OSE Immuno presents cancer drug candidate at medical conference
OSE Immuno presented preclinical and early clinical data for its cancer drug candidate OSE279, a PD-1 blocking antibody, at the AACR-NC-EORTC conference in Boston.
Nantes, France – OSE Immuno presented preclinical and early clinical data for its novel cancer drug candidate OSE279 at the AACR-NC-EORTC conference in Boston on October 19, 2023. OSE279 is a PD-1 blocking monoclonal antibody being developed as a potential backbone for bifunctional checkpoint inhibitor therapies.
Preclinical evaluations demonstrated that OSE279 exhibits full antagonist activity against the PD-1 receptor, comparable to established therapies such as pembrolizumab and nivolumab. Simulations predicted a high receptor occupancy in circulation. The drug's safety profile was assessed in primate models, establishing a No Observed Adverse Event Level (NOAEL).
As of September 2023, a Phase I/II First-In-Human study had enrolled 13 patients with advanced malignancies, representing eight different tumor types. The median number of prior metastatic treatment lines was two. Treatment-related adverse events (TRAEs) were reported in 76.9% of patients, with two serious TRAEs – pneumonitis and hepatitis – occurring in 15.4% of patients.
The study observed one confirmed partial response (PR) in a patient with hepatocellular carcinoma (HCC) following a single administration of OSE279. Two unconfirmed partial responses were also reported in subjects with other tumor types. Pharmacokinetic profiles were promising, showing dose-proportional exposure and maintained receptor occupancy. The recommended Phase 2 dose (RP2D) was determined to be 300 mg every three weeks (q3w).
OSE Immuno plans to proceed with further studies and expansion cohorts to confirm the safety and tolerability of OSE279 and to further evaluate its efficacy in a broader patient population.