NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Some prefer to focus on, or argue and debate about the past or ancient history., such as: (1) why did Toucan / Linda Powers start Cognate in 2002, or (2) was DCVax-L approved by the Swiss in 2007?

But, I believe it is important to focus on the present and the future. I believe that starting in 2022, we will see the following become reality:

DCVax-L will be approved to treat newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM), in the US, UK, Canada, Germany and the rest of the EU.

Then, also in 2022, I believe we will see NWBio (or the BP that acquires NWBio) initiate an Investigational New Drug application (IND) with the FDA for both DCVax-L and DCVax Direct. I believe these 2 INDs will help start a Phase II/III clinical trial to confirm the safety and efficacy, and establish both DCVax-L (operable solid tumor cancers) and DCVax Direct (inoperable solid tumor cancers) as personalized immuno-oncology and immunotherapy platforms to treat all or most solid tumor cancers.

I also believe each of these Phase II/III clinical trials for DCVax-L and DCVax Direct will be a “Basket Trial” with a Master Protocol design, and will simultaneously evaluate multiple solid tumor cancer types ( such as: lung, stomach, colon, breast, testicular, ovarian, prostate, uterine, pancreas, bladder, etc.) in one trial. This will greatly accelerate how long it will take for both DCVax-L and DCVax Direct to be approved as platform immunological vaccine to treat all or most solid tumor cancers.

I believe that each of these clinical trials for DCVax-L and DCVax Direct will be based on the guidance issued by the FDA, where the single investigational biologic is DCVax-L with or without a PD-1 inhibitor in 1 basket trial, and DCVax Direct with or without a PD-1 inhibitor in the other basket trial. Then, the Disease Type (D1, D2, D3, D4, D5, etc.) will be different solid tumor cancers (Lung, Prostate, Colon, Breast, Pancreas, etc.)





https://www.fda.gov/media/125556/download

This is similar to the Istari Oncology basket trial for solid tumor cancers, using PVSRIPO with or without a PD-1 inhibitor. It is also similar to the CytoDyn Phase II basket trial evaluating the safety and efficacy of Leronlimab in treating 22 different types of solid tumor cancers, including: melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, etc.:

https://finance.yahoo.com/news/istari-oncology-announces-fda-clearance-120300015.html

https://www.cytodyn.com/newsroom/press-releases/detail/416/cytodyns-phase-2-basket-trial-for-22-solid-cancer-tumors