Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative
clinical-stage biotechnology company developing induced pluripotent
stem cell (iPSC)-derived cell therapies in immuno-oncology,
announced today that the first patient has been dosed in the
first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in
patients with relapsed or refractory CD19 positive B-cell
lymphomas. CNTY-101 is the Company’s first allogeneic cell therapy
product candidate engineered with multiple complementary
functionalities 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.
As a leading next-generation allogeneic cell therapy candidate,
CNTY-101 is the first to test the potential of a finite, repeat
dosing regimen and the ability to deliver more durable responses
enabled by Allo-Evasion™ gene edits. CNTY-101 is manufactured
from a clonal iPSC master cell bank that yields homogeneous
product, in which all infused cells have the intended
modifications.
“Today’s achievement marks our transition to a clinical-stage
company and represents an important milestone for both Century and
for patients with relapsed or refractory CD19 positive B-cell
lymphomas who are lacking efficacious therapeutic options,” said
Lalo Flores, Ph.D., Chief Executive Officer, Century Therapeutics.
“With our vision of a finite multi-dosing regimen combined with
core Allo-Evasion™ edits, we are attempting to pave the way for our
future product candidates and a new paradigm for allogeneic cell
therapies.”
The Phase 1 trial, ELiPSE-1 (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 pending U.S. Food and
Drug Administration consent.
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, Inc. (NASDAQ: IPSC) is a clinical-stage
biotechnology company 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 https://www.centurytx.com/.
Forward-Looking Statements
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,”
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“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “forecast,” “potential” or “continue” or the negative of
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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 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 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 future 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; 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:
Company: Elizabeth Krutoholow –
investor.relations@centurytx.com
Investors: Melissa Forst/Maghan Meyers –
century@argotpartners.com
Media: Joshua R. Mansbach – century@argotpartners.com
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