- Data affirm positive immune effects of AdAPT-001 plus a
checkpoint inhibitor in sarcomas and triple negative breast cancer
with established checkpoint-inhibitor resistance
- The paucity of immune related adverse events suggests that
AdAPT-001 may protect against them.
TORREY PINES, Calif.,
May 23, 2024 /PRNewswire/ --
EpicentRx, a clinical-stage biopharmaceutical company, announced
that The American Society of Clinical Oncology (ASCO) has invited
Dr. Anthony P. Conley, an MD
Anderson Cancer Center (MDACC) Sarcoma Specialist and Lead PI, to
give an oral presentation on the unprecedented clinical activity of
AdAPT-001 plus an immune checkpoint inhibitor (ICI) in the ongoing
Phase 2 open-label BETA PRIME clinical trial that has so far
enrolled close to 70 patients. This activity includes complete
responses and several durable partial responses in established
checkpoint inhibitor-resistant tumor types like sarcoma and triple
negative breast cancer, with some patients on treatment for nearly
two years.
![EpicentRx, Inc. (PRNewsfoto/EpicentRx, Inc.) EpicentRx, Inc. (PRNewsfoto/EpicentRx, Inc.)](https://mma.prnewswire.com/media/2092212/EpicentRx_Logo.jpg)
To date, no dose-limiting toxicities or AdAPT-001 related
serious adverse events have occurred and only one immune related
adverse event (irAE) has been reported. This lack of irAEs suggests
that AdAPT-001 may prevent or attenuate ICI-mediated immune attack
on normal tissues but not cancerous ones.
Lead EpicentRx therapy, AdAPT-001, is the most clinically
advanced TGF-β ligand trap that antagonizes the immunosuppressive
effects of TGF-β and augments responses to ICIs, even ICIs which
patients previously failed. BETA PRIME is a multicenter Phase 2a
clinical trial led by Dr. Anthony P.
Conley from MDACC and Dr. Lucy B.
Kennedy from the Cleveland Clinic. AdAPT-001 is dosed every
two weeks in combination with an ICI.
"This is incredibly exciting news to have been selected for an
oral presentation at ASCO, where the most important trials are
presented, discussed, and reviewed," said lead PI, Dr. Anthony P. Conley. "It is a great honor and an
indication of the activity, safety, and tolerability of AdAPT-001
in combination with a checkpoint inhibitor. Credit to our clinical
trial patients, the EpicentRx team and everyone from MDACC
associated with the management of the BETA PRIME clinical
trial."
The abstract is available on ASCO.org/abstracts.
Presentation details:
Abstract Number for Publication: 2506
Abstract Title: Phase 1/2 study of the
TGF-β-trap-enhanced oncolytic adenovirus, AdAPT-001, plus an immune
checkpoint inhibitor for patients with immune refractory
cancers.
Session Type and Title: Oral Abstract
Session – Developmental Therapeutics -
Immunotherapy
About AdAPT-001
AdAPT-001 is an investigational immunotherapy with a TGF-β
receptor-immunoglobulin Fc fusion trap, designed to neutralize
isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and
immunosuppressive cytokine, TGF-β, and to sensitize resistant
tumors to checkpoint blockade. It is the most clinically
advanced TGF-β ligand trap in development.
In the ongoing Phase 2 BETA PRIME trial, AdAPT-001 was
administered as single-agent and in combination with checkpoint
inhibitors to patients with treatment-refractory tumors.
Importantly, AdAPT-001 plus checkpoint inhibitors improved
toxicity and AE profile over what is typically observed with
checkpoint inhibitors. No dose limiting toxicities, AdAPT-001
related serious adverse-events, or dose reductions have been
observed to date.
About EpicentRx
EpicentRx is at the epicenter of innovative drug development
with therapies like AdAPT-001 and RRx-001 that target diseases and
toxicities of hugely unmet medical need.
For more information about the trial and EpicentRx's pipeline,
please visit www.epicentrx.com.
Business Development Contact:
Sa'ar Yaniv
EpicentRx
syaniv@epicentrx.com
Media Contact:
Ashley
Thomaz
MCS Healthcare Public Relations
ashleyt@mcspr.com
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SOURCE EpicentRx, Inc.