ANYARA is a tumor targeting immunotherapy that enhances the ability of the immune system to recognize and kill the tumor. Since October 2016, Active Biotech has a licensing agreement with NeoTX Therapeutics Ltd. for the worldwide development and commercialization of ANYARA for cancer therapy.
Mode of Action and Therapy Concept
ANYARA, a Tumor Targeting Superantigen (TTS), is a fusion protein containing the Fab-fragment of an antibody that targets the tumor-associated 5T4 antigen, expressed in a high number of solid tumors. The antibody part is fused with an engineered bacterial superantigen that activates T cells, expressing a particular set of T cell receptors.
ANYARA activates T lymphocytes and targets them to the 5T4-expressing tumors, resulting in massive effector lymphocyte infiltration into the tumor and tumor cell killing.
ANYARA enhances tumor recognition
Immune checkpoint inhibitors are drugs that unleash an immune system attack against tumor cells. Despite recent success with such drugs, the immune system’s ability to recognize the tumor is still a key challenge. Emerging clinical data highlight the need to improve recognition of the tumor to optimize the benefit of checkpoint inhibition, e.g. PD-1 therapy. ANYARA enhances the ability of the immune system to recognize the tumor and data from experimental tumor models show synergistic activity on tumor growth when combining ANYARA with a PD-1 inhibitor.
Clinically, the previous development of ANYARA has mainly focused on cancer forms with a high medical need. Phase 1 studies have been performed in patients with advanced non-small cell lung cancer, renal cell carcinoma and pancreatic cancer. Based on the phase 1 results, a phase 2/3 trial in combination with interferon alpha in patients with renal cell carcinoma was performed. The study demonstrated a favorable safety profile, but did not achieve its primary endpoint of showing a prolonged overall survival in the patient population.
Currently, preparations are ongoing for a clinical trial with ANYARA in combination with a PD-1 inhibitor in patients with various solid cancer forms, which are refractory or marginally responsive to anti-PD-1 therapies, with the trial to start second half of 2018.