BI 770371 / Boehringer Ingelheim, OSE Immunotherapeutics - LARVOL DELTA

An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors. (ASCO 2025) - P1 | "No DLTs were reported during the MTD evaluation period with BI 770371 monotherapy or with the combination; 1 pt in the monotherapy group had a DLT (grade 2 encephalitis, which resolved within 1 week) during the on-treatment period (likely due to prior nivolumab and ipilimumab treatment). These preliminary data indicate that BI 770371 is well tolerated alone and in combination with ezabenlimab, with promising antitumor activity seen in heavily pretreated pts with advanced solid tumors. The MTD of BI 770371 was not reached in either group."

Clinical • Combination therapy • Metastases • P1 data • CNS Disorders • Dermatology • Fatigue • Oncology • Pruritus • Solid Tumor • SIRPA

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2026 ➔ Dec 2025

Trial completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Oncology • Solid Tumor

Boehringer Ingelheim to present early clinical evidence of innate immune modulation and anti-tumor activity via SIRPα blockade in two ongoing trials at ASCO 2025 (GlobeNewswire) - P1b | N=48 | NCT05249426 | P1 | N=36 | NCT05327946 | Sponsor: Boehringer Ingelheim | "In a Phase 1b study conducted by Boehringer, its potential, first-in-class SIRPα monoclonal antibody, BI 765063, demonstrated a manageable safety profile as well as preliminary signs of immune activation and additive antitumor activity when combined with PD-1 inhibitor ezabenlimab and cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Additionally, in an open-label, Phase I trial conducted by Boehringer, its next-generation SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab, was shown to be well tolerated in patients with advanced solid tumors. There were no dose-limiting toxicities in either treatment arm, and the maximum tolerated dose was not reached in either group."

P1 data • Squamous Cell Carcinoma of Head and Neck

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Jun 2025 ➔ Oct 2025

Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

OSE Immunotherapeutics Highlights Abstracts Selected for Presentation at ASCO 2025 (GlobeNewswire) - "OSE Immunotherapeutics SA...announced that several abstracts highlighting the Company's innovative assets have been selected for presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 1-5, 2025, in Chicago, Illinois."

Clinical • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Oct 2025 ➔ Dec 2026

Trial completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jun 2026 ➔ Sep 2025

Trial completion date • Oncology • Solid Tumor

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Mar 2025 ➔ Jun 2026

Trial completion date • Oncology • Solid Tumor

A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Monotherapy • New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P2 trial • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: May 2025 ➔ Aug 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Oncology • Solid Tumor

Boehringer Ingelheim and OSE Immunotherapeutics advance clinical development of first-in-class SIRP cancer immunology treatment BI 770371 (GlobeNewswire) - "Today Boehringer Ingelheim and OSE Immunotherapeutics SA (OSE)...announced that Boehringer will be progressing their first-in-class SIRPα immuno-oncology program into the next phase in clinical development. As part of the program, Boehringer will move forward with an improved next generation SIRPα inhibitor antibody, which will now be tested in a Phase 1b study."

Pipeline update • Oncology

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Oct 2024 ➔ Mar 2025 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

OSE Immunotherapeutics and Boehringer Ingelheim expand collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases (GlobeNewswire) - "Today OSE Immunotherapeutics SA...and Boehringer Ingelheim announced a major expansion of their partnership...Reflecting an amendment of the existing collaboration and license agreement for the anti-SIRPα immuno-oncology compounds BI 765063 and BI 770371...A new preclinical program will be launched to develop immune-cell activating treatments based on OSE’s cis-targeting anti-PD1/cytokine platform via an asset acquisition...The development of the ongoing anti-SIRPα compounds for a new indication adds to the company’s comprehensive CRM pipeline with the initiation of a Phase 2 clinical study planned for later this year."

Licensing / partnership • New P2 trial • Oncology • Solid Tumor

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Nov 2025 ➔ Jan 2025 | Trial primary completion date: Mar 2025 ➔ Jul 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Boehringer Ingelheim | N=22 ➔ 12 | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Nov 2023 ➔ Apr 2024

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

Open-label, phase I, dose escalation/expansion trial of the anti-SIRPα monoclonal antibody BI 770371 in patients with advanced solid tumours, alone or in combination with the anti-PD-1 monoclonal antibody ezabenlimab (ESMO 2023) - P1 | "Conclusions BI 770371 showed manageable toxicity alone and in combination with ezabenlimab. The trial is ongoing."

Clinical • Combination therapy • Metastases • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • SIRPA

OSE Immunotherapeutics Announces First Clinical Results for BI 770371, a Novel Anti-SIRPα Monoclonal Antibody (Businesswire) - P1 | N=42 | NCT05327946 | Sponsor: Boehringer Ingelheim | "OSE Immunotherapeutics...announced that first Phase 1 results for BI 770371, a novel anti-SIRPα monoclonal antibody evaluated in advanced solid tumors, have been presented, at the European Society for Medical Oncology conference....The first clinical results of BI 770371 presented at ESMO 2023 conference (Madrid, Abstract #697P) showed that adverse events were manageable during the on-treatment period, Maximal Tolerated Dose (MTD) has not been reached. This clinical trial is ongoing."

P1 data • Solid Tumor

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Combination therapy • New P1 trial • Oncology • Solid Tumor