BI 765063 / OSE Immunotherapeutics, Boehringer Ingelheim - LARVOL DELTA

OSE Immunotherapeutics Reports First Half 2025 Financial Results (GlobeNewswire) - "Research and development expenses increased by 6.7% over the period, amounting to €14.8 million in the first half of 2025, compared to €13.9 million the prior year. This increase reflects our development programs moving forward, notably the ongoing Phase 3 trial of Tedopi – Artemia – actively recruiting...Operating loss amounted to €(15.8) million in the first half of 2025, compared to a profit of €63.3 million a year earlier, essentially reflecting an exceptional income in 2024 related to the AbbVie licensing agreement on OSE-230 and the amendment on the BI 765063 (OSE-172) agreement as well as the asset purchase agreement from the “cis-targeting” anti-PD1/cytokine platform by Boehringer Ingelheim."

Commercial • Immunology • 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=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

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 Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=100 | Completed | Sponsor: OSE Immunotherapeutics | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2025

Trial completion • Trial completion date • Colorectal Cancer • Endometrial Cancer • Solid Tumor • SIRPA

An open-label, phase Ib trial of the SIRPα inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma. (ASCO 2025) - P1 | "This Phase Ib study (NCT05249426) is investigating the efficacy and safety of BI 765063 in combination with ezabenlimab + cetuximab (Cohort A) or ezabenlimab + chemotherapy (Cohort B) in pts with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), or in combination with ezabenlimab ± BI 836880 (anti-VEGF/Ang2) in pts with hepatocellular carcinoma. These preliminary data indicate that BI 765063 in combination with ezabenlimab and cetuximab has a manageable safety profile and promising efficacy as second-line treatment in pts with R/M HNSCC. Biomarker data will be presented at the meeting."

Clinical • Combination therapy • IO biomarker • P1 data • Anemia • Cardiovascular • Congestive Heart Failure • Dermatitis • Dermatology • Endocrine Disorders • Head and Neck Cancer • Heart Failure • Hematological Disorders • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • 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

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 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 to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Apr 2026 ➔ Jul 2026

Trial completion date • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Aug 2025 ➔ Apr 2026

Trial completion date • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

CD 47 Inhibitors As An Immunotherapy Targeted Therapy In Patients With Advanced Ovarian Cancer. (ESGO 2025) - "Methodology The efficacy of BI 765063 an antibody antagonist of SIRPa, as a monotherapy and with the combination of pro-phagocytic CD47-SIRPa axis monoclonal antibodies and Fc-dependent have been studied in patients with advanced ovarian cancer...CD47/SIRPa immunotherapy holds the potential to stand as a promising option, on par with PD-1/PDL1. Enhancing the efficacy and safety of CD47 antagonists for the treatment of advanced ovarian cancer requires prime and maintenance dosing strategy, structure modification, dual blockade strategies, BsAbs and fusion proteins, small-molecule inhibitors, novel drug delivery systems, SIRP-1 and SIRP-2 applications cis and trans interactions, and tumor selectivity enhancement"

Clinical • IO biomarker • Metastases • Oncology • Ovarian Cancer • Solid Tumor • CD47 • PD-1 • PD-L1 • 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: 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 to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Nov 2024 ➔ Jul 2024

Combination therapy • Metastases • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

Target Engagement and Saturating Effects demonstrated with quantitative Zr-89 PET imaging for the Therapeutic Anti-SIRPα Antibody BI 765063 in Early Clinical Development (SNMMI 2024) - P1 | "Target engagement was demonstrated in all lesions by Patlak linearization with the tracer dose. After infusion of treatment doses for the anti-SIRPα antibody BI 765063, saturating effects were observed in 8 out of 11 lesions."

Clinical • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • 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: 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 to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2025 ➔ Nov 2024

Combination therapy • Enrollment closed • Metastases • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting | Trial primary completion date: Aug 2024 ➔ Apr 2025

Combination therapy • Enrollment open • Metastases • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) - P1 | N=47 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Boehringer Ingelheim | Completed ➔ Terminated; Company decision

Adverse events • Combination therapy • Surgery • Trial termination • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Boehringer Ingelheim | N=150 ➔ 45

Enrollment change • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery (clinicaltrials.gov) - P1 | N=2 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Neoadjuvant ezabenlimab or pembrolizumab in combination with an anti-SIRPα antibody in resectable colorectal cancer (SITC 2023) - P1 | "Methods This phase I, open-label, parallel-cohort, single-center trial (NCT05446129) was designed to assess the safety, feasibility, clinical efficacy, and biological activity of BI-765063 (an anti-SIRPα antibody) in combination with either ezabenlimab (Cohort A) or pembrolizumab (Cohort B), both anti-PD-1 antibodies, in patients with early-stage, resectable CRC (figure 1). Tissue, blood, and stool will be collected prior to treatment administration and at the time of resection. Immune monitoring will be performed using multiplex and single-cell analysis platforms to define the immunodynamic effects of these therapies."

Clinical • Combination therapy • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD47 • CTLA4 • 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=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