Century Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates
-- Expansion of Phase 1 CALiPSO-1 trial of CNTY-101 in autoimmune disease to include diffuse cutaneous systemic sclerosis and idiopathic inflammatory myopathy --
-- Overall response rate $(ORR.AU)$ of 83% observed at CNTY-101 Dose Level 3B alongside a favorable safety profile in patients with r/r B-cell lymphomas in Phase 1 ELiPSE-1 study --
-- CNTY-101 shows persistence upon repeated cell dosing at Dose Level 3B, consistent with the anticipated protective activity of Century's proprietary Allo-Evasion$(TM)$ technology --
-- Ended third quarter 2024 with cash, cash equivalents, and investments of $244.7 million; organizational efficiencies extend expected cash runway into second half of 2026 --
PHILADELPHIA, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. ("Century", NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune disease, today reported financial results and business highlights for the third quarter ended September 30, 2024.
"Broadening our strategic focus in autoimmune indications to include idiopathic inflammatory myopathy and diffuse cutaneous systemic sclerosis will give us greater insight into the potential of CNTY-101 in an underserved therapeutic category that we believe is uniquely suited to allogeneic iNK cell therapies. Our confidence in the application of CNTY-101 in autoimmune diseases continues to be reinforced by the Phase 1 ELiPSE-1 trial in patients with r/r B-cell lymphomas where updated interim data shows increased overall response rates at higher doses and observations of deepening responses with additional cycles, alongside a continued favorable safety profile," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. "The advancement of our pre-clinical pipeline across multiple cell types is similarly promising, as highlighted by what we believe to be the industry-first presentation of iPSC-derived CD4+ and CD8+ CAR T cells that demonstrate <ALPHA><BETA>-like T cell function at the upcoming American Society of Hematology Annual Meeting. Building on this progress, we are conducting a strategic review of Century's pre-clinical pipeline and expect to announce the outcome in the first quarter of 2025. We have recently refined our organizational structure to enhance ongoing efficiencies and program alignment. On behalf of everyone here at Century, I'd like to thank departing colleagues for their important contributions to building the company's programs and technology. Supported by extended cash runway from these changes, we remain focused on execution in the period ahead and look forward to delivering our next set of potential catalysts."
Research & Development Highlights
-- Consistent with Century's commitment to expand investigation of
autoimmune disease indications during the second half of 2024, the
company recently amended the Phase 1 CALiPSO-1 trial of CNTY-101
(NCT06255028) and Investigational New Drug $(IND.AU)$ application to include
evaluation of idiopathic inflammatory myopathy $(IIM)$ and diffuse
cutaneous systemic sclerosis (dcSSc). This builds upon earlier alignment
with the U.S. Food and Drug Administration to expand clinical development
to lupus nephritis (LN) in addition to systemic lupus erythematosus
$(SLE)$. With the implementation of this amendment, CALiPSO-1 consists of a
basket protocol study design, with four arms designed to evaluate the
safety and preliminary efficacy of CNTY-101. The study will enroll
participants >=17 years old with refractory B-cell-mediated autoimmune
diseases following an inadequate response to at least two lines of prior
standard of care immunosuppressive therapies, now including those with
moderate to severe IIM and dcSSc with treatment-resistant and active
disease alongside those with moderate to severe SLE with or without LN.
Century has activated multiple clinical sites in the United States, and
expects to activate additional sites in the coming months, with ability
to enroll patients across indications. To further facilitate enrollment,
the company plans to expand trial sites to select European countries.
Century will provide updated timing on initial clinical data from
CALiPSO-1 once a clear cadence of patient enrollment has been established
across indications.
-- Updated interim clinical data from Century's ongoing Phase 1 ELiPSE-1
study evaluating CNTY-101 (NCT05336409) in relapsed or refractory (R/R)
non-Hodgkin lymphoma (NHL) has shown increased overall response rates at
higher doses and observations of deepening responses with additional
cycles alongside a favorable safety profile, building on encouraging
interim data previously presented at the 2024 American Society of
Clinical Oncology Annual Meeting. As of the data snapshot October 15,
2024, eight additional participants have been treated with CNTY-101 for a
total of 20 participants evaluable for safety and 19 for preliminary
efficacy. Treatment with CNTY-101 continued to be safe and generally well
tolerated with no dose-limiting toxicities reported, no additional cases
of immune effector cell-associated neurotoxicity syndrome (ICANS), and no
Grade 3 or higher cytokine release syndrome $(CRS)$. Consistent with the
manageable safety profile observed to date, a majority of participants
received CNTY-101 infusions in an outpatient setting. Dose level DL3B (1
billion cells in each of three weekly doses per cycle), which represents
the largest single trial cohort (n=6), has shown an overall response rate
$(ORR.UK)$ of 83% and a complete response rate $(CRR.AU)$ of 33%, with all
participants receiving additional cycles of treatment.A dose-dependent
increase in CNTY-101 exposure was observed as evaluated by a novel
pharmacokinetics cell-free DNA (cfDNA) method for detecting total body
presence of CNTY-101. Preliminary cfDNA data from Schedule B (three
weekly CNTY-101 infusions per cycle) showed that in cycles starting with
lymphodepletion, a similar level of exposure was observed between the
first and third infusion when the patients' endogenous T and NK cells had
recovered. This supports persistence upon repeated cell dosing,
consistent with the anticipated protective activity of Century's
proprietary Allo-Evasion(TM) technology.Efficient B-cell depletion was
observed in all participants treated with CNTY-101 who had measurable
circulating B cells at baseline. Evaluable re-emergent B cells (N=4
participants) were enriched for naive subtypes with minimal
class-switched memory subsets detected. This profile in re-emergent B
cells has been associated with SLE responses after CD19 cell therapy
treatment, which we believe further supports application of CNTY-101 in
the CALiPSO-1 study. Based on favorable safety and encouraging early
efficacy data at DL3B, Century is proceeding with DL4B (3 billion cells
in each of three weekly doses per cycle), and recently treated the first
participant at this dose. The company expects to provide updated clinical
data by mid-2025.Further details pertaining to the ELiPSE-1 data update
can be found in Century's corporate presentation housed on the investor
relations section of the website.
-- Century separately announced the acceptance of five poster presentations
at the upcoming 66th American Society of Hematology Annual Meeting to be
held in San Diego, CA from December 7-10, 2024. The presentations include
demonstration of pre-clinical function comparable to autologous T cells
by allogeneic iPSC-derived CD4+ and CD8+ CAR T cells, alongside
additional innovations that highlight the engineerability of the
iPSC-derived immune effector cells, a core benefit of the company's
platform. These include data from advanced CAR endo-domains that improved
cytotoxicity and persistence, enhanced Allo-Evasion(TM) via a novel
CD300a TASR that demonstrated universal protection from NK cells, and
differentiation stage specific promoters that allow for selective control
of gene expression.
Business Highlights
-- Following the integration of Clade Therapeutics, Century is conducting a
strategic review of the pre-clinical pipeline to leverage the unique
capabilities and technologies at Century towards high-value and
differentiated programs. The company expects to conclude and communicate
the results of this review in the first quarter of 2025. As part of this
review, in October, Century implemented changes to the organization
structure including elimination of overlapping technical and research
capabilities to enhance ongoing efficiencies and alignment with the
company's key programs. With these changes, Century has extended expected
cash runway into the second half of 2026.
-- In September 2024, Century announced the appointments of Morgan Conn,
Ph.D., as Chief Financial Officer and Chad Cowan, Ph.D., as Chief
Scientific Officer. The company also announced the transition of Hy
Levitsky, M.D., President of Research and Development, from operational
duties to serve as an advisor to Century.
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