RE:AEZS update next?AEZS: July 2023:
AIM Biological: Next Steps
"Evaluation of manufacturing strategy and initiation of production of selected development candidates.
Ongoing compilation of a comprehensive pre-clinical data package for scientific advice meetings with regulatory authorities, expected to take place in the near future."
If AEZS has locked in a clinical trial candidate and manufacturing strategy for human trials and has defined the human clinical trial program to proceed the AIM Biologicals program may be near a 'go' decision for human testing. Tolerability in humans appears substantially de-risked and it appears to work. AEZS has spent years developing a robust data set for this program. Being able to leave the cash burning and ultra-high risk preclinical stage and move into human testing where value accretive steps can accelerate with human data would be an important milestone. The platform could address markets in the billions.
Platform technology can be adapted to different diseases by antigen selection:
Lead target indication: NMOSD: Expected to be a US$2.5 billion market by 2028
- Excellent tolerability expected which could leave efficacy risk.
- Does it work? It's based on the natural science that allows a mother's immune system not to reject a fetus despite half of its proteins being from the father. It induces specific immune tolerance as opposed to knocking down the immune system more generally exposing the patient to the risk of infections diseases and cancer.
- Works across various in-vitro and in-vivo models strengthening the case: "Demonstrated positive pre-clinical proof-of-concept in various in-vitro and in-vivo models."
- They know how it works in two different diseases further strengtheing the case: "Confirmed AIM Biologicals’ mechanism of action and efficacy in ex-vivo studies in human blood samples from both NMOSD and PD patients."
- July 2023: "Ongoing compilation of a comprehensive pre-clinical data package for scientific advice meetings with regulatory authorities, expected to take place in the near future."
Second target indication: Parkinson's: Current treatment market of $4.28
- Demonstrated improvements in preclinical Parkinson's disease model.
Exciting: AIM Biologicals is a platform technology that can be adapted to different diseases by antigen selection.