Chinese biotech company Fapon Biopharma announced on Friday that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address the unmet need in patients with solid tumours refractory to anti-PD-1 therapy.

According to the company, FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its haematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation.

This breakthrough is intended to offer a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumours. Fapon Biopharma says that it is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialisation.

"Global collaboration is central to our vision," said Fapon Biopharma president Vincent Huo. "We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumour immunotherapy."