NW Bio releases promising new data on DCVax-Direct Phase I trial for inoperable solid tumors

Northwest Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, over the weekend in Chicago released promising new data on their Phase I trial of DCVax-Direct for direct injection into all types of inoperable solid tumors.

The patients enrolled in the trial had late stage cancers, with an average of three inoperable tumors. The patients had failed multiple prior therapies and had a poor prognosis.

The trial enrolled 40 patients, and 39 were evaluable. A conservative treatment regimen was used. Although the patients had multiple inoperable tumors, only 1 tumor was injected with DCVax-Direct. The treatments included only 3 injections in the first 2 weeks (Day 0, 7 and 14), and up to 3 additional injections spaced months apart thereafter (Weeks 8, 16 and 32), over a total period of 8 months.

Patients typically received their first injection about 1-1/2 months after recruitment. Four patients are still in the process of completing the study visits, and data collection is ongoing on all of the patients.

The trial tested three different dose levels of DCVax-Direct, two different methods of activating the dendritic cells that comprise DCVax-Direct, and a dozen different cancers. Findings to date include encouraging survival data and substantial induction of immune checkpoint expression (PDL-1).

The webcast and presentation by Dr. Bosch can be found on the Company's website at nwbio.com/webcast

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.

"We are quite encouraged to see these results across diverse types of cancers, in late stage patients with multiple inoperable tumors who have exhausted other treatment options, and with quite a conservative DCVax-Direct treatment regimen," commented Linda Powers, CEO of NW Bio. "We are looking forward to proceeding with Phase II trials applying the lessons learned from this informative Phase I trial."