminology such as “aim,”
“anticipate,” “assume,” “believe,” “contemplate,” “continue,”
“could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,”
“may,” “objective,” “plan,” “positioned,” “potential,” “predict,”
“seek,” “should,” “target,” “will,” “would” and other similar
expressions that are predictions of or indicate future events and
future trends, or the negative of these terms or other comparable
terminology. All statements other than statements of historical
facts contained in this press release are forward-looking
statements. These forward-looking statements include, but are not
limited to, statements about: advancement of CARGO’s clinical and
preclinical programs; the potential benefits of CARGO’s product
candidates, including efficacy, durability and safety profile of
firi-cel; and timing of data reports, including the release of
interim data from the Company’s ongoing Phase 2 clinical trial of
firi-cel. Forward-looking statements are not guarantees of future
performance and are subject to risks and uncertainties that could
cause actual results and events to differ materially from those
anticipated, including, but not limited to, risks and uncertainties
related to: the company’s ability to obtain necessary capital to
fund its clinical programs; the early stages of clinical
development of the company’s product candidates; the company’s
ability to obtain regulatory approval of and successfully
commercialize its product candidates; any undesirable side effects
or other properties of the company’s product candidates; the
company’s reliance on third-party suppliers and manufacturers,
including CROs; the outcomes of any future collaboration
agreements; and the company’s ability to adequately maintain
intellectual property rights for its product candidates. For a
detailed discussion of the risks and uncertainties that could cause
actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to CARGO’s
business in general, please refer to the risk factors identified in
the Company’s filings with the Securities and Exchange Commission
(SEC), including but not limited to its Quarterly Report on Form
10-Q for the quarter ended March 31, 2024 filed on May 14, 2024.
Any forward-looking statements that the company makes in this press
release are made pursuant to the Private Securities Litigation
Reform Act of 1995, as amended, and speak only as of the date of
this press release. Except as required by law, the company
undertakes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events
or otherwise. CARGO’s results for the quarter ended March 31, 2024
are not necessarily indicative of its operating results for any
future periods.
Media Contact:Kimberly
Muscarakimberly@redhousecomms.com
Investor Contact:Jessica Serra
jserra@cargo-tx.com
Laurence Wattslaurence@newstreetir.com
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