Below is Part of Andrew's write-up on X
My question: Do the patient still need to send in their Tumor or just a sample of the Immune System (Blood / dendritic cells)?
Can this also be more complicated than the older Standard care routines, making the approval drag on? Like it is now
(Andrew's)
Most people think DCVAX L is a personalized tumor vaccine, but that is not exactly true. The real genius is that it trains your immune system using a prebuilt tumor lysate library, without needing a fresh tumor sample. The personalization comes not from the tumor, but from the dendritic cells, which must be your own. This design changes everything. It is scalable, efficient, and still fully individualized.
🧬 The Lysate is Shared
For years, people assumed the power of DCVAX came from pulsing a patient’s dendritic cells with their own tumor. But that is not how it works. And that is the point.
The tumor lysate used in DCVAX L is allogeneic. It comes from other people’s GBM tumors, not your own. NWBO built a standardized lysate library made up of shared glioblastoma antigens. That library is what trains the immune system, and it works across patients because GBM tends to express many of the same antigenic signals.
🧠 The Dendritic Cells Are Yours
So if the lysate is shared, what makes it personalized?
The dendritic cells.
Those must come from you. Your own monocytes, collected via leukapheresis. Because your immune system only listens to you. Another person’s dendritic cells would be seen as foreign. The dendritic cell is the immune messenger, the teacher that presents the tumor’s signature to your T cells.
📚 The Immune Classroom Analogy
The result is a system that is both scalable and individualized:
The lysate is the textbook
Your dendritic cells are the teacher
Your immune system is the student
📦 Why This Matters
(Note: the lysate used in the Phase 3 and combo trials is confirmed to be allogeneic, not patient-specific.)
This model does two things brilliantly:
It removes the need to collect, clean, or qualify the patient’s own tumor, which is often damaged, necrotic, or too small.
It allows NWBO to build a centralized, GMP compliant tumor antigen library that can be manufactured, validated, and applied across thousands of patients.
Where Mill Creek and Merck Fit In
That is where partners like Mill Creek Life Sciences come in. They help create the environment where tumor tissue can be collected, banked, processed, and standardized. This also helps explain why Merck may be funding continued tissue infrastructure, even in paused GBM trials. Not for patient dosing, but to build out the antigen archive for future immunotherapy combinations.
In fact, over three million dollars was paid to a Mayo Clinic investigator in 2022 under a Keytruda GBM trial that had already been suspended. Why? Possibly to retain the infrastructure and access to tissue. To gather and process lysate from high-grade glioma cases. To prepare for a future combination trial, perhaps one powered by DCVAX.
Mayo used shared lysate. UCLA required at least 2 grams of patient tumor. Both showed immune activation. But only one path is scalable. DCVAX L does not depend on tumor harvest, and that is the difference between innovation and infrastructure.
Bullish
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