ALX Oncology Provides Corporate Update and Highlights Key Milestones in 2023
05 January 2023 - 11:00PM
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 2023.
“2022 marked a successful year of continued clinical and
corporate accomplishments for ALX Oncology. Marked by steady
progress in the clinical development of our lead program,
evorpacept, for the treatment of multiple solid tumor indications
and hematological malignancies, we expanded clinical development of
evorpacept in new indications and combinations. These included a
Phase 1 trial in urothelial cancer (“UC”) in combination with
PADCEV®, an investigator-sponsored Phase 2 trial in refractory
microsatellite stable metastatic colorectal cancer in combination
with ERBITUX® and KEYTRUDA®, and a new investigational treatment
arm in the I-SPY-P1 trial for the treatment of patients with
unresectable or metastatic HER2-positive and HER2-low breast cancer
in combination with ENHERTU® and in partnership with Quantum
Leap Healthcare Collaborative. 2023 is expected to be an exciting
year for ALX Oncology as we look forward to the presentation of
data from ASPEN-06, a randomized Phase 2 trial of evorpacept in
combination with trastuzumab, ramucirumab and paclitaxel for the
treatment of patients with HER2-positive gastric/gastroesophageal
junction (“GEJ”) cancer and presentation of dose optimization
results from ASPEN-02, a Phase 1b clinical trial of evorpacept in
combination with azacitidine in patients with myelodysplastic
syndromes (“MDS”). We are also on track to file an Investigational
New Drug (“IND”), in collaboration with Tallac Therapeutics, for
ALTA-002 that will further expand our clinical pipeline beyond
evorpacept,” said Jaume Pons, Ph.D., Founder, President and Chief
Executive Officer of ALX Oncology.
Key Clinical Accomplishments in 2022
- Presented initial clinical data from
the Phase 1a dose escalation portion of the ASPEN-05 trial
evaluating evorpacept in combination with azacitidine and
venetoclax for the treatment of patients with relapsed or
refractory (“r/r”) or new diagnosed (“ND”) acute myeloid leukemia
(“AML”) at the American Society of Hematology (“ASH”) annual
meeting.
- Presented trial in progress poster
from ASPEN-03 and ASPEN-04, the Company’s Phase 2 head and neck
squamous cell carcinoma (“HNSCC”) studies, at the Society for
Immunotherapy of Cancer (“SITC”) annual meeting. ALX Oncology
continues to advance ASPEN-03 and ASPEN-04, which are two distinct
randomized Phase 2 studies for the treatment of patients with
advanced HNSCC in combination with KEYTRUDA (pembrolizumab) with or
without chemotherapy. Patient enrollment for ASPEN-03 and ASPEN-04
continues as planned.
- Announced a new investigational
treatment arm in the I-SPY-P1 TRIAL in collaboration with Quantum
Leap Healthcare Collaborative, for the treatment of patients with
unresectable or metastatic HER2-positive and HER2-low breast
cancer. A Phase 1 (open-label), multi-center study arm will
investigate evorpacept in combination with
ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed
antibody-drug conjugate (“ADC”), to determine the safety,
tolerability and efficacy of this drug combination.
- Dosed first patient in a Phase 2
investigator-sponsored trial of evorpacept in combination with
ERBITUX (cetuximab) and pembrolizumab in patients with mCRC who
have progressed on at least two lines of systemic therapy.
- The Food and Drug Administration
(“FDA”) granted Fast Track designation to evorpacept in combination
with pembrolizumab for the first-line treatment of patients with
PD-L1 expressing metastatic or unresectable, recurrent HNSCC, which
is the second Fast Track designation granted in HNSCC. Previously
the FDA granted Fast Track designation for evorpacept in
combination with pembrolizumab, platinum, and fluorouracil for the
first-line treatment of adult patients with metastatic or
unresectable, recurrent HNSCC.
- FDA granted Orphan Drug Designation
(“ODD”) to evorpacept for the treatment of patients with AML.
- Initiated ASPEN-07, a Phase 1 trial
of evorpacept for the treatment of patients with UC. ASPEN-07 will
investigate evorpacept in combination with an antibody-drug
conjugate (“ADC”), PADCEV® (enfortumab vedotin-ejfv).
- Began enrolling patients in
ASPEN-06, a Phase 2/3 study evaluating the combination of
evorpacept and CYRAMZA® (ramucirumab), Eli Lilly and Company’s
anti-VEGFR2 antibody, added to HERCEPTIN® (trastuzumab) and
paclitaxel for the treatment of patients with HER2-positive
gastric/GEJ cancer.
- FDA granted ODD to evorpacept for
the treatment of patients with gastric/GEJ cancer.
Key Corporate Accomplishments in 2022
- Entered into a loan facility with
Oxford Finance LLC and Silicon Valley Bank for up to $100 million
of non-dilutive financing. Under the terms of the loan agreement,
ALX Oncology drew $10 million of an initial $50 million tranche at
closing, with the remaining $40 million available at its discretion
through the end of 2023. ALX Oncology also has access up to an
additional $50 million with $12.5 million available in each of two
tranches based upon the achievement of milestones related to the
development of evorpacept and one pre-clinical product candidate,
and $25 million available at the Lenders’ discretion.
- Strengthened board of directors by
adding two independent board members with significant operational
and commercial leadership experience in the biopharmaceutical
industry:
- Itziar Canamasas, Ph.D.,
most recently the Head of Oncology EMEA and Commercial Lead
for Oncology for Bayer Consumer Care AG and has more than 20 years
of biopharmaceutical experience with Bayer and brings expertise in
driving business growth and operational excellence.
- Scott Garland, currently CEO of Pact
Pharma and previously CEO of Portola Pharmaceuticals, has more than
30 years of biopharmaceutical industry knowledge and brings deep
commercial and executive leadership experience.
Anticipated Milestones in 2023
- Presentation of data from a
randomized Phase 2 trial of evorpacept in combination with
trastuzumab, ramucirumab and paclitaxel for the treatment of
patients with HER2-positive gastric/GEJ cancer (ASPEN-06) in the
second half of 2023.
- Presentation of dose optimization
results of a Phase 1b clinical trial of evorpacept in combination
with azacitidine in patients with MDS (ASPEN-02) in the second half
of 2023.
- Initiation of a Phase 1b dose
optimization clinical trial of evorpacept in combination with
azacitidine and venetoclax for the treatment of patients with r/r
or ND AML (ASPEN-05) in the second half of 2023.
- Initiation of a Phase 1 trial of
evorpacept in combination with antibody drug conjugate, PADCEV®
(enfortumab vedotin-ejfv), for the treatment of patients with UC
(ASPEN-07) in the first half of 2023.
- Filing an IND for ALTA-002, a SIRPα
Toll-like receptor agonist antibody conjugate (“TRAAC”) in
collaboration with Tallac Therapeutics in the first half of
2023.
- Expansion of the ADC platform
acquired from ScalmiBio to identify clinical development candidates
by the second half of 2023.
Cash Position and Financial Guidance
- ALX Oncology ended the third quarter
2022 with approximately $293.1 million in cash and cash
equivalents. The Company expects that its cash, and cash
equivalents, investments and the $50 million to which it has access
under its term loan are sufficient to fund planned operations
through mid-2025.
Upcoming Presentation at 41st Annual J.P. Morgan
Healthcare Conference
ALX Oncology will present at the 41st Annual J.P. Morgan
Healthcare Conference on Tuesday, January 10, 2023 at 10:30 am PT
at the Westin St. Francis in San Francisco. A live webcast of the
presentation will be 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 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 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 commercial 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.
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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