evorpacept (ALX148) / ALX Oncology - LARVOL DELTA

Neoadjuvant SBRT followed by evorpacept and pembrolizumab in HPV-mediated head and neck squamous cell carcinoma: Investigation of pathologic response. (ASCO 2025) - P2 | "This trial of neoadjuvant SBRT followed by evorpacept and pembrolizumab in HPV+ HNSCC has fulfilled an interim futility analysis with pCR in all patients, and an acceptable rate of reversible grade III or greater toxicity related to systemic immunotherapy. Further enrollment will proceed to define primary pCR endpoints and secondary functional and oncologic endpoints."

Clinical • Head and Neck Cancer • Hepatology • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

ALX Oncology Highlights Differentiated Design, Preclinical Data and Development Plans for EGFR-Targeted ADC, ALX2004, in R&D Webcast Event (GlobeNewswire) - "A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window by reducing toxicity; Following recent IND clearance from U.S. FDA, ALX2004 will enter clinical studies mid-year 2025 with initial safety data anticipated in 1H 2026; Trials evaluating the Company’s lead investigational therapy, CD47-blocker evorpacept, in breast and colorectal cancers planned to initiate in mid-2025 with multiple key inflection points from evorpacept and ALX2004 development programs anticipated in 2026"

New P1 trial • P1 data • Breast Cancer • Colorectal Cancer • Solid Tumor

A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07) (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: ALX Oncology Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

THE BCMA NK CELL ENGAGER SAR'514 INDUCES MACROPHAGE-MEDIATED PHAGOCYTOSIS WHICH IS IMPROVED BY COMBINATION WITH EVORPACEPT, A CD47 BLOCKER, IN MULTIPLE MYELOMA (EHA 2025) - P1/2 | "In summary, these results demonstrate the potential of the combination of SAR'514 and evorpacept in improving SAR'514-mediated phagocytosis and provide support for exploring SAR'514 in combination with CD47 blockade in treatment of patients with MM."

Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • CD47 • FCGR3A • SIRPA

ALX Oncology Reports First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Clinical Milestones: Breast Cancer: Patient dosing anticipated to initiate for ASPEN-BREAST Phase 2 clinical trial in mid-year 2025. Interim results from this trial are anticipated in 2H 2026; Colorectal Cancer: Patient dosing anticipated to initiate for ASPEN-CRC Phase 1b clinical trial in mid-year 2025. Safety and early efficacy data are anticipated in 1H 2026."

P1 data • P2 data • Trial status • Breast Cancer • Colorectal Cancer

A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02) (clinicaltrials.gov) - P1/2 | N=65 | Active, not recruiting | Sponsor: ALX Oncology Inc. | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2023 ➔ Jan 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

ZWI-ZW25-204: A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Jazz Pharmaceuticals | Trial primary completion date: Apr 2025 ➔ Sep 2025

Trial primary completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • HER2 Breast Cancer • Oncology

ALX Oncology Reports First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "ALX2004: Patient dosing anticipated to initiate in mid-2025, following IND clearance from the FDA in April 2025. Safety data are anticipated in 1H 2026; Breast Cancer: Topline results from Phase 1b I-SPY clinical trial of evorpacept with ENHERTU® are anticipated in 2H 2025."

P1 data • Trial status • Breast Cancer • Oncology

Final results of a phase I trial of evorpacept (ALX148), lenalidomide, and rituximab for patients with B-cell non-Hodgkin lymphoma (AACR 2025) - P1/2 | "The combination of evorpacept and R2 has a safe toxicity profile, promising anti-tumoral activity (historical CR rate 30%), and induces favorable biological effects on multiple components of the tumoral immune microenvironment. A phase 2 study investigating its efficacy in pts with previously untreated and high tumor burden iNHL has completed enrollment."

Clinical • Late-breaking abstract • P1 data • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • SIRPA

ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=47 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Richter's Syndrome

ALX Oncology Announces Encouraging Final Results from Phase 1 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with B-cell Non-Hodgkin Lymphoma (GlobeNewswire) - P1/2 | N=47 | NCT05025800 | "Final results from the Phase 1 portion of the trial will be presented Tuesday, April 29, during a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago...After a median follow-up of 28 months (95% CI, 18-28 months) the two-year progression-free survival (PFS) rate was 69% and two-year overall survival (OS) rate was 84%. Sixteen patients (80%) achieved complete responses and the best overall response rate (ORR) was 90%. As previously reported at the AACR 2024 Annual Meeting, the CR rate among the 18 patients with iNHL was 83%. This complete response rate achieved by evorpacept + R2 in this trial compares favorably to the 34% historical CR rate for R2 alone. During treatment, a significant increase in T cells and anti-tumoral macrophages was observed....The Phase 2 portion of this IST in patients with previously untreated iNHL is ongoing and has completed enrollment."

P1 data • Trial status • Indolent Lymphoma • Non-Hodgkin’s Lymphoma

ALX Oncology Reports ASPEN-03 and ASPEN-04 Phase 2 Trials Evaluating Evorpacept with a Checkpoint Inhibitor for the Treatment of Head and Neck Cancers Did Not Meet Primary Endpoints (GlobeNewswire) - P2 | N=189 | ASPEN-03 (NCT04675294) | P2 | N=172 | ASPEN-04 (NCT04675333) | Sponsor: ALX Oncology Inc. | "The company’s investigational CD47-blocker evorpacept, when added to Merck’s...KEYTRUDA (pembrolizumab) with or without chemotherapy, did not meet the primary endpoints in the ASPEN-03 and ASPEN-04 trials of improved objective response rates (ORR) as compared to historical controls of pembrolizumab alone and pembrolizumab with chemotherapy, respectively, as a first-line treatment in patients with advanced head and neck squamous cell carcinoma...The combination of evorpacept and pembrolizumab with or without chemotherapy in ASPEN-03 and ASPEN-04 demonstrated a manageable safety profile....multiple clinical trials of evorpacept in combination with anti-cancer antibodies will continue based on established proof-of-concept....Detailed findings from the ASPEN-03 and ASPEN-04 trials will be submitted to a future medical meeting."

P2 data • Squamous Cell Carcinoma of Head and Neck

Evorpacept plus rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma: results from the phase I ASPEN-01 study. (PubMed, Haematologica) - P1 | "In response-evaluable patients (n=32), objective response rate was 50.0% (95% confidence interval 33.1%- 69.8%). The safety, tolerability, and promising antitumor activity of evorpacept plus rituximab support continued evaluation of this combination in NHL (ClinicalTrials.gov identifier: NCT03013218)."

IO biomarker • Journal • P1 data • B Cell Non-Hodgkin Lymphoma • Cardiovascular • Congestive Heart Failure • Fatigue • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • CD47 • SIRPA

PRE-I-SPY-PI: PRE-I-SPY Phase I/Ib Oncology Platform Program (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: QuantumLeap Healthcare Collaborative | N=54 ➔ 124 | Trial completion date: Dec 2027 ➔ Dec 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2028

Biomarker • Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

KEYNOTE-B88: Evorpacept (ALX148) in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) (clinicaltrials.gov) - P2 | N=172 | Active, not recruiting | Sponsor: ALX Oncology Inc. | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

KEYNOTE-B87: Evorpacept (ALX148) in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) (clinicaltrials.gov) - P2 | N=189 | Active, not recruiting | Sponsor: ALX Oncology Inc. | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event (GlobeNewswire) - "Event to include updates on ongoing evorpacept clinical development program and introduction of clinical trials in breast and colorectal cancers. Advancing novel EGFR-targeted antibody-drug conjugate (ADC) candidate, ALX2004, into clinical-stage development with IND submission planned for Q1 2025....We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data."

IND • Pipeline update • Breast Cancer • Colorectal Cancer

ALX Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Clinical Milestones:...(i) Breast Cancer: Patient dosing anticipated to initiate for ASPEN-BREAST Phase 2 clinical trial in mid-year 2025; (ii) Colorectal Cancer (CRC): Patient dosing anticipated to initiate for ASPEN-CRC Phase 1b clinical trial in mid-year 2025; (iii) New ADC Clinical Candidate: Novel EGFR-directed ADC, ALX2004, planned IND submission in March 2025."

IND • New trial • Breast Cancer • Colorectal Cancer

ALX Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Clinical Milestones: (i) Head and Neck Squamous Cell Carcinoma: Topline results from Phase 2 ASPEN-03 randomized clinical trial of evorpacept with KEYTRUDA (pembrolizumab) anticipated in Q2 2025; (ii) Head and Neck Squamous Cell Carcinoma: Topline results from Phase 2 ASPEN-04 randomized clinical trial of evorpacept with KEYTRUDA and chemotherapy anticipated in Q2 2025; (iii) Urothelial Cancer: Updated results from Phase 1 ASPEN-07 clinical trial of evorpacept in combination with PADCEV (enfortumab vedotin) anticipated in Q2 2025; (iv) Gastric/GEJ Cancer: Regulatory guidance on the gastric cancer registrational path to be provided in Q2 2025; (v) Breast Cancer: Topline results from Phase 1b I-SPY clinical trial of evorpacept with ENHERTU (fam-trastuzumab deruxtecan-nxki) anticipated in 2H 2025."

P1 data • P2 data • Regulatory • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

ALX Oncology to Host Virtual R&D Day on March 5, 2025 (GlobeNewswire) - "ALX Oncology Holdings Inc...announced that it will host a virtual Research and Development (R&D) Day webcast on Wednesday, March 5, 2025, at 6:00 a.m. PT/9:00 a.m. ET. The virtual webcast event will focus on information and updates related to the company’s pipeline, lead investigational CD47-blocker evorpacept, as well as business and financial updates."

Pipeline update • Hematological Malignancies • Solid Tumor

Final analysis of the randomized phase 2 part of the ASPEN-06 study: A phase 2/3 study of evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with HER2-overexpressing gastric/gastroesophageal cancer (GC). (ASCO-GI 2025) - P2/3 | " The ASPEN-06 randomized phase 2 trial evaluates Evo in combination with standard trastuzumab (T), ramucirumab (R) and paclitaxel (P) for the treatment of patients with HER2+ GC. The addition of Evo to TRP showed promising activities in HER2+ GC. The magnitude of response was greatest in tumors identified as HER2+ using fresh biopsies emphasizing the importance of biopsies post anti HER2 therapy. Consistent with Evo's mechanism of enhancing antibody dependent phagocytosis, these data support its ongoing investigation as an adjunct to anti-HER2 gastric cancer therapy."

Checkpoint inhibition • Clinical • P2/3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

ALX Oncology Presents Positive Updated Data from ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Generates Strong Response and Durable Clinical Benefit in Patients with HER2-Positive Gastric Cancer (GlobeNewswire) - P2/3 | N=450 | ASPEN-06 (NCT05002127) | Sponsor: ALX Oncology Inc. | "Oral presentation at 2025 ASCO Gastrointestinal Cancers Symposium today highlights evorpacept as the first CD47 blocker to show substantial tumor response and a well-tolerated safety profile in a prospective randomized trial. Greatest benefit observed among patients with confirmed HER2-positive cancer, as demonstrated by either fresh biopsy or ctDNA HER2-expression, with confirmed ORR of 48.9% and mDOR of 15.7 months vs. 24.5% ORR and mDOR of 9.1 months in the control group, and a PFS Hazard Ratio of 0.64....Evorpacept plus TRP was generally well tolerated, with the incidence of adverse events in the evorpacept population consistent with those in TRP control."

P2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: University of Colorado, Denver | N=80 ➔ 48 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment change • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

ALX Oncology to Host Virtual Company Event Highlighting Updated Data from ASPEN-06 Phase 2 Trial Presented at 2025 ASCO GI (GlobeNewswire) - "ALX Oncology Holdings...announced that the company will host a virtual event on Thursday, January 23, at 1:00 p.m. PT/4:00 p.m. ET to discuss updated data from the ASPEN-06 Phase 2 clinical trial evaluating the company’s investigational CD47-blocker evorpacept in patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The ASPEN-06 data will be featured in an oral presentation (Abstract #332) at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) earlier the same day."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Zanidatamab in combination with evorpacept in HER2-positive and HER2-low metastatic breast cancer: Results from a phase 1b/2 study. (SABCS 2024) - P1/2 | "Background: Patients (pts) with HER2-expressing breast cancer (BC) are in need of novel therapies, including chemotherapy-free treatments and more options post-progression on available therapies, such as trastuzumab deruxtecan (T-DXd). Zani + evo showed a manageable safety profile and promising antitumor activity, particularly in pts with heavily pretreated HER2+ mBC, including prior exposure to T-DXd. Further development of this novel chemotherapy-free regimen is warranted."

Combination therapy • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2