OSE Immunotherapeutics has halted the accrual of patients in its Phase III study for Tedopi, as the biotech is rethinking the study’s patient profile.

OSE’s stocks have plunged by 20% this morning, hitting their lowest point in 5 years, as the company announced that it is temporarily halting patient enrollment in its ongoing Phase III study for lead candidate Tedopi in non-small cell lung cancer (NSCLC). While treatment of patients that are already enrolled in the study will continue, the biotech said it wants to reassess the study’s current patient profile with regards to Tedopi’s potential benefit.

Tedopi is OSE’s only Phase III program and consists of a combination of 10 tumor-associated neo-epitopes designed to activate cytotoxic T cells to take on the cancer cells. The current Phase III trial for Tedopi has been running in the US and in Europe to compare Tedopi’s performance with current standard chemotherapies in patients with advanced or metastatic NSCLC.

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OSE-Tedopi-NSCLC

OSE’s Neoepitopes have been optimized to both efficiently bind to T cell receptors as well as the HLA-A2 Major Histocompatibility Complex.

According to OSE’s CEO Dominique Costantini, Tedopi has previously revealed a general longer-term activity compared to chemotherapy, which might impede its benefit in patients with advanced stages of the disease.

Patients eligible for inclusion in the Atalante 1 study are cancer patients at an advanced stage who have failed a first-line treatment with chemotherapy or failed second-line therapy with checkpoint inhibitors (…). This cancer progression may be difficult to control for some patients in the near-term due to the generally longer-term activity observed with a combination of neoepitopes (…),” commented Constantini in a press release.

The biotech now plans to review the available patient data to decide if the trial will be continued as such, or whether it will be reworked to included specific patient sub-groups. The safety profile of the candidate was, however, fine and consistent with that of previous trials.

The news from OSE certainly raises questions about the current therapeutic strategy for Tedopi, as checkpoint inhibitors are lining up for approval as first-line treatments for NSCLC. OSE is also planning a Phase II study in combination with a checkpoint inhibitor in NSCLC. For now, it’s unclear if this could be OSE’s last resort for its cancer vaccine.

If the worst case materializes and this is the end for Tedopi, the biotech might find success in its broad pipeline containing a number of early-stage candidates both in the immuno-oncology and the autoimmune space.

Images via shutterstock.com /  wonderisland and ose-immuno.com

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