On March 3, 2020 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it has completed patient enrollment in the phase I trial with ONCOS-102 in combination with Keytruda (pembrolizumab) in patients with advanced anti-PD1 checkpoint inhibitor (CPI) refractory melanoma (Press release, Targovax, MAR 3, 2020, View Source [SID1234555157]).

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In this trial, ONCOS-102 immune activation is being tested in patients with advanced, unresectable melanoma who have had disease progression on treatment with anti-PD1 CPI. This is a particularly challenging patient population, with few treatment alternatives available. In July 2019, Targovax reported encouraging results from part 1 of the trial – see link to press release here.

Part 2 of this trial is testing an extended ONCOS-102 dosing regimen with up to twelve injections compared to three injections in part 1. The enrollment of 12 patients into part 2 of the trial has now been completed. The last patients will complete their six months treatment and data on a total of 21 patients are expected in the second half of 2020.

The primary and secondary endpoints of the trial are to assess safety, immune activation and clinical responses of ONCOS-102 and Keytruda combination treatment. The main scientific aim is to test the hypothesis that ONCOS-102 can immune activate anti-PD1 refractory patients to respond to re-challenge with an anti-PD1 CPI.

Magnus Jäderberg, CMO of Targovax, said: "We are very pleased to have completed enrollment of our melanoma trial. ONCOS-102 is currently one of the most clinically advanced oncolytic viruses in this difficult to treat cancer, and therefore a high priority for us. With this trial also being a proof of concept trial, clinical and immune data from this study will not just indicate whether ONCOS-102 in combination with CPIs can help patients with hard to treat melanoma but potentially also other tumor indications. Supportive data could open the path for a registrational trial."