ALX Oncology Announces First Patient Dosed in ASPEN-07, a Phase 1 Study of Evorpacept for the Treatment of Patients with Urothelial Cancer
16 February 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 announced the first
patient has been dosed in the ASPEN-07 study evaluating evorpacept,
a next generation CD47 blocker, in combination with PADCEV®
(enfortumab vedotin-ejfv), an antibody drug conjugate (“ADC”), in
patients with urothelial cancer (“UC”).
ASPEN-07 is a phase 1, open-label, multi-center study to
evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of evorpacept in combination with enfortumab
vedotin-ejfv in subjects with unresectable locally advanced or
metastatic UC (NCT05524545).
“Outcomes for patients diagnosed with locally advanced or
metastatic UC remain poor, and treatment options after initial
chemotherapy and immunotherapy are limited," said Sophia
Randolph, M.D., Ph.D., ALX Oncology’s Chief Medical Officer. "We
are excited to initiate ASPEN-07 to investigate this novel
combination therapy that has the potential to change the treatment
course of advanced UC. We are encouraged that PADCEV is the first
ADC therapy to demonstrate meaningful clinical activity in these
difficult-to-treat patients, and the addition of a CD47 blocker is
expected to act through different but complementary mechanisms to
positively impact efficacy without increasing toxicity.”
About Bladder and Urothelial CancerAs estimated
by the National Cancer Institute, bladder cancer is the sixth most
common cancer type in the United States. Urothelial cancer is the
most common type of bladder cancer and accounts for approximately
90% of all bladder cancer cases. 81,000 new cases of bladder cancer
will be diagnosed in the United States in 2022 with over 17,000
deaths. The five-year survival for patients with metastatic bladder
cancer is less than 8%. Worldwide, over 573,000 new cases of
bladder cancer and over 212,000 deaths occurred in 2020 according
to The Global Cancer Observatory.
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.
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@macdougall.bio
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