ALX Oncology Announces Evorpacept Clinical Program Updates
June 03 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 clinical program
updates for its lead program, evorpacept, a next generation CD47
blocker.
Introducing ASPEN-07, a Phase 1 Trial of
Evorpacept for the Treatment of Patients with Urothelial Carcinoma
(“UC”)
-
ALX Oncology will initiate a new clinical study, ASPEN-07, to
investigate evorpacept in combination with an antibody-drug
conjugate (“ADC”), PADCEV® (enfortumab vedotin-ejfv), for the
treatment of patients with urothelial carcinoma (“UC”) in the
fourth quarter of 2022.
-
Enfortumab vedotin-ejfv is an ADC directed to Nectin-4, a protein
located on the surface of cells that is highly expressed in
UC.
- In
April 2022, ALX Oncology successfully completed a pre-IND
consultation with the U.S. Food and Drug Administration (“FDA”) for
a Phase 1 study of evorpacept in combination with enfortumab
vedotin-ejfv in patients with previously treated locally advanced
or metastatic UC.
-
The IND application for ASPEN-07 was submitted to the FDA in May
2022.
“We continue to pursue strategies to expand the
potential value of evorpacept as a cornerstone therapy for the
treatment of patients with cancer,” said Jaume Pons, Ph.D.,
Founder, President and Chief Executive Officer of ALX Oncology.
“ASPEN-07 further expands our solid tumor investigations and will
be the first combination study of evorpacept with an ADC. The
addition of evorpacept is expected to enhance the
antibody-dependent cellular phagocytosis mediated by enfortumab
vedotin-ejfv to improve efficacy in patients with UC without
increasing toxicity. Our currently enrolling randomized Phase 2
studies remain a key priority for us in order to maintain ALX
Oncology’s leadership position in solid tumors in the CD47
space.”
Update of ASPEN-05, a Phase 1 / 2 Clinical
Trial of Evorpacept in Combination with Venetoclax and Azacitidine
in Acute Myeloid Leukemia (“AML”), and ASPEN-02, a Phase 1/2 Study
of Evorpacept in Combination with Azacitidine in Myelodysplastic
Syndrome (“MDS”)
- The
Phase 1 dose escalation portion of ASPEN-05 has successfully
completed enrollment with no safety concerns to date up to the
highest protocol defined dose level of 60 mg/kg evorpacept once
every four weeks. This portion of the study is designed to
characterize the initial safety of evorpacept in combination with
venetoclax and azacitidine for the treatment of patients with
relapsed/refractory AML and previously untreated AML who are not
candidates for intensive induction therapy.
-
Patient enrollment will be paused before proceeding into the Phase
1 dose optimization portion of ASPEN-05 pending completion of the
Phase 1 portion of ASPEN-02, a Phase 1/2 study of evorpacept in
combination with azacitidine in patients with MDS. Data from
ASPEN-02 will be used to inform the optimal dose(s) of evorpacept
to be studied in the ASPEN-05 study in combination with venetoclax
and azacitidine. Ongoing patients in ASPEN-05 will continue to be
treated and followed per protocol.
“The decision to pause ASPEN-05 is based on the
desire to leverage upcoming dose optimization data from the
ASPEN-02 MDS study to effectively inform dose optimization in
ASPEN-05,” said Sophia Randolph, M.D., Ph.D., Chief Medical Officer
of ALX Oncology. “MDS and AML are indications where evorpacept
possesses a similar mechanism of action, and this strategy allows
us to evaluate evorpacept in a cost-efficient manner in patients
with AML while maintaining our focus in our solid tumor programs.
We anticipate preliminary dose escalation data from ASPEN-05 to be
presented at a scientific conference in 2022, and initial dose
optimization data from ASPEN-02 to be presented at a scientific
conference in mid-2023.”
Update of ASPEN-03 and ASPEN-04, which
are two distinct randomized Phase 2 studies for the treatment of
patients with advanced head and neck squamous cell carcinoma
(“HNSCC”)
- ALX
Oncology continues to advance evorpacept in two randomized Phase 2
studies in patients with HNSCC in combination with KEYTRUDA®
(pembrolizumab), Merck’s anti-PD-1 therapy, with or without
chemotherapy. Both studies are being conducted in collaboration
with Merck, known as MSD outside the United States and Canada. The
first study, ASPEN-03, is evaluating the efficacy of evorpacept in
combination with pembrolizumab for the first-line (“1L”) treatment
of patients with PD-L1 expressing metastatic or unresectable,
recurrent HNSCC with a Combined Positive Score (“CPS”) ≥ 1. The
second study, ASPEN-04, is investigating evorpacept in combination
with pembrolizumab and standard chemotherapy for the 1L treatment
of patients with metastatic or unresectable, recurrent HNSCC (any
CPS value).
-
Patient enrollment for ASPEN-03 and ASPEN-04 continues as planned
with results expected to be presented by mid-2024.
Update of ASPEN-06, a Phase 2/3 Study of
Evorpacept for the Treatment of Patients with Advanced Gastric or
Gastroesophageal Junction (“GEJ”) Cancer
-
ASPEN-06 is a randomized Phase 2 (open-label) / Phase 3
(double-blind), international, multi-center study to evaluate the
efficacy of evorpacept and CYRAMZA® (ramucirumab) added to
trastuzumab and paclitaxel for the treatment of patients with
HER-positive gastric/GEJ cancer whose tumors have progressed
following treatment with HER2-targeted therapy and chemotherapy.
ASPEN-06 is being conducted in collaboration with Eli Lilly and
Company.
- In
March 2022, the first patient was dosed in the Phase 2/3 ASPEN-06
study.
-
Patient enrollment continues to progress and results from the Phase
2 portion of ASPEN-06 are expected to be presented in 2023.
About ALX OncologyALX 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 StatementsThis 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.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway,
NJ, USA.
CYRAMZA® is a registered trademark owned or
licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.
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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