Full Press Release Details
Century Therapeutics
Presents Interim Results from Phase 1 ELiPSE-1 Study at ASCO 2024 Annual Meeting
escalation, CNTY-101 has demonstrated a manageable safety profile with no observed DLTs or GvHD and with majority of patients treated
in outpatient setting
Encouraging preliminary
efficacy in heavily pretreated R/R NHL at initial dose levels
DNA method for detecting total body PK suggests CNTY-101 persists outside the bloodstream
Enrollment continues
in dose escalation phase of ELiPSE-1 at dose levels 3B (three weekly infusions of 1 billion cells) and 4A (single infusion of 3 billion
PHILADELPHIA, June 3, 2024 -
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 a poster presentation highlighting interim
results from the ongoing Phase 1 ELiPSE-1 study evaluating CNTY-101 in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) at the
American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 - June 4, 2024 in Chicago, Illinois.
CNTY-101 is an investigational CD19
targeting allogeneic, iPSC-derived natural killer (NK) cell therapy with six precision gene edits powered by Century's Allo-Evasion
technology enabling repeat dosing without the need for continued lymphodepletion. ELiPSE-1 (NCT05336409) is an ongoing Phase 1, multicenter,
open-label clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CNTY-101 in patients with
R/R, CD19-positive B-cell malignancies.
"These interim results continue
to support our belief in the potential of CNTY-101, which shows additional responses across escalating doses and different types of B-cell
malignancies in heavily pretreated patients with predominantly aggressive or high-risk histologies," said Adrienne Farid, PhD,
Chief Operations Officer and Head of Early Development. "We are also encouraged by the safety profile we are seeing at higher doses,
with no dose-limiting toxicities to date, after multiple treatment cycles, which we believe was achieved by leveraging our proprietary
Allo-Evasion technology to avoid host rejection. Further, the majority of these cycles have been administered in the outpatient
setting, providing additional support for CNTY-101 as a new paradigm for allogeneic cell therapies. We look forward to completing dose
escalation and moving into dose expansion in the coming months."
Interim Results from the ELiPSE-1
Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B-Cell Malignancies
Poster Board Number: 6
Session Title: Hematologic Malignancies-Lymphoma
and Chronic Lymphocytic Leukemia
Session Date & Time: Monday,
June 3, 2024, from 9:00 am - 12:00 pm CDT
CNTY-101 is Century's lead iNK
cell therapy and the first iPSC-derived NK cell therapy engineered with six precision gene edits, featuring antigen-specific killing
of CD19+ B cells, homeostatic cytokine support for enhanced persistence, Allo-Evasion edits to prevent rejection by the patients'
immune system, and a safety switch. CNTY-101 is being assessed in heavily pre-treated relapsed or refractory NHL patients with predominantly
aggressive or high-risk indolent histologies who have received two to five prior therapies, four of whom received prior CAR-T therapy.
The Company previously announced initial data in December 2023, demonstrating a favorable safety profile in the initial seven patients
treated with Dose Level 1 (100 million cells) and Dose Level 2 (300 million cells) on a once monthly schedule. In these low dose levels,
CNTY-101 demonstrated encouraging early response signals, including two complete responses (CRs) and one partial response (PR).
As of the interim data cutoff date of
March 27, 2024, preliminary safety and efficacy were evaluated across Dose Level 1, Dose Level 2 and Dose Level 3 (one billion cells)
and two dosing schedules (Schedule A with single infusion, and Schedule B with three weekly infusions, per cycle). CNTY-101 infusions
of up to one billion cells per cycle (as a single infusion of one billion cells, or 3 weekly infusions of 300 million cells) demonstrated
a favorable safety profile with no observations of graft-versus-host disease (GvHD) or dose-limiting toxicities (DLT), and 8/12 subjects
received at least one cycle of CNTY-101 in an outpatient setting. Preliminary efficacy in all evaluable patients (n=10) across dose schedules
and histologies demonstrated a complete response rate (CRR) of 30% and an objective response rate (ORR) of 40% in heavily pretreated
patients, with a 40% CRR and 60% ORR observed in the five patients treated with the two higher Schedule A dose levels, 300 million cells
and one billion cells.
Pharmacokinetics (PK) evaluated by a
novel cell-free DNA (cfDNA) method for detecting total body PK showed that CNTY-101 rapidly traffics out of circulation and persists
outside the bloodstream, with AUC trending to increase with dose level. In patients who received additional cycles of CNTY-101 without
lymphodepleting chemotherapy, three out of four patients had positive detection of CNTY-101 on Day 3 and beyond. The ELiPSE-1 study is
currently ongoing in the dose escalation phase and is enrolling in Dose Level 3B (one billion cells in three weekly infusions per cycle),
and Dose Level 4A (single infusion of 3 billion cells per cycle).
The full poster will be available on
the Scientific Resources page of Century's website at the start of the poster presentation.
CNTY-101 is an 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 preclinically to improve functionality and persistence. Further, to address potential safety considerations,
the iNK cells were engineered with an EGFR safety switch, and preclinical proof-of-concept studies have demonstrated that the cells can
be quickly eliminated in vivo 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. The Company intends to initiate its second Phase 1 clinical trial assessing CNTY-101
in patients with moderate to severe systemic lupus erythematosus, in addition to pursuing additional regulatory filings in other prioritized
autoimmune disease indications.
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 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.
About Century Therapeutics
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
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 and the
initial safety and efficacy profiles of CNTY-101 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
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"contemplate," "believe," "estimate," "predict," "forecast," "potential"