ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a
clinical-stage immuno-oncology company developing therapies to
block the CD47 checkpoint mechanism, today announced that ALX148
clinical results have been selected for presentation at the SITC
35th Anniversary Annual Meeting, November 9 –14, 2020.
The abstract for our presentation appeared briefly and in error
on the SITC website this morning, prior to its intended release on
November 9th 2020, and as a result the abstract is provided in full
below.
Poster
Presentation
Details
Title: ALX148, a CD47 blocker, in
combination with standard chemotherapy and antibody regimens in
patients with gastric/gastroesophageal junction (GC) cancer and
head and neck squamous cell carcinoma (HNSCC) (Abstract 404)
Presentation Time: November 11
– 14, 2020, 9:00am – 5:00pm ET
Location: Virtual Poster
Hall
Abstract authors: Keun-Wook
Lee,1 Hyun Cheol Chung,2 Won Seog Kim,3 Laura QM Chow,4* Nehal
Lakhani,5 Wells Messersmith,6 Yung-Jue Bang,7 Patricia LoRusso,8
Philip Fanning,9 Pierre Squifflet,10 Feng Jin,9 Allison Forgie,9
Hong Wan,9 Jaume Pons,9 Sophia Randolph,9 Justin Gainor,11
1Seoul National University Bundang Hospital, Seoul National
University College of Medicine, Seongnam, Korea; 2Yonsei Cancer
Center, Yonsei University College of Medicine, Seoul, Korea;
3Sungkyunkwan University School of Medicine, Samsung Medical
Center, Seoul, Korea; 4University of Washington, Seattle, WA;
5START Midwest, Grand Rapids, MI; 6University of Colorado Cancer
Center, Aurora, CO; 7Seoul National University College of Medicine,
Seoul, Korea; 8Yale Cancer Center, New Haven, CT; 9ALX Oncology,
Burlingame, CA, USA, 10International Drug Development Institute,
Brussels, Belgium, 11Massachusetts General Hospital Cancer Center,
Boston, MA
Full Abstract
Background: CD47 is a myeloid checkpoint
up-regulated by tumors to evade the anticancer immune response.
ALX148 is a high affinity CD47-blocking fusion protein with an
inactive Fc region designed to safely enhance anticancer
therapeutics [1,2]. ALX148 in combination with standard
chemotherapy and antibody regimens was evaluated in patients (pts)
with advanced HER2-positive GC or HNSCC.
Methods: Pts with previously treated advanced
HER2-positive GC or untreated advanced HNSCC received ALX148 (A) 10
mg/kg QW or 15 mg/kg QW in combination with trastuzumab (T) +
ramucirumab (ram) + paclitaxel (pac) as 2nd or later-line treatment
or pembrolizumab (P) + 5FU + platinum (cisplatin or carboplatin) as
1st line therapy, respectively. The primary endpoint was dose
limiting toxicity (DLT). Tumor response, pharmacokinetic (PK), and
pharmacodynamic (PD) markers were assessed in all pts. Preliminary
data from enrolling cohorts, and follow-up data from pts with GC
administered A+T, and with HNSCC administered A+P are also reported
as of 30June2020.
Results: Fifty-five pts enrolled into this
portion of the study. Twelve patients with ≥2L GC received
A+T+ram+pac and were evaluated for safety. No DLTs, were reported,
and the ALX148 maximum administered dose was 15 mg/kg QW. Out of
the 9 pts who experienced any adverse event, 7 pts reported
treatment-related adverse events (TRAE). The most common TRAEs were
low grade diarrhea, fatigue, pruritus and rash (each n=2,17%). Nine
of the 12 patients were response-evaluable and reported a 66% ORR
with 6PR and 3SD (including one ongoing near PR, ↓29.6%). Three
patients with 1L HNSCC were administered A+P+5FU+platinum. No DLTs
were reported and accrual to 15 mg/kg QW continues. Three pts
experienced any AE, none were treatment-related. Of 3 evaluable
patients with HNSCC, 2PR and 1SD were reported. Initial ALX148
combination PK and CD47 target occupancy are similar to that of
single agent administration. Response duration and survival
follow-up of 19 pts with HER2-positive GC administered A+T (2nd or
later-line; 21% ORR) and of 10 pts with checkpoint inhibitor naïve
HNSCC administered A+P (2nd or later-line; 40% ORR) will be
reported. Results of all cohorts will be updated at time of
presentation.
Conclusions: Initial data suggests the myeloid
checkpoint inhibitor, ALX148, is well tolerated in combination with
the above anticancer antibodies, T-cell checkpoint inhibitor, and
cytotoxic chemotherapy regimens with early anticancer signals in GC
and HNSCC that compare favorably with historic controls. No MTD has
been reached in any combination to date and accrual to chemotherapy
combination regimens is ongoing. ClinicalTrials.gov identifier
NCT03013218.
References:
1. Kauder S, Kuo T, Harrabi O, Chen A, Sangalang E, et al.
ALX148 blocks CD47 and enhances innate and adaptive antitumor
immunity with a favorable safety profile. PLoS ONE. 2018;13(8).
2. Chow L, Gainor J, Lakhani N, et al. A phase I study of
ALX148, a CD47 blocker, in combination with standard anticancer
antibodies and chemotherapy regimens in patients with advanced
malignancy. Journal of Clinical Oncology 2020; 38:15_suppl,
3056-3056.
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. For more
information, please visit ALX Oncology’s website
at https://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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