biOasis Technologies Ord Shs V.BTI.H

Bioasis Corporate Presentation Slide Deck from March 2019

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I think this is the first Bioasis slide deck posted to the website since Dr. Deborah Rathjen became CEO. Looks to have a date of 3/22/2019. Nice presentation that emphasizes that the primary lead program is xB3-001 (xB3 peptide fused to Herceptin antibody) for HER2+ breast cancer brain metastases and that the secondary lead program is xB3-007 for Gaucher's disease.

xB3-007 is xB3 + Imiglucerase, which is a recombinant analogue of human β-glucocerebrosidase. Currently, the Imiglucerase enzyme replacement therapy can treat peripheral but not neurological symptoms of Gaucher's due to the inefficient ability of enzymes to cross the BBB. It is not clearly stated that xB3-007 is a fusion protein; however, since Imiglucerase is a recombinantly produced enzyme it makes sense that xB3-007 will be a fusion protein.

Clearly stated timelines for both the xB3-001 and xB3-007 programs stated in slide deck. As stated previously, FDA pre-IND meeting for xB3-001 is anticipated in June 2019, with first-in-human for xB3-001 projected to start in H2 2020. xB3-007 is still pre-clincal and isn't projected to have pre-IND meeting with FDA until late 2020 with first in human for xB3-007 not projected until late 2021 or early 2022. Also interesting that this slide deck brings up the biologics license application (BLA) in addition to the new drug application (NDA). Here's a link to an FDA page on the BLA application. 

https://bioasisprodcdn.azureedge.net/wp-content/uploads/BTI.V-Corporate-Presentation-March-2019-03.22.19.pdf

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