NorthWest Biotherapeutics Inc (NWBO)

[DoGood_DoWell]

You might find Highwayman's post more informative:

From FDA website:

Clinical trial endpoints serve different purposes. In conventional oncology drug development, early phase clinical trials evaluate safety and identify evidence of biological drug activity, such as tumor shrinkage. Endpoints for later phase efficacy studies commonly evaluate whether a drug provides a clinical benefit such as prolongation of survival or an improvement in symptoms. The following sections discuss the general regulatory requirements for efficacy and how they have influenced endpoint selection for the approval of cancer drugs. Later sections describe these endpoints in more detail and discuss whether they might serve as measures of disease activity or clinical benefit in various clinical settings.

NWBO Phase 1 Direct Data:

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.


Based on the findings from the Phase I trial, the Company plans to enhance its Phase II trials in several ways, including by:

Using only the preferred activation method of the DCVax dendritic cells.

Injecting multiple inoperable tumors at each treatment visit, not just one.

Providing more frequent treatments and a larger total number of treatments.

The Company plans to pursue Phase II trials in non-small cell lung cancer and sarcoma, as well as a Phase II trial for multiple diverse types of cancers similar to the Phase I study. The Company also plans to expand the trial sites to include countries beyond the U.S.

Seems pretty straight forward. What else would you like commented on for this Ph I trial?