betifisolimab (MSB2311) / Transcenta - LARVOL DELTA

MSB2311-CSP-002t: A Study of MSB2311 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Recruiting ➔ Completed | N=60 ➔ 42

Enrollment change • Metastases • Trial completion • Oncology • Solid Tumor

A Phase I Study of MSB2311 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | N=19 ➔ 42

Enrollment change • Metastases • Oncology • Solid Tumor

Phase I study of MSB2311, a novel pH-dependent anti-PD-L1 monoclonal antibody, treating patients with advanced solid tumors and lymphoma. (PubMed, Cancer Immunol Immunother) - "One partial response was also observed among 6 patients with lymphoma. MSB2311 demonstrated a manageable safety profile and promising antitumor activity in patients with advanced solid tumors and lymphomas."

IO biomarker • Journal • Metastases • P1 data • Tumor mutational burden • Diabetes • Endocrine Disorders • Epstein-Barr Virus Infections • Hematological Disorders • Hematological Malignancies • Lymphoma • Microsatellite Instability • Oncology • Renal Disease • Solid Tumor • MSI • TMB

[VIRTUAL] Updated safety and efficacy of MSB2311 (an anti-programmed death-ligand 1 antibody) in Chinese patients with advanced solid tumors and hematological malignancies from a phase 1 study. (ASCO 2021) - P1 | "MSB2311 demonstrated a manageable safety profile and promising preliminary antitumor activity in patients with advanced solid tumors and selected lymphomas."

Clinical • IO biomarker • P1 data • Anemia • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Renal Disease • Solid Tumor • TMB

[VIRTUAL] MSB2311, an anti-programmed death-ligand 1 antibody, in advanced solid tumors and hematological malignancies: Safety and tolerability, early anti-cancer activities from a phase I study in Chinese patients. (ASCO 2020) - "MSB2311 demonstrated a manageable safety profile and promising preliminary antitumor activity in patients with advanced solid tumors and hematological malignancies. Research Funding: MabSpace"

Clinical • IO biomarker • P1 data • Dyslipidemia • Endocrine Disorders • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hypertriglyceridemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer

Transcenta Announced the Results of the Phase I Clinical Study of PD-L1 Antibody MSB2311 with Advanced Solid Tumors and Hematological Malignancies (PRNewswire) - P1, N=60; NCT04272944; Sponsor: Mabspace Biosciences (Suzhou) Co., Ltd.; "Transcenta Holding Limited...announced that the updated Phase I clinical study (NCT04272944) data...have been presented as an abstract online publication at the 2021 Annual Meeting of the American Society of Clinical Oncology...Of the 17 efficacy evaluable solid tumor patients with biomarker expression, 6 achieved confirmed partial response with an ORR of 35%: 2/8 (25%) at 10mg/kg Q2W and 4/9 (44%) at 20mg/kg Q3W. Additionally, one patient achieved sustained iPR per iRECIST. 4 out of 7 responding patients (including one iPR) achieved tumor shrinkage of more than 50%, 3 of them got durable response (≥24 weeks). 1 out of 6 lymphoma patients achieved PR."

P1 data • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Transcenta Announces Updated Clinical Data from Phase I Study of pH-Dependent PD-L1 Antibody MSB2311 to Be Presented at the 2021 ASCO Annual Meeting (PRNewswire) - "Transcenta Holding Limited (Transcenta)...announced that the updated phase I clinical data on the safety and efficacy of MSB2311, a pH-dependent PD-L1 antibody, in Chinese patients with advanced solid tumors and hematological malignancies will be presented as an abstract online publication at the 57th American Society of Clinical Oncology (ASCO) Annual Meeting. The 2021 ASCO Annual Meeting will be held online from June 4th to June 8th EDT."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

A Study of MSB2311 in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Mabspace Biosciences (Suzhou) Co., Ltd.; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Phase I Study of MSB2311 in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=19; Completed; Sponsor: Mabspace Biosciences (Suzhou) Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Oncology • Solid Tumor

Transcenta presents first data from phase 1 study of pH-dependent PDL1 antibody MSB2311 in patients with pre-treated advanced solid tumors and select hematological malignancies (PRNewswire) - P1, N=60; NCT04272944; Sponsor: Mabspace Biosciences (Suzhou) Co., Ltd; "Results of the study showed durable responses among patients with solid tumors (n=18) who were treated with MSB2311 across dose groups, ranging from 3 mg/kg-20 mg/kg every three weeks. At the 20 mg/kg dose (n=12), the objective response rate (ORR) was 33 percent (4/12); responses were deep and persisted. At the time of data cut-off, 75 percent (3/4) of patients who achieved a response remained in the study with an ongoing response. Additional dose expansion with alternative dosing regimen at 10 mg/kg every two weeks of the study is ongoing. In addition, 6 patients with hematological malignancy (three T cell lymphoma and three B cell lymphoma) were tested at 20 mg/kg. One of the three T cell lymphoma patients achieved partial response lasting for 6 weeks."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

A Study of MSB2311 in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Mabspace Biosciences (Suzhou) Co., Ltd.

Clinical • New P1 trial

A Phase I Study of MSB2311 in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: Mabspace Biosciences (Suzhou) Co., Ltd.; Trial primary completion date: Apr 2019 ➔ Apr 2020

Clinical • PD(L)-1 Biomarker • Trial primary completion date