ALX Oncology Announces First Patient Dosed in ASPEN-06, a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Cancer
March 02 2022 - 7:00AM
ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”), a
clinical-stage immuno-oncology company developing therapies to
block the CD47 checkpoint mechanism, today announced the first
patient has been dosed in the Phase 2/3 ASPEN-06 study evaluating
the combination of evorpacept, a next generation CD47 blocker, and
CYRAMZA® (ramucirumab), Eli Lilly and Company’s anti-VEGFR2
antibody, added to trastuzumab and paclitaxel for the treatment of
patients with HER2-positive gastric cancer or gastroesophageal
junction (“GEJ”) cancer.
ASPEN-06 (NCT05002127) is a randomized phase 2 (open-label) /
phase 3 (double-blind), international, multi-center study to
evaluate the efficacy of evorpacept in combination with
ramucirumab, trastuzumab, and paclitaxel for the treatment of
patients whose tumors have progressed following treatment with
HER2-targeted therapy and chemotherapy. Approximately 450 adult
patients will be enrolled in the study across both phases.
This study follows the ongoing ASPEN-01 Phase 1b trial in
patients with HER2-positive gastric/GEJ cancer who have progressed
following treatment with HER2-targeted therapy and chemotherapy
(NCT03013218). As presented at the Society for Immunotherapy of
Cancer’s 36th Annual Meeting in 2021, evorpacept used in
combination with ramucirumab, trastuzumab, and paclitaxel
demonstrated an initial confirmed objective response rate of 72.2%
with a median duration of response of 14.8 months, a 12-month
overall survival rate of 79%, and a median overall survival of 17.1
months in patients who historically have low response rates and
poor outcomes in this clinical setting [SITC 2021 poster].
“Patients with HER2-positive gastric/GEJ cancer are in need of
tolerable and effective treatments, particularly in the 2nd line
and later settings where resistance to HER2-directed therapy may
have developed,” said Keun-Wook Lee, M.D., Ph.D., Professor of
Seoul National University College of Medicine and Director of
Clinical Trials Center, Seoul National University Bundang Hospital,
Seoul, Korea. “Evorpacept’s favorable tolerability coupled with its
novel approach of enhancing antibody dependent cellular
phagocytosis engages the individual’s own innate anti-cancer immune
response distinguishing it from other HER2-targeted
approaches.”
“We are greatly encouraged by the exciting data that continue to
emerge from ASPEN-01 and are pleased to announce the first patient
dosed in ASPEN-06,” said Sophia Randolph, M.D., Ph.D., Chief
Medical Officer, ALX Oncology. “This milestone is an important step
towards establishing evorpacept as a unique CD47 blocker that may
be used in combination with other anti-cancer drugs for
difficult-to-treat solid tumors, such as gastric/GEJ cancer, where
more treatment options are desperately needed to improve disease
outcomes.”
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 gastric/GEJ cancer at all stages in the
U.S. in 2021, and approximately 17 percent of all gastric/GEJ
cancer patients have HER2-positive disease. The five-year survival
rate is only 5.5 percent for those patients diagnosed with
metastatic disease. Gastric/GEJ cancer 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
alxoncology@argotpartners.com
Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macbiocom.com
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