Pharma Focus Europe

Pieris Pharmaceuticals Achieves Milestone as Boston Pharmaceuticals Initiates Phase 1/2 Study of BOS-342, a Promising 4-1BB/GPC3 Immuno-oncology Bispecific

Friday, August 18, 2023

Pieris Pharmaceuticals, Inc. recently achieved an undisclosed milestone payment from Boston Pharmaceuticals, a result of successfully dosing the first patient in a phase 1/2 study sponsored by Boston Pharmaceuticals. The study is centered around BOS-342 (formerly PRS-342), an innovative immuno-oncology antibody-Anticalin fusion (Mabcalin™) bispecific protein that targets both 4-1BB and GPC3. This novel therapeutic approach, developed by Pieris and licensed to Boston Pharmaceuticals, aims to enhance the activation of T-cells, thereby boosting tumor-killing activity.

The phase 1/2 study, led by Boston Pharmaceuticals, is an open-label investigation that aims to evaluate BOS-342's safety, tolerability, pharmacokinetics, and efficacy. The initial phase of the study involves adults with hepatocellular carcinoma (HCC) who have not responded to previous treatments. The primary goal is to establish the recommended dose for the subsequent phase 2, which will primarily assess the overall response rate as a measure of treatment effectiveness.

The global rights for BOS-342 were licensed to Boston Pharmaceuticals in April 2021, making them responsible for the funding and execution of the clinical study. In addition to the recent milestone achievement, Pieris has the potential to receive further milestone payments totaling around $350 million, contingent on developmental, regulatory, and sales-related milestones. Furthermore, the company could receive tiered royalties based on BOS-342's sales.

Stephen S. Yoder, CEO and President of Pieris, expressed satisfaction with Boston Pharmaceuticals' commitment to the BOS-342 program. Yoder emphasized that BOS-342's progression into clinical development marks a significant milestone for their platform, as it represents the fourth 4-1BB-targeted therapy from Pieris to enter this stage. He underscored the importance of 4-1BB as a promising target for cancer immunotherapy, highlighting the impact of collaborative efforts on advancing cancer treatment approaches.

Sophie Kornowski, CEO of Boston Pharmaceuticals, echoed the significance of dosing the first patient with BOS-342. She emphasized the potential of BOS-342 to address the unmet needs of patients with GPC3+ HCC and noted the critical role it could play in improving treatment outcomes for this patient group.

In essence, the recent milestone payment reflects a significant stride in the development of BOS-342, a promising immuno-oncology therapy designed to enhance tumor-killing activity in patients with hepatocellular carcinoma.

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