NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

I looked more into Mark Lowdell.

https://www.aiche.org/community/bio/mark-lowdell

In this image you see, Mark Lowdell is working together with NWBO regarding ATMP devices.



In this image, you see his contract with InmuneBio. He is ON NWBOs SAB Board. He and NWBO has not been PR'ing this in any way.

https://contracts.justia.com/companies/inmune-bio-inc-5947/contract/292204/



https://www.researchgate.net/profile/Mark-Lowdell

In his own words:

Mark Lowdell
Clinical Scientist (Rheumatology)

Research area
Translational cellular immunotherapy and regenerative medicine.

Research programme
Bioengineered tissue transplantation
Research summary
My group is focussed on the development of cell and tissue medicines for immunotherapy and transplantation. Our work ranges from basic science of how human natural killer cells target tumours to make our anti-cancer immunotherapy better through the effect of stress and strain on human stem cell attachment and differentiation on 3-D tissue scaffolds. Each of our basic research projects is tightly linked to associated translational projects including clinical trials of adoptive NK-immunotherapy in blood cancers, tissue-engineered tracheal replacements, tissue-engineered laryngeal replacements, oesophageal engineering for transplantation, muscle sheet creation for congenital diaphragmatic hernia and engineered epithelial sheets.

In partnership with colleagues we are developing a iPS cell therapy for macula dystrophy and a genetically modified MSC immunotherapy to target lung cancer.

The CCGTT is the foremost academic facility for the manufacture of cell and tissue medicines, so-called Advanced Therapy Medicinal Products (ATMPs), in the UK. We are licensed by the UK MHRA and HTA for the procurement, production and storage of human cells & tissues for therapy and ATMP manufacture.

The CCGTT incorporates the UCL/RFH BioBank within the IIT which stores both therapeutic and non-therapeutic research samples for clinical trials and collaborative projects as a resource across UCL Partners.

Patient involvement
As a non-clinical lecturer and consultant scientist I have no direct patient contact. I hold Qualified Person status for the legal release of Investigational cell and gene therapies, one of only two academics in the UK. This greatly facilitates our ability to support early phase clinical trials in ATMPs. I sit on the clinical development team and clinical trial team of all of the ATMP trials in which we are involved and I am a consultant to many commercial cell and gene therapy trials in immunotherapy and regenerative medicine.

Large Amrop interview with him

https://www.amrop.com/media/tnybxwyh/creating-cultures-leadership-interview-with-prof-mark-lowdell.pdf

He started Novomune together with Linda Powers in 2018. She has 2/3 of the company and Mark 1/3.

This is from a SEC filing for InmuneBio of which he is a consultant. We can see that InmuneBio is a customer at AdventBio, doing

INKmune Manufacturing

We intend to contract with third parties for the manufacture of our compounds for investigational purposes, for preclinical and clinical testing and for any FDA approved products for commercial sale. Pre-clinical and clinical material for the early clinical trials with INKmune has been manufactured under the direction of Mark Lowdell and Advent Bioservices International, our strategic partner, at a licensed GMP facility.

What is INKMune

INKmune™ is an investigational immunotherapy developed by INmune Bio, designed to enhance the body's natural killer (NK) cells to combat cancer. It consists of a pharmaceutical-grade, replication-incompetent human tumor cell line that interacts with resting NK cells, delivering multiple essential priming signals. This interaction transforms the patient's resting NK cells into tumor-killing memory-like NK (mlNK) cells, which exhibit enhanced cancer-fighting capabilities.
INMUNEBIO

Administered via a simple intravenous infusion, INKmune™ does not require pre-medication, conditioning, or additional cytokine therapy, making it a patient-friendly treatment option. It is currently being evaluated in clinical trials for various cancers, including metastatic castration-resistant prostate cancer (mCRPC). Recent studies have demonstrated its safety and potential efficacy in increasing NK cell activity in patients.

Advent Bioservices is owned by a significant shareholder of the Company.

NOTE 5 – RELATED PARTY TRANSACTIONS

A significant shareholder of the Company is also the owner of various companies that conduct business with the Company, including Luminus Holdings, Inc. (“Luminus”), Novamune, and Advent Bioservices, Inc. (“Advent Bioservices”) as follows:

Short-term debt – related party

On May 9, 2016, the Company received cash proceeds of $350,000 from the issuance of a convertible note to Novamune that matured on August 1, 2016, with a conversion rate of $1.50 per share, and an annual interest rate of 8%. On September 3, 2016, the maturity date was extended to March 3, 2017. The convertible note was converted into 233,345 shares of common stock of the Company during 2017. Novamune is owned by a significant shareholder of the Company.
Accounts payable and accrued liabilities – related parties

At December 31, 2017, the Company owed Advent Bioservices $173,314 for medical research provided on behalf of the Company. Advent Bioservices is owned by a significant shareholder of the Company.

What has Mark Lowdell to do with INKMune

Dr. Mark Lowdell, a co-founder and Chief Scientific Officer of INmune Bio, is the inventor of INKmune™. With over 30 years of experience in translational immunotherapy, he has been instrumental in developing this investigational immunotherapy designed to enhance the body's natural killer (NK) cells to combat cancer. Dr. Lowdell's extensive research and leadership have been pivotal in advancing INKmune™ through preclinical studies and clinical trials, aiming to provide a novel treatment option for various cancers.

Lykiri already found out a lot about Lowdell in 2018. Link between Mark Lowdell and J Kelly Ganjei, now AmplifyBio CEO, former Cognate, former Toucan with Linda Powers, inventor on the combo patent.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143727323
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144767476

JOINT DEVELOPMENT AGREEMENT INMUNE BIO AND NOVAMUNE

https://www.sec.gov/Archives/edgar/data/1711754/000164033418001703/inmune_s1.htm

And Mark Lowdell is also a Consultant to NWBO.

He was at the NWBO presentation at ASCO, by the way.

He is the qualified person at CCGTT which is the largest CGT in London, which hold the manufacturing licenses, under which Advent produce DCVaxL for the UK Specials scheme.
He routinely deals with regulators.

Good man to know (as I've posted previously, along with your links!)

No harm in a bit of reiteration, in this case.

This is a 40 minute video with Mark Lowdell (none of these can be watched more than 1-2 minutes)

They show that Lowdell has been consultant to NWBO since at least 2015.

ATMPs from academia to industry getting it right first time (GIRFT)



44 min video

The ethics and regulation of cell and tissue therapies in the UK

https://hstalks.com/t/4877/atmps-from-academia-to-industry-getting-it-right-f/

Last but not least I fed ChatGPT with all the above info and your article about MHRA Business Plan 2024/2025

The intricate connections between Northwest Biotherapeutics (NWBO), its CEO Linda Powers, Professor Mark Lowdell, Advent Bioservices, and various other entities represent a strategic alignment of resources, technologies, and regulatory insights, particularly as NWBO advances its DCVax-L product in the UK under MHRA's evolving framework. Here are some key perspectives and possibilities:

1. Strategic Influence and Regulatory Alignment

MHRA Point of Care Framework: The new UK regulatory approach for manufacturing innovative medicines closer to patient care could facilitate the distribution of cell and gene therapies like DCVax-L. Given Mark Lowdell's longstanding MHRA relationship and role as a Qualified Person at CCGTT, his influence might support NWBO’s positioning within this framework, which could simplify the delivery of DCVax-L, particularly with its time-sensitive, personalized nature.
Advent Bioservices’ Role: Advent’s expertise in GMP manufacturing and its close relationship with MHRA are advantageous as DCVax-L approaches regulatory certification. Advent has served as the GMP-certified manufacturer for DCVax-L, and this alignment bolsters NWBO's credibility, especially as Advent has experience with related ATMP processes for INKmune, potentially leveraging shared technology advancements.

2. Flaskworks Eden and ATMP Manufacturing Automation

Flaskworks Eden and GMP Compliance: NWBO’s move to manufacture GMP-compliant units for Flaskworks Eden suggests a forward-looking approach to automated and scalable production of cell therapies. Since Flaskworks Eden aligns with Lowdell’s specialization, particularly in process automation for ATMPs, this could allow NWBO to streamline manufacturing further, potentially under the point-of-care framework, making therapies more accessible while reducing logistic complexities.

Advent’s Role in Automation: Advent has been testing and optimizing Flaskworks Eden for DCVax-L, a crucial step toward ensuring reliable automated production of cell therapies. This reflects a shared strategic goal with NWBO, reinforcing their collaborative advantage in handling personalized therapies that demand both precision and scalability.

3. Cross-Company Ties and Potential Synergies

Linda Powers’ and Mark Lowdell’s Partnership: The ownership structure of Novamune, where Linda Powers holds a controlling interest, and Lowdell holds a significant share, indicates an investment in ATMP and immunotherapy development. Novamune's dormant status could imply readiness for activation if regulatory or clinical developments favor NWBO's goals.

INmune Bio’s INKmune Product: INKmune, developed under Lowdell’s leadership at INmune Bio and manufactured by Advent, showcases a model of leveraging GMP facilities for innovative NK-cell-based therapies. This collaboration suggests a potential for technology and expertise exchange that could benefit NWBO, particularly as NK cell research overlaps with some immunotherapy aspects that DCVax-L might address.

4. Clinical Trials and UK Health Infrastructure

MHRA and NHS Collaboration: With the UK’s accelerated focus on ATMPs in clinical trials, NWBO's activities in the UK seem well-timed. The National Contract Value Review (NCVR) incorporating ATMP trials can provide standardized, streamlined cost structures, encouraging quicker trial setups.
Lowdell’s Clinical Experience: Lowdell’s role in various academic and commercial trials, coupled with his regulatory insight, brings an advantage to NWBO, particularly with the potential of clinical data to support further FDA filings. His knowledge could help NWBO navigate MHRA regulations effectively, particularly if they pursue expanded compassionate use cases or additional UK-based trials.

5. Future Prospects and Unanswered Questions

Potential Activation of Novamune: With both Powers and Lowdell involved, Novamune may serve as a strategic vehicle for further immunotherapy research or partnerships, particularly in ATMPs. Its dormant status might be temporary, aligning with regulatory shifts that allow innovative medicines' proximity to patient care, suggesting a future role for Novamune if further collaborations with MHRA or NHS arise.

Point-of-Care Manufacturing and Expansion: The regulatory shift in the UK towards point-of-care manufacturing opens possibilities for portable and localized ATMP production, a method that aligns well with Flaskworks Eden’s automation capabilities. As this regulatory framework progresses, NWBO might explore setting up small-scale manufacturing units across hospitals in the UK, enhancing patient access.

In summary, the connections between NWBO, Advent Bioservices, Linda Powers, and Mark Lowdell form a strong network that appears poised to capitalize on MHRA’s progressive stance on ATMPs. Lowdell’s clinical trial experience, regulatory insight, and expertise in NK cell therapies complement NWBO’s ongoing work in cell-based immunotherapy, potentially accelerating both regulatory approval and wider therapeutic adoption. As Flaskworks Eden moves toward regulatory certification, NWBO is strategically positioned to leverage both Advent and UK regulatory advancements to extend the reach of DCVax-L and possibly other ATMPs in development.