NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

iclight,

Thanks for reposting your opinions about the Keytruda study again. It is always worthwhile to remind us about the small but mighty PD1 combo study that is ongoing at UCLA today! The P3 looks like the tip of the iceberg and it is interesting to consider the P3 data in light of the emerging combo data!

A full-context overview might help us think about the prospective value of DCVax technology as a platform…

The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include multiple trials spanning years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.

The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.



https://clinicaltrials.gov/ct2/show/NCT04201873


In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.

The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.



The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.

NIH-funded DCVax-L research is ongoing at UCLA today.

NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.




https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/



https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life

https://www.braintumourresearch.org/stories/in-hope/in-hope-stories/kat-charles

https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials

https://www.uclahealth.org/news/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020



https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter



https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials

https://www.societyns.org/about/officers-detail/linda-m-liau-md-phd-mba-4


https://www.jci.org/articles/view/169314