ALX Oncology Announces New Data from ASPEN-01, the Phase 1b Study of ALX148, Showing Promising Initial Clinical Responses in...
09 Novembre 2020 - 2:10PM
ALX Oncology Holdings Inc., (“ALX Oncology”)
(Nasdaq: ALXO), a clinical-stage immuno-oncology company developing
therapies to block the CD47 checkpoint mechanism, today announced
new results from ASPEN-01, the ALX148 Phase 1b study, evaluating
patients with solid tumor malignancies at the Society for
Immunotherapy of Cancer’s 35th Anniversary Annual Meeting [abstract
404].
ALX Oncology reports new preliminary data from the
gastric/gastroesophageal junction cancer (“GC”) patient cohort
receiving ALX148 plus trastuzumab plus chemotherapy, and from the
head and neck squamous cell carcinoma (“HNSCC”) patient cohort
receiving ALX148 plus pembrolizumab plus chemotherapy. In addition,
updated data are presented from the GC patient cohort receiving
ALX148 plus trastuzumab, and from the HNSCC patient cohort
receiving ALX148 plus pembrolizumab. All data reflect response
evaluable patients as of October 1, 2020.
- In patients with >2L HER2 positive GC (n=14), whose tumors
have progressed upon prior trastuzumab therapy, ALX148 demonstrates
a promising initial objective response rate (ORR) of 64% in
combination with trastuzumab plus ramucirumab and paclitaxel that
compares favorably with historical data.
- In initial patients with 1L HNSCC who have not received prior
treatment for their advanced disease (n=4), ALX148 demonstrates a
promising initial ORR of 75%, including a complete response, in
combination with pembrolizumab plus 5-fluorouracil and
platinum.
- Updated data from patients with >2L HER2 positive GC
receiving ALX148 plus trastuzumab suggests promising clinical
activity after their tumors have progressed upon prior trastuzumab
therapy.
- Updated data from patients who have never been treated with a
PD-1/PD-L1 inhibitor for their >2L HNSCC and who received ALX148
plus pembrolizumab suggests clinical activity beyond that expected
from pembrolizumab monotherapy.
- Preliminary data suggests that ALX148 can be safely combined
with multi-agent chemotherapy regimens studied with no maximum
tolerated dose reached. The maximum administered dose of ALX148 in
combination was 15 mg/kg once per week.
“This remarkable emerging data suggest that ALX148 in
combination with the standard chemotherapy based regimens studied
may induce meaningful clinical benefit in patients with advanced
HER2 positive gastric as well as head and neck cancers,” said Dr
Keun-Wook Lee, Professor of Internal Medicine at Seoul National
University College of Medicine, and Chief of The Clinical Trials
Center at Seoul National University Bundang Hospital, South
Korea.
“To our knowledge, these data are the first to support this
degree of clinical activity in patients with solid tumors by a CD47
targeted agent,” said Dr. Sophia Randolph, M.D., Ph.D., Chief
Medical Officer, ALX Oncology. “Importantly, these results and
ALX148’s favorable tolerability profile further differentiate it
from other CD47 targeted approaches, and we look forward to
continuing its clinical development in our robust phase 2
program.”
Conference Call on November
16th at 5:00pm
EST
ALX Oncology will host a conference call on
Monday, November 16, 2020 at 5:00 p.m. EST to further discuss the
new GC data from ASPEN-01, the Phase 1b study of ALX148 that was
presented at the SITC 35th Anniversary Annual Meeting. In addition
to ALX Oncology’s executive management team, Dr. Yung-Jue Bang,
Professor Emeritus and former Director of Cancer Research
Institute, Seoul National University College of Medicine and
Hospital, South Korea, will be featured on the call to discuss the
latest ALX148 clinical data in patients with GC.
To access the conference call, please dial (844) 467-7655
(local) or (409) 983-9840 (international) at least 10 minutes prior
to the start time and refer to conference ID 4766826. Presentation
slides will be available to download under “News & Events” (see
“Events”) in the Investors section of the ALX Oncology website at
www.alxoncology.com.
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, 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 and myelodysplastic syndromes. For more information,
please visit ALX Oncology’s website
at www.alxoncology.com.
Cautionary Note Regarding Forward-Looking
Statements
This 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 August 27, 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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