BOS-342 / Boston Pharma, Palvella Therapeutics - LARVOL DELTA

A First-in-Human, Open-label, Phase 1/2 Study of BOS-342 in Patients with Hepatocellular Carcinoma (HCC) and other Glypican 3 (GPC3)-expressing Tumors (ANZCTR) - P1/2 | N=81 | Terminated | Sponsor: Boston Pharmaceuticals, Inc. | Recruiting ➔ Terminated

Trial termination • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

A First-in-Human, Open-label, Phase 1/2 Study of BOS-342 in Patients with Hepatocellular Carcinoma (HCC) and other Glypican 3 (GPC3)-expressing Tumors (ANZCTR) - P1/2 | N=81 | Recruiting | Sponsor: Boston Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

A First-in-Human, Open-label, Phase 1/2 Study of BOS-342 in Patients with Hepatocellular Carcinoma (HCC) and other Glypican 3 (GPC3)-expressing Tumors (ANZCTR) - P1/2 | N=81 | Not yet recruiting | Sponsor: Boston Pharmaceuticals, Inc.

New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Pieris Pharmaceuticals Announces Milestone Achievement for Boston Pharmaceuticals' Initiation of Phase 1/2 Study of BOS-342, a 4-1BB/GPC3 Immuno-Oncology Bispecific (Issuer Direct) - "Pieris Pharmaceuticals...announced that the Company has achieved an undisclosed milestone payment from Boston Pharmaceuticals. The milestone is based on dosing the first patient in a Boston Pharmaceutical-sponsored phase 1/2 study of BOS-342 (formerly PRS-342)....The open-label phase 1/2 study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BOS-342....In addition to the milestone announced today, Pieris could potentially be entitled to receive up to approximately $350 million in development, regulatory and sales-based milestone payments, and tiered royalties on sales of BOS-342."

Financing • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Pieris Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update (Pieris Press Release) - "PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific Mabcalin compound, towards the clinic, with phase 1 expected to begin in the next six months."

New P1 trial • Oncology

Pieris Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update (Pieris Press Release) - "Pieris and Servier continue to enroll the escalation portion of the phase 1/2 study of PRS-344/S095012...for the treatment of solid tumors, for which Pieris holds full U.S. rights and will receive royalties on ex-U.S. sales by Servier. The companies expect to present data from the study at a medical meeting in 2023. Additionally, Servier is continuing development of PRS-352/S095025, an OX40/PD-L1 bispecific Mabcalin compound."

Enrollment status • P1/2 data • Pipeline update • Oncology • Solid Tumor

Pieris Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update (Issuer Direct) - "PRS-344/S095012 and Servier Collaboration: Pieris and Servier continue to enroll the escalation portion of the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 Anticalin-based bispecific for the treatment of solid tumors for which Pieris holds full U.S. rights and will receive royalties on ex-U.S. sales by Servier. The companies expect to initiate expansion cohorts in jointly-vetted indications next year....PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific, towards the clinic, with phase 1 expected to begin in the first half of 2023."

New P1 trial • Trial status • Oncology • Solid Tumor

Pieris Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update (Yahoo Finance) - "PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific, towards the clinic, with an IND filing expected within the next 12 months."

IND • Oncology

"Pieris Pharmaceuticals and Boston Pharmaceuticals Enter into an Exclusive Worldwide Product License for PRS-342, a 4-1BB/GPC3 Immuno-Oncology Bispecific https://t.co/01xO0l3RUv" (@NewsFromBW)

Oncology • GPC3

Pieris Pharmaceuticals and Boston Pharmaceuticals Enter into an Exclusive Worldwide Product License for PRS-342, a 4-1BB/GPC3 Immuno-Oncology Bispecific (Businesswire) - "Pieris Pharmaceuticals...and Boston Pharmaceuticals today announced that the companies have entered into an exclusive product license agreement to develop PRS-342, a 4-1BB/GPC3 preclinical immuno-oncology Anticalin®-antibody bispecific fusion protein. Under the terms of the agreement, Boston Pharmaceuticals has exclusively licensed worldwide rights to PRS-342. Pieris will receive an upfront payment of $10 million and is further entitled to receive up to approximately $353 million in development, regulatory, and sales-based milestone payments, and tiered royalties on sales of PRS-342."

Licensing / partnership • Oncology

Costimulatory T-cell engagement by PRS-342, a GPC3/4-1BB bispecific molecule, leads to activation of T-cells and tumor growth inhibition in a HCC humanized mouse model (AACR 2019) - "PRS-342 was designed to elicit 4-1BB costimulatory effects in a tumor-localized manner. Here we report potent T-cell activation that is strictly dependent on the presence of GPC3-positive tumor cells. Collectively our in vitro and in vivo data support the continued development of PRS-342."

Preclinical

Pieris Pharmaceuticals presents preclinical data for GPC3/4-1BB bispecific PRS-342 at the 2019 American Association for Cancer Research (PipelineReview) - "Pieris Pharmaceuticals...announced the presentation of preclinical data for PRS-342, a GPC3/4-1BB immuno-oncology bispecific drug candidate, at a poster session at the 2019 American Association for Cancer Research (AACR) Annual Meeting...PRS-342 also demonstrated a localized increase of tumor-infiltrating lymphocyte (TIL) levels in a humanized hepatocellular carcinoma (HCC) xenograft mouse model. The data presented suggest potent T-cell activation that is strictly dependent on the presence of GPC3-positive tumor cells."

Preclinical