APL-501 (PD-1)

APL-501: Anti Programmed Death-1

APL-501 is a novel IgG4 humanized monoclonal antibody against the Programmed Death-1 (PD-1) membrane receptor on immune cells. APL-501 specifically binds to PD-1 expressed on the surface of T-cells. It prevents T-cells from binding to PD-L1 present on the surface of tumor cells, thereby allowing T-cells to cause tumor cell death. Preclinical studies have demonstrated that APL-501 has anti-tumor activity comparable to a marketed anti-PD-1 antibody, and a good safety profile with very low antibody-dependent cell mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

The PD-(L)1 checkpoint inhibitors, a kind of immune-oncology drug, act through interfering with the PD-(L)1 pathway, which prevents T-cells from attacking tumor cells within the tumor microenvironment. In the cancer disease state, the use of an inhibitor that blocks the interaction between PD-L1 and the PD-1 receptor can prevent certain tumor cells from evading the immune system. PD-(L)1 inhibitors are increasingly used for the treatment of many cancers, and have been proven to have a better efficacy profile and fewer side effects in a number of cancer indications compared to traditional cancer treatments, such as chemotherapy.

PD-(L)1 inhibitors are remarkable for their tolerability and their clinical activity in shrinking tumors across a wide range of tumor types, causing durable responses. These attributes position them as favorable agents in combination therapies.

Anti-tumor activity has been demonstrated in clinical trials of APL-501 run by our China partner, Genor, in patients with r/r peripheral T-cell lymphoma or relapsed/metastatic/unresectable alveolar soft part sarcoma by our partner. In general, these studies showed that APL-501 demonstrates anti-tumor activities across multiple tumor types and has a favorable safety profile. 

Apollomics retains worldwide rights to APL-501 outside mainland China.

Competitive Advantages

  • Preclinical anti-tumor activity comparable to marketed anti-PD-1 antibody

  • Good preclinical safety profile with very low antibody-dependent cell mediated cytotoxicity

  • Bind selectively to human PD-1 with no binding to other members of the CD28 family

  • Favorable preclinical tumor inhibit rate over an equal dose of a marketed product

Clinical Trials

APL-501 is currently being evaluated in several ongoing clinical trials. For additional information, please click on the trial links below.

Trial Details
Trial Name: APOLLO
Agents: APL-101 (c-Met inhibitor) + APL-501 (anti-PD-1)
Indication: Hepatocellular Carcinoma
Trial: NCT03655613
Trial Details
Type: Single Agent
Indication: Solid Tumors
Trial: NCT03053466

China Partner & Clinical Trials:

Genor BioPharma Co. Ltd. has development rights in China for APL-501 where it is referred to as GB226.

Trial Details
Type: Single Agent
Indication: Peripheral T Cell Lymphoma
Trial: NCT03502629

Type:               Single Agent
Indication:       B-cell Non-Hodgkin’s Lymphoma
Trial:               NCT03639181

Trial Details
Type: Single Agent
Indication: Alveolar Soft Part Sarcoma
Trial: NCT03623581
Trial Details
Type: Single Agent
Indication: Cervical Cancer
Trial: NCT03808857
Trial Details
Type: Combination + fruquintinib
Indication: Non-Small Cell Lung Cancer
Trial: NCT03976856
Trial Details
Type: Single Agent
Indication: Solid Tumors, Lymphoma
Trial: NCT03374007
Trial Details
Type: Combination + fruquintinib
Indication: Colorectal Cancer
Trial: NCT03977090

Posters & Publications

Posters and Publications on our assets can be found here.