NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

PLEASE COMMENT:




Hello AE, my question is:

Why would DCVAX_L succeed as an outlier where all the others who have tried the same MOA failed?

The same tech has already been tried and failed in ndGBM multiple times:(and every other indication it has been tried in)—both PFS and OS:

Since 1996 over 200 DC based vaccines (mainly lysate) have been tested and all with the exception of one (Provenge) have failed.
source=August 2019 "Dendritic cells in cancer immunology and immunotherapy"
https://www.nature.com/articles/s41577-019-0210-z

Both AV0113 (aka “Trivax”) and Audencel are whole tumor lysate loaded DC vaccines just like DCVax-L, and they both failed to show a survival benefit in ndGBM (add in ICT-107 loaded with synthetic antigens for good measure).

AUDENCEL fail- Published: 5 October 2018
https://www.mdpi.com/2072-6694/10/10/372/htm

"Dendritic cells (DCs) are antigen-presenting cells that are capable of priming anti-tumor immune responses, thus serving as attractive tools to generate tumor vaccines. In this multicentric randomized open-label phase II study, we investigated the efficacy of vaccination with tumor lysate-charged autologous DCs (Audencel) in newly diagnosed glioblastoma multiforme (GBM). Patients aged 18 to 70 years with histologically proven primary GBM and resection of at least 70% were randomized 1:1 to standard of care (SOC) or SOC plus vaccination (weekly intranodal application in weeks seven to 10, followed by monthly intervals). The primary endpoint was progression-free survival at 12 months. Secondary endpoints were overall survival, safety, and toxicity. Seventy-six adult patients were analyzed in this study. Vaccinations were given for seven (3–20) months on average. No severe toxicity was attributable to vaccination. Seven patients showed flu-like symptoms, and six patients developed local skin reactions. Progression-free survival at 12 months did not differ significantly between the control and vaccine groups (28.4% versus 24.5%, p = 0.9975). Median overall survival was similar with 18.3 months (vaccine: 564 days, 95% CI: 436–671 versus control: 568 days, 95% CI: 349–680; p = 0.89, harzard ratio (HR) 0.99). Hence, in this trial, the clinical outcomes of patients with primary GBM could not be improved by the addition of Audencel to SOC."