ALX Oncology Provides Corporate Update and Highlights Key Milestones in 2022
10 January 2022 - 10:00PM
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a
clinical-stage immuno-oncology company developing therapies that
block the CD47 checkpoint pathway, today provided a corporate
update and highlighted key milestones anticipated in 2022.
“2021 was a year of substantial corporate and
clinical accomplishments for ALX Oncology. We initiated numerous
clinical trials, including two Phase 2 trials in head and neck
squamous cell carcinoma (“HNSCC”) and presented encouraging Phase
1b data from the ASPEN-01 trial in gastric/gastroesophageal
junction (“GEJ”) cancer and HNSCC, along with early Phase 1b data
from the ASPEN-02 trial in myelodysplastic syndromes (“MDS”),” said
Jaume Pons, Ph.D., Founder, President and Chief Executive Officer
of ALX Oncology.
“On the business development front, we
collaborated with Tallac Therapeutics to jointly develop,
manufacture, and commercialize a novel toll-like receptor nine
agonist antibody conjugate, and late last year we acquired
privately held ScalmiBio, giving us full access to their
proprietary SHIELD platform for conditional activation of
antibodies in the tumor microenvironment and proprietary cytotoxic
payloads for antibody-drug conjugates. We expect 2022 to be an
exciting and productive year with multiple clinical trial
initiations and data readouts for evorpacept,” Dr. Pons
continued.
Accomplishments in 2021
- Presented initial
Phase 1a clinical data of evorpacept in combination with
azacitidine in patients with MDS (ASPEN-02) at ASH. Accrual is
ongoing in the Phase 1 dose expansion part of the study.
- Presented updated
Phase 1b clinical trial data of evorpacept in combination with
pembrolizumab with and without chemotherapy in patients with HNSCC
and evorpacept in combination with trastuzumab, ramucirumab, and
paclitaxel in patients with gastric/GEJ cancer (ASPEN-01) at
SITC.
- Initiated a Phase
1a clinical trial of evorpacept in combination with azacitidine and
venetoclax in acute myeloid leukemia (“AML”) (ASPEN-05).
- Acquired privately
held ScalmiBio, giving ALX Oncology full access to their
proprietary SHIELD platform for conditional activation of
antibodies in the tumor microenvironment and proprietary cytotoxic
payloads for antibody drug conjugates.
- Initiated a Phase
1b/2 clinical trial of evorpacept in combination with zanidatamab
in patients with advanced HER2-positive breast cancer, HER2-low
breast cancer and additional non-breast HER2-expressing solid
tumors being conducted by Zymeworks (NYSE: ZYME).
- Entered into a
clinical trial collaboration and supply agreement with Eli Lilly
(NYSE: LLY) to evaluate the combination of evorpacept and CYRAMZA®
(ramucirumab), Eli Lilly’s anti-VEGFR2 antibody, for the treatment
of patients with HER2-positive gastric/GEJ cancer.
- Initiated two
randomized Phase 2 studies of evorpacept in combination with
KEYTRUDA® (pembrolizumab) in patients with HNSCC. The first study
(ASPEN-03) evaluated the efficacy of evorpacept in combination with
pembrolizumab for the first line treatment of patients with PD-L1
expressing metastatic or unresectable, recurrent HNSCC. The second
study (ASPEN-04) evaluated evorpacept in combination with
pembrolizumab and standard chemotherapy for the first line
treatment of patients with metastatic or unresectable, recurrent
HNSCC.
- Entered into a
collaboration with Tallac Therapeutics, a privately held
biopharmaceutical company harnessing the power of innate and
adaptive immunity to fight cancer to jointly develop, manufacture
and commercialize a novel class of cancer immunotherapeutics.
Anticipated Milestones in
2022
- Initiation of a
randomized Phase 2/3 clinical trial of evorpacept in combination
with Herceptin® (trastuzumab), Cyramza® (ramucirumab) and
paclitaxel in patients with 2nd line or greater gastric/GEJ cancer
(ASPEN-06).
- Dose optimization
readout of a Phase 1b clinical trial of evorpacept in combination
with azacitidine in patients with MDS (ASPEN-02).
- Add to and report
on investigator sponsored clinical trials with evorpacept
(non-Hodgkin’s lymphoma).
- Report on ongoing
collaboration with Zymeworks in HER2-expressing breast cancer and
other solid tumors.
- Select development
candidate(s) from preclinical pipeline.
Cash Position and Financial
Guidance
ALX Oncology ended the third quarter of 2021
with approximately $385.1 million in cash and cash equivalents. The
Company expects that its cash and cash equivalents will be
sufficient to fund its planned operations through mid-2024.
Upcoming Presentation at 40th
Annual J.P. Morgan Healthcare Conference
ALX Oncology will present at the 40th Annual J.P. Morgan
Conference on Tuesday, January 11, 2022 at 10:30 AM Eastern Time. A
live webcast of the presentation is available here and can be
accessed by visiting the Investors section of ALX Oncology’s
website at www.alxoncology.com and selecting Events under the News
and Events tab. A replay of the webcast will be archived for up to
30 days following the presentation date.
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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