Immunic has enrolled the first subject in its Phase I clinical trial of IMU-935 to treat metastatic castration-resistant prostate cancer (mCRPC).
IMU-935 is a highly potent and selective inverse RORγt agonist and has additional activity on the dihydroorotate dehydrogenase (DHODH) enzyme.
The open-label, non-randomised Phase I study is designed in two parts, notably a dose-escalation part and an optional dose-expansion portion.
It is expected to enrol 42 participants, with around 18 to 24 participants planned to be enrolled for the dose-escalation part.
In this portion of the trial, three IMU-935 dose levels will be given to the participants for three 28-day cycles.
A safety analysis after 28 days and an interim analysis after three months of the IMU-935 treatment will be performed at each of the three-dose levels.
The trial’s main analysis is scheduled to be conducted following the last participants’ six months study treatment.
Safety and tolerability of IMU-935’s increasing doses evaluation to establish the maximum tolerated dose, as well as the recommended dose for the Phase II study, will be evaluated as the trial’s primary goal.
IMU-935’s anti-tumour activity will also be assessed in the trial by circulating tumour cell (CTC) numbers, prostate-specific antigen (PSA) levels, and radiographic response assessments of tumour progression.
Immunic president and CEO Daniel Vitt said: “Based on the compelling preclinical data highlighting the therapeutic potential of IMU-935 to affect mCRPC, which is the second leading cause of cancer-related death among men, we recognise the potential importance of this programme.
“We are pleased to have enrolled the first patient on plan and look forward to continuing to progress the trial.”
The company stated that the patients who benefit from treatment with IMU-935 will have a chance to continue treatment until progression.
An expansion part of the trial at one or two active dose levels with up to 18 more patients could be conducted after all dose-escalation cohorts conclude.
This will support the selection of a recommended dose for the Phase II trial.
The trial’s initial clinical data is anticipated in the third quarter of next year.
Furthermore, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the Research Ethics Committee (REC) and the Health Research Authority (HRA) approved the clinical trial.
In February 2021, Immunic announced that the main analysis data from the Phase II CALVID-1 trial of IMU-838 showed evidence of clinical activity in hospitalised patients with moderate Covid-19.