On December 12, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, reported 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") (Press release, ALX Oncology, DEC 12, 2022, View Source [SID1234625079]). The new results, shared in a poster at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) ("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.

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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."

"The initial data from this early part of the ASPEN-05 study support the tolerability and activity of evorpacept in patients with AML, and provide further validation for adding our CD47 myeloid checkpoint blocker to established backbone regimens in patients with cancer," said Sophia Randolph M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are pleased to see this initial data as part of our ongoing studies of evorpacept in both solid tumor indications and hematologic malignancies, which support the emerging role of CD47-blockade in enhancing the innate immune anti-cancer response."

Conference Call on December 13th at 7:30 a.m. EST

ALX Oncology will host a conference call on Tuesday, December 13, 2022 at 7:30 a.m. EST to further discuss the initial AML data from ASPEN-05. In addition to ALX Oncology’s executive management team, Harry Erba M.D., Director of the Leukemia Program in the Division of Hematologic Malignancies and Cellular Therapy at Duke University, Durham, NC will be featured on the call to discuss the results.

To access the conference call, please dial (800) 715-9871 (U.S./Canada) or (646) 307-1963 (international) at least 10 minutes prior to the start time and refer to conference ID 1300143. 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.