PE0116 / HyaMab - LARVOL DELTA

PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Shanghai HyaMab Biotech Co.,Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: May 2023 ➔ Sep 2023

Enrollment open • Metastases • Trial initiation date • Gastrointestinal Cancer • Oncology • Solid Tumor

PE0116 Injection in Treatment of Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Shanghai HyaMab Biotech Co.,Ltd. | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase Ib/II Clinical Trial of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

New P1/2 trial • Head and Neck Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

PE0116 Injection in Treatment of Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Shanghai HyaMab Biotech Co.,Ltd.

Metastases • New P1 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Shanghai HyaMab Biotech Co.,Ltd.

Metastases • New P1/2 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

Development and characterization of a novel human CD137 agonistic antibody with anti-tumour activity and a good safety profile in non-human primates. (PubMed, FEBS Open Bio) - "PE0116 is a ligand blocker, which is also the case for Utomilumab (one of the leading CD137 agonistic drugs); PE0116 partially overlaps with Urelumab's recognized epitope. In vivo, PE0116 exhibits a good safety profile and has typical pharmacokinetic characteristics of an IgG antibody in preclinical studies of non-human primates. In summary, PE0116 is a promising anti-CD137 antibody with a good safety profile in preclinical studies."

Journal • Immune Modulation • Inflammation • Oncology • ICOS

First-in-human/phase I trial of PE0116 (4-1bb Ig G4 McAb) as single agent in patients with solid tumors progressed after lines of therapies in China. (ASCO 2022) - "HE0116 administrated intravenously every 3 weeks is well tolerated with minimal toxicities. Preliminary data are very encouraging as single agent HE0116 showed durable responses with 1 iPR, 4 iSD in several difficult to treat late-stage cancer pts. Dose escalation is ongoing as per study protocol."

Clinical • P1 data • Anemia • Cardiovascular • Endocrine Disorders • Heart Failure • Hematological Disorders • Hepatology • Immune Modulation • Inflammation • Musculoskeletal Pain • Oncology • Ovarian Cancer • Pain • Pulmonary Disease • Solid Tumor • CTLA4 • PD-1