ALX Oncology to Collaborate with Merck on Phase 2 Immuno-Oncology Studies Evaluating ALX148, Targeting CD47, in Combination w...
22 Settembre 2020 - 1:00PM
ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology
company developing therapies that block the CD47 checkpoint
pathway, today announced it has entered into a clinical trial
collaboration with Merck, known as MSD outside the United States
and Canada, to evaluate the combination of ALX148, an
investigational next generation CD47 blocker, and
KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the
treatment of patients with Head & Neck Squamous Cell Carcinoma
(HNSCC).
Under the terms of the agreement, ALX Oncology will conduct a
Phase 2 program comprising two separate Phase 2 studies. The first
study will evaluate the efficacy of ALX148 in combination with
KEYTRUDA for the first line treatment of patients with PD-L1
expressing metastatic or unresectable, recurrent HNSCC. The second
study will evaluate ALX148 in combination with KEYTRUDA and
standard chemotherapy for the first line treatment of patients with
metastatic or unresectable, recurrent HNSCC.
These new studies will be initiated based on promising data from
ALX148 in combination with pembrolizumab generated by ALX Oncology
in a Phase 1b trial evaluating patients with HNSCC that was the
basis for ALX148’s Fast Track Approval granted by the U.S. Food and
Drug Administration. Phase 1b trial results presented at ASCO 2020
showed that patients with HNSCC who had progressed on prior
platinum therapy and who had never received a checkpoint inhibitor
treated with ALX148 in combination with pembrolizumab demonstrated
a 40% objective response rate (ORR), a median progression-free
survival (PFS) of 4.6 months with a median overall survival (OS)
that was not reached.
“ALX148 was designed for use in combination to maximize clinical
activity with a range of anti-cancer agents. We believe that
blocking the CD47 myeloid checkpoint pathway bridges the innate and
adaptive immune response against cancer to enhance efficacy. This
collaboration builds upon the compelling combination activity
observed in patients with ALX148 and KEYTRUDA,” said Jaume Pons,
Ph.D., Founder, President and Chief Executive Officer of ALX
Oncology. “Our goal is to transform treatment options for patients
with cancer by developing ALX148 as a foundational checkpoint
immunotherapy.”
ALX Oncology owns worldwide commercial rights to ALX148.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
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,
ALX148, is a next generation CD47 blocking therapeutic that
combines a high-affinity CD47 binding domain with an inactivated,
proprietary Fc domain. ALX148 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 advance ALX148 into clinical development for
the treatment of myelodysplastic syndromes and to continue clinical
development for the treatment of a range of solid tumor
indications.
Cautionary Note Regarding
Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended. Such
forward-looking statements are based on ALX Oncology Holdings
Inc.’s (the “Company”) 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 the Company’s actual
results, performance or achievements to be materially different
from those expressed or implied by the forward-looking
statements. These statements include but are not limited to
statements regarding the Company’s continued reliance on third
parties to conduct clinical trials of ALX148, the Company’s
expectations regarding the beneficial characteristics, safety,
efficacy and therapeutic effects of ALX148, the design, progress
and timing of clinical trials for ALX148, including enrollment and
its regulatory plans, and the ability of the Company’s clinical
trials to demonstrate the safety and efficacy of ALX148. These and
other risks are described more fully in the Company’s filings with
the Securities and Exchange Commission (“SEC”), including the
Company’s Quarterly Report on Form 10-Q, filed with the SEC on
August 27, 2020, and other documents the Company subsequently files
with the SEC from time to time. Except to the extent required by
law, the Company 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
CFO, 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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