Full Press Release Details
Century Therapeutics
Receives FDA Clearance of IND Application for CNTY-101 in Systemic Lupus Erythematosus
second IND clearance for CNTY-101, the Company's lead iPSC-derived CD19-targeted CAR NK cell product candidate, and first
in an autoimmune and inflammatory disease indication -
plans to initiate the Phase 1 clinical trial in the first half of 2024; initial data expected by year-end 2024 -
is the first cell therapy product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasion technology,
IL-15 cytokine support and a safety switch -
December [X], 2023 - Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent
stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that the Company
has been notified by the U.S. Food and Drug Administration (FDA) that the Company's Phase 1 clinical trial may proceed to assess
CNTY-101 in patients with moderate to severe systemic lupus erythematosus (SLE) who have failed at least two standard immunosuppressive
therapies. This represents the first Investigational New Drug (IND) application clearance for an autoimmune and inflammatory disease
indication for CNTY-101, and is built on the emerging data and experience gained from administering multiple cycles of CNTY-101, with
and without lymphodepletion, under the open IND for CNTY-101 in relapsed/refractory B-cell malignancies.
advances, therapies for SLE have failed to make a significant impact on morbidity, and induction of remission remains rare, while treatment
toxicity and disease flares are common. B-cell-directed autologous CAR T cell therapies have provided new hope for durable remissions
through an "immune reset". However, some of the challenges encountered with auto-CAR-T in oncology related to product availability,
toxicities, and potential long-term risks could hamper their wide-spread adoption in non-oncology indications. Century is pursuing an
alternative approach with CNTY-101, an allogeneic, off-the-shelf iPSC-derived NK cell product candidate. CNTY-101 contains 6 genetic
edits at defined loci, engineered via homology directed repair using CRISPR. These include three Allo-EvasionTM edits, secreted
IL-15, a CD19 CAR, and a safety switch allowing for cell removal if required. As a homogenous NK cell candidate derived from a single
iPSC clone, CNTY-101 has been designed with uniquely engineered features which Century believes may provide multiple potential treatment
advantages. These potential advantages include availability of a consistent off-the-shelf frozen product, an improved tolerability profile,
ability to be re-dosed without lymphodepletion while avoiding allo-rejection of the product, and a product design that may enable the
elimination of B cells to effect a decline in auto-antibodies without prolonged B cell aplasia.
marks an important milestone in Century's evolution as a company. We believe the unique profile of CNTY-101, which incorporates
multiple precision edits including our Allo-EvasionTM technology, positions it as an off-the-shelf allogeneic treatment option
that could meaningfully improve outcomes for patients with SLE for whom existing therapies fall short," said Brent Pfeiffenberger,
Pharm.D., Chief Executive Officer of Century Therapeutics. "The expansion of the CNTY-101 program into SLE represents a significant
achievement for the Company, and, importantly, serves as a testament to the unwavering dedication of our team as we continue to execute
on our mission to advance differentiated and potentially curative cell therapies to patients with cancer and autoimmune and inflammatory
Phase 1 clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and clinical response of CNTY-101 in patients
with moderate to severe SLE who have failed at least two standard immunosuppressive therapies. The trial will evaluate one to two cycles
of 3 weekly doses of CNTY-101, with lymphodepletion only included prior to the first CNTY-101 infusion. The Company plans to initiate
the trial in the first half of 2024, with initial data expected by the end of 2024.
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 2m, 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.
investigational off-the-shelf 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 clinical trial and intends to initiate its second Phase 1 clinical trial assessing CNTY-101 in patients
with moderate to severe systemic lupus erythematosus.
Century Therapeutics
(NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune and inflammatory
diseases that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived
cell product candidates are designed to specifically target hematologic and solid tumor cancers, with a broadening application to autoimmune
and inflammatory diseases. 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 and autoimmune and inflammatory disease care. For more information on Century
Therapeutics please visit www.centurytx.com.
Century Therapeutics
Forward-Looking Statement
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
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"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; the timing of and our ability
to initiate and successfully enroll the Phase 1 SLE trial, 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 clearance of 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 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:
Melissa Forst/Maghan Meyers - century@argotpartners.com