OSE Immunotherapeutics - Timely FR104/VEL-101 update with Phase II plans
OSE Immunotherapeutics (OSE) has shared a positive update on the FIRsT clinical trial assessing FR104/VEL-101 (an anti-CD28 monoclonal antibody) as a maintenance therapy for kidney transplant patients. Long-term maintenance therapy in kidney transplant patients remains an ongoing medical need that has seen little progression in the last 20 years. Although OSE is in the early stages of clinical development, we believe there could be a significant opportunity. Encouragingly, the results show no safety concerns with FR104/VEL-101 treatment (seven patients for 12 months post-transplantation, and one ongoing at four months) and no cases of acute rejection, both of which are key objectives for this Phase I/II trial. While the FIRsT study involves a relatively small group size (eight evaluable patients), we believe the update is encouraging, and note that Veloxis Pharmaceuticals (OSE’s partner for this programme) is already preparing for a subsequent Phase II trial involving a larger patient population. We expect full results from the FIRsT study after all patients have completed the 12-month treatment protocol, most likely in H224.Ose Immunotherapeutics SA, formerly Orphan Synergy Europe Pharma SA, is a France-based company principally engaged in the clinical stage biotechnological sector. The Company develops immunotherapy products against invasive or metastatic late-stage cancers. The Company offers a technology, called Memopi, which helps the immune system to eliminate malignant cells; it re-educates the body's immunological memory so that the immune system (and particularly T cytotoxic cells) attacks tumor cells by increasing the patient's specific cytotoxic T response against their cancer. The Company's main product, Texopi, is a patented combination of ten epitopes, selected and optimized from five tumor associated antigens.
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