"Determination of mOBD will be made by Cohort Review Committee (CRC) review and requires successive dosing within cohorts of at least 3 patients each. Our PD1-Vaxx CRC consists of all study investigators and is co-chaired by an independent clinical immunologist and Imugene’s CMO, Dr Rita Laeufle. The CRC meet to review safety and tolerability data after the last patient in each cohort has completed 30 days treatment. If the CRC confirms a particular dose as safe and tolerable, then approval is given to enrol patients to the next dose level. The highest dose level with the best immune response becomes the mOBD."
Read the above excerpt from the announcement. 30 days after last patient of each cohort, we get NEWS of safety and tolerability. Won't have to wait until 2022 at all. Might even get news by first quarter of 2021 if all 3 patients in first cohort is dosed within January/February.
And if deem safe and tolerable, then they increase the dosage for next cohort of patients and so on. So we will be getting news update every few months here.
Exciting time ahead for sure. Imagine after first cohort and they say, 'yep, non-toxic and tolerated beautifully'. They might even see positive cancer response! Who knows, right?
I am no medical person so there is one thing I would like people who understand to please confirm for me. This trial is only using PD1-Vaxx without any chemo, right? Thanks.
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