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Message: Upcoming biOasis Non-Human Primate Studies
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There were some very interesting phrases used in the news release from last week. I am very curious to hear what "non-invasive brain imaging" methodologies that biOasis and its partner will be using to "assess targets for their ability to get to the needed site of action in the brain."
Armagen has published various reports of their NHP studies that used a radioiodinated form of the HIRMAb-enzyme fusion to assess brain uptake. However, these animals are euthanized two hours after infusion of the labeled drug in order to harvest the brain, section the brain and perform autoradiography to image the brain. Here are a couple of Armagen's examples for two lysosomal storage diseases: MPSI/Hurler Syndrome/alpha-L-iduronidase (IDU) deficiency and MPSII/Hunter Syndrome/iduronate-2-sulfatase (I2S) deficiency:
https://www.ncbi.nlm.nih.gov/pubmed/24059813
https://www.ncbi.nlm.nih.gov/pubmed/28279069
This Armagen approach is far from "non-invasive," which leads me to believe that some label other than 125-I radioiodination will be used with the Mtfp-drug imaging. Perhaps biOasis will use some form of MRI, PET or CT scan with a compatible label to allow for their non-invasive brain imaging.
Beyond showing just an ability to get to the brain, the biOasis news release states "Only those targets showing actual target engagement will advance into phase 0 microdosing studies. This means we advance only those drugs where we see significant uptake in NHP imaging. The drugs with the best brain uptake will be prioritized for their use in human phase 0 studies....Target Engagement: The drug must reach its target in the brain (e.g., brain metastasis/glioblastoma) in sufficient quantities to be able to test the hypothesis in the clinic."
How will they define "significant update" and "sufficient quantities?" These are very likely going to be short-term studies in a non-disease NHP model, so it is highly unlikely that they will be assessing any biological outcomes (i.e. tumor size, LSD accumulation of metabolites, etc). The two Armagen studies linked above found brain uptake of their fusion proteins to be 1 to 1.2% of injected dose/brain. Will the most important read out of these biOasis NHP studies be the percent brain uptake of the injected dose? If so, is the 1 to 1.2% value achieved by Armagen the the benchmark? How will they know that "sufficient quantities" have been achieved if there is not a biological readout associated with these NHP studies? Will their non-invasive imaging allow for the assessment of tissue uptake into peripheral tissues?
I look forward to hearing more about these studies in the near future!
BearDownAZ
How will they define "significant update" and "sufficient quantities?" These are very likely going to be short-term studies in a non-disease NHP model, so it is highly unlikely that they will be assessing any biological outcomes (i.e. tumor size, LSD accumulation of metabolites, etc). The two Armagen studies linked above found brain uptake of their fusion proteins to be 1 to 1.2% of injected dose/brain. Will the most important read out of these biOasis NHP studies be the percent brain uptake of the injected dose? If so, is the 1 to 1.2% value achieved by Armagen the the benchmark? How will they know that "sufficient quantities" have been achieved if there is not a biological readout associated with these NHP studies? Will their non-invasive imaging allow for the assessment of tissue uptake into peripheral tissues?
I look forward to hearing more about these studies in the near future!
BearDownAZ
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