BI-836880

OSE’s Tedopi is a neoepitope-based immunotherapy activating tumour-specific T-cell cancer vaccine. Image Credit: Gorodenkoff / Shutterstock. The French company OSE Immunotherapeutics has provided an update for its clinical pipeline, with plans to start a confirmatory Phase III study for its cancer vaccineTedopi in the US in Q2 2024. The company has received positive recommendations from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) based on the positive data from the Phase III trial (NCT02654587) evaluating Tedopi as a second or third-line therapy in patients with advanced non-small cell lung cancer patients following treatment failure with immune checkpoint inhibitors (ICI). Additionally, OSE is seeking approval from the FDA to validate the companion diagnostic test for Tedopi, developed by Genome Diagnostics. Tedopi is a neoepitope-based immunotherapy activating tumour-specific T-cell cancer vaccine. Apart from the Phase III trial, OSE is also conducting three Phase II trials evaluating Tedopi as a combination therapy in solid tumours such as pancreatic, ovarian and lung cancers. The results from the Phase II trial of Tedopi in combination with chemotherapy in pancreatic cancer patients are expected this year. Data from the Phase II trials (NCT04713514 and NCT03806309) for Tedopi in combination with MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb ’s Opdivo (nivolumab), respectively, is expected in 2025. OSE’s ulcerative colitis therapy lusvertikimab (OSE-127) is being investigated in a Phase II placebo-controlled trial (NCT04882007). The recruitment for the trial is expected to be completed in Q1 of this year, with initial results expected by mid-2024, as per a 19 January press release. The interleukin (IL)-7 receptor antagonist is also being evaluated in preclinical studies as a treatment for acute lymphoblastic leukaemia (ALL). In July 2023, OSE received a positive opinion on Orphan Drug Designation for lusvertikimab for the treatment of ALL by the EMA. OSE-279 is a programmed cell death 1 (PD-1) inhibiting monoclonal antibody. It is being evaluated as a treatment for solid tumours or lymphomas in a dose-finding and expansion Phase I trial (NCT05751798). OSE is also developing two monoclonal antibodies against signal regulatory protein α (SIRPα), BI 765063/ OSE-172 and BI 770371, in collaboration with Boehringer Ingelheim. BI 765063 is being evaluated as a combination therapy with different cancer therapies such as Boehringer’s ezabenlimab, BI 836880, chemotherapy and Eli Lilly’s Erbitux (cetuximab) in a Phase I trial (NCT05249426). BI 770371 is being evaluated as a monotherapy and in combination with a PD1 inhibitor, BI 754091, in an international Phase I dose escalation and expansion trial (NCT05327946) in patients with solid tumours. OSE is advancing the anti-CD28 selective monoclonal antibody FR104/VEL-101 in partnership with Denmark-based Veloxis Pharmaceuticals. It is researched as a treatment to help prevent organ rejection in people who have had a kidney transplant. In February 2022, the therapy received a fast track designation by the FDA for prophylaxis against transplant rejection. Veloxis is planning Phase II trials for the subcutaneous therapy.