Medigene has been given a green light by regulators in Germany to start human trials of MDG1011, the lead candidate to come out of its modified T-cell program.
The Munich-based biotech says it will start a combined phase 1/2 safety and feasibility trial of the T-cell receptor (TCR) cancer immunotherapy in about 92 patients with acute myeloid leukemia (AML), myelodysplastic syndrome or multiple myeloma “within the coming weeks.”
Analysts at Edison said in a recent research note that this will be one of the first TCR trials in Germany and moves Medigene “further into the spotlight as a promising immunotherapy player.”
They think Medigene’s TCR approach could have safety and efficacy advantages over other cell-based immunotherapies such as CAR-T, including no evidence as yet that they can stimulate cytokine-release syndrome (CRS) and seem to have greater specificity for target proteins. That potential has already attracted the attention of Bluebird Bio, which cut a TCR-focused dealwith the German biotech in 2016.
The trial approval has come a little later than expected, as Medigene had hoped to get the go-ahead before the end of last year, but comes at an opportune time as the biotech says its contract manufacturer has also just been given a license for the process of combining TCRs with patient-derived T cells.
“Attaining these approvals for MDG1011 is an important step towards the start of our clinical trial, and a further validation of our research and product development work,” commented Kai Pinkernell, M.D., Medigene’s chief medical officer.
“With our specific study design, we are able to evaluate our T cell therapy simultaneously in various diseases and to generate data in three hematological indications in parallel.”
The first phase of the trial—which could be completed in about 12 months—will enroll 12 patients whose cancers test positive for the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma), which is targeted by MDG1011. This phase will include three or possibly four doses of the therapy, and, if positive, phase 2 will then begin in two of the three blood cancer indications.
Edison notes that the trial gives Medigene a second clinical-stage development program to go alongside its patient-derived dendritic cell vaccines, headed by an AML candidate which should complete a phase 1/2 trial in the next few months.