ALX Oncology Announces Update on ASPEN-03 and ASPEN-04, the ALX148 Phase 2 Head and Neck Cancer Studies
14 Giugno 2021 - 1:00PM
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a
clinical-stage immuno-oncology company developing therapies that
block the CD47 checkpoint pathway, today announced updates on its
ALX148 Phase 2 studies in patients with advanced head and neck
squamous cell carcinoma (“HNSCC”). The U.S. Food and Drug
Administration (“FDA”) informed ALX Oncology that it reviewed its
standard non-clinical safety study and has lifted the previously
set partial clinical hold and cap on patient enrollment. The two
randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially
registrational with patient enrollment unimpacted in either study.
ASPEN-03 has initiated with enrollment ongoing.
ALX Oncology is advancing ALX148 into two randomized Phase 2
studies in subjects with HNSCC in combination with pembrolizumab,
marketed as KEYTRUDA®, the market leading anti-programmed cell
death protein-1, or PD-1, checkpoint inhibitor, with or without
chemotherapy. Both studies are being conducted in collaboration
with Merck. The first study, ASPEN-03, is evaluating the efficacy
of ALX148 in combination with pembrolizumab for the first-line
(“1L”) treatment of patients with PD-L1 expressing metastatic or
unresectable, recurrent HNSCC with a Combined Positive Score
(“CPS”) ≥ 1. The second study, ASPEN-04, is evaluating ALX148 in
combination with pembrolizumab and standard chemotherapy for the 1L
treatment of patients with metastatic or unresectable, recurrent
HNSCC (any CPS value). Further details can be found here.
“We are very pleased that the FDA has reviewed our standard
non-clinical safety study and has removed the partial clinical hold
and patient cap on our two Phase 2 studies of ALX148 in patients
with HNSCC,” said Sophia Randolph, M.D., Ph.D., Chief Medical
Officer, ALX Oncology. “Patients with advanced HNSCC are in need of
novel therapeutic options, and we look forward to expediting the
global enrollment of patients into ASPEN-03 and ASPEN-04 in the
coming months and evaluating ALX148’s contribution to standard
pembrolizumab-based therapy.”
About ALX OncologyALX Oncology is a publicly
traded, clinical-stage immuno-oncology company focused on helping
patients fight cancer by developing therapies that block the CD47
checkpoint pathway and bridge the innate and adaptive immune
system. ALX Oncology’s lead product candidate, ALX148, is a
next-generation CD47 blocking therapeutic that combines a
high-affinity CD47 binding domain with an inactivated, proprietary
Fc domain. ALX148 has demonstrated promising clinical responses
across a range of hematologic and solid malignancies in combination
with a number of leading anti-cancer agents. ALX Oncology intends
to continue clinical development of ALX148 for the treatment of
multiple solid tumor indications and hematologic malignances,
including AML and myelodysplastic syndromes (MDS).
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements that involve substantial risks and uncertainties.
Forward-looking statements include statements regarding future
results of operations and financial position, business strategy,
product candidates, planned preclinical studies and clinical
trials, results of clinical trials, research and development costs,
regulatory approvals, timing and likelihood of success, plans and
objects of management for future operations, as well as statements
regarding industry trends. Such forward-looking statements
are based on ALX Oncology’s beliefs and assumptions and on
information currently available to it on the date of this press
release. Forward-looking statements may involve known and unknown
risks, uncertainties and other factors that may cause ALX
Oncology’s actual results, performance or achievements to be
materially different from those expressed or implied by the
forward-looking statements. These and other risks are described
more fully in ALX Oncology’s filings with the Securities and
Exchange Commission (“SEC”), including ALX Oncology’s Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q and other
documents ALX Oncology files with the SEC from time to time. Except
to the extent required by law, ALX Oncology undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were
made.
Investor Contact:
Peter GarciaChief Financial Officer, ALX Oncology(650) 466-7125
Ext. 113peter@alxoncology.com
Argot Partners(212)-600-1902alxoncology@argotpartners.com
Media Contact:Karen SharmaMacDougall(781)
235-3060alx@macbiocom.com
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