$NWBO
Czech Trial: The Missing Link
With the help of @d_stock07734's due diligence, it seems like we are able to uncover what must have been quite a challenge at that time for Masaryk University.
The manufactoring of the dendritic cell vaccine for the trial.
Czech Trial: The Missing Link
With the help of @d_stock07734's due diligence, it seems like we are able to uncover what must have been quite a challenge at that time for Masaryk University.
The manufactoring of the dendritic cell vaccine for the trial.
Please follow @d_stock07734 for additional due diligence regarding the Czech Trial results and other possible links.
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https://x.com/d_stock07734/status/1919062992500543831
1/
In 2014, Masaryk University launched a pediatric trial using a dendritic cell vaccine called MyDendrix to treat children with metastatic/refractory tumors.
The methods looked strikingly familiar to NWBO’s DCVax-L platform.
But how?
In 2014, Masaryk University launched a pediatric trial using a dendritic cell vaccine called MyDendrix to treat children with metastatic/refractory tumors.
The methods looked strikingly familiar to NWBO’s DCVax-L platform.
But how?
2/
The therapy was complex:
✔️ Patient tumor tissue
✔️ Autologous dendritic cells
✔️ Tumor lysate pulsing
✔️ Multi-dose cryopreservation
✔️ Intradermal injections
A ~90% match with DCVax-L. But how did this platform appear without IP or licensing?
The therapy was complex:
✔️ Patient tumor tissue
✔️ Autologous dendritic cells
✔️ Tumor lysate pulsing
✔️ Multi-dose cryopreservation
✔️ Intradermal injections
A ~90% match with DCVax-L. But how did this platform appear without IP or licensing?
3/
Key distinction: Masaryk’s Advanced Cell Immunotherapy Unit (ACIU) was GMP-certified since 2007, authorized to produce ATMPs under Czech law.
But certification doesn't equal innovation.
Key distinction: Masaryk’s Advanced Cell Immunotherapy Unit (ACIU) was GMP-certified since 2007, authorized to produce ATMPs under Czech law.
But certification doesn't equal innovation.
4/
Despite GMP status, Masaryk:
Filed no patents on MyDendrix
Published no proprietary methods
Never claimed platform invention
Yet it delivered a mature, complex DC therapy.
Despite GMP status, Masaryk:
Filed no patents on MyDendrix
Published no proprietary methods
Never claimed platform invention
Yet it delivered a mature, complex DC therapy.
5/
But another institution had all of this:
Fraunhofer IZI - NWBO’s official European manufacturer for DCVax-L from 2011–2017.
They had:
🏥 GMP licenses
📦 EU-wide distribution approval
📑 Validated SOPs for autologous DC vaccines (DCVax-L)
But another institution had all of this:
Fraunhofer IZI - NWBO’s official European manufacturer for DCVax-L from 2011–2017.
They had:
🏥 GMP licenses
📦 EU-wide distribution approval
📑 Validated SOPs for autologous DC vaccines (DCVax-L)
6/
In 2013, NWBO announced Fraunhofer would manufacture DCVax-L in Germany and ship it to trial sites in “the UK and other European countries.”
Czechia would have been logistically feasible - and legally permitted.
🔗 Link
In 2013, NWBO announced Fraunhofer would manufacture DCVax-L in Germany and ship it to trial sites in “the UK and other European countries.”
Czechia would have been logistically feasible - and legally permitted.
🔗 Link
7/
And in 2013, NWBO announced something key:
Cross-border manufacturing and distribution was operational.
Fraunhofer IZI was producing DCVax-L in Germany and shipping to other EU countries.
🧾 NWBO PR, Mar 12, 2013
And in 2013, NWBO announced something key:
Cross-border manufacturing and distribution was operational.
Fraunhofer IZI was producing DCVax-L in Germany and shipping to other EU countries.
🧾 NWBO PR, Mar 12, 2013
8/
So while Masaryk had cleanrooms, it’s likely that key technical support - assays, cryopreservation methods, or release testing - came via Fraunhofer.
A hybrid setup: certified on paper, externally enabled in practice.
So while Masaryk had cleanrooms, it’s likely that key technical support - assays, cryopreservation methods, or release testing - came via Fraunhofer.
A hybrid setup: certified on paper, externally enabled in practice.
9/
Worth noting:
Masaryk University filed NO patents, published no proprietary manufacturing methods, and disclosed no platform IP for MyDendrix.
Yet the product mirrored DCVax-L.
This strongly implies the use of existing tech - likely from Fraunhofer.
Worth noting:
Masaryk University filed NO patents, published no proprietary manufacturing methods, and disclosed no platform IP for MyDendrix.
Yet the product mirrored DCVax-L.
This strongly implies the use of existing tech - likely from Fraunhofer.
10/
By 2019, Masaryk publications began stating that MyDendrix was manufactured in-house under GMP.
But early trial papers (2014–2016) made no mention of their facilities - suggesting a gradual internalization of capabilities.
By 2019, Masaryk publications began stating that MyDendrix was manufactured in-house under GMP.
But early trial papers (2014–2016) made no mention of their facilities - suggesting a gradual internalization of capabilities.
11/
MyDendrix mirrored DCVax-L in almost every way except one:
The Czech trial used IL-12-polarized dendritic cells, a slight enhancement not used in DCVax-L but within reach for Fraunhofer’s capabilities
An enhancement now belonging to NWBOs patent portfolio
Similarity: ~90%
MyDendrix mirrored DCVax-L in almost every way except one:
The Czech trial used IL-12-polarized dendritic cells, a slight enhancement not used in DCVax-L but within reach for Fraunhofer’s capabilities
An enhancement now belonging to NWBOs patent portfolio
Similarity: ~90%
12/
Then in 2023, the missing link became official:
The EU funded CREATIC, a €15M Horizon Europe grant.
Lead: Masaryk University
Key partner: Fraunhofer IZI
Now the relationship is formal.
creatic.muni.cz/strategic-part…
Then in 2023, the missing link became official:
The EU funded CREATIC, a €15M Horizon Europe grant.
Lead: Masaryk University
Key partner: Fraunhofer IZI
Now the relationship is formal.
creatic.muni.cz/strategic-part…
13/
CREATIC includes 6 Fraunhofer scientists, including:
🧬 Ulrike Köhl
🧪 Stephan Fricke
🔬 Ulrich Blache
These individuals were part of IZI Frauenhofers NWBO’s DCVax-L manufacturing team.
A direct human and institutional connection.
CREATIC includes 6 Fraunhofer scientists, including:
🧬 Ulrike Köhl
🧪 Stephan Fricke
🔬 Ulrich Blache
These individuals were part of IZI Frauenhofers NWBO’s DCVax-L manufacturing team.
A direct human and institutional connection.
14/
Then came the name change:
The Czech product, MyDendrix, was renamed Murcidencel in 2024 - the WHO-assigned INN for NWBO’s DCVax-L.
The alignment is now official, clinical, and regulatory.
Then came the name change:
The Czech product, MyDendrix, was renamed Murcidencel in 2024 - the WHO-assigned INN for NWBO’s DCVax-L.
The alignment is now official, clinical, and regulatory.
15/
Why this matters:
NWBO’s UK approval process requires a Pediatric Investigation Plan (PIP) under MHRA rules.
The Czech trial may now fulfill those PIP (Pediatric Investigation Plan) requirements - without needing a new trial.
Why this matters:
NWBO’s UK approval process requires a Pediatric Investigation Plan (PIP) under MHRA rules.
The Czech trial may now fulfill those PIP (Pediatric Investigation Plan) requirements - without needing a new trial.
16/
The Czech trial reported promising outcomes in a high-risk pediatric population:
📊 Median OS: 7.03 years
🛡️ Disease control: 53–68%
🧬 PD-1 synergy: 60% mortality risk reduction (HR = 0.40)
✅ No severe adverse events
[PubMed, 2024; Frontiers in Oncology, 2019]
The Czech trial reported promising outcomes in a high-risk pediatric population:
📊 Median OS: 7.03 years
🛡️ Disease control: 53–68%
🧬 PD-1 synergy: 60% mortality risk reduction (HR = 0.40)
✅ No severe adverse events
[PubMed, 2024; Frontiers in Oncology, 2019]
17/
The Czech trial was never a side project.
It looks more like a strategic pediatric extension of DCVax-L - quietly aligned with NWBO’s platform, using existing tech, and surfacing only when regulatory timing made it useful.
The Czech trial was never a side project.
It looks more like a strategic pediatric extension of DCVax-L - quietly aligned with NWBO’s platform, using existing tech, and surfacing only when regulatory timing made it useful.
18/
Now, with:
✅ The renaming to Murcidencel
✅ CREATIC’s formal partnership
✅ Historical Fraunhofer capacity
✅ Regulatory alignment in the UK
…the Czech trial completes the picture.
Now, with:
✅ The renaming to Murcidencel
✅ CREATIC’s formal partnership
✅ Historical Fraunhofer capacity
✅ Regulatory alignment in the UK
…the Czech trial completes the picture.
19/
The Czech trial MAY very well reflect Linda Powers’ long-view strategy, quietly extending NWBO’s platform via trusted partners like Fraunhofer.
In parallel, she set up dormant UK/US entities in 2014, laying global groundwork years before DCVax-L neared approval.
Foresight.
The Czech trial MAY very well reflect Linda Powers’ long-view strategy, quietly extending NWBO’s platform via trusted partners like Fraunhofer.
In parallel, she set up dormant UK/US entities in 2014, laying global groundwork years before DCVax-L neared approval.
Foresight.
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