Servier / Pieris Pharmaceuticals, Inc.

Solid tumor immuno-oncology (PD-1 checkpoint resistance)

$23.0B Global PD-(L)1 inhibitor market 2022 (Fierce Pharma)

Disease Overview

Solid tumors evade the immune system through checkpoint pathways like PD-1, which suppresses T-cell killing. Despite Keytruda and Opdivo successes, only 20-30% of patients respond, leaving large unmet need for next-generation bispecific checkpoint approaches that can engage exhausted T-cells co-expressing multiple inhibitory receptors.

Competitive Landscape

By 2017 the PD-1/PD-L1 class was dominated by Merck's Keytruda (pembrolizumab) and BMS's Opdivo (nivolumab), with Roche's Tecentriq (atezolizumab), AstraZeneca's Imfinzi (durvalumab), and Pfizer/Merck KGaA's Bavencio (avelumab) rounding out the field. The class was approved across 9 tumor types by end of 2017 and is now a >$23B global market. The next competitive frontier became bispecifics that combine PD-1 blockade with a second checkpoint (LAG-3, TIM-3, TIGIT) on a single molecule. Pieris's Anticalin scaffold offered a non-antibody, smaller-format alternative to bispecific IgG approaches from Akeso/Summit (ivonescimab, PD-1xVEGF) and Roche/Genentech (vibostolimab-class assets). PRS-332 (anti-PD-1 Anticalin bispecific) was the lead asset; Servier's January 2017 deal gave Servier ex-US rights across five programs. The deal ultimately failed: Servier terminated in July 2024 citing safety concerns from the S095012 Phase 1 study, and PRS-332 itself never advanced to clinic.