Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative
biotechnology company developing induced pluripotent stem cell
(iPSC)-derived cell therapies in immune-oncology, today announced
the upcoming presentation of initial data from its ongoing
first-in-human Phase 1 ELiPSE-1 trial of CNTY-101 in
relapsed/refractory CD19 positive B-cell lymphomas. The data, which
support the potential for a multi-dosing strategy for CAR iNK
enabled by Allo-Evasion™ edits, will be featured during a poster
session at the 65th American Society of Hematology (ASH) Annual
Meeting and Exposition being held December 9-12, 2023 in San Diego.
CNTY-101 is the Company’s first allogeneic cell
therapy product candidate engineered with multiple complementary
functionalities designed to enhance its product profile. These
features include a CD19 CAR for tumor targeting, IL-15 support for
enhanced persistence, Allo-Evasion™ technology to prevent host
rejection and enhance persistence, and a safety switch to provide
the option to eliminate the drug product if ever necessary.
A copy of the abstract, which highlights a case
study of a patient with high risk relapsed/refractory follicular
lymphoma who completed four 28-day cycles of CNTY-101 as of a July
10, 2023 data cutoff, is now available online via the ASH website
at www.hematology.org. The patient, who received four prior lines
of therapy, completed four 28-day cycles of CNTY-101 at the 100
million cell dose level (Dose Level 1), the first two of which were
administered following lymphodepletion while the most recent two
were administered without lymphodepletion. CNTY-101 was well
tolerated, with no measurable functional pre-existing or induced
anti-drug-antibodies observed. Pharmacokinetic measurements
demonstrated that CNTY-101 cells were detected after each infusion
with comparable kinetics, with a limited duration in circulation.
The patient achieved a complete response that is ongoing as of five
months following their first CNTY-101 infusion. The Company
believes these preliminary data support the potential for a
multi-dosing strategy for CAR iNK enabled by Allo-Evasion™
edits.
Updated data to be announced in December will
include additional results from patients treated at Dose Level 1 as
of a more recent cutoff date, as well as preliminary data from
patients treated at the 300 million cell dose level (Dose Level
2).
“We are thrilled to share the first clinical
evidence supporting the potential for our proprietary Allo-Evasion™
technology to engineer differentiated allogeneic cell therapies
capable of delivering a multi-dosing regimen,” said Adrienne Farid,
Ph.D., Chief Operations Officer and Head of Early Development at
Century Therapeutics. “While this is a significant achievement in
and of itself, data also demonstrate that CNTY-101 is, to our
knowledge, the first therapy of its kind to be re-dosed without
lymphodepletion, a procedure commonly associated with high rates of
toxicity. We look forward to sharing additional patient data next
month which we believe will continue to support the potential for
Century to deliver novel cell therapies with increased drug
exposure via a multi-dosing approach to ultimately drive deeper and
more durable responses. The potential of our platform to enable
dosing without lymphodepletion is particularly exciting for both
oncology and non-oncology indications, where the side effect
profile of lymphodepletion may be prohibitive.”
Details for the presentation are as follows:
- Abstract: 1654
-
Title: Multiple Doses of CNTY-101, an
iPSC-Derived Allogeneic CD19 Targeting CAR-NK Product, are Safe and
Result in Tumor Microenvironment Changes Associated with Response:
A Case Study
- Session Name: 622.
Lymphomas: Translational – Non-Genetic: Poster I
- Date: Saturday,
December 9, 2023
- Session Time: 5:30
PM - 7:30 PM PT
About ELiPSE-1 Trial
The Phase 1 ELiPSE-1 trial (NCT05336409) is
intended to assess the safety, tolerability, pharmacokinetics, and
preliminary efficacy of CNTY-101 in patients with relapsed or
refractory CD19-positive B-cell lymphomas. All patients will
receive an initial standard dose of conditioning chemotherapy
consisting of cyclophosphamide (300 mg/m2) and fludarabine
(30mg/m2) for 3 days. Schedule A of the trial includes a
single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule
B will evaluate a three-dose schedule per cycle of CNTY-101.
Patients who demonstrate a clinical benefit are eligible for
additional cycles of treatment with or without additional
lymphodepletion.
About Allo-Evasion™
Century’s proprietary Allo-Evasion™ technology
is used to engineer cell therapy product candidates with the
potential to evade identification by the host immune system so they
can be dosed multiple times without rejection, enabling increased
persistence of the cells during the treatment period and
potentially leading to deeper and more durable responses. More
specifically, Allo-Evasion™ 1.0 technology incorporates three gene
edits designed to avoid recognition by patient/host CD8+ T cells,
CD4+ T cells and NK cells. Knockout of beta-2-microglobulin or β2m,
designed to prevent CD8+ T cell recognition, knock-out of the Class
II Major Histocompatibility Complex Transactivator, or CIITA,
designed to prevent CD4+ T cell recognition, and knock-in of the
HLA-E gene, designed to enable higher expression of the HLA-E
protein to prevent killing of CNTY-101 cells by host NK cells.
Allo-Evasion™ technology may allow the implementation of more
flexible and effective repeat dosing protocols for off-the-shelf
product candidates.
About CNTY-101
CNTY-101 is an investigational off-the-shelf
cancer immunotherapy product candidate that utilizes iPSC-derived
natural killer (NK) cells with a CD19-directed chimeric antigen
receptor (CAR) and includes Century’s core Allo-Evasion™ edits
designed to overcome the three major pathways of host versus graft
rejection - CD8+ T cells, CD4+ T cells and NK cells. In addition,
the product candidate is engineered to express IL-15 to provide
homeostatic cytokine support, which has been shown pre-clinically
to improve functionality and persistence. Further, to potentially
improve safety, the iNK cells were engineered with an EGFR safety
switch, and proof-of-concept studies have demonstrated that the
cells can be quickly eliminated by the administration of cetuximab,
an antibody against EGFR approved by the U.S. Food and Drug
Administration for certain cancers. Century is currently assessing
CNTY-101 in patients with relapsed or refractory CD19-positive
B-cell lymphomas in its Phase 1 ELiPSE-1 trial.
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is
harnessing the power of adult stem cells to develop curative cell
therapy products for cancer that we believe will allow us to
overcome the limitations of first-generation cell therapies. Our
genetically engineered, iPSC-derived iNK and iT cell product
candidates are designed to specifically target hematologic and
solid tumor cancers. We are leveraging our expertise in cellular
reprogramming, genetic engineering, and manufacturing to develop
therapies with the potential to overcome many of the challenges
inherent to cell therapy and provide a significant advantage over
existing cell therapy technologies. We believe our commitment to
developing off-the-shelf cell therapies will expand patient access
and provide an unparalleled opportunity to advance the course of
cancer care. For more information on Century Therapeutics please
visit www.centurytx.com.
Century Therapeutics Forward-Looking
Statement
This press release contains forward-looking
statements within the meaning of, and made pursuant to the safe
harbor provisions of, The Private Securities Litigation Reform Act
of 1995. All statements contained in this press release, other than
statements of historical facts or statements that relate to present
facts or current conditions, including but not limited to,
statements regarding our clinical development plans and timelines,
are forward-looking statements. These statements involve known and
unknown risks, uncertainties and other important factors that may
cause our actual results, performance, or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. In some cases, you can identify forward-looking
statements by terms such as “may,” “might,” “will,” “should,”
“expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “forecast,” “potential” or “continue” or the negative of
these terms or other similar expressions. The forward-looking
statements in this press release are only predictions. We have
based these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our business, financial
condition, and results of operations. These forward-looking
statements speak only as of the date of this press release and are
subject to a number of risks, uncertainties and assumptions, some
of which cannot be predicted or quantified and some of which are
beyond our control, including, among others: our ability to
successfully advance our current and future product candidates
through development activities, preclinical studies, and clinical
trials; our dependence on the success of our lead product
candidate, CNTY-101; uncertainties inherent in the results of
preliminary data, pre-clinical studies and earlier-stage clinical
trials being predictive of the results of early or later-stage
clinical trials; our ability to obtain FDA acceptance for our
future IND submissions and commence clinical trials on expected
timelines, or at all; our reliance on the maintenance of certain
key collaborative relationships for the manufacturing and
development of our product candidates; the timing, scope and
likelihood of regulatory filings and approvals, including final
regulatory approval of our product candidates; the impact of the
COVID-19 pandemic, geopolitical issues, banking instability and
inflation on our business and operations, supply chain and labor
force; the performance of third parties in connection with the
development of our product candidates, including third parties
conducting our clinical trials as well as third-party suppliers and
manufacturers; our ability to successfully commercialize our
product candidates and develop sales and marketing capabilities, if
our product candidates are approved; our ability to recruit and
maintain key members of management and our ability to maintain and
successfully enforce adequate intellectual property protection.
These and other risks and uncertainties are described more fully in
the “Risk Factors” section of our most recent filings with the
Securities and Exchange Commission and available at www.sec.gov.
You should not rely on these forward-looking statements as
predictions of future events. The events and circumstances
reflected in our forward-looking statements may not be achieved or
occur, and actual results could differ materially from those
projected in the forward-looking statements. Moreover, we operate
in a dynamic industry and economy. New risk factors and
uncertainties may emerge from time to time, and it is not possible
for management to predict all risk factors and uncertainties that
we may face. Except as required by applicable law, we do not plan
to publicly update or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
For More Information:
Investors and Media: Melissa Forst/Maghan Meyers –
century@argotpartners.com
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