ALX Oncology Receives U.S. FDA Orphan Drug Designation for Evorpacept for the Treatment of Patients with Acute Myeloid Leukemia
June 29 2022 - 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 that the U.S.
Food and Drug Administration (“FDA”) granted orphan drug
designation (“ODD”) to evorpacept, a next-generation CD47 blocker,
for the treatment of patients with acute myeloid leukemia (“AML”).
“Receiving orphan drug designation in AML, and previously in
gastric cancer, from the FDA is an important regulatory milestone
and reflects the FDA’s recognition of evorpacept’s potential to
improve clinical outcomes in patients with these advanced cancers,”
said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX
Oncology. “In our ongoing Phase 1/2 ASPEN-05 study (NCT04755244),
we are excited to evaluate the combination of evorpacept with
venetoclax and azacitidine in patients with previously untreated
AML who are not candidates for intensive induction therapy or with
relapsed/refractory AML.”
The FDA’s Office of Orphan Products Development grants ODD
status to drugs and biologics intended for the safe and effective
treatment, diagnosis or prevention of rare diseases or conditions
affecting fewer than 200,000 people in the United States. ODD
provides benefits to drug developers designed to support the
development of drugs and biologics for small patient populations
with unmet medical needs. These benefits include assistance in the
drug development process, tax credits for qualified clinical costs,
exemptions from certain FDA fees and seven years of marketing
exclusivity.
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 20,050 new cases and 11,540 deaths
from AML in the United States in 2022. 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 31%.
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, 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 malignancies.
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
alx@argotpartners.com
Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macdougall.bio
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