Pipeline

Our initial programs with ALX148 are focused on targeting CD47 across various oncology indications. Many forms of cancer use CD47 expression as a means of evading immune response. We are targeting the hematologic malignancies and solid tumor indications where we believe we have the greatest potential to address large unmet medical needs.

Indication
Combination Agent
IND Filing Preparation
IND Submitted
Phase 1
Phase 2
Phase 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: HNSCC (Head and Neck Squamous Cell Carcinoma)

HNSCC

Head and Neck Squamous Cell Carcinoma

Combination Agent: Keytruda
Keytruda
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: HNSCC (Head and Neck Squamous Cell Carcinoma)

HNSCC

Head and Neck Squamous Cell Carcinoma

Combination Agent: Keytruda + 5FU + Platinum
Keytruda + 5FU + Platinum
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: GC (Gastric/Gastroesophageal Junction Cancer)

GC

Gastric/Gastroesophageal Junction Cancer

Combination Agent: Herceptin
Herceptin
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: GC (Gastric/Gastroesophageal Junction Cancer)

GC

Gastric/Gastroesophageal Junction Cancer

Combination Agent: Herceptin + Cyramza + Paclitaxel
Herceptin + Cyramza + Paclitaxel
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: Breast Cancer ()

Breast Cancer

Combination Agent: Zanidatamab
Zanidatamab
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
HEMATOLOGY
Indication: MDS (Myelodysplastic Syndromes)

MDS

Myelodysplastic Syndromes

Combination Agent: Azacitidine
Azacitidine
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
HEMATOLOGY
Indication: AML (Acute Myeloid Leukemia)

AML

Acute Myeloid Leukemia

Combination Agent: Azacitidine + Venetoclax
Azacitidine + Venetoclax
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
HEMATOLOGY
Indication: NHL (Non-Hodgkin's Lymphoma)

NHL

Non-Hodgkin's Lymphoma

Combination Agent: Rituximab
Rituximab
IND Filing Preparation
IND Submitted
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner

Clinical Trials

We plan to advance ALX148 for the treatment of MDS, a hematologic malignancy affecting over 70,000 people in the United States.

We also plan to develop ALX148 for the treatment of AML, a hematologic malignancy affecting over 40,000 people in the United States with nearly 20,000 newly diagnosed patients and over 11,000 deaths annually from the disease. Over half of patients are diagnosed at age 65 or older.

ALX148 has generated promising clinical data in solid tumors in combinations with a leading tumor antigen targeting antibody, a leading checkpoint inhibitor and chemotherapy.

We are investigating ALX148 for the first-line treatment of head and neck squamous cell carcinoma, or HNSCC. In the United States there are over 38,000 people living with metastatic HNSCC.

We are also investigating ALX148 for the second-line treatment of HER2-positive gastric/gastroesophageal junction, or GEJ, carcinoma. In the United States there are over 25,000 people living with metastatic gastric/GEJ carcinoma.

Information on Our Current Trials

Publications

  • ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma View poster (EHA 2020)
  • A Phase 1 Study of ALX148, a CD47 Blocker, in Combination with Standard Anti Cancer Antibodies and Chemotherapy Regimens in Patients with Advanced Malignancy View poster (ASCO 2020)

ClinicalTrials.gov

Expanded Access Policy

ALX Oncology is a 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. The goal of our current clinical study program is to enroll patients and obtain clinical data on ALX148 that is required by the US Food and Drug Administration (FDA) and other regulatory authorities for review and approval of marketing applications for this investigational agent.

We believe that focusing on clinical studies is the most appropriate way to achieve this goal; therefore, we do not currently offer access to ALX148 outside of clinical studies and, at this time, we have no Expanded Access Program (sometimes referred to as “compassionate use” or “pre-approval access”).

If you have additional questions regarding this policy, please speak with your health care provider or contact: info@alxoncology.com