The US Food and Drug Administration (FDA) has granted its fast track designation to Innovent Biologics' IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein to treat advanced unresectable locally advanced or metastatic melanoma.
The designation will expedite the clinical development and review process for IBI363, which is currently undergoing Phase I/II clinical trials in China, the US and Australia.
The product blocks the PD-1/PD-L1 pathway and activates the IL-2 pathway, targeting melanoma patients who have progressed after systemic therapy, including a PD-1/L1 inhibitor.
However, it is not aimed at treating choroidal melanoma.
Promising results from ongoing clinical studies have shown that of 37 melanoma patients who had previously received immunotherapy, 11 achieved objective responses after being treated with 1mg/kg of IBI363.
This includes one complete response and ten partial responses, with an objective response rate of 29.7% and a disease control rate (DCR) of 73%.
Fast track status is a process that facilitates the development of assets addressing serious conditions with unmet medical needs.
It allows for more frequent interactions with the FDA, which can lead to earlier approval for medicines.
Innovent Biologics senior vice-president Dr Hui Zhou stated: “As a first in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favourable safety profile in melanoma subjects who have previously received immunotherapy.
“We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma.”
Innovent recently received approval from China’s National Medical Products Administration for its KRAS G12C inhibitor, Dupert (fulzerasib), for treating advanced non-small cell lung cancer in adults.
