ALX Oncology Announces Updates on Planned ALX148 Phase 2 Head and Neck Cancer Studies
07 Dicembre 2020 - 1:00PM
ALX Oncology Holdings Inc., (“ALX Oncology” or “Company”) (Nasdaq:
ALXO), a clinical-stage immuno-oncology company developing
therapies to block the CD47 checkpoint pathway, today announced
updates on its planned ALX148 Phase 2 studies in patients with
advanced head and neck squamous cell carcinoma (“HNSCC”). The U.S.
Food and Drug Administration (“FDA”) verbally informed the Company
that given its planned initiation of two Phase 2 HNSCC studies that
could be potentially registrational, they require completion
of a routine non-clinical safety study that the Company
currently has in process. The FDA noted that for any drug
development program moving swiftly through development, this
non-clinical study is still required prior to the
initiation of a clinical trial that could be considered
pivotal. ALX Oncology is allowed to initiate both Phase 2 HNSCC
studies with the enrollment capped at a total of 50 subjects
treated with ALX148 across both studies (excluding safety lead-in
cohorts) pending acceptance of the non-clinical safety study
report. The Company expects to provide the required report to the
FDA prior to reaching the 50-patient enrollment cap.
While this cap on enrollment is defined as a partial clinical hold,
no delays are anticipated in the Company’s current clinical study
timelines.
ALX Oncology plans to advance ALX148 into two Phase 2 studies in
subjects with HNSCC in combination with pembrolizumab, marketed as
KEYTRUDA®, the market leading anti-programmed cell death protein-1,
or PD-1, checkpoint inhibitor, with or without chemotherapy, in the
first half of 2021. Both studies will be conducted in collaboration
with Merck. The first study will evaluate the efficacy of ALX148 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 will evaluate ALX148 in combination with pembrolizumab
and standard chemotherapy for the 1L treatment of patients with
metastatic or unresectable, recurrent HNSCC (any CPS value).
“We are pleased that the FDA is allowing us to initiate our two
planned Phase 2 studies of ALX148 in patients with HNSCC and we are
on track to complete the standard ongoing non-clinical safety
study. We do not anticipate any delays in our planned clinical
study timelines,” said Sophia Randolph, M.D., Ph.D., Chief Medical
Officer, ALX Oncology. “Importantly, this recent FDA communication
is not in response to any adverse events seen in ALX Oncology’s
ongoing clinical studies of ALX148. We are excited to have
demonstrated encouraging anti-tumor activity with ALX148 in
combination treatment in patients with HNSCC as well as
HER2-positive gastric and gastroesophageal junction cancer. We
believe these indications, in addition to our myelodysplastic
syndromes (“MDS”) program (ASPEN-02), offer potential registration
pathways in combination with existing approved therapies and we
intend to accelerate ALX148 development in solid and hematological
indications in 2021.”
ALX Oncology recently announced that ALX148 in combination with
pembrolizumab, 5-fluoropyrimidine and platinum achieved a 75.0%
(n=4) overall response rate (“ORR”), including a complete response,
in the Company’s Phase 1b expansion cohort (ASPEN-01) for the 1L
treatment of patients with metastatic or unresectable, recurrent
HNSCC who have not received prior treatment for their advanced
disease. The Company also reported recent ASPEN-01 data that ALX148
in combination with pembrolizumab achieved a 40.0% ORR (n=10) in
patients with 2L HNSCC who had never received a checkpoint
inhibitor for their advanced disease. ALX Oncology intends to
pursue a strategy that will leverage the data generated from its
planned Phase 2 randomized studies of ALX148 and pembrolizumab with
and without chemotherapy to request from the FDA that ALX148 be a
candidate for accelerated approval in the 1L treatment of
HNSCC.
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 continue clinical development of ALX148 for the treatment of a
range of solid tumor indications as well as MDS and acute myeloid
leukemia. For more information, please visit ALX Oncology’s website
at www.alxoncology.com.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’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 statements include but are
not limited to statements regarding ALX Oncology’s clinical
pipeline and timeline, strategy, the expectations regarding the
beneficial characteristics, safety, efficacy and therapeutic
effects of ALX148, and the statements made by ALX Oncology’s Chief
Medical Officer. These and other risks are described more fully in
ALX Oncology’s filings with the Securities and Exchange Commission
(“SEC”), including ALX Oncology’s Quarterly Report on Form 10-Q,
filed with the SEC on November 12, 2020, and other documents ALX
Oncology subsequently 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 GarciaChief Financial Officer, ALX Oncology(650) 466-7125
Ext. 113peter@alxoncology.com
Argot Partners(212)-600-1902alx@argotpartners.com
Media Contact:
Karen SharmaMacDougall(781) 235-3060alx@macbiocom.com
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