AI
Tuesday, September 09, 2025 1:34:28 AM
Read the following, the longs may take a guess on why the MHRA approval takes perversely long. But I don't worry about the approval at all. The RWE data from the UK Specials Programs which have been including poly-iclc since January 2016 is the insurance for the approval.
https://braintumourresearch.org/blogs/research-campaigning-news/now-we-need-progress-for-brain-tumour-patients?srsltid=AfmBOop-1Z-ObGnxk7zsaNX8c0sZX7QY-AallXNlhO_yMouGbguTY0H9
BioNTech expands UK partnership with up to $1.33 billion investment
https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-plans-up-133-billion-investment-united-kingdom-2025-05-20/
Since I believe all those DC vaccine trials that have amazing efficacy are related to $NWBO's core technology and sooner or later the two spin-offs: Mill Creek Life Sciences and Immuorestoration will be merged with $NWBO, I picture LP will give the longs a big surprise and the approval based on the new FDA pilot voucher program could be the big surprise.
Take a look at the table from the Direct trial. Among five melanoma patients, three patients had significant t-cell infiltration activated by the Direct. I supposed the other two patients should also have significant t-cell infiltration if they were available for being determined.
Can we imagine what would happen if keytruda were added to make infiltrating t-cells spot cancer cells better? That's why the following trial should have blockbuster results if the DC vaccine was the Direct. How could the results not be amazing? Keytruda was added along with Prevnar 13. Cyrosurgery can even boost anti-tumor immune response more. The procedure can pulverize tumor tissue and make the DCs pick up tumor antigens in-situ more effectively and efficiently. Don't be intimidated by the trial status marked as 'Terminated'. The variation of the trial status makes the trial even more interesting.
Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma
https://clinicaltrials.gov/study/NCT03325101
•Intratumoral DCs + Cryosurgery + pembrolizumab + Prevnar13
Record Verification: 2017-10 Overall Status: Not yet recruiting
Record Verification: 2017-10 Overall Status: Recruiting
Record Verification: 2019-05 Overall Status: Recruiting
Record Verification: 2020-05 Overall Status: Recruiting
Record Verification: 2020-11 Overall Status: Suspended
Record Verification: 2021-12 Overall Status: Active, not recruiting
Record Verification: 2024-07 Overall Status: Active, not recruiting
Record Verification: 2024-08 Overall Status: Completed
Record Verification: 2024-08 Overall Status: Terminated
The following figure is from the trial on lymphoma which had no keytruda.
Can we expect blockbuster results from the following trial too given that keytruda was added to the combination? Absolutely!
Phase I/II Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation and Anti-PD-1 Antibody (Pembrolizumab) for Patients With Non-Hodgkin Lymphoma
https://clinicaltrials.gov/study/NCT03035331
•Intratumoral DCs + cryosurgery + pembrolizumab + Prevnar13
Of course, the combo trial on rGBM which is about DCVax-L has absolutely stunning results and should be granted approval right away.
https://braintumourresearch.org/blogs/research-campaigning-news/now-we-need-progress-for-brain-tumour-patients?srsltid=AfmBOop-1Z-ObGnxk7zsaNX8c0sZX7QY-AallXNlhO_yMouGbguTY0H9
BioNTech expands UK partnership with up to $1.33 billion investment
https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-plans-up-133-billion-investment-united-kingdom-2025-05-20/
Since I believe all those DC vaccine trials that have amazing efficacy are related to $NWBO's core technology and sooner or later the two spin-offs: Mill Creek Life Sciences and Immuorestoration will be merged with $NWBO, I picture LP will give the longs a big surprise and the approval based on the new FDA pilot voucher program could be the big surprise.
Take a look at the table from the Direct trial. Among five melanoma patients, three patients had significant t-cell infiltration activated by the Direct. I supposed the other two patients should also have significant t-cell infiltration if they were available for being determined.
Can we imagine what would happen if keytruda were added to make infiltrating t-cells spot cancer cells better? That's why the following trial should have blockbuster results if the DC vaccine was the Direct. How could the results not be amazing? Keytruda was added along with Prevnar 13. Cyrosurgery can even boost anti-tumor immune response more. The procedure can pulverize tumor tissue and make the DCs pick up tumor antigens in-situ more effectively and efficiently. Don't be intimidated by the trial status marked as 'Terminated'. The variation of the trial status makes the trial even more interesting.
Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma
https://clinicaltrials.gov/study/NCT03325101
•Intratumoral DCs + Cryosurgery + pembrolizumab + Prevnar13
Record Verification: 2017-10 Overall Status: Not yet recruiting
Record Verification: 2017-10 Overall Status: Recruiting
Record Verification: 2019-05 Overall Status: Recruiting
Record Verification: 2020-05 Overall Status: Recruiting
Record Verification: 2020-11 Overall Status: Suspended
Record Verification: 2021-12 Overall Status: Active, not recruiting
Record Verification: 2024-07 Overall Status: Active, not recruiting
Record Verification: 2024-08 Overall Status: Completed
Record Verification: 2024-08 Overall Status: Terminated
The following figure is from the trial on lymphoma which had no keytruda.
Can we expect blockbuster results from the following trial too given that keytruda was added to the combination? Absolutely!
Phase I/II Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation and Anti-PD-1 Antibody (Pembrolizumab) for Patients With Non-Hodgkin Lymphoma
https://clinicaltrials.gov/study/NCT03035331
•Intratumoral DCs + cryosurgery + pembrolizumab + Prevnar13
Of course, the combo trial on rGBM which is about DCVax-L has absolutely stunning results and should be granted approval right away.
Excited for the new National Priority Voucher pilot program! pic.twitter.com/YsIciT0f5P
— Dr. Marty Makary (@DrMakaryFDA) August 21, 2025
FDA Commissioner @DrMakaryFDA talks about promising treatments in the pipeline and the innovations and breakthroughs he’d like to see in the future. pic.twitter.com/KdJKF8QB0w
— U.S. FDA (@US_FDA) July 11, 2025
