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![andrewcaravello Avatar](https://lunarcrush.com/gi/w:24/cr:twitter::244291506.png) Andrew Caravello, DO [@andrewcaravello](/creator/twitter/andrewcaravello) on x 1070 followers
Created: 2025-07-10 11:37:46 UTC

$NWBO 🛸 The Signal That Was Jammed by $MRK ⁉️ (Part Deux)

How Three Dendritic Cell Trials in Colorectal Cancer Were Silenced  (Until They Weren’t)

🗞️ Why I Deleted the Original Post 

On July 9, I deleted the first version of this post, originally titled “The Signal That Was Jammed.” It was based on a promising but misdirected listing (NCT03735290) that pointed to a different terminated study, a basket trial using an allogeneic dendritic cell vaccine with checkpoint inhibitors in cold tumors like gastric and gastroesophageal junctional adenocarcinomas. It wasn’t the Roswell colorectal trial I was looking for.

And yes, that story deserves its own thread. But without hard proof linking NCT03735290 to Roswell’s autologous DC trial, I couldn’t justify leaving the post up.

So I pulled it.

Then I went back. I retraced the breadcrumbs. I found the ASCO abstract which led me to the updated listing. I even found the full NWBO press release confirming the Mainz trial. I found what had been buried in plain sight the whole time. And, in the process, I discovered something even bigger:

There was a third trial. A follow-up CRC study at Roswell, fully registered, ready to launch, and then pulled before enrollment. That final confirmation sealed the arc of this narrative.

🛸 The Trial That Disappeared

Three weeks earlier, I had published:

🔗

🕳️ The Trial That Disappeared

How $NWBO’s DCVax-L May Have Cracked Colorectal Cancer and Why No One Will Talk About It

It told the story of a Phase II trial at Johannes Gutenberg University Mainz that combined DCVax-L with pembrolizumab for patients with liver metastases from MSS colorectal cancer. The trial ran from 2017 to 2020, but there was no trace of it online.

Critics said the trial was a myth. A figment. A narrative invention.

I created a post about that absence, because that absence said something.

Then I found it.  It was real, public, and hiding in plain sight.

➤

The press release from NWBO confirms everything (the trial location, duration, agents, and indication.)

And while we already had the German RLP-Forschung registry listing:

➤

The PR made one thing clear:
This was not speculation. This was operational.

And for the record: trials do not just disappear after four years. According to EU regulations and ICMJE guidance, any interventional trial must submit results within XX months of conclusion or apply for exemption with justification. No results were submitted. No exemption was disclosed. And silence is not compliance.

If the Mainz trial ended in failure, it would be published as such.

Implication: If this trial had reported even preliminary immune activation, DCVax-L’s tissue-agnostic potential would have become visible. The GBM results wouldn’t be isolated, they’d be part of a multi-indication foundation. That makes this erasure strategic, not academic.

🧾 Trial 1: Mainz, Germany (2017–2020)

The Trial That Disappeared

•Platform: DCVax-L (autologous dendritic cells pulsed with lysate)
•Checkpoint: Pembrolizumab (Keytruda)
•Indication: MSS colorectal cancer
•Registry: ➤
•Press Release: ➤
•PI: Prof. Markus Moehler
•Status: Disappeared,  no public results, no follow-up

Implication: If made public, this trial could have confirmed the viability of using DCVax-L in a cold tumor setting. It would have established a precedent of successful immune priming across tumor types and threatened the strategic narrative Merck had been building around checkpoint monotherapy.

🧾 Trial 2: Roswell Park (2018–2022)

The Signal That Was Jammed

•Platform: ST-αDC1s (Kalinski autologous dendritic cells)
•Checkpoint: Pembrolizumab
•Indication: MSS colorectal cancer
•Design: Intratumoral DC injection + IV PD-1 inhibitor
•Trial ID: NCT05518032
•Registry Link:
•PI: Dr. Sarbajit Mukherjee 
•Status: Terminated, no publication or data shared

Implication: This trial represented the first true combination of Kalinski’s DC priming and Merck’s checkpoint blockade in colorectal cancer. Its silent termination, just before the release of DCVax-L’s Phase II results, suggests it may have succeeded, and that its data posed commercial threat.

🧾 Trial 3: Roswell Park (2022–2024)

The Trial That Tried Again

•Title: Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory CRC
•Trial ID: NCT05518032
•Registry: ➤
•Status: Withdrawn before enrollment

Implication: This was the reboot. But it never left the launchpad. The similarity of its design to the prior trial  (and its abrupt withdrawal) confirms deliberate containment. The immune stack was never the problem. Its effectiveness was.

🧬 Same Mechanism, Same Goal

MSS colorectal cancer is immune silent. It lacks lymphocyte infiltration. It resists immune checkpoint therapy. Keytruda has failed in every standalone trial targeting it.

The only known workaround: priming the immune system first.

That is what DCVax-L and Kalinski’s αDC1 (alpha‑type‑1 polarized dendritic cells) were built to do.

Both platforms aim to:

•Capture tumor antigens (either via ex vivo lysate or in situ uptake)
•Train dendritic cells to process and present those antigens
•Use cytokines like IL-1β, TNFα, IFNγ, and Poly-IC to promote Th1 bias and lymph node migration
•Activate a T-cell response
•Then unmask tumors with PD-1 inhibition

This is the immune stack.
And in principle, it works.

The DCVax-Direct Phase I trial treated XX patients across XX solid tumors.
It included colorectal cancer.
Bosch presented distant tumor responses and immune signatures that correlated with survival,   despite the platform being uncalibrated and exploratory.

And that’s what scared Merck most:
It worked too well without optimization.

These CRC trials were its spiritual successors, but now properly designed, matured, and manufactured.

🔬 What If These Trials Had Been Published?

The implications go far beyond colorectal cancer:

• DCVax L and Kalinski’s dendritic cell platforms would have been validated as first in class cold tumor primers

• Keytruda’s poor performance in MSS and other immune excluded tumors would no longer be seen as a biological mystery, but a sequencing failure , checkpoint blockade without prior immune activation

• Merck’s XXX million dollar acquisition of Immune Design and with it the intratumoral TLR4 agonist G100 would have been recast not as a shelved workaround, but as a potent booster within a dendritic cell anchored immune stack

• Linda Powers’ immune stack model with DCVax as the priming layer and agents like G100 as targeted enhancers would have become the industry’s cold tumor playbook

• NWBO would control the priming axis, the upstream layer that determines whether downstream checkpoint strategies succeed at all

And here’s the twist:
We didn’t need those trials to be published

Because in 2025, Dr. Marnix Bosch showed what happens when DCVax Direct is used alone, no lysate, no calibration, no checkpoint, and critically, no G100, and still triggers systemic immune activation in cold tumors like colorectal cancer

That data changes everything

What the Mainz and Roswell trials might have proven, Bosch’s presentation already made clear:
All versions of DCVax now functionally include and surpass the benefit G100 would have added

In other words, G100 is no longer an optional enhancer, it’s a historical footnote
The booster has been absorbed into the platform

Merck paid XXX million dollars for G100 when it still had standalone potential
Had the data been published earlier, G100’s value would have skyrocketed, but only as a component, no longer the driver
That upside is now locked inside the DCVax platform itself

And that’s why this history matters

Merck wasn’t just defending Keytruda
They were protecting the valuation of their entire immunomodulation stack

• Immune Design (G100, TLR4 agonist, 2019, XXX million dollars)
• Pandion Therapeutics (IL2 Treg modulation, 2021, X point XX billion dollars)
• Prometheus Biosciences (IBD immuno mapping, 2023, XX point X billion dollars)
• Verona Pharma (COPD and immunopathology, 2024, approximately XX billion dollar valuation)

Had DCVax data surfaced sooner, it would have flipped the immuno oncology stack
From checkpoint first to priming first
From volume based to precision based
From Merck led to NWBO controlled

But now, it’s too late to contain

Because Bosch didn’t just revive the signal
He proved that the entire immune stack is already live

And it doesn’t need permission anymore

♟️ The Linda Powers Play Wasn’t Leverage. It Was Chess.

Linda Powers doesn’t speak often. Critics sometimes interpret that silence as inaction. But during that quiet period, significant structural moves were made.

She secured an exclusive license for Dr. Pawel Kalinski’s dendritic cell polarization method from Roswell Park, a defined cytokine maturation process designed to yield Type-1 polarized dendritic cells, capable of supporting T-cell activation in immune-resistant tumors.

There was no announcement.
Instead, the method was integrated directly into the DCVax framework.

The system became part of a broader immune priming platform, one that aligned with Flaskworks, NWBO’s closed-loop manufacturing technology. Together, the components formed a scalable and modular infrastructure for delivering autologous dendritic cell therapy with greater precision.

This took place quietly.

At the same time, Merck was acquiring companies focused on immunomodulation, including Immune Design (TLR4), Pandion (IL-2), and Prometheus (IBD). Powers’ move focused not on volume, but on specificity: targeting the immune priming layer that underpins effective checkpoint response, particularly in cold tumors.

No press cycle. No escalation. Just integration.

The trials that followed (Mainz, Roswell, and the planned 2024 reboot) each used elements of this system to test dendritic cell priming in microsatellite-stable colorectal cancer, a setting where checkpoint inhibitors alone have repeatedly failed.

None of those trials reached publication. But the platform remained intact. The rights to the method, the underlying manufacturing process, and the application to checkpoint resistance, all remained under NWBO’s control.

📅 Timeline of Suppression: The Events That Pulled the Plug

Let’s walk through what happened (and when) with context:

• 2018: DCVax-Direct Phase I results quietly reference immune activation, including in colorectal cancer. Although uncalibrated and early-stage, the signals suggest the platform could be effective in cold tumors, a threat to the dominant checkpoint monotherapy paradigm.

• 2019: Merck acquires Immune Design for $XXX million. G-100, a TLR4-based intratumoral agonist, is positioned as a cold tumor workaround, directly aimed at the priming gap DCVax-Direct had begun to expose.

• 2020: The Mainz DCVax-L + Keytruda colorectal trial quietly concludes after four years. No results are published. No explanation is given. Its disappearance goes largely unnoticed.

• November 2021: DCVax-L Phase III data is published in JAMA Oncology. Tumor progression is delayed. A survival benefit is observed. A new immune architecture begins to emerge, patient-specific and checkpoint-independent.

• March 2022: The Roswell Park CRC trial is terminated without disclosure. No publication, no announcement. It’s pulled a few months before the next DCVax paper drops.

• May 2022: Nature Communications publishes long-term survival data from the DCVax-L Phase II trial. Validation becomes concrete, and hard to ignore.

• 2024: A third Roswell CRC trial appears, using autologous dendritic cells and pembrolizumab, same agents, same design, and is withdrawn before enrollment. This time, it’s shut down preemptively.

🧊 A Final Signal

There was a trial that disappeared.
Then a post that disappeared.
Then both returned.
And just when we thought that was the whole story, a third trial surfaced.

Mainz was the anomaly.
Roswell was the relay.
The third was the fail-safe.

All three were silenced.
All three were denied oxygen.
All three followed the same pattern:
• Designed to work
• Proved to work in Phase I
• Shut down before the world could know

For years, the trail went cold.
But not forever.

What vanished is visible again.
What was jammed is transmitting.
What seemed lost is now undeniable.

Linda Powers holds the ignition.
Flaskworks holds the engine.
Kalinski’s imprint is etched deep in the architecture.

So when critics ask, “Where’s the data?”

Just smile.
Because the signal didn’t die.
It only went dark.
And now, it’s breaking through again. 🛸

$MRK $BMY $PFE $AZN $LLY $AMGN $REGN $GILD $JNJ $NVS $ROG $SNY $BNTX $VRTX $GSK $BLUE $ICPT $NBIX $EXEL $CRSP $BEAM $ALNY $SRPT $XBI

#Immunotherapy #Biotech #Oncology #CancerResearch #CheckpointInhibitors #DCVaccines #CellTherapy #MSSCRC #GBM #Glioblastoma #DendriticCells #PrecisionMedicine #CancerImmunology #TCellTherapy #ImmuneOncology #CDMO #Biopharma #AdaptiveImmunity #CancerVaccine #Flaskworks #RegulatoryScience #NatureCommunications #StrategicSuppression #ClinicalTrials #TranslationalResearch


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andrewcaravello Avatar Andrew Caravello, DO @andrewcaravello on x 1070 followers Created: 2025-07-10 11:37:46 UTC

$NWBO 🛸 The Signal That Was Jammed by $MRK ⁉️ (Part Deux)

How Three Dendritic Cell Trials in Colorectal Cancer Were Silenced (Until They Weren’t)

🗞️ Why I Deleted the Original Post

On July 9, I deleted the first version of this post, originally titled “The Signal That Was Jammed.” It was based on a promising but misdirected listing (NCT03735290) that pointed to a different terminated study, a basket trial using an allogeneic dendritic cell vaccine with checkpoint inhibitors in cold tumors like gastric and gastroesophageal junctional adenocarcinomas. It wasn’t the Roswell colorectal trial I was looking for.

And yes, that story deserves its own thread. But without hard proof linking NCT03735290 to Roswell’s autologous DC trial, I couldn’t justify leaving the post up.

So I pulled it.

Then I went back. I retraced the breadcrumbs. I found the ASCO abstract which led me to the updated listing. I even found the full NWBO press release confirming the Mainz trial. I found what had been buried in plain sight the whole time. And, in the process, I discovered something even bigger:

There was a third trial. A follow-up CRC study at Roswell, fully registered, ready to launch, and then pulled before enrollment. That final confirmation sealed the arc of this narrative.

🛸 The Trial That Disappeared

Three weeks earlier, I had published:

🔗

🕳️ The Trial That Disappeared

How $NWBO’s DCVax-L May Have Cracked Colorectal Cancer and Why No One Will Talk About It

It told the story of a Phase II trial at Johannes Gutenberg University Mainz that combined DCVax-L with pembrolizumab for patients with liver metastases from MSS colorectal cancer. The trial ran from 2017 to 2020, but there was no trace of it online.

Critics said the trial was a myth. A figment. A narrative invention.

I created a post about that absence, because that absence said something.

Then I found it. It was real, public, and hiding in plain sight.

➤

The press release from NWBO confirms everything (the trial location, duration, agents, and indication.)

And while we already had the German RLP-Forschung registry listing:

➤

The PR made one thing clear: This was not speculation. This was operational.

And for the record: trials do not just disappear after four years. According to EU regulations and ICMJE guidance, any interventional trial must submit results within XX months of conclusion or apply for exemption with justification. No results were submitted. No exemption was disclosed. And silence is not compliance.

If the Mainz trial ended in failure, it would be published as such.

Implication: If this trial had reported even preliminary immune activation, DCVax-L’s tissue-agnostic potential would have become visible. The GBM results wouldn’t be isolated, they’d be part of a multi-indication foundation. That makes this erasure strategic, not academic.

🧾 Trial 1: Mainz, Germany (2017–2020)

The Trial That Disappeared

•Platform: DCVax-L (autologous dendritic cells pulsed with lysate) •Checkpoint: Pembrolizumab (Keytruda) •Indication: MSS colorectal cancer •Registry: ➤ •Press Release: ➤ •PI: Prof. Markus Moehler •Status: Disappeared, no public results, no follow-up

Implication: If made public, this trial could have confirmed the viability of using DCVax-L in a cold tumor setting. It would have established a precedent of successful immune priming across tumor types and threatened the strategic narrative Merck had been building around checkpoint monotherapy.

🧾 Trial 2: Roswell Park (2018–2022)

The Signal That Was Jammed

•Platform: ST-αDC1s (Kalinski autologous dendritic cells) •Checkpoint: Pembrolizumab •Indication: MSS colorectal cancer •Design: Intratumoral DC injection + IV PD-1 inhibitor •Trial ID: NCT05518032 •Registry Link: •PI: Dr. Sarbajit Mukherjee •Status: Terminated, no publication or data shared

Implication: This trial represented the first true combination of Kalinski’s DC priming and Merck’s checkpoint blockade in colorectal cancer. Its silent termination, just before the release of DCVax-L’s Phase II results, suggests it may have succeeded, and that its data posed commercial threat.

🧾 Trial 3: Roswell Park (2022–2024)

The Trial That Tried Again

•Title: Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory CRC •Trial ID: NCT05518032 •Registry: ➤ •Status: Withdrawn before enrollment

Implication: This was the reboot. But it never left the launchpad. The similarity of its design to the prior trial (and its abrupt withdrawal) confirms deliberate containment. The immune stack was never the problem. Its effectiveness was.

🧬 Same Mechanism, Same Goal

MSS colorectal cancer is immune silent. It lacks lymphocyte infiltration. It resists immune checkpoint therapy. Keytruda has failed in every standalone trial targeting it.

The only known workaround: priming the immune system first.

That is what DCVax-L and Kalinski’s αDC1 (alpha‑type‑1 polarized dendritic cells) were built to do.

Both platforms aim to:

•Capture tumor antigens (either via ex vivo lysate or in situ uptake) •Train dendritic cells to process and present those antigens •Use cytokines like IL-1β, TNFα, IFNγ, and Poly-IC to promote Th1 bias and lymph node migration •Activate a T-cell response •Then unmask tumors with PD-1 inhibition

This is the immune stack. And in principle, it works.

The DCVax-Direct Phase I trial treated XX patients across XX solid tumors. It included colorectal cancer. Bosch presented distant tumor responses and immune signatures that correlated with survival, despite the platform being uncalibrated and exploratory.

And that’s what scared Merck most: It worked too well without optimization.

These CRC trials were its spiritual successors, but now properly designed, matured, and manufactured.

🔬 What If These Trials Had Been Published?

The implications go far beyond colorectal cancer:

• DCVax L and Kalinski’s dendritic cell platforms would have been validated as first in class cold tumor primers

• Keytruda’s poor performance in MSS and other immune excluded tumors would no longer be seen as a biological mystery, but a sequencing failure , checkpoint blockade without prior immune activation

• Merck’s XXX million dollar acquisition of Immune Design and with it the intratumoral TLR4 agonist G100 would have been recast not as a shelved workaround, but as a potent booster within a dendritic cell anchored immune stack

• Linda Powers’ immune stack model with DCVax as the priming layer and agents like G100 as targeted enhancers would have become the industry’s cold tumor playbook

• NWBO would control the priming axis, the upstream layer that determines whether downstream checkpoint strategies succeed at all

And here’s the twist: We didn’t need those trials to be published

Because in 2025, Dr. Marnix Bosch showed what happens when DCVax Direct is used alone, no lysate, no calibration, no checkpoint, and critically, no G100, and still triggers systemic immune activation in cold tumors like colorectal cancer

That data changes everything

What the Mainz and Roswell trials might have proven, Bosch’s presentation already made clear: All versions of DCVax now functionally include and surpass the benefit G100 would have added

In other words, G100 is no longer an optional enhancer, it’s a historical footnote The booster has been absorbed into the platform

Merck paid XXX million dollars for G100 when it still had standalone potential Had the data been published earlier, G100’s value would have skyrocketed, but only as a component, no longer the driver That upside is now locked inside the DCVax platform itself

And that’s why this history matters

Merck wasn’t just defending Keytruda They were protecting the valuation of their entire immunomodulation stack

• Immune Design (G100, TLR4 agonist, 2019, XXX million dollars) • Pandion Therapeutics (IL2 Treg modulation, 2021, X point XX billion dollars) • Prometheus Biosciences (IBD immuno mapping, 2023, XX point X billion dollars) • Verona Pharma (COPD and immunopathology, 2024, approximately XX billion dollar valuation)

Had DCVax data surfaced sooner, it would have flipped the immuno oncology stack From checkpoint first to priming first From volume based to precision based From Merck led to NWBO controlled

But now, it’s too late to contain

Because Bosch didn’t just revive the signal He proved that the entire immune stack is already live

And it doesn’t need permission anymore

♟️ The Linda Powers Play Wasn’t Leverage. It Was Chess.

Linda Powers doesn’t speak often. Critics sometimes interpret that silence as inaction. But during that quiet period, significant structural moves were made.

She secured an exclusive license for Dr. Pawel Kalinski’s dendritic cell polarization method from Roswell Park, a defined cytokine maturation process designed to yield Type-1 polarized dendritic cells, capable of supporting T-cell activation in immune-resistant tumors.

There was no announcement. Instead, the method was integrated directly into the DCVax framework.

The system became part of a broader immune priming platform, one that aligned with Flaskworks, NWBO’s closed-loop manufacturing technology. Together, the components formed a scalable and modular infrastructure for delivering autologous dendritic cell therapy with greater precision.

This took place quietly.

At the same time, Merck was acquiring companies focused on immunomodulation, including Immune Design (TLR4), Pandion (IL-2), and Prometheus (IBD). Powers’ move focused not on volume, but on specificity: targeting the immune priming layer that underpins effective checkpoint response, particularly in cold tumors.

No press cycle. No escalation. Just integration.

The trials that followed (Mainz, Roswell, and the planned 2024 reboot) each used elements of this system to test dendritic cell priming in microsatellite-stable colorectal cancer, a setting where checkpoint inhibitors alone have repeatedly failed.

None of those trials reached publication. But the platform remained intact. The rights to the method, the underlying manufacturing process, and the application to checkpoint resistance, all remained under NWBO’s control.

📅 Timeline of Suppression: The Events That Pulled the Plug

Let’s walk through what happened (and when) with context:

• 2018: DCVax-Direct Phase I results quietly reference immune activation, including in colorectal cancer. Although uncalibrated and early-stage, the signals suggest the platform could be effective in cold tumors, a threat to the dominant checkpoint monotherapy paradigm.

• 2019: Merck acquires Immune Design for $XXX million. G-100, a TLR4-based intratumoral agonist, is positioned as a cold tumor workaround, directly aimed at the priming gap DCVax-Direct had begun to expose.

• 2020: The Mainz DCVax-L + Keytruda colorectal trial quietly concludes after four years. No results are published. No explanation is given. Its disappearance goes largely unnoticed.

• November 2021: DCVax-L Phase III data is published in JAMA Oncology. Tumor progression is delayed. A survival benefit is observed. A new immune architecture begins to emerge, patient-specific and checkpoint-independent.

• March 2022: The Roswell Park CRC trial is terminated without disclosure. No publication, no announcement. It’s pulled a few months before the next DCVax paper drops.

• May 2022: Nature Communications publishes long-term survival data from the DCVax-L Phase II trial. Validation becomes concrete, and hard to ignore.

• 2024: A third Roswell CRC trial appears, using autologous dendritic cells and pembrolizumab, same agents, same design, and is withdrawn before enrollment. This time, it’s shut down preemptively.

🧊 A Final Signal

There was a trial that disappeared. Then a post that disappeared. Then both returned. And just when we thought that was the whole story, a third trial surfaced.

Mainz was the anomaly. Roswell was the relay. The third was the fail-safe.

All three were silenced. All three were denied oxygen. All three followed the same pattern: • Designed to work • Proved to work in Phase I • Shut down before the world could know

For years, the trail went cold. But not forever.

What vanished is visible again. What was jammed is transmitting. What seemed lost is now undeniable.

Linda Powers holds the ignition. Flaskworks holds the engine. Kalinski’s imprint is etched deep in the architecture.

So when critics ask, “Where’s the data?”

Just smile. Because the signal didn’t die. It only went dark. And now, it’s breaking through again. 🛸

$MRK $BMY $PFE $AZN $LLY $AMGN $REGN $GILD $JNJ $NVS $ROG $SNY $BNTX $VRTX $GSK $BLUE $ICPT $NBIX $EXEL $CRSP $BEAM $ALNY $SRPT $XBI

#Immunotherapy #Biotech #Oncology #CancerResearch #CheckpointInhibitors #DCVaccines #CellTherapy #MSSCRC #GBM #Glioblastoma #DendriticCells #PrecisionMedicine #CancerImmunology #TCellTherapy #ImmuneOncology #CDMO #Biopharma #AdaptiveImmunity #CancerVaccine #Flaskworks #RegulatoryScience #NatureCommunications #StrategicSuppression #ClinicalTrials #TranslationalResearch

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