Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology
company developing induced pluripotent stem cell (iPSC)-derived
cell therapies in immuno-oncology, today announced preclinical data
from the Company’s iPSC-based cell therapy platform were featured
in two posters at the Society for Immunotherapy of Cancer (SITC)
37th Annual Meeting. Additionally, the Company provided pipeline
program updates ahead of its virtual Research and Development
(R&D) Day taking place today, November 11, at 8:00 AM ET.
“Developing a best-in-class iPSC derived gamma delta CAR T cell
platform is a top priority at Century and we are excited to share
additional data supporting our strategic decision to leverage this
platform to address the complexities of solid tumors,” said Lalo
Flores, Ph.D., Chief Executive Officer, Century Therapeutics.
“Accordingly, we are pleased to announce the nomination of our
newest pipeline program for solid tumors, CNTY-107, a Nectin-4
targeted gamma delta iT cell product candidate for which we expect
to file an IND in 2025. Additionally, we continue to make progress
with our iNK cell platform and are pleased to add to the
preclinical data package supporting our iNK 3.0 platform, which
shows enhanced functionality and illustrates the power and
efficiencies of our platform. We look forward to discussing these
updates later this morning during our virtual R&D Day.”
Data Presented at SITC Annual Meeting and Pipeline
Updates
A copy of each poster presentation from the SITC Annual Meeting
is available on Century’s website.
Gamma Delta iT Cell Platform
Gamma delta (γδ) T cells have been shown to exhibit the
cytolytic features of conventional alpha beta (αβ) CD8+ T cells
with additional capabilities for innate recognition of tumors and
lack the risk for graft-versus-host-disease compared to αβ T cells.
The Company has developed an iPSC-derived chimeric antigen receptor
(CAR) γδ T cell platform which can target solid tumors through
CAR-mediated recognition, CD16-mediated antibody-dependent cellular
cytotoxicity (ADCC) when combined with therapeutic antibodies, and
naturally innate receptors such as natural cytotoxicity receptors
(NCRs) which can recognize and eliminate tumor cells.
Preclinical data presented today demonstrate that iPSC-derived
γδ T cells derived from reprogrammed primary γδ T cells can be
efficiently engineered and produced with robust yield. In
preclinical human xenograft models, iPSC-derived γδ-CAR T cells
were shown to be effective in controlling solid tumors as a
monotherapy and in combination with a therapeutic antibody.
Significant CAR-specific killing of EGFR+ tumor cells was
demonstrated in vitro by γδ-CAR T cells in multiple solid tumor
cell lines. γδ T cells expressing endogenous CD16 effectively
elicited ADCC of HER2+ solid tumor cells in the presence of
trastuzumab. The in vitro cytokine profile of γδ T cells in the
presence of various target cells indicated γδ T cells secrete IFNγ
and TNFα after CAR activation.
Next Generation Platform for iPSC-derived NK cells (iNK
Cells)
Preclinical data presented today describe the Company’s next
generation platform for iNK cells (iNK 3.0) that include genetic
enhancements for improved Allo-EvasionTM, cell fitness, tumor
targeting, in vivo imaging, and safety. A clonal iPSC line was
derived with eleven total genetic modifications introduced through
four sequential gene editing steps. By adopting a common progenitor
(CP) strategy, an engineered iPSC master cell bank will be used as
the starting point for future therapies across diverse indications.
The CP iPSC is uniform and confirmed to contain all gene edits that
will be shared by multiple product candidates which the Company
expects will not be accompanied by any undesirable off-target
effects. By adding different CARs to the CP, Century believes
multiple product candidates can be engineered with a single gene
editing step. Future iNK cell therapies are expected to be derived
from the CP by addition of CAR(s) for indication-specific
tumor targeting.
Pipeline Updates
The Company today provided an update on its solid tumor
strategy, including the nomination of its next pipeline program,
CNTY-107, a Nectin-4 CAR γδ iT product candidate. The Company
expects to file an Investigational New Drug (IND) Application in
2025 for Nectin-4+ cancers.
Virtual Research & Development Update
The Company will host a virtual R&D Day today,
Friday, November 11, 2022 from 8:00 AM - 9:30 AM EST. The R&D
Day will feature presentations from the Company’s management team
and Jonathan Rosenberg, M.D., Chief of the Genitourinary Oncology
Service at the Memorial Sloan Kettering Cancer Center (MSKCC),
Physician at Memorial Hospital at MSKCC, and Professor of Medicine
at Weill Cornell Medical College. For additional information on how
to access the event, please visit the Events & Presentations
section of Century’s website.
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 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.comInvestors: Melissa
Forst/Maghan Meyers – century@argotpartners.comMedia: Joshua R.
Mansbach – century@argotpartners.com
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