Harnessing the power of cell therapies
Diseases of the brain and CNS are of the largest medical challenges of our time.
Patients with degenerative diseases have few treatment options, and none of the current therapeutic modalities modify the disease itself necessitating novel advanced stem cell therapy with CURATIVE or DISEASE MODIFYING potential.
Oscine will expand the possibilities for curing diseases by developing regenerative medicine products and pioneer the biotechnological revolution taking place within cell therapy.
Recent groundbreaking scientific insights into the genetic causes and biological processes underlying neurodegenerative and white matter diseases demonstrate that several of these diseases are attributable to dysfunction or loss of single cell types and thus offer an unprecedented opportunity for the discovery and development of effective and potentially curative cell based medicines.
Oscine will expand the possibilities for defeating degeneration and curing diseases attributable to dysfunction or loss of single cell types originating from Glia Progenitor Cells.
Oscines is pioneering the development of a robust Glia Progenitor Cell platform that is applicable to a variety of cell sources including embryonic stem cells (ESC) and induced pluripotent stem cells (iPSC).
Initially Oscine will progress a hESC based therapeutic candidate into the clinic for PMD, SPMS and HD in 2020 while continuing the assessment of iPSC derived products which in the current regulatory environment are expected to face longer time to clinic and potential higher risk of tumor generation.
To unlock the potential of cell therapy to transform medicine Oscine’s broadly patented platform has been developed and refined over decades with support from major funding agencies and top KOLs in the stem cell field.
Many protocols describe enrichment of glia progenitor cell populations through isolation by their expression of gangliosides recognized by mAb A2B5, however this marker also identifies lineage-restricted astrocytes and immature neurons thus limiting the potential of such a population as therapeutic vector both in terms of efficacy and risk of tumorigenicity.
Oscine’s propriety protocols provide pure cell populations consisting of Glia Progenitor Cells that are highly homogeneous as to bipotential astrocyte-oligodendrocyte progenitor cells (Sim, Nature Biotech, 2011; Goldman, Science, 2012; Wang, Cell Stem cell, 2013, Douvaras lab, Stem Cell Reports, 2014; Wang, Stem Cells and Development, 2013).
The robust protocol provides a Cd140a population incidence reliably at >70% by 180 DIV, and >80% at 210 DIV. Following sorting via immunomagnetic separation before transplant the sorted populations are invariably >99% CD140a.
Oscine uses Waisman Biomanufacturing as our CMO partner.
The starting material for the our cell product will be cGMP-grade ESC or cGMP-grade iPSC and all raw materials and reagents are of the highest grade available. Any raw materials of animal origin are tested to ensure they are free of adventitious viruses. The final cell product undergo characterization and release testing. In addition, cells are monitored via in-process testing. The cell product will be distributed to the clinical site where it will be processed before delivery to patients – and ultimately providing a transformative cell therapy that’s the first of its kind.
Leading cell biologists and process developers associated with Oscine and our corporate partner Sana Biotechnology work closely to optimize our process with respect to ensure implementation of forefront automatization and next generation bioreactor technologies.