ALX Oncology Announces Initial Data from ASPEN-02, the Ongoing Phase 1 / 2 Study of Evorpacept in Combination with Azacitidine, Demonstrating Safety and Preliminary Activity in Patients with Myelodysplastic Syndrome
December 12 2021 - 9:00AM
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a
clinical-stage immuno-oncology company developing therapies to
block the CD47 checkpoint pathway, today announced the presentation
of initial clinical data from its ongoing trial evaluating
evorpacept in combination with azacitidine for the treatment of
patients with previously untreated higher-risk (“HR”) or relapsed
or refractory (“r/r”) myelodysplastic syndrome (“MDS”). The new
results, shared in a poster at the 63rd American Society of
Hematology (“ASH”) Annual Meeting [Abstract #2601], show that the
combination of evorpacept and azacitidine is active and well
tolerated. As of October 25, 2021, 22 patients with either
previously untreated HR or r/r MDS have been treated with
evorpacept in the Phase 1 dose escalation part of the study,
administered at 20 mg/kg or 30 mg/kg once every 2 weeks (“Q2W”) or
60 mg/kg once every 4 weeks (“Q4W”) together with standard dosing
of azacitidine. Median follow-up is 3.4 months, and accrual is
ongoing.
- Evorpacept in combination with azacitidine was well tolerated
(N=22) with no dose limiting toxicities, no observed treatment
related serious adverse events, and a maximum administered dose of
60 mg/kg Q4W.
- In 6 previously untreated HR MDS response-evaluable patients, 3
patients achieved an objective response (“OR”) (2 complete response
(“CR”), 1 marrow CR), and 2 patients achieved stable disease
(“SD”). Two out of 4 transfusion dependent patients achieved
transfusion independence on study.
- Among 5 previously untreated HR MDS patients with TP53 mutation
and complex cytogenetic abnormalities, 3 achieved an OR (2 CR and 1
marrow CR).
- Five of 9 patients with response-evaluable relapsed or
refractory MDS that had progressed upon prior hypomethylating
agents achieved an OR (5 marrow CRs). In addition, 2 patients
achieved SD.
“Evorpacept’s preliminary clinical activity seen in patients
with a difficult to treat subset of MDS including disease with TP53
mutation, poor risk cytogenetics, and progression on prior
hypomethylating agent regimens, is encouraging,” said Guillermo
Garcia-Manero M.D., Professor, Department of Leukemia, at MD
Anderson Cancer Center, Houston, TX. “Additionally, evorpacept’s
favorable initial tolerability profile in combination with
azacitidine suggests it may be safely added without worsening
cytopenias, which is particularly notable for this patient
population.”
“The initial tolerability and activity of evorpacept seen in
ASPEN-02 further support CD47 as a relevant therapeutic target in
patients with MDS,” said Sophia Randolph M.D., Ph.D., Chief Medical
Officer, ALX Oncology. “Evaluation of evorpacept in our myeloid
malignancy program including studies in both MDS and acute myeloid
leukemia is built on a strong scientific rationale and we are
pleased to now also see initial clinical data supporting its role
in enhancing the innate immune anti-cancer response.”
Conference Call on December
13th at 8:00 a.m.
EST
ALX Oncology will host a conference call on
Monday, December 13, 2021 at 8:00 a.m. EST to further discuss the
initial MDS data from ASPEN-02. In addition to ALX Oncology’s
executive management team, Dr. Guillermo Garcia-Manero, Professor,
Department of Leukemia, at MD Anderson Cancer Center, Houston, TX
will be featured on the call to discuss the emerging clinical data
in MDS patients.
To access the conference call, please dial (844) 467-7655
(U.S./Canada) or (409) 983-9840 (international) at least 10 minutes
prior to the start time and refer to conference ID 7598031.
Presentation slides will be available to download under “News &
Events” (see “Events”) in the Investors section of the ALX Oncology
website at www.alxoncology.com.
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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