NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Recently, I noticed the extension of Advent Bioservices’ MIA/IMP license, specifically for the importation of QP-certified IMPs.

[ 2.3 ] Other Importation Activities
[ 2.3.4 ] Other
Importation of QP-certified IMPs from a country on the approved country for import list.

https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923

This raised the question of whether DCVax-L is still considered an IMP(Investigational Medicinal Product) in the UK, or whether the product, since the trial stopped recruiting, should instead fall under the Specials framework.

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

16. We import an IMP for a clinical trial which has just been halted for ethical reasons. We need to continue to supply the IMP as a therapy to patients who were on the trial. What is the regulatory situation here?

Once a trial has stopped, the product ceases to be an IMP and becomes a medicinal product. If it is a licenced medicinal product then it can be purchased and supplied as normal from the authorised supply chain. However, more often than not, the ex-IMP will not be licenced

https://mhrainspectorate.blog.gov.uk/2023/02/03/manufacture-of-investigational-medicinal-products-frequently-asked-questions/?utm_source=chatgpt.com

My view is that MHRA applies the same principle not only when a trial is halted early for ethical reasons, but also when a study has reached its official end. Once an “end of trial” has been formally declared, the product ceases to be considered an IMP, IMO.

NWBio has clarified that the pivotal Phase III trial is not yet formally complete: while no new patients are being treated, overall survival is still being monitored for those who remain alive. In that sense, DCVax-L continues to carry IMP status IMO.

My query:

Dear George,

Thank you for your prompt reply and for clarifying the regulatory context. I appreciate the information on IMPs and Specials.

To clarify my original question: I’m specifically interested in the status of the DCVax-L pivotal clinical trial in the UK. Has the trial been officially closed, or is data still being collected from patients who are still alive? Essentially, I’m trying to understand whether the trial is considered formally complete in the UK, regardless of ongoing compassionate use under the Specials scheme.

Thank you for any further clarification you can provide.

Best regards,
XXXXX

Reply from George Zavoico:

Hi XXXXX,

Thanks for your follow-up query. Sorry I wasn’t as prompt this time to respond to you query. I’m multi-tasking as I’m sure you know!

If you look up our Phase III trial on Clinicaltrials.gov (NCT00045968) you’ll see under the heading “What is the study measuring?” that our protocol states that the time frame for the overall survival outcome measure is “until death.” So, to answer your question, yes, we are monitoring the status of our patients who are still alive. So, at least in that regard, our trial is not “formally complete” even though we are no longer, as you know, recruiting and treating new patients.

I hope that helps.

Cheers, George