ALX Oncology Announces Updated Data from ASPEN-01, the Ongoing Phase 1b Study of ALX148, Showing Robust, Durable Activity in ...
07 Dicembre 2020 - 4:00PM
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a
clinical-stage immuno-oncology company developing therapies to
block the CD47 checkpoint pathway, today announced the presentation
of updated clinical data from its ongoing trial evaluating ALX148
in combination with rituximab for the treatment of patients with
advanced relapsed and refractory (“r/r”) non-Hodgkin lymphoma
(“NHL”). The new results, shared in a poster at the 62nd American
Society of Hematology (“ASH”) Annual Meeting, show that the
combination of ALX148 and rituximab is highly active and well
tolerated in patients with r/r NHL [abstract 3016]. As of the data
cutoff of October 1, 2020, 33 patients have been treated with
ALX148 administered at 15 or 10 mg/kg once weekly (“QW”) with
standard regimens of rituximab.
- In response-evaluable patients (n=10) who received ALX148 at 15
mg/kg QW, the objective response rate (“ORR”) was 70.0%.
- The ORR was 50.0% in patients (n=6) with aggressive lymphoma
(r/r Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma) and
100% in patients (n=4) with indolent lymphoma (Follicular Lymphoma
and Marginal Zone Lymphoma).
- In response-evaluable patients (n=22) who received ALX148 at 10
mg/kg QW, the ORR was 40.9%.
- The ORR was 33.3% in patients (n=15) with aggressive lymphoma
and 57.1% in patients (n=7) with indolent lymphoma.
- ALX148 in combination with rituximab was well tolerated with no
dose limiting toxicities observed. A significant improvement in
clinical response was demonstrated with increased ALX148 exposure
across the doses evaluated (p=0.023).
“It is notable that higher ALX148 exposure is associated with
greater objective response in this patient population,” said Sophia
Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology.
“ALX148’s favorable tolerability profile permits the use of higher
doses that may drive further improvements in clinical activity. We
are excited to investigate higher doses of ALX148 in our planned
Phase 2 program that includes patients with myelodysplastic
syndromes (“MDS”), acute myeloid lymphoma (“AML”), head and neck
cancer, gastric cancer, and breast cancer.”
“Furthermore, we believe there is a strong and compelling
scientific rationale for using ALX148 in combination with different
anti-cancer therapies. Thus, we are pleased to present preclinical
data at the 62nd ASH Annual Meeting [abstract 1965] demonstrating
superior tumor control and significant prolongation of survival in
aggressive murine models of AML with ALX148 in combination with
venetoclax and azacitidine. We believe these preclinical data
further support our combination strategy and expand upon ASPEN-01’s
encouraging clinical findings as we plan a robust Phase 2
program.”
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 AML. 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 the expectations regarding the beneficial
characteristics, safety, efficacy and therapeutic effects of
ALX148. 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 Garcia
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113
peter@alxoncology.com
Argot Partners
(212)-600-1902
alx@argotpartners.com
Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macbiocom.com
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