On September 27, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, reported that the FDA has accepted the protocol and given the formal go-ahead to proceed with the planned ONCOS-102 phase 2 trial in melanoma. Study initiation activities are proceeding according to the communicated timeline, with the aim to start enrolling patients in late 2022 or early 2023 (Press release, Targovax, SEP 27, 2022, View Source [SID1234621468]).

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PD-1 CPI refractory advanced melanoma is a major unmet medical need affecting up to 25,000 patients per year globally in the major markets. The diagnosis has poor prognosis and there are currently no approved treatment options available. In a recently reported phase 1 trial, ONCOS-102 demonstrated a highly competitive response rate (ORR) of 35% in this patient population in combination with a PD-1 CPI. Importantly, the strong ORR outcome was corroborated by biomarker data showing significant increase in T-cell infiltration and broad and persistent activation of immune-related gene signatures in responding patients.

Based on these promising early clinical results, Targovax is planning to conduct a larger, phase 2 multi-cohort study to further explore and validate the benefit of ONCOS-102 in PD-1 CPI refractory melanoma. This phase 2 study will be run in collaboration with Targovax’s partner Agenus, who will provide their Fc-enhanced CTLA-4 (botensilimab) and PD-1 (balstilimab) CPIs for combination with ONCOS-102.

In the first part of the study, two groups will evaluate the safety and efficacy of (1) a higher dose of ONCOS-102 to be tested as a monotherapy and (2) the low and new higher dose of ONCOS-102 in combination with the PD-1 CPI balstilimab. Following confirmation of the safety of the increased ONCOS-102 dose, the study will proceed into its second part adding two more groups. In group (3) ONCOS-102 will for the first time be combined with a CTLA-4 CPI (botensilimab) and, ultimately, in (4) the triple combination of ONCOS-102, balstilimab and botensilimab will be tested.

Dr. Lone Ottesen, Chief Medical Officer of Targovax ASA, said: "We are very pleased to get the formal go-ahead from the FDA for our phase 2 melanoma study. With the proposed design, we will answer important clinical questions relating to safety, dosing and contribution of components that are critical to enable subsequent registrational trials. I am particularly excited about the combination with the next generation Fc-enhanced CTLA-4 CPI botensilimab, which is expected to enhance systemic activity and deepen tumor responses. We anticipate that the triple combination of ONCOS-102 with PD-1 and CTLA-4 blockade will boost response rates above the already strong 35% ORR, and firmly establish ONCOS-102 as class-leading candidate in PD-1 CPI refractory melanoma".