$NWBO @DCarnival46

#CancerMoonshot today will not only be about glioblastoma, but about the horrible DIPG (diffuse intrinsic pontine glioma) occuring in children and young adults.

You know who got their PIP plan approved last year by the MHRA in the UK? Image
You know who ANNOUNCED a new center of cancer excellence in Sutton in the UK two months ago, 130 miles from Sawston, focusing on DIPG? Image
You know who donated 2.5 million pounds to the center and that Hugh Adams works for them and have helped NWBO meeting british politicians and he wrote the "Pathway to a Cure" report, where politicians urges MHRA and NICE to get DCVax-L to patients? Image
SAME DAY MHRA announced this

"This new funding will accelerate the delivery of cutting-edge treatments like cancer vaccines" Image
One week later the MHRA announced this. Image
The new Quarterly SEC filing says

"We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit."

You know NWBO already had planned DCVax-Direct trials in 2019 targeting DIPG?

nwbio.com/wp-content/upl… Image
Just saying.

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More from @FlemmingBruce

May 29
$NWBO

Adding these pieces of information, not least considering the Regulation 17 update in February, makes a rejection out of the question. Image
Image
Image
Read 8 tweets
May 25
$NWBO

Is the new MHRA draft on external control arms a DIRECT outcome of the APPGBT’s years-long glioblastoma inquiries and the Pathway to a Cure recommendations?

And was the DCVax-L trial the precursor that proved the case?

Diving into it ... it seems so.

Yes! Image
2/

In May 2025, the UK’s MHRA released a draft guideline:

“Using External Control Arms Based on Real-World Data to Support Regulatory Decisions.”

To most, this looks like a global trend.

But looking closer, it seems directly influenced by the DCVax-L trial.
3/

The MHRA draft came 2 years after the UK Parliament’s Pathway to a Cure report, which called for:

No placebos in brain tumour trials

Use of real-world external controls

Regulatory flexibility for cell therapies like DCVax-L
Read 9 tweets
May 21
$NWBO

Great find from @HenryMuney 🙏

1/11

Key UK regulatory update for Advent BioServices:

Their Human Tissue Authority (HTA) license was updated on May 19, 2025 to explicitly include "Procurement" of human tissues and cells.

This is a major enabler for Flaskworks Eden. Image
2/11

Let’s clarify a common question about $NWBO's Flaskworks Eden rollout:

“If the Grade C labs weren’t built at the time of the MAA… how close are we really to Eden manufacturing?”
3/11

✅ First, Advent BioServices already has Grade C cleanrooms in place at the Sawston facility.

These are licensed and actively used under MHRA and HTA for GMP-grade manual manufacturing.
Flaskworks Eden is designed to run within these existing Grade C environments.
Read 11 tweets
May 19
$NWBO

The Regulatory Reality: Masaryk’s Murcidencel and Its Link to DCVax-L

A Deep Dive into the EMA’s Active Substance Classification Requirements

The EMA guideline:

ema.europa.eu/en/documents/s…Image
2/9

In the EU Clinical Trials Register, Masaryk University’s trial lists “Murcidencel” as the active substance.

But here’s the kicker: it is classified explicitly alongside DCVax-L and Canpuldencel-T.

This is not a casual mention.

This is a regulatory declaration. Image
3/9

Why does this matter?

EMA’s guidelines demand that such classifications are substantiated with analytical, biological, and regulatory justification.

Section S.1.1 states: Image
Read 9 tweets
May 10
Murcidencel (DCVax-L) is now listed as "CANCER" on the NHS High-Cost Drugs List (HCDL), not just glioblastoma.

This change could signal broader potential for solid tumors beyond GBM. Here’s why that might be the case. 👇 Image
2/13

Clinical Experience Across Tumors

The Czech trial under Murcidencel includes various cancers:

Brain Tumors (GBM, Astrocytoma)
Sarcomas (Ewing's, Rhabdomyo, Osteo)

Others (Neuroblastoma, Burkitt's Lymphoma)

This suggests potential multi-cancer reach. Image
3/13

ASCO 2023 Insights from Dr. Marnix Bosch

At ASCO, Bosch shared:

"We have treated almost 600 GBM patients and also patients with Merkel cell carcinoma, breast cancerthyroid cancer, and more."

He added:

“We believe it could apply to any solid tumor.”
Read 13 tweets
May 9
$NWBO

1/8

Would this explain the delay?

It would!

🔥 Major Update: Murcidencel (DCVax-L) is no longer listed as just for "Glioblastoma" on the NHS High Cost Drugs List.

It's now classified simply as "Cancer". This is not just a name change-a signal of something much bigger. Image
2/8

💡 Why This Matters:

A shift from a specific cancer (Glioblastoma) to a broad "Cancer" label means the NHS is ready for broader patient access.

It opens doors for Individual Funding Requests (IFRs) across multiple solid tumor types.
3/8

📌 What Changed?

To achieve this, there must have been significant regulatory groundwork laid out during the MHRA assessment - which is now over 420 days long.

This COULD strongly hint at a label expansion during the MAA review process.
Read 8 tweets

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