itanistomig (LB101) / Centessa - LARVOL DELTA

A Study to Evaluate Safety, Tolerability and Preliminary Activity of LB101 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=25 | Terminated | Sponsor: Centessa Pharmaceuticals (UK) Limited | Trial completion date: Jan 2027 ➔ Sep 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2025 ➔ Jan 2025; Sponsor terminated the study due to non-safety reasons. Based on the data and the current competitive landscape, Sponsor made the decision to close the study.

First-in-human • Platinum resistant • Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI • PD-L1

A Study to Evaluate Safety, Tolerability and Preliminary Activity of LB101 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=25 | Active, not recruiting | Sponsor: Centessa Pharmaceuticals (UK) Limited | Recruiting ➔ Active, not recruiting | N=190 ➔ 25 | Trial primary completion date: Jan 2027 ➔ Oct 2025

Enrollment change • Enrollment closed • Trial primary completion date • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI • PD-L1

Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the First Quarter of 2024 (Centessa Pharma Press Release) - "LockBody Technology Platform - The Phase 1/2a FIH clinical study of LB101 (PD-L1xCD47 LockBody) for the treatment of solid tumors is ongoing."

Trial status • Oncology • Solid Tumor

Centessa Pharmaceuticals Reports Business Highlights and Financial Results for the Fourth Quarter and Full-Year 2023 (GlobeNewswire) - "LockBody Technology Platform: Ongoing Phase 1/2a study of LB101 (PD-L1xCD47) for the treatment of solid tumors."

Trial status • Solid Tumor

Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Second Quarter of 2023 (GlobeNewswire) - "Anticipated Upcoming Program Milestones...PD-L1xCD47 LockBody (LB101) - The Phase 1/2a first-in-human clinical study is ongoing. PD-L1xCD3 LockBody (LB206) - LB206 has been named as a development candidate."

New molecule • Trial status • Oncology • Solid Tumor

A Study to Evaluate Safety, Tolerability and Preliminary Activity of LB101 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Centessa Pharmaceuticals (UK) Limited

Metastases • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI • PD-L1

Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the First Quarter of 2023 (GlobeNewswire) - "In March, the first subject was dosed in the Phase 1/2a first-in-human clinical trial of LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody from the Company's LockBody technology platform for the treatment of solid tumors....Solid Tumors (PD-L1xCD47 LockBody LB101)- The Phase 1/2a first-in-human clinical study is ongoing."

Trial status • Oncology • Solid Tumor

Centessa Pharmaceuticals Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of LB101, First LockBody Candidate, for Solid Tumors (GlobeNewswire) - "Centessa Pharmaceuticals plc...announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human, clinical trial of LB101 for the treatment of solid tumors....'We look forward to initiating the Phase 1/2a trial of LB101 as soon as possible'."

IND • New P1/2 trial • Oncology • Solid Tumor

Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Third Quarter of 2022 (GlobeNewswire) - "Anticipated Upcoming Program Milestones: Q4 2022: LB101 - Investigational New Drug application (IND) submission."

IND • Oncology

Centessa Pharmaceuticals Announces Non-Human Primate Pharmacokinetic and Safety Data for LB101 (PD-L1xCD47) Demonstrating Potential for Enhanced Therapeutic Index (GlobeNewswire) - "Centessa Pharmaceuticals plc...announced non-clinical pharmacokinetic (PK) and safety data in non-human primates (NHPs) for LB101 (PD-L1xCD47), its first LockBody^® candidate for solid tumors....In the study, male and female cynomolgus monkeys were administered LB101 intravenously, every 7 days over 28 days (q7 days x 4) at doses of 5mg/kg, 20mg/kg, and 50mg/kg. The pharmacokinetics of LB101 were assessed and exhibited a typical IgG1-like PK profile. There were no adverse changes in hematologic parameters (including no anemia and no thrombocytopenia), no changes in body weights and no adverse toxicology findings."

Preclinical • Oncology • Solid Tumor

LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody (mAb), combines tumor microenvironment (TME) targeted delivery (PD-L1) and a single biological high potency effector (CD47). (ASCO 2022) - "Single agent LB101 immunotherapy delivered systemically in a difficult to treat syngeneic mouse model resulted in PD-L1 directed, local tumor-specific CD47 effector engagement leading to significant tumor regressions as compared to atezolizumab without overt toxicity. Future developments will focus on developing LB101 as a single agent therapeutic and exploring the potential of LockBody technology in improving the therapeutic index of other anti-cancer biological effectors through conditional activation within the TME."

Biomarker • IO biomarker • Tumor microenvironment • Anemia • Hematological Disorders • Oncology • Solid Tumor • CD14 • CD47

Centessa Pharmaceuticals Announces Poster Presentation of First Preclinical Data for LockBody Program at 2022 ASCO Annual Meeting (GlobeNewswire) - "The poster includes in vivo data in a MC38 hPD-L1+ syngeneic mouse model, which demonstrated significantly improved efficacy with durable responses for single-agent LB101 (26 of 32 tumors eradicated across two doses) compared to isotype control IgG (0 of 16) and atezolizumab (4 of 32 across two doses). In rechallenge experiments, none of the mice from groups with prior LB101-induced regressions exhibited tumor growth compared to all naïve mice which rapidly established tumors."

Preclinical • Oncology • Solid Tumor

Centessa Pharmaceuticals Reports Fourth Quarter and 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Upcoming Program Milestones - LB101 and LB201 in Solid Tumors: LB101, a PD-L1xCD47 LockBody®, is designed to selectively drive potent CD47 effector function activity while avoiding systemic toxicity. We anticipate sharing foundational preclinical data at ASCO 2022, with an IND for LB101 planned for late 2022. LB201, a PD-L1xCD3 LockBody®, is designed to selectively drive potent CD3 effector function activity while avoiding systemic toxicity. IND for LB201 is planned for 2023."

IND • Preclinical • Oncology • Solid Tumor