NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Some of the primary points, that I find most interesting and positive, in the new article in Nature about ATL-DC (DCVax-L) along with poly-ICLC are the following:

(1) The size of the future DCVax-L initial addressable market size for brain cancer patients continues to grow. At first, NWBio was only focused on treating newly diagnosed Grade IV Glioblastoma (nGBM) patients. Then, because of the outstanding results of the DCVax-L Phase III trial, now the addressable market was increased to include Grade IV recurrent GBM (rGBM) patients.

Now, as a result of this study, and the exceptional efficacy results, with adding poly-ICLC, DCVax-L will also eventually add Grade III malignant brain tumors to its approved label. This will include Anaplastic Astrocytoma (AA) and Anaplastic Oligodendroglioma (AO). This will effectively double the size of the DCVax-L addressable market in all of its approved markets worldwide.

(2) I believe that this study and the subsequent analysis was primarily done to help set the stage for tissue agnostic approvals for DCVax-L.

This study was small, and according to the study authors, was not powered for efficacy, but was primarily powered for immune biomarkers analysis. This is consistent with what is needed to determine if a new drug or biologic is tissue agnostic.

This study also included extensive proteomics analysis. If you combine this analysis, with the proteomics and mechanism of action (MOA) analysis that Dr. Marnix Bosch presented at ASCO 2023, you can see that NWBio is building a very strong case for tissue agnostic approvals for DCVax-L.

Here are some quotes from the study regarding biomarker analysis:

Patients who had higher expression of interferon response genes lived significantly longer and had longer time to progression compared to those with lower expression. The results suggest that ATL-DC in conjunction with adjuvant poly-lCLC induces a polarized interferon response in circulating monocytes and specific activation of a CD8+ T cell population, which may represent an important blood biomarker for immunotherapy in this patient population

https://assets.researchsquare.com/files/rs-3287211/v1_covered_39e6c81f-e46d-481d-979a-0dc7594a1c6c.pdf?c=1694496784

Here are some quotes from the FDA’s Tissue Agnostic drug development guidance:

For the purpose of this guidance, the term tissue agnostic oncology drug refers to a drug that targets a specific molecular alteration(s)3 (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type. A tissue agnostic oncology drug can therefore be used to treat multiple types of cancer (e.g., colorectal, thyroid, and breast cancers) with the targeted molecular alteration (e.g., either the same targeted molecular alteration or targeted molecular alterations affecting a single pathway).

https://www.fda.gov/media/162346/download