ALX Oncology Announces Initial Data from ASPEN-05 Study of Evorpacept in Combination with Azacitidine and Venetoclax, Demonstrating Tolerability and Preliminary Activity in Patients with Acute Myeloid Leukemia

— Antileukemic activity demonstrated in patients with both relapsed/refractory and newly diagnosed AML

— No evorpacept-related cytopenias observed and no maximum tolerated dose identified in combination with azacitidine and venetoclax

— ALX Oncology to Host Conference Call on December 13^th at 7:30 a.m. EST

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Dec. 12, 2022 (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 presentation of clinical data from the Phase 1a dose escalation part of the ASPEN-05 trial evaluating evorpacept in combination with azacitidine and venetoclax for the treatment of patients with relapsed or refractory (“r/r”) or newly diagnosed (“ND”) acute myeloid leukemia (“AML”). The new results, shared in a poster at the 64^th American Society of Hematology (“ASH”) Annual Meeting [Abstract #4076], show that the combination of evorpacept with azacitidine and venetoclax is active and generally well tolerated. As of October 3, 2022, 14 patients with either r/r or ND AML have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks (“Q2W”) or 60 mg/kg once every 4 weeks (“Q4W”) together with standard dosing of azacitidine and venetoclax.

• Evorpacept in combination with azacitidine and venetoclax was generally well tolerated (N=14) with no maximum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W.
  
• In 10 relapsed or refractory AML response-evaluable patients, including 8 that had progressed after prior venetoclax treatment, all experienced a reduction in bone marrow blasts, and 4 achieved a response.
  
• In 3 newly diagnosed AML response-evaluable patients, all 3 achieved a response, including 1 complete response (“CR”), 1 CR with incomplete hematologic recovery (“CRi”), and 1 morphologic leukemia free state (“MLFS”).

“It is extremely encouraging to observe evorpacept’s preliminary clinical activity in a population of difficult to treat AML patients with primarily relapsed or refractory disease after prior venetoclax therapy, as well as TP53 mutation and adverse risk genetics,” said Harry Erba M.D., Director of the Leukemia Program in the Division of Hematologic Malignancies and Cellular Therapy at Duke University, Durham, NC. “Additionally, evorpacept’s favorable initial tolerability profile in combination with azacitidine and venetoclax suggests it may be safely added to this AML backbone therapy without worsening cytopenias, which is particularly important for this patient population.”

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