NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

TiltMyBrain, DCVax is about to give a knockout 1-2 punch against brain tumors and will mark a historic moment to the joy of cancer patients and oncologists.

1. Regulatory approvals (first UK, then globally) DCVax-L for stage 4 brain tumors/GBM
(replaces standard of care, generates robust immune memory, potential for cure, non-toxic)

2. Validation for off-label to add Poly-ICLC (adjuvant to DCVax-L therapy) for stage 3 brain tumors
(UCLA phase 2 clinical trial results, Nature scientific publication)

Excerpts from this Nature publication on the UCLA Phase 2 clinical trial:
- "results support the conclusion that DC vaccination with poly-ICLC induces Type I and Type II IFN responses more effectively than with adjuvant resiquimod or a dendritic cell vaccine alone"
- "combination of ATL-DC vaccination and TLR agonist was safe and found to enhance systemic immune responses"
- "placebo: 7.7 months, poly-ICLC: 52.5 months"
- "for the IDH mutant/Grade III cohort, all four patients that received ATL-DC + poly-ICLC treatment are still alive at the cutoff date (three of the patients have survival >120 months and one > 112 months), and they have significantly longer OS and PFS compared to... ATL-DC + resiquimod or ATL-DC alone"

Off-label drug use is common in cancer treatment because
- many cancer drugs are effective against more than one type of cancer
- cancer treatment often involves the use of combination chemotherapy
...
The FDA usually does not approve combinations of chemotherapy. There are so many of them that it would not be practical to approve each combination.

Health insurance coverage of off-label drugs in cancer treatment
Medicare and many insurance companies pay for off-label drugs for cancer treatment, as long as the off-label uses are listed in an approved compendium. A compendium is a collection of drug summaries put together by experts who have reviewed data about the drug’s use in patients.

https://www.cancer.gov/about-cancer/treatment/drugs/off-label