PM8001 / BioNTech - LARVOL DELTA

A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Biotheus Inc. | Initiation date: Dec 2022 ➔ Oct 2023

Combination therapy • Metastases • Monotherapy • Trial initiation date • Oncology • Solid Tumor

A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Biotheus Inc.

Combination therapy • Monotherapy • New P1 trial • Oncology • Solid Tumor

Phase I/IIa study of PM8001, a bifunctional fusion protein targeting PD-L1 and TGF‑β, in patients with advanced tumors. (ASCO 2022) - "PM8001 showed an acceptable safety profile and promising anti-tumor activity in advanced solid tumors, especially in patients previously treated with checkpoint inhibitors, which supports further studies to explore the safety and efficacy of PM8001 as a monotherapy and in combination with other anti-tumor agents. Global Phase II monotherapy and combination studies are currently ongoing."

Clinical • P1/2 data • Anemia • Hematological Disorders • Oncology • Solid Tumor • TGFB1

Biotheus' Bifunctional Therapeutic PM8001 has been Approved by the USFDA to Enter Phase II Studies (PRNewswire) - “Biotheus Inc., has announced that its proprietary anti-PD-L1/TGF-β bifunctional therapeutic, named PM8001, has been approved by the USFDA (United States Food and Drug Administration) for conducting clinical phase II studies as part of an international multicenter clinical trial. PM8001 enhances anti-tumor immune responses by blocking PD-L1/PD-1-mediated checkpoint signals and neutralizes TGF-β in the tumor microenvironment. PM8001 has a smaller size than a conventional antibody (~110 kDa) that could potentially improve its tumor penetration efficiency and is also depleted of its Fc-related effector function to mitigate any potential off-target effects.”

FDA event • New P2 trial • Oncology