Targovax ASA (OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, announces that clinical trials investigating ONCOS-102 in the treatment of melanoma and mesothelioma have successfully passed their respective first, planned, independent safety reviews. These are the first studies to investigate ONCOS-102 in combination with other drugs.
The safety reviews of ONCOS-102 in the first four patients in the melanoma trial and first three patients in the mesothelioma trial have been completed without any safety concerns. The review reports conclude that, to date, ONCOS-102 has been well-tolerated in combination with either checkpoint inhibitor (KEYTRUDA®), or chemotherapy (pemetrexed/cisplatin), and both trials were recommended to be continued by the study-specific safety committees.
The melanoma trial is an open-label phase I trial exploring the safety, immune activation and clinical response of sequential treatment with ONCOS-102 and the checkpoint inhibitor KEYTRUDA® (pembrolizumab, an anti-PD-1 monoclonal antibody) in patients with advanced or unresectable melanoma, whose tumors have continued to grow despite checkpoint inhibitor therapy. The goal of the trial is to investigate whether the immune system of patients, who have already failed to respond to checkpoint inhibitors, can be reactivated by priming with ONCOS-102 and whether this reactivation enables them to respond to subsequent retreatment with a checkpoint inhibitor.
The mesothelioma trial is a randomized phase II, open-label, multi-center trial with a phase Ib safety lead-in of ONCOS-102 and standard of care pemetrexed/cisplatin (chemotherapy) in patients with unresectable malignant pleural mesothelioma. The trial will include six patients in a lead-in to evaluate safety, followed by a randomized part of the trial to compare the combination treatment with the standard of care chemotherapy.
Dr Magnus Jäderberg, CMO of Targovax, said: “We are pleased that the first combination trials of ONCOS-102 have passed the initial safety reviews without any issues. As such, ONCOS-102 appears to be well-tolerated in combination with both checkpoint inhibition and chemotherapy, and we can proceed with the trials as planned. Our plan now is to evaluate immune responses in the first subset of patients”.
Immune response data readout schedule
Over the coming weeks and months, Targovax expects to release immune response data in a subset of patients for these two trials, in addition to the TG02 RAS neo-antigen vaccine trial in colorectal cancer, according to the following schedule:
In December: TG02 in colorectal cancer
In January: ONCOS-102 in melanoma
In February: ONCOS-102 in mesothelioma