NorthWest Biotherapeutics Inc (NWBO)

[tunnelvisionofplenty]

[Apologies in advance, bio, but this post is only tangentially related to the post I'm replying to. When I posted about this subject recently (#608208), it got very little attention. It could be because I'm a nobody on this board, or it could be because the flood of garbage on this board is becoming so great that there's less opportunity for people to catch items like this. Anyway, I'm just riding the coattails of your notoriety and credibility here. So sorry, and thanks.]

When I posted the other day about the CHM endorsing the formation of an expert working group on cancer vaccines during their March meeting, I felt pretty certain this group was being formed specifically to advise on how to handle NWBO's application. Unfortunately, the CHM minutes are extremely vague, often incomplete, and are only released to the public several months after the fact.

Fortunately, the MHRA's meeting materials are much more complete, and are released in a much more timely fashion.

In their two most recent meetings, the MHRA board has specifically discussed this group, as well as how the body is handling 'cancer vaccines' more broadly. From their materials, it seems clear to me that 'cancer vaccines' means DC-Vax. I've excerpted the relevant comments below, and have provided links to both the meeting info packs as well as the recordings of the meetings. (I only skimmed through the videos; there may be more texture there, if someone is interested in watching them in their entirety.)

MHRA Board Meeting 3/21
March meeting video

What are the most important activities and priorities from the CEO’s point of view?

‘TOP 10’ HEADLINES

#1 A cross-Agency team has been created to work at pace to deliver an end-to-end regulatory pathway for personalised immunotherapy particularly cancer vaccines

…

Cancer vaccines
1.12 Cancer vaccines have the potential to transform patient outcomes. The personalised nature – using genomic sequencing of the patient's tumour to create a vaccine that invokes an immune response – has shown promising signs in initial clinical trials. With the potential for on-site manufacturing to ensure vaccines can be developed and administered as quickly as possible, should the early promise be realised then a new, novel approach to regulation may be required. We are working at pace to consider the end-to-end regulatory pathway that will be needed to ensure that personalised cancer vaccines are both safe and effective, with the potential to adapt the pathway for other personalised medicines

MHRA Board Meeting 5/16
May meeting video

What are the most important activities and priorities from the CEO’s point of view?

‘TOP 10’ HEADLINES

#4 The Commission on Human Medicines has established an Expert Working Group on
cancer vaccines which will advise on the regulatory pathway for this important innovation

…

Innovation
1.1 The MHRA was awarded £10m as part of March’s Spring Statement, to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as those made and approved by other trusted regulatory partners globally. Over the next two years this funding will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments with the greatest promise to meet the UK’s healthcare priorities, such as cancer vaccines and AI-based therapeutics for mental ill-health. We are currently prioritising areas for investment, likely to include the Innovation Accelerator Group and clinical trials.

Cancer vaccines
1.3 The Commission on Human Medicines (CHM) has agreed to establish an Expert Working Group to advise on the regulation of cancer vaccines. The Expert Working Group will initially highlight the questions that personalised immunotherapies pose of the existing regulatory system. Ensuring that regulation is proportionate whilst allowing for a high degree of clarity over the safety and efficacy of cancer vaccines is of paramount importance, and once the appropriate regulatory path is determined, there is potential for this to similarly apply to the regulation of other immunotherapies targeting rare diseases. Highly relevant will be the forthcoming legislation on Point-of-Care manufacture.

Personalised immunotherapy
2.1 The Commission on Human Medicines has agreed to establish an Expert Working Group (EWG) on cancer vaccines, to provide independent scientific advice on this important new type of personalised immunotherapy. The EWG will be considering the distinction between platform technology and personalised product delivery, and how it influences the pathway that is initiated following biopsy of a cancer, to enable sequencing, analysis, antigen/target selection and development of the vaccine.

What does this mean? I look forward to hearing other people's takes, but to me this pretty much says it all: "The MHRA was awarded £10m ... to accelerate routes for bringing innovative medical products developed in the UK onto the market ... this funding will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments with the greatest promise to meet the UK’s healthcare priorities, such as cancer vaccines..."

Before any bad-faith participants of this board attempt to call me out for eliding over "Over the next two years" in this excerpt, and to then claim that this means DC-Vax can't be approved or even submitted before two years from now, I believe this elision is appropriate. In the January meeting, the MHRA CEO specifically cites AI in medicine as a longer-term goal (around the 9:00 mark). Given that AI is mentioned in the MHRA's two-year plan for speeding up innovative approvals, I don't think it's reasonable to conclude that all actions taken by the MHRA during that time will have two-year time horizons. It would also strike me as absurd that, given the MHRA's goal of "speed[ing] up the approval process for cutting-edge treatments," they would implement a regime that would cause DC-Vax to be approved slower than the existing protocol. But on the other hand, I've also read Kafka.

Anyway, to you point, bio, I agree that the company is clearly working very hard to get this approved. And not only the company, but the MHRA as well. They wouldn't be taking all these actions if they didn't recognize the importance of getting this approved ASAP – or in the more modest UK tongue, "at pace."

Also, the MHRA held another meeting on July 11, and judging from the past two meetings it looks like they release materials within 1-2 weeks. So we should be seeing another update from the MHRA board pretty soon.