Aptevo Therapeutics Inc (Aptevo) is advancing novel immunotherapy candidates for cancer treatment. The company has established two platform technologies Adaptir and Adaptir-Flex, that enable the rational design of precision immune-modulatory drugs. Its Adaptir and Adaptir-Flex platforms enable the creation of monospecific, bispecific, and multi-specific immunotherapeutic proteins. These candidates target tumor and immune cells to enhance, suppress, or regulate immune responses, primarily focusing on oncology and exploring inflammatory disease indications. The company is currently advancing two clinical candidates: Mipletamig (APVO436) and ALG.APV-527, along with three preclinical candidates: APVO603, APVO442 and APVO711. Mipletamig (APVO436) is a CD3xCD123 T-cell engager. It is undergoing clinical evaluation for acute myelogenous leukemia (AML). This bispecific Adaptir molecule is engineered to redirect T-cells to target and destroy leukemia cells expressing the CD123 molecule. The company’s product portfolio includes clinical candidates such as mipletamig, a CD3xCD123 T cell engager being evaluated for the treatment of acute myelogenous leukemia (AML), and ALG.APV-527, which targets 4-1BB and 5T4 for the treatment of multiple solid tumor types. A comprehensive Phase 1b dose expansion trial has been completed, evaluating APVO436 as a monotherapy and in combination with standard-of-care treatments. ALG.APV-527 is designed to simultaneously target the co-stimulatory receptor 4-1BB (CD137) and the tumor antigen 5T4. This bispecific Adaptir candidate, developed in collaboration with Alligator Bioscience AB, has the potential to enhance the immune response against a variety of cancers, including malignant pleural mesothelioma, non-small cell lung cancer, and several other solid tumors that overexpress the 5T4 antigen. APVO603 is a dual agonist bispecific Adaptir that targets 4-1BB and OX40 (CD134). This candidate aims to synergistically co-stimulate T cells, potentially amplifying their cytotoxic functions and enhancing anti-tumor responses. APVO603's mechanism is designed to address the challenges posed by immunosuppressive tumor microenvironments, making it suitable for a range of solid tumors without dependence on a single tumor antigen. APVO442 leverages the Adaptir-Flex platform. It binds to PSMA with two identical binding domains while also binding to CD3 with a reduced affinity. This design is intended to enhance drug distribution to PSMA-positive tumors, specifically targeting prostate cancer, while minimizing interactions with circulating T cells. Preclinical studies indicate promising results in directing immune responses against PSMA-bearing tumor cells. APVO711 is designed to simultaneously stimulate CD40 on antigen-presenting cells and inhibit the PD-1/PD-L1 pathway. This dual mechanism has the potential to foster an anti-tumor response.

Aptevo Inc is focused on developing novel immunotherapy candidates for the treatment of different forms of cancer. Aptevo’s lead product candidate, Mipletamig, targets both CD123 and CD3 for treating acute myeloid leukemia (AML), with plans for Phase 2 trials in frontline and relapsed/refractory patients. The company has developed two versatile and enabling platform technologies, ADAPTIR and ADAPTIR-FLEX, for the rational design of precision immune modulatory drugs. These platforms are designed to generate monospecific, bispecific, and multispecific antibody candidates capable of enhancing the human immune system against cancer cells. The company is advancing clinical candidates such as mipletamig, a CD3xCD123 T cell engager for acute myelogenous leukemia (AML), and ALG.APV-527, targeting 4-1BB and 5T4 for multiple solid tumor types. APVO603 is being developed as a bispecific candidate for multiple solid tumor types, while APVO442 is a multi-specific candidate targeting prostate cancer. APVO711 represents a dual mechanism bispecific designed to potentially serve as a novel checkpoint molecule, highlighting Aptevo’s commitment to innovative cancer therapies. In FY2024, the company invested US$14.3 million in its research and development activities, which declined 15.9% YoY.