NorthWest Biotherapeutics Inc (NWBO)

[CogDiss 1188X]

G100 has shown single-agent activity, unlike DCVax-Direct.

All of the following, from the initial PR, seems to suggest single agent activity. Especially given the fact that systemic effects were seen after a single local injection. Certainly much more work to be done to optimize its use but stating Direct has not shown single agent activity seems incorrect.

This is not to say that their release of data around DCVAX-D isn’t sorely lacking. I may be wrong but I don’t believe the full results have been published. The release of Wheler calculations only for the top responders raises questions needlessly.

https://nwbio.com/nw-bio-announces-data-date-dcvax-direct-phase-trial/
Findings to date include the following:
• 27 of 39 patients are still alive at up to 18 months after first injection.
• Patient survival correlates with the method of dendritic cell activation used.  With the preferred method, 18 of 21 patients are still alive.
• Treatment effects have been observed in diverse cancers, including lung, breast, colorectal, pancreatic, sarcoma, melanoma, neuro-endocrine and other cancers.
• Patient survival correlates with the number of DCVax-Direct injections.
• Patient survival also correlates with stabilization of disease at Week 8 (4th injection visit).  Among patients treated with the preferred method of dendritic cell activation, 16 of 19 achieved stable disease (i.e., less than 25% increase in tumor size from baseline) at Week 8.
 
Findings to date relating to immunological responses include the following:
• Induction of PDL-1 immune checkpoint expression was seen in 64% of evaluable patients (14 of 22) following DCVax-Direct treatment.  This suggests that the tumors are putting up defenses against the immune responses induced by DCVax-Direct, and marks these patients as potential candidates for treatment with checkpoint inhibitor therapies.
• An increase in T-cell infiltration into tumors, by functionally active T-cells, was seen following DCVax-Direct treatment.
• Both local effects (in the injected tumor) and systemic effects were observed.