Thursday, July 10, 2025 11:54:40 PM
Chiugray, appreciate your post. You’re correct that INDs can’t be transferred from Mayo to MCLS. That’s accurate. But there’s additional context that helps clarify the situation.
The Mayo trials didn’t just explore a similar approach they applied the same core immune strategy described in the Roswell Park patents now exclusively licensed to NWBO.
Both trials:
NCT01957956 (newly diagnosed GBM)
https://clinicaltrials.gov/study/NCT01957956
NCT03360708 (recurrent GBM)
https://clinicaltrials.gov/study/NCT03360708
used autologous dendritic cells pulsed with pooled tumor lysate from other glioblastoma patients. That approach aligns directly with the key elements in NWBO’s licensed intellectual property:
1. Prepare autologous dendritic cells
2. Pulse them with pooled tumor antigens
3. Re-administer to stimulate a T-cell response targeting tumor-associated features, including vasculature
In NCT01957956, Dr. Linda Liau was involved through a formal collaboration between Mayo Clinic and UCLA.
That’s confirmed by the Ivy Foundation:
https://ivyfoundation.org/research_funded/combining-a-patients-optimized-dendritic-cells-potent-immune-stimulators-with-pooled-and-well-characterized-lysates-from-other-patients-brain-tumor-cultures-to-generate-an-anti-tum/
Dr. Liau is the principal investigator for the DCVax-L trial. Her involvement in the Mayo study shows a clear link between that trial design and the approach used in DCVax.
The Ivy Foundation also funded both programs:
~1.97 million dollars to Mayo for the pooled lysate trial
~ 1.2 million dollars to Dr. Liau for DCVax research at UCLA
https://ivyfoundation.org/uncategorized/ivy-foundation-grants-1-2-million-for-brain-cancer-study/
The shared funding, shared mechanism, and shared personnel suggest strategic alignment rather than independent efforts.
It’s true that MCLS would need to file a new IND if they planned to move this forward. But the larger issue is intellectual property. NWBO holds the exclusive license to Roswell Park patents that protect the method itself:
“A method of treating cancer comprising administering to a subject a composition comprising autologous dendritic cells pulsed ex vivo with tumor cell lysate derived from multiple allogeneic tumors”(U.S. Patent No. 8,445,024)
This description matches the approach used in NCT01957956. Any effort to commercialize that method would likely require a license from NWBO.
To clarify for those following the discussion: no one is claiming NWBO owns dendritic cells.
The company holds the rights to a specific method combining pooled tumor lysate with autologous dendritic cells to induce immune responses against solid tumors. That is the approach Mayo studied, Mill Creek manufactured, and NWBO controls under its license.
Taken together, the data, funding, and regulatory position suggest that while development occurred across institutions, the underlying platform method remains within NWBO’s IP framework.
The Mayo trials didn’t just explore a similar approach they applied the same core immune strategy described in the Roswell Park patents now exclusively licensed to NWBO.
Both trials:
NCT01957956 (newly diagnosed GBM)
https://clinicaltrials.gov/study/NCT01957956
NCT03360708 (recurrent GBM)
https://clinicaltrials.gov/study/NCT03360708
used autologous dendritic cells pulsed with pooled tumor lysate from other glioblastoma patients. That approach aligns directly with the key elements in NWBO’s licensed intellectual property:
1. Prepare autologous dendritic cells
2. Pulse them with pooled tumor antigens
3. Re-administer to stimulate a T-cell response targeting tumor-associated features, including vasculature
In NCT01957956, Dr. Linda Liau was involved through a formal collaboration between Mayo Clinic and UCLA.
That’s confirmed by the Ivy Foundation:
https://ivyfoundation.org/research_funded/combining-a-patients-optimized-dendritic-cells-potent-immune-stimulators-with-pooled-and-well-characterized-lysates-from-other-patients-brain-tumor-cultures-to-generate-an-anti-tum/
Dr. Liau is the principal investigator for the DCVax-L trial. Her involvement in the Mayo study shows a clear link between that trial design and the approach used in DCVax.
The Ivy Foundation also funded both programs:
~1.97 million dollars to Mayo for the pooled lysate trial
~ 1.2 million dollars to Dr. Liau for DCVax research at UCLA
https://ivyfoundation.org/uncategorized/ivy-foundation-grants-1-2-million-for-brain-cancer-study/
The shared funding, shared mechanism, and shared personnel suggest strategic alignment rather than independent efforts.
It’s true that MCLS would need to file a new IND if they planned to move this forward. But the larger issue is intellectual property. NWBO holds the exclusive license to Roswell Park patents that protect the method itself:
“A method of treating cancer comprising administering to a subject a composition comprising autologous dendritic cells pulsed ex vivo with tumor cell lysate derived from multiple allogeneic tumors”(U.S. Patent No. 8,445,024)
This description matches the approach used in NCT01957956. Any effort to commercialize that method would likely require a license from NWBO.
To clarify for those following the discussion: no one is claiming NWBO owns dendritic cells.
The company holds the rights to a specific method combining pooled tumor lysate with autologous dendritic cells to induce immune responses against solid tumors. That is the approach Mayo studied, Mill Creek manufactured, and NWBO controls under its license.
Taken together, the data, funding, and regulatory position suggest that while development occurred across institutions, the underlying platform method remains within NWBO’s IP framework.
Bullish
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