ALX Oncology Receives Orphan Drug Designation from the European Commission for Evorpacept for the Treatment of Patients with Gastric Cancer
26 Juin 2023 - 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 that evorpacept,
a next-generation CD47 blocker, has received orphan drug
designation (“ODD”) from the European Commission (“EC”) for the
treatment of patients with gastric cancer. This ODD indication
includes both gastric cancer and gastroesophageal junction
adenocarcinoma (collectively “GC”). The U.S. Food and Drug
Administration (“FDA”) also granted ODD to evorpacept for the
treatment of patients with GC as previously announced in January
2022.
“Receiving orphan drug designation from both the EC and the FDA
represents a significant regulatory achievement for ALX Oncology
and signifies the growing recognition of evorpacept as a potential
new drug to improve clinical outcomes in patients with GC,” said
Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology.
“Evorpacept has demonstrated promising and consistent anti-cancer
activity in the solid tumor setting, and we look forward to
presenting data in the second half of 2023 for ASPEN-06, a
randomized Phase 2 trial of evorpacept in combination with
trastuzumab, paclitaxel and CYRAMZA® (ramucirumab) for the
treatment of patients with HER2-positive GC.”
Orphan drug designation is granted by the EC for medicines in
development to treat rare conditions affecting no more than five in
10,000 people in the European Union, provided there is no other
satisfactory treatment option or the medicine can be of significant
benefit to those affected by the condition. Medicines that are
granted orphan drug designation by the EC qualify for financial and
regulatory incentives including protocol assistance, possible
exemptions or reductions in certain regulatory fees, and, if
approved for marketing, ten years of market exclusivity in the
European Union.
About Gastric Cancer and Gastroesophageal Junction
Cancer (section to be updated)
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. Approximately 17 percent of all GC patients have
HER2-positive disease, and the five-year survival rate is only 5.5
percent for those patients diagnosed with metastatic
disease (SEER). The National Cancer Institute estimates there
will be over 26,000 newly diagnosed cases of GC and 11,000 deaths
in the U.S. in 2023. In comparison, GC is significantly more common
in Europe with over 130,000 newly diagnosed cases and 96,000
deaths in 2020 (Globocan).
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.
ALX Oncology 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
ALX Oncology Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macdougall.bio
ALX Oncology (NASDAQ:ALXO)
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