ALX Oncology to Present New Evorpacept Clinical Data in Myelodysplastic Syndromes at 63rd ASH Annual Meeting
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced the presentation of early clinical data from its Phase 1/2 ASPEN-02 study at the upcoming ASH Annual Meeting on December 12, 2021. The study evaluates evorpacept combined with azacitidine for treating myelodysplastic syndromes (MDS). As of July 15, 2021, 13 subjects were enrolled, with promising responses observed, including complete and marrow complete responses in patients with TP53 mutations. No dose-limiting toxicities were noted, indicating a favorable safety profile. Further results will be disclosed at the conference.
- Evorpacept showed promising responses in patients with MDS, including complete and marrow complete responses.
- No dose-limiting toxicities were observed in any cohort, indicating a favorable safety profile.
- None.
SOUTH SAN FRANCISCO, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- 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 Company will be presenting early clinical data from ASPEN-02, its ongoing Phase 1/2 study evaluating evorpacept in combination with azacitidine for the treatment of myelodysplastic syndromes (“MDS”) in a poster presentation at the 63rd American Society of Hematology (“ASH”) Annual Meeting held December 11-14, 2021 in Atlanta, Georgia.
Key Abstract Data
As of July 15, 2021, 13 subjects with newly diagnosed (“ND”) higher risk or relapsed/refractory (“R/R”) MDS were enrolled into phase 1 cohorts receiving escalating doses of evorpacept (20 mg/kg Q2W, 30 mg/kg Q2W, and 60 mg/kg Q4W) combined with standard doses of azacitidine. Of the 7 ND subjects, 4 had therapy-related MDS, and 5 had TP53 mutation with complex cytogenetics. Of the 6 R/R subjects, all had received at least one hypomethylating agent-based regimen.
Among the 5 ND subjects evaluable for response (all with TP53 mutation), there were 2 subjects with cytogenetic response who met criteria for complete response (“CR”) subsequent to the date of this abstract, 1 subject with a best response of marrow complete response (“mCR”) with hematologic improvement (“HI”), and 1 subject each with stable disease (“SD”) and progressive disease (“PD”). Of the 4 ND subjects who were transfusion dependent at baseline, 2 achieved transfusion independence. Among the 5 R/R subjects evaluable for response, there were 2 subjects with a best response of mCR, 2 with SD, and 1 with PD. No dose-limiting toxicities were observed in any cohort and no maximum tolerated dose was reached. Additional results will be presented at the conference.
Poster Presentation Details
Title: Evorpacept (ALX148), a CD47-Blocking Myeloid Checkpoint Inhibitor, in Combination with Azacitidine: A Phase 1/2 Study in Patients with Myelodysplastic Syndrome (ASPEN-02)
Session Name: 637. Myelodysplastic Syndromes – Clinical and Epidemiological: Poster II
Presentation Date and Location: December 12, 2021, 6:00pm – 8:00pm ET, Georgia World Congress Center, Hall B5
Publication Number: 2601
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, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept 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 evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. 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 and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology 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.
FAQ
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