- ACE2016 Is an Allogeneic Gamma Delta 2 (γδ2) T Cell Therapy
Targeting the Epidermal Growth Factor Receptor (EGFR) in Patients
With Solid Tumors.
- Phase 1 Clinical Study Expected to Begin in H2 2024.
ALAMEDA,
Calif. and TAIPEI,
Feb. 4,
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 that the U.S. Food and Drug
Administration (FDA) has cleared the company's investigational new
drug (IND) application for ACE2016, an allogeneic gamma delta 2
(γδ2) T cell therapy for the treatment of epidermal growth
factor receptor (EGFR)-expressing malignancies in patients with
solid tumors.
This clearance enables Acepodia to initiate a Phase 1,
first-in-human trial evaluating the safety, tolerability and
pharmacodynamics of ACE2016 in adults with locally advanced or
metastatic EGFR-expressing solid tumors. Acepodia expects to begin
the trial in the coming months and treat the first patient in the
second half of 2024.
"This milestone is a key step as we advance our pipeline of next
generation cell therapies and explore the potential of our novel
Antibody-Cell Conjugation (ACC) technology in solid tumors, which
remain to be unmet medical needs in the cell therapy field," said
Sonny Hsiao, Ph.D., chief executive
officer of Acepodia. "The rapid progression of obtaining the third
IND approval within 18 months highlights the team's remarkable
efficiency and dedication to advancing innovative programs swiftly.
With our third program in the clinic, we are proud to continue
progressing the field of cell therapy with the goal of delivering
powerful, accessible treatments for patients through a
first-of-its-kind approach."
About ACE2016
ACE2016 is an off-the-shelf γδ2 T cell therapy candidate
developed from Acepodia's proprietary ACC platform. ACE2016 targets
EGFR-expressing solid tumors through antibody conjugated γδ2 T
cells that target tumors driven by the cancer-causing EGFR gene.
Leveraging the advantages of ACC technology and Acepodia's
proprietary γδ2 T cell platform, ACE2016 has shown promising
cytotoxicity against several EGFR-expressing cancers in various
pre-clinical study models. The Phase 1 trial will evaluate the
safety, tolerability and pharmacodynamics of ACE2016 in patients
with locally advanced or metastatic EGFR-expressing solid tumors.
The trial is expected to dose its first patient in the second half
of 2024.
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-fda-clearance-of-investigational-new-drug-application-for-ace2016-a-first-in-class-allogeneic-anti-egfr-cell-therapy-302052466.html
SOURCE Acepodia Inc.