ALX Oncology Receives U.S. FDA Orphan Drug Designation for Evorpacept for the Treatment of Patients with Gastric Cancer and Gastroesophageal Junction Cancer
January 27 2022 - 5:51PM
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 gastric cancer and
gastroesophageal junction cancer (collectively “GC”).
“Receiving orphan drug designation from the FDA is an important
regulatory milestone for ALX Oncology and reinforces the FDA’s
recognition of evorpacept’s potential to improve clinical outcomes
in patients with GC,” said Sophia Randolph, M.D., Ph.D., Chief
Medical Officer, ALX Oncology. “In ASPEN-01, patients with >2L
HER2 positive GC (n=18) treated with evorpacept in combination with
trastuzumab plus ramucirumab and paclitaxel demonstrated an initial
objective response rate of 72.2% with a median duration of response
of 14.8 months and a median overall survival of 17.1 months [SITC
2021 poster]. These results compare favorably with the clinical
experience with both ramucirumab plus paclitaxel and
trastuzumab-deruxtecan in similar populations. With promising and
consistent anti-cancer activity demonstrated in the solid tumor
setting, we are focused on advancing the clinical development of
evorpacept and enrolling ASPEN-06 (NCT05002127), a Phase 2/3 study
of evorpacept for the treatment of patients with advanced HER2
positive GC.”
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 Gastric Cancer and Gastroesophageal Junction
Cancer
Gastric cancer begins in the cells lining the inner wall of the
stomach and spreads through the outer layers and eventually the
body as it grows. It is estimated that there will be over 26,000
newly diagnosed cases of GC at all stages in the U.S. in 2021, and
approximately 17 percent of all GC patients have HER2-positive
disease. The five-year survival rate is only 5.5 percent for those
patients diagnosed with metastatic disease. GC is even much more
common in East Asian countries, with incidence rates 4 to 10 times
higher than in the U.S.
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, 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
alx@argotpartners.com
Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macdougall.bio
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