Nordic Life Science 1
PHASE I TARGOVAX COMPLETES ONCOS-102 TRIAL ENROLL
MENT In this Phase I trial ONCOS-102 is being tested in combination with Keytruda in patients with advanced anti-PD1 checkpoint inhibitor (CPI) refractory melanoma. ONCOS-102 IMMUNE activation is being tested in patients with advanced, unresectable melanoma Color amet this Uli Hacksell, CEO, Medivir who have had disease progression on treatment with anti-PD1 CPI. In July 2019, Targovax reported PH A SE I A The company has presented new data from its completed phase Ia study with MIV-818. HE PRIMARY OBJECTIVE of the study was to evaluate safety and tolerability of MIV-818 in liver cancer patients. A total of nine patients with advanced disease were included: six patients with metastatic liver cancer, two with hepatocellular carcinoma and one with intrahepatic cholangiocarcinoma. The pharmacokinetic analysis showed that patients were exposed only to low levels of MIV-818 and troxacitabine outside of the liver, providing experimental support for MIV-818’s liver targeting. The adverse events were mainly mild and the more serious side effects observed were reversible. Biomarker analysis of liver biopsies from patients showed a selective liver cancer effect of MIV-818: while tumor tissue had clear DNA damage, healthy liver tissue showed only minimal or no DNA damage. Based on an independent expert analysis of liver tumor growth, five of the nine patients were assessed to have stable liver disease after treatment. “This confirms our conclusion from the first six patients and provides strong support for the continued development of MIV-818 as a new and effective treatment for liver cancer. MIV-818 is our most important project and therefore it feels very good that our confidence in the possibilities of the compound is further strengthened by the new data presented today,” says Uli Hacksell, CEO, Medivir. encouraging results from part 1 of the trial. 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 is 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 immunologically activate anti-PD1 refractory patients to respond to re-challenge with an anti-PD1 CPI. Magnus Jäderberg, CEO, Targovax PHOTO © JOUKO KESKI-SÄNTTI 2013