Pipeline

Our initial programs with evorpacept (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 (Study Name)
Discovery
IND Enabling
Phase 1
Phase 2
Phase 3
Fast Track
Collaboration Partner
Evorpacept Combination Studies
SOLID TUMORS
Indication: HNSCC (Head and Neck Squamous Cell Carcinoma)

HNSCC

Head and Neck Squamous Cell Carcinoma

Combination Agent (Study Name): Keytruda (ASPEN-03)
Keytruda (ASPEN-03)
Discovery
IND Enabling
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 (Study Name): Keytruda + 5FU + Platinum (ASPEN-04)
Keytruda + 5FU + Platinum (ASPEN-04)
Discovery
IND Enabling
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 (Study Name): Herceptin (ASPEN-01)
Herceptin (ASPEN-01)
Discovery
IND Enabling
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 (Study Name): Herceptin + Cyramza + Paclitaxel (ASPEN-06)
Herceptin + Cyramza + Paclitaxel (ASPEN-06)
Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: Urothelial Cancer

Urothelial Cancer

Combination Agent (Study Name): Padcev (ASPEN-07)
Padcev (ASPEN-07)
Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: Breast Cancer

Breast Cancer

Combination Agent (Study Name): Zanidatamab
Zanidatamab
Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
SOLID TUMORS
Indication: Breast Cancer

Breast Cancer

Combination Agent (Study Name): Enhertu (I-SPY)
Enhertu (I-SPY)
Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
HEMATOLOGY
Indication: MDS (Myelodysplastic Syndromes)

MDS

Myelodysplastic Syndromes

Combination Agent (Study Name): Azacitidine (ASPEN-02)
Azacitidine (ASPEN-02)
Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
HEMATOLOGY
Indication: AML (Acute Myeloid Leukemia)

AML

Acute Myeloid Leukemia

Combination Agent (Study Name): Azacitidine + Venetoclax (ASPEN-05)
Azacitidine + Venetoclax (ASPEN-05)
Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
HEMATOLOGY
Indication: NHL (Non-Hodgkin's Lymphoma)

NHL

Non-Hodgkin's Lymphoma

Combination Agent (Study Name): Rituximab (ASPEN-01)
Rituximab (ASPEN-01)
Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner
ALTA-
002*
Indication: Advanced Cancer

Advanced Cancer

Discovery
IND Enabling
Ph 1
Ph 2
Ph 3
Fast Track
Collaboration Partner

*SIRPα Toll-like receptor agonist antibody conjugate (TRAAC)

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 evorpacept 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 evorpacept 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