Replies to post #470047 on NorthWest Biotherapeutics Inc (NWBO)

[GoodGuyBill]

The trial IS successful. Doc Logic, Senti and Danish Dude can shed additional details, but the presentation was unmistakably clear.

Conclusions (1)

• The completion of a large, phase 3 trial including 331 patients,
94 sites, over 70 clinical investigators, in 4 countries using an
autologous, dendritic cell, tumor lysate (DCVax-L) shows
efficacy to meet the primary and secondary end-points of an
increase in O.S. for nGBM and rGBM

• The vaccine is easily administered and has a favorable safety
profile.

• The use of external, contemporaneous clinical trials (n = 5 for
nGBM and n =10 for rGBM) is innovative, and going forward,
could be transformative given the poor track record and
numerous failed trails in neuro-oncology.

• There is a significant percentage of long-term survivors,
consistent with an immune memory effect by the T-cells,
potentially changing the natural history of GBM from a
uniformly fatal to a chronic, manageable disease.

Conclusions(2)

• Specific subpopulations show an unanticipated benefit
including; a) older patients, and b) patients with residual
disease after surgery. As expected, patients with methylated
MGMT promoter fare better than unmethylated group.

• The feasibility of the vaccination process enables widespread
application in the community setting, as well as in major
academic centers of excellence.

• The use of dendritic cells as the master, professional antigen
presenting cells allows for combination therapy using other
approaches such as blockade of immunosuppressive
cytokines, CAR T cells, viral oncolytic therapy, electric field
therapy, DNA vaccines, etc.

• Preliminary data shows evidence of T cell infiltration into the
target tissue (Glioblastoma).