- First dosing dohort was completed with complete
response and disease stabilization identified at three months at
the lowest dose level in the Phase 1 study
- No ACE1831-related serious adverse events,
including GvHD, neurotoxicity, high-grade CRS or dose limiting
toxicities were observed
- Results shared during a fireside chat hosted by William Blair & Company on May 7th, 2024. An archived recording
will be available for 7 days following the event
at https://www.acepodia.com/newsroom/media/.
ALAMEDA,
Calif. and TAIPEI,
May 8,
2024 /PRNewswire/ -- Acepodia (6976:TT), a clinical
stage biotechnology company developing first-in-class cell
therapies with its unique Antibody-Cell Conjugation (ACC) and
allogeneic gamma delta 2 (γδ2) T cell platforms to address
gaps in cancer care, today announced preliminary data from its
Phase 1 dose escalation clinical trial of ACE1831, an anti-CD20
antibody conjugated allogeneic gamma delta T cell therapy being
evaluated in patients with non-Hodgkin's lymphoma (NHL).
Key Results From Preliminary Clinical Data
- One out of five patients demonstrated complete response (CR)
and three out of five patients experienced disease stabilization
(SD) with single dose of ACE1831 at the lowest dose level. Among
those patients, one CR and two SD patients were previously treated
with CD19 CAR-T.
- Durability of clinical response was observed for three months
after a single dose of ACE1831.
- The lowest dose of ACE1831 was well tolerated with no
ACE1831-related serious adverse events or dose
limiting toxicities. Dose escalation is ongoing.
ACE1831 is Acepodia's first cell therapy to enter clinical
development from its proprietary ACC platform, which uses
biorthogonal chemistry to conjugate gamma delta 2 (γδ2) T
cells with antibodies targeting CD20. The platform, based on the
pioneering work of 2022 Nobel Prize laureate Dr. Carolyn Bertozzi that applied click chemistry to
living systems, creates an off-the-shelf, non genetically
engineered version of CAR-T cell therapy that is more easily scaled
and avoids cytokine release storms, neurotoxity and other side
effects associated with CAR-T cell therapies. The preliminary data
demonstrates that ACE1831 activates both an innate and adaptive
immune response by direct killing of tumor cells, tumor
opsonization, and recruitment of T cells through cytokine
secretion, and may therefore generate a more comprehensive immune
response than standard CAR-T cell therapies.
"This ongoing trial is the first to demonstrate potential
clinical benefit to patients using biorthogonal chemistry and opens
the door to a powerful, new approach for cell therapy that
overcomes limitations of current CAR-T cell therapies and is more
accessible to patients," said Sonny
Hsiao, Ph.D., chief executive officer of Acepodia. "We are
encouraged to see a robust and durable effect after a single
treatment at the lowest dose, and remain focused on the continued
development of this first-of-its kind treatment option."
The first-in-human, phase 1 trial is an open-label, dose
escalation study that aims to evaluate the safety and tolerability,
pharmacokinetics, and efficacy of ACE1831 in patients with
relapsed/refractory non-Hodgkin's lymphoma. The multi-center trial
is expected to enroll up to 42 patients in the United States and Taiwan.
About ACE1831
ACE1831 is an off-the-shelf gamma delta T cell therapy candidate
developed from Acepodia's proprietary ACC platform. ACE1831 targets
CD20-expressing hematological cancers using anti-CD20 antibody
conjugated gamma delta T cells. Taking advantage of the high
expression of NK cell activating receptors of the gamma delta T
cells to scavenge the malignant blood cells, ACE1831 has
demonstrated in models enhanced cytotoxicity against cancer cells
both in vitro and in vivo. ACE1831 is currently being
evaluated in a Phase 1, first-in-human clinical trial for patients
with non-Hodgkin's lymphoma.
About Acepodia
Acepodia is a clinical-stage biotechnology company
developing first-in-class cell therapies with its unique
Antibody-Cell Conjugation (ACC) platform technology to address gaps
in cancer care. Leveraging its ACC technology, the company links
tumor-targeting antibodies to its proprietary immune cells, such as
natural killer and gamma delta T cells to create novel ACE
therapies, which have increased binding strength against tumors
that express low levels of tumor antigens.
Acepodia is made up of seasoned leaders and scientific experts
dedicated to advancing its robust pipeline of ACE therapies with
the potential to bring innovative, effective, and affordable cell
therapies to a broad population of patients across a variety of
solid tumors and hematologic cancers. For more information,
visit www.acepodia.com and follow Acepodia
on Twitter and LinkedIn.
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content:https://www.prnewswire.com/news-releases/acepodia-announces-preliminary-clinical-data-from-phase-1-clinical-trial-of-ace1831-first-ever-anti-cd20-antibody-conjugated-allogenic-gamma-delta-t-cell-therapy-for-non-hodgkins-lymphoma-302139302.html
SOURCE Acepodia Inc.