ALX Oncology Announces First Patient Dosed in ASPEN-05, a Phase 1/2 Study of Evorpacept in Combination with Venetoclax and Azacitidine in Patients with Acute Myeloid Leukemia
October 21 2021 - 7:00AM
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a
clinical-stage immuno-oncology company developing therapies that
block the CD47 checkpoint pathway, today announced the first
patient has been dosed in the Phase 1/2 ASPEN-05 study evaluating
the combination of evorpacept, a next-generation CD47 blocker, with
venetoclax and azacitidine for the treatment of patients with acute
myeloid leukemia (“AML”).
The Phase 1 portion of the ASPEN-05 study will characterize the
safety and confirm the dose of evorpacept in combination with
venetoclax and azacitidine in patients with relapsed/refractory AML
and previously untreated AML who are not candidates for intensive
induction therapy. The Phase 2 portion of the study will evaluate
the efficacy of the combination in patients with previously
untreated AML who are not candidates for intensive induction
therapy.
ASPEN-05 is based on promising preclinical data with evorpacept
in combination with venetoclax and azacitidine in non-clinical
models of leukemia, as well as clinical data from an ongoing phase
1 study (NCT03013218) evaluating evorpacept in combination with
multiple anti-cancer agents in both solid and hematologic
malignancies.
“Patients with either relapsed/refractory AML or previously
untreated AML who are not considered eligible for intensive
induction regimens remain in urgent need of tolerable and effective
new therapies,” said Harry Erba, M.D., Ph.D., Director of the
Leukemia Program at the Duke Cancer Institute. “We are looking
forward to evaluating the addition of evorpacept to venetoclax and
azacitidine. ALX148 was specifically designed for use in
combination to maximize phagocytosis of tumor cells while
minimizing the toxicities commonly associated with other
CD47-targeted approaches.”
“ASPEN-05 builds upon compelling evorpacept combination activity
observed in non-clinical models of leukemia. With demonstrated
tolerability of evorpacept in multi-agent chemotherapy regimens, we
are excited to characterize evorpacept with this standard backbone
of AML therapy,” said Sophia Randolph, M.D., Ph.D., Chief Medical
Officer of ALX Oncology. “Through blockade of the CD47 myeloid
checkpoint, evorpacept in combination with venetoclax and
azacitidine may potentially transform treatment options for
patients with AML.”
The ASPEN-05 trial is registered under NCT04755244. ALX Oncology
owns worldwide commercial rights to evorpacept.
About Acute Myeloid Leukemia
AML is an aggressive blood cell cancer that can rapidly progress
and lead to death if not treated promptly. AML is the most common
form of acute leukemia in adults, with an estimated 19,940 new
cases and 11,180 deaths from AML in the United States. Due to
advanced age and comorbidities at the time of diagnosis, a
significant number of patients are not considered eligible for
intensive and potentially curative therapies. Despite advances in
available care, the estimated 5-year survival for patients in the
United States with AML remains only 29%.
About ALX Oncology
ALX 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, evorpacept (also known as ALX148), is a
next-generation CD47 blocking therapeutic that combines a
high-affinity CD47 binding domain with an inactivated, proprietary
Fc domain. Evorpacept 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 evorpacept for the treatment of
multiple solid tumor indications and hematologic malignances,
including acute myeloid leukemia and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking
Statements
This 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 Garcia
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113
peter@alxoncology.com
Argot Partners
(212)-600-1902
alxoncology@argotpartners.com
Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macbiocom.com
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