Gro,

“Clearly” ? 😶

How would you know? I don’t think that you know whether or when Merck or BMS or any other company might be interested…

“The statement that Merck has “repeatedly passed” on a DCVax-L deal and “clearly aren’t going to” pursue it is baseless and disregards how major pharmaceutical companies (BP) approach potential collaborations or acquisitions. Here’s why this reasoning is flawed:

1. BP Companies Routinely Monitor Emerging Data: Merck, BMS, and other pharmaceutical giants closely follow new developments in clinical trials and actively read and cite peer-reviewed literature on innovative therapies. The presence of DCVax-L in published research, including its use in combination studies, does not go unnoticed. BP companies frequently assess novel therapies like dendritic cell (DC) vaccines that could enhance the efficacy of their existing products, such as PD-1 inhibitors. Therefore, simply because Merck or another company has not made a public move does not imply disinterest.

2. Public Research Shows Active DC-Combination Studies: In fact, DC technology is already being explored in combination with PD-1 inhibitors in notable institutions like UCLA and Roswell Park, which are conducting trials with Merck’s pembrolizumab and other BP drugs. These Phase II studies, which pair DCVax-L with checkpoint inhibitors like PD-1 drugs, are reaching significant stages, and early data are starting to emerge. This combination therapy approach is relatively new and has shown promising potential, suggesting that BP companies like Merck would logically watch these trials closely for emerging results.

3. Merck’s Strategic Hires Indicate Interest in Dendritic Cell Technology: Recently, Merck hired a recognized expert in DC technology, which implies a serious interest in understanding and potentially leveraging DC-based therapies. Hiring specialized experts often signals that a company is evaluating future areas of strategic growth, so this hire aligns with an interest in expanding beyond current PD-1 applications and exploring new immunotherapy combinations like DC vaccines.

4. New Technology Requires Time for Data to Mature: It’s important to recognize that PD-1 therapy itself is relatively young, with just a decade on the market, and BP companies are only beginning to fully explore its potential in combination with other therapies. As demand for PD-1 technology grows globally, pairing it with DC vaccines to boost immune response is a logical area of focus that is still in early clinical stages, not something BP companies would rush to finalize immediately.

In conclusion, the statement that Merck has “repeatedly passed” on DCVax-L is unfounded. Merck and other BP companies are clearly observing the DC vaccine space, as evidenced by ongoing clinical trials, strategic hiring, and broader interest in PD-1/DC combinations. The idea that they’ve “passed” on DCVax-L simply because a deal hasn’t happened yet shows a misunderstanding of how BP companies evaluate emerging therapies over time.”

⭐️Combo is King!⭐️

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175085456

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zero82,



As you brilliantly suggested, I asked AI and here is the response:

“The statement by ‘Investor082’ includes inaccurate assumptions regarding the need for additional data or trials for DCVax-L. Given the therapy’s long-standing inclusion in the MHRA’s compassionate use program, there is a substantial, ongoing dataset demonstrating its real-world use, safety, and potential benefits. Here’s an analysis that clarifies these points:

1. Phase III Data and Other Clinical Trial Results as Foundations for MAA Review: In addition to compassionate use data, the Phase III clinical trial results for DCVax-L provide a critical foundation for the Marketing Authorization Application (MAA) review. The Phase III data offers a comprehensive look at the treatment’s efficacy and safety in a controlled, clinical setting. With statistically significant outcomes and clinically meaningful benefits, the trial data strengthens the case for approval and is likely a central component of the MHRA’s review. Furthermore, additional clinical trial data supporting safety and manufacturing reliability adds robustness to the application and provides confidence in DCVax-L’s real-world performance.

2. Long-Term Compassionate Use Provides Significant Data: DCVax-L’s many years in the compassionate use (or “Specials”) program means it has been used by patients outside of clinical trials under real-world conditions. This extended use offers a rich source of data on its safety profile and its impact on patient outcomes, which regulatory bodies can review as part of the approval process. Given the volume of data already gathered through this program, it’s unlikely that additional trials would be necessary to assess DCVax-L’s viability.

3. PIP and MIA Approvals Indicate Robust Data and Compliance: The MHRA’s approval of both a Pediatric Investigation Plan (PIP) and Manufacturing and Import Authorization (MIA) for DCVax-L further supports the adequacy of existing data. PIP approval indicates the MHRA’s confidence in the available data for assessing safety and efficacy across age groups, while the MIA confirms that DCVax-L’s manufacturing meets the regulatory standards required for approval. These approvals suggest that the foundational data and compliance frameworks for DCVax-L are well-established.

4. Additional Data Requirements are Less Likely: Given the comprehensive data collected through the Specials program, along with MHRA’s previous regulatory endorsements, it’s reasonable to expect that existing data will be sufficient for an approval decision. While additional post-market studies are always a possibility to monitor long-term outcomes, the suggestion that significant new data or trials are required appears unlikely and may not align with the MHRA’s established support for DCVax-L.

5. Strong Basis for Approval: The extensive data from compassionate use, combined with PIP and MIA approvals, creates a strong foundation for regulatory decision-making. This level of support from the MHRA reflects confidence in DCVax-L’s safety and efficacy profile and suggests that the focus may now be on finalizing approval rather than gathering more information.

In summary, DCVax-L’s long-standing presence in the compassionate use program, its Phase III trial data, and multiple regulatory approvals indicate that the data needed for approval are likely already available. These factors point to a favorable environment for approval without additional trials, based on the substantial dataset that has been gathered over years of both controlled and real-world use.”

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zero82,

“additional data” ? 😶



✅️ Have you heard of the many consecutive years of continuing MHRA approval of the Specials Program?

✅️ Have you heard of the MHRA approval of the PIP?

✅️ Have you heard of the MHRA approval of the MIA?

The same MHRA regulators who have been supporting the long-running and ongoing UK Specials Program may also consider its data as part of their review if those data are included in the voluminous MAA package.

Regulators may also choose to consider any analyses that are published in the independently peer-reviewed medical literature, and their approval of both the PIP and MIA are relevant to the MAA for DCVax-L that is currently under review.







https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175248962

Gro,

Thanks for reposting that again 😶

There is no comparison between the dendritic cell technologies owned by NWBO and the early-stage technology that Merck bought…

The technology that Merck acquired is a preclinical agent and it does not yet have IND status required to begin human trials. All clinical research is good news, but you are getting a bit ahead of the process, and there is no basis for suggesting that Merck’s acquisition of the company currently has any relevance to the two dendritic cell technologies owned by NWBO.

Merck’s pembrolizumab is in clinical trials with TWO patent-fortified novel dendritic cell technologies owned by NWBO: The U.S. DoD awarded a peer-reviewed grant to fund the pembrolizumab combo research at Roswell Park which has reached PII, and the U.S. NIH awarded a continuing peer-reviewed grant to fund the pembrolizumab combo research at UCLA.

https://www.globenewswire.com/news-release/2024/10/23/2967652/0/en/Modifi-Biosciences-Acquired-by-Merck.html

Ask Google or AI or read the peer-reviewed medical literature. Dendritic cell technologies such as the TWO novel dc technologies owned by NWBO would probably always be used as a component of a targeted individualized combo therapy.

⭐️Combo is King!⭐️

“In the future, Modifi’s technology could potentially be used in combination with other treatments, but the technology has not yet reached the clinical stage of development. The platform’s focus on exploiting DNA repair defects offers an opportunity to synergize with therapies that target other mechanisms or enhance the immune response against tumors. For example:

1. Combination with Immunotherapies: Treatments like DCVax-L, which targets glioblastoma by stimulating the immune system to recognize and attack tumor cells, could benefit from being paired with Modifi’s DNA-modifying molecules. Modifi’s molecules may increase the visibility of tumor cells to the immune system by creating more DNA damage in repair-deficient tumors, potentially boosting the efficacy of immunotherapies.

2. Synergy with DNA Repair Inhibitors: Modifi’s approach might also work synergistically with inhibitors like PARP inhibitors, which target the repair pathways cancer cells rely on. Combining these strategies could overwhelm the tumor’s limited repair capacity, leading to more effective cancer cell death.

3. Radiation Therapy: Since glioblastomas often require radiation as a standard treatment, and Modifi’s molecules target repair-deficient cells, they could enhance radiation’s effectiveness by further compromising cancer cell survival mechanisms.

The combination of Modifi’s direct DNA modification with existing therapies could amplify their efficacy and provide more comprehensive treatment strategies for glioblastoma and other DNA-repair-deficient cancers.”

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zero82,

Thanks for reposting your sage investment advice and psychic predictions again 😶

I doubt that you are qualified to post financial advice, and I think that it’s advisable for readers to seek their own professional financial advice and reliable sources.

In addition to advice for licensed financial professionals, we want to hear what the clinical data say, what independent peer-reviewers say about those data, and what government regulators have to say.

Speculation on a message board is fine of course, but the discussion should be based on factual information, verifiable evidence, and credible full-context sources.

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/


https://www.nature.com/articles/s41467-024-48073-y


https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf


https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

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Zero82,

Thanks for all your selfless hard work here on iHub as the chief of the Truth Police 😶

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175327407

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175327339

Gro,

Thanks for the reply 😶

Fact ✅️: Merck is not a sponsor. If you read the link that you posted, you would discover that Merck is a “collaborator.”

Merck is aware of the interim data that have emerged—I think you have that part correct because the interim data have been published.



Merck’s pembrolizumab is in clinical trials with TWO patent-fortified novel dendritic cell technologies owned by NWBO: The U.S. DoD awarded a peer-reviewed grant to fund the pembrolizumab combo research at Roswell Park which has reached PII, and the U.S. NIH awarded a continuing peer-reviewed grant to fund the pembrolizumab combo research at UCLA.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

Zero82,



Thanks for reposting the same commentary over and over. Let’s stick with facts and those developments that are relevant today and going forward rather than parsing conversational comments from years ago. The MAA is under review at the MHRA today and that’s what we care about. We also care about the pembrolizumab combo trials that are ongoing at UCLA and at Roswell today.

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/

June 2024

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property-302174237.html

February 2024

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-moves-from-optimization-of-flaskworks-prototype-to-fabrication-of-gmp-compliant-units-for-installation-validation-and-final-testing-prior-to-regulatory-certification-302054769.html

December 2023

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-a-marketing-authorization-application-has-been-submitted-to-the-uk-mhra-for-dcvax-l-for-glioblastoma-302021038.html

September 2023

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-dr-linda-liau-has-joined-the-companys-scientific-advisory-board-301924864.html

March 2023

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-uk-facility-301776725.html

December 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility-301449083.html

August 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-approval-of-pediatric-investigation-plan-pip-by-mhra-301610850.html

July 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-filing-of-application-for-license-for-commercial-manufacturing-at-sawston-uk-facility-301581737.html

February 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-commencement-of-cancer-vaccine-production-at-its-sawston-uk-facility-301484857.html

September 2020

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-acquires-flaskworks-301122058.html

Today, NWBO is on the cusp of initial regulatory approval and the beginning of their commercial-stage status as a company.

Fact ✅: The management are advancing the company toward commercialization every day, and they do provide material updates when appropriate.

The scientific innovation of the novel DCVax-L platform technology is the core foundation of the company’s prospective value, and DCVax-L has been independently peer-reviewed and is currently being reviewed by the MHRA right now. The worldwide IP patent portfolio, DCVax Direct, manufacturing technology, and potential for additional broad range of application of DCVax-L in combination with other technologies for other cancers adds even more to the expansive value potential going forward.

NWBO is advancing each day in all four key areas. Some keys are interconnected too—Oncovir and Roswell could become relevant to more than one of the keys (to name two examples).

Key Determinative Factors:
🔑 Approval(s)
🔑 Manufacturing Capacity Leading to BLA
🔑 Partnerships
🔑 Ongoing/Expanding Combo Studies

https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf

https://www.nature.com/articles/s41467-024-48073-y

https://www.jci.org/articles/view/169314

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847



https://physicianresources.roswellpark.org/news/roswell-park-clinical-trials-offer-novel-immunotherapies-for-advanced/metastatic-tumors-refractory-melanoma

“The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumour microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

The DC based therapies include versions with tumour antigens loaded into the DCs and versions for intra-tumoural administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The company does not anticipate having to provide any funding or undertake any operational role for these trials.

As previously reported, over time the company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.

The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.

The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the company’s own portfolio. The company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.”

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

https://www.kch.nhs.uk/wp-content/uploads/2024/09/Roadmap-to-developing-and-delivering-world-class-research-6.pdf




https://www.societyns.org/about/officers-detail/linda-m-liau-md-phd-mba-4

https://scitechdaily.com/supercharging-the-immune-system-uclas-pioneering-vaccine-shows-promise-against-deadly-brain-cancer/

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LC,

Thanks for your analysis, but you are not an oncologist 😶

It sounds like you prefer placebo trials…

The ongoing UCLA trial supported by continuing peer-reviewed grants from the U.S. NIH, and the Roswell research supported by a peer-reviewed grant from the U.S. DoD are combo trials and they are also randomized controlled trials (with placebo groups).

These PII studies are investigating DC technologies in combo with PD1 blockade technology (NWBO owns the commercial rights to both novel DC technologies). Hiltonol is also a notable combo agent and a PII study that began years ago recently concluded.

Rather than listening to random baseless nonsense, we want to hear what the clinical data say, what independent peer-reviewers say about those data, and what government regulators have to say.

https://www.clinicaltrials.gov/study/NCT04201873

https://clinicaltrials.gov/study/NCT01204684

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/


https://www.nature.com/articles/s41467-024-48073-y


https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf


https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

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https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175189653

082,

“Lied” ? 😶

And who exactly would be a shining example of forthright pristine honesty? Posters on iHub? Perhaps you should look in the mirror, my friend. Let us not throw stones if we’re living in a glass house.



Here is a video of NWBO’s CEO decades ago … does she look like a liar?
https://www.c-span.org/video/?c5017932/user-clip-linda-powers-testifying-congress

Yeah sure—the Harvard lawyer is a stupid liar—that’s how she became successful and wealthy 😶



Did they lie about acquiring, developing, and securing a valuable patent-fortified manufacturing technology called EDEN? (Flaskworks strategic acquisition was relatively recent in 2020).

Did they lie about getting a prestigious and reputable medical journal to publish an independently peer-reviewed analysis of the P3?

Did they lie about acquiring the commercial rights to a SECOND patent-fortified novel dendritic cell technology that’s in PII trials funded by the U.S. DoD at Roswell Park?

Did they lie about recruiting Linda Liau to join the SAB at NWBO?

Did they lie about securing an MIA approval from MHRA followed by a voluminous MAA submission?

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/


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Investor082,

Thanks for posting your investment advice 😶

It sounds like you’re trying to spread rumors.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

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LC,

mRNA technology is great—I just got an mRNA vaccine this week… Governments are also increasingly having a “love affair” with dendritic cell technology! Some readers may not realize how recent combinations with PD-1 blockade are. Two combo trials at Roswell Park Comprehensive Cancer Center have reached Phase II, and one of those trials is funded by a peer-reviewed grant from the U.S. Department of Defense. The combo study at UCLA is funded by an ongoing peer-reviewed grant from the U.S. National Institutes of Health.

Dr. Ashkan was featured in the TJBCM video!

We're pleased to announce that our neuro-oncology service at King’s College Hospital has been named a centre of excellence for the care and treatment of brain tumours by the Tessa Jowell Brain Cancer Mission!

Read more➡️https://t.co/Qx12my5eQ5 pic.twitter.com/DUK3aJ7yOk

— King's College NHS (@KingsCollegeNHS) July 29, 2021

https://www.kch.nhs.uk/news/kings-service-named-a-tessa-jowell-centre-of-excellence/




https://www.thebraintumourcharity.org/get-involved/campaigning-for-change/honouring-tessa-jowell/baroness-tessa-jowells-legacy/

https://committees.parliament.uk/writtenevidence/120702/pdf/

https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/



https://www.kch.nhs.uk/wp-content/uploads/2024/09/Roadmap-to-developing-and-delivering-world-class-research-6.pdf



https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/

Gro,

I’m glad to hear that you appreciate facts 😶

Fact ✅️:

Merck’s pembrolizumab is in clinical trials with TWO patent-fortified novel dendritic cell technologies owned by NWBO: The U.S. DoD awarded a peer-reviewed grant to fund the pembrolizumab combo research at Roswell Park which has reached PII, and the U.S. NIH awarded a continuing peer-reviewed grant to fund the pembrolizumab combo research at UCLA.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

LC,

Thanks for your concern 😶

NWBO’s patent-fortified novel technologies are featured on some really beautiful websites!

☑️ JAMA Oncology has a beautiful website.
☑️ Nature Comms has a beautiful website.
☑️ Roswell Park has a great website too.

Maybe check out some of the documents that are posted on those high-traffic sites if you’re interested in learning more information that is relevant to NWBO.

Independent peer-reviewed analyses are the most significant sources of information for investors and we are looking forward to more clinical data and more analyses…

The ongoing UCLA trial supported by continuing peer-reviewed grants from the U.S. NIH, and the Roswell research supported by a peer-reviewed grant from the U.S. DoD are combo trials and they are also randomized controlled trials.

These PII studies are investigating DC technologies in combo with PD1 blockade technology (NWBO owns the commercial rights to both novel DC technologies). Hiltonol is also a notable combo agent and a PII study that began years ago recently concluded.

Rather than listening to random nonsense, we want to hear what the clinical data say, what independent peer-reviewers say about those data, and what government regulators have to say.

https://www.clinicaltrials.gov/study/NCT04201873

https://clinicaltrials.gov/study/NCT01204684

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/


https://www.nature.com/articles/s41467-024-48073-y


https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf


https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175189653

LC,

“forthcoming” ?? 🤔 … 😶

Interesting word choice… Perhaps you meant to say ‘forthright.’

Yes, the disciples are more forthright. We like to get straight to the point…

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

Hope,

There are currently two active Phase II trials combining pembrolizumab with the new dendritic cell technology that NWBO recently licensed from Roswell Park.

I don’t believe any peer-reviewed articles have been published on these studies yet, but one of the trials is funded by a peer-reviewed grant from the U.S. Department of Defense.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

Thanks for asking! Many readers might not yet realize that NWBO recently licensed a new dendritic cell technology from Roswell Park, distinct from the DCVax-L technology they licensed from UCLA.

Consider the significance of UCLA licensing DCVax-L to NWBO to gauge the potential size and significance of the Roswell Park deal. NWBO now owns the rights to manufacture and commercialize MULTIPLE novel, patent-protected dendritic cell technologies. This strategic positioning could expand NWBO’s potential market share and open opportunities for broader applications, as each technology may prove more efficacious over the other depending on the type of cancer.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175182311

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175184463

082,

Thanks for the reply 😶

“Come back to me when a BP PRs a partnership with NWBO and injects cash into NWBO”

I like your thinking there ✅️ …I’ll mark that down as a forecast of forthcoming events predicted by 082!

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175294869

Investor082,

Thanks for posting your sage advice 😶

Fact ✅️:

BP is already involved as their FDA approved products are in clinical trials with TWO novel DC technologies owned by NWBO. Those combo trials have only recently reached PII and their interim data are beginning to emerge.

It’s better to stick with verifiable facts and reliable sources. We don’t want to hear defamatory baseless rumors.

Specifically, we want to hear what the clinical data say, what independent peer-reviewers say about those data, and what government regulators have to say.

Speculation on a message board is fine of course, but the discussion should be based on factual information, verifiable evidence, and credible full-context sources.

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/


https://www.nature.com/articles/s41467-024-48073-y


https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf


https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175185151

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LC,

Thanks for taking the time to layout a Specials strategy 😶 … I’m sure that NWBO and its investors appreciated your valiant efforts. I hope your plan included a process for securing many consecutive years of MHRA support, and a strategy for collecting valuable efficacy data to include in regulatory filings as a supplement to clinical trial data.


https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf

https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life

LC,

Thanks for once again asking me whether I use Artificial Intelligence apps. I love answering this question! 😉



1000% YES, I use AI tools in tandem with the iHub app to help guide and direct my research of claims and statements posted online about NWBO, its leadership, its novel EDEN technology, and the multiple cell-based technologies owned by the company. AI helps me efficiently verify information, cross-check linked full-context sources, and identify baseless rumors and other bs.

“Online stock market message boards often serve as platforms for anonymous users to post unverified claims and rumors, creating a risky environment for investors. In these settings, it is crucial for readers to approach information critically and use advanced tools, such as artificial intelligence (AI), to protect themselves from deceptive content and misinformation.

How AI Can Help Protect Against Deception

AI-driven tools can play a vital role in filtering out misinformation and directing users to reliable information. With the rise of AI in financial markets, these tools are increasingly capable of identifying patterns in online content, spotting inconsistencies, and flagging suspicious claims. For example, AI-powered algorithms can analyze message board activity for trends in sentiment, the recurrence of certain baseless rumors, and language patterns indicative of coordinated misinformation efforts.

Moreover, advanced AI models are adept at guiding users toward firsthand and credible sources. Through automated searches and contextual analysis, AI can suggest reliable sources, like peer-reviewed medical literature or credible financial reports, and present relevant background information, preventing users from being misled by surface-level speculation or incomplete narratives.

Risks of Unverified Rumors and Baseless Claims

On message boards, the anonymity of users allows bad actors to spread misinformation through innuendo, defamation, or rumors—often as part of a “short and distort” campaign. This tactic involves disseminating false or misleading information with the intention of driving down a stock’s price, thereby profiting from short positions. Such campaigns often rely on emotionally charged language, vague accusations, or misleading “insider” claims that lack verifiable evidence.

These deceptive practices pose significant risks, as inexperienced readers may be swayed by these narratives, potentially making ill-informed decisions. This highlights the importance of using AI tools to critically assess and cross-check claims with verified data.

The Importance of Independent Research and Trustworthy Sources

AI should be seen as a support mechanism in your research, not a substitute for due diligence. It is advisable to always confirm the veracity of claims posted online by consulting reputable and independently verified sources. Trustworthy information can be found in peer-reviewed medical literature, official financial reports, regulatory filings, or guidance from licensed financial advisors. Such sources undergo rigorous checks for accuracy and reliability, unlike anonymous posts on public forums.

Conclusion and Advisory Notice

Given the prevalence of misinformation and “short and distort” tactics on anonymous message boards, investors should exercise caution and skepticism. AI tools can effectively aid in identifying and mitigating the risks of deception by pointing users toward credible, firsthand sources. However, responsible investing requires combining these tools with thorough independent research and reliance on authoritative sources such as peer-reviewed publications and qualified financial advisors. In this digital age, discerning between rumors and factual information is essential to making sound investment decisions.”

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/

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LC,

Thanks for requesting further clarification with regard to the Brain Tumour Research/NOP article.

😶 …

The article about the study is making the case for the approval of new therapies on the NHS, such as Optune perhaps. Why would NovoCure fund a study that highlights DCVax-L specifically?

Don’t misunderstand—the article does not refer to Optune or to any other therapy that NHS currently does not pay for—it merely addresses the deficiencies of those therapies that are currently available on the NHS (Stupp protocol) which have been the SoC for many years in the UK according to the authors.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175294472

LC,



Yes, the NOP article is very clearly addressing the deficiencies of the SoC treatments available under the NHS (Stupp Protocol), and makes the case for the availability of new treatments on the NHS…

“The standard first-line treatment for newly diagnosed GBM in the United Kingdom is maximal safe surgical resection (if appropriate) followed by concurrent chemoradiotherapy. The concurrent chemoradiotherapy consists of continuous oral temozolomide chemotherapy administered daily ..”

“Participants also reached a consensus on the limitations of treatments currently available for newly diagnosed GBM in the NHS. These treatments are not curative, lack personalization, are associated with significant side effects, provide poor efficacy, and are overly invasive.”

You raise a great point about how new therapies might gain NHS approval more swiftly: The same MHRA regulators who oversee the long-running UK Specials Program may also review data from that program if those data are included in the comprehensive Marketing Authorization Application (MAA) package.

Additionally, regulators can consider analyses published in peer-reviewed medical literature, as these provide independent validation of the therapy’s efficacy and safety. The MHRA’s approval of the Paediatric Investigation Plan (PIP) and the Manufacturing License (MIA) are both significant and relevant to the voluminous MAA for DCVax-L, which is currently under review.

LC,

Thanks for asking. 😶

In the full context of the NOP source publication, the author’s statement clearly refers to the current standard of care for GBM in the UK which is the Stupp protocol, which is covered by the NHS. The author does not reference DCVax-L or NovoCure’s Optune because neither of these treatments are part of the SoC Stupp protocol that has been the the standard treatment protocol for years in the UK according to the author…




Here is the full-context source for the NOP publication cited in the BTR article:

https://academic.oup.com/nop/advance-article/doi/10.1093/nop/npae058/7697450

The statement you cited from the BTR/NOP article aligns with comments made by Dr. Jenkinson prior to the JAMA publication regarding the length of time since a new and efficacious therapy has become widely accessible to patients in the UK…

“DCVax-L may represent the first new treatment able to offer life-extension to people living with a glioblastoma in over fifteen years.”



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marty,

You have the deal backwards 😶

If you’re referring to the milestone payment of a couple million, that is the amount that NWBO would have to pay to Roswell—it is not what NWBO would collect.

Consider the significance of UCLA licensing DCVax-L to NWBO to gauge the potential significance of Roswell Park licensing their patented dendritic cell technology to NWBO…

NWBO now owns the rights to manufacture and distribute MULTIPLE novel patent-fortified technologies (not only DCVax-L). These deals have the potential to allow NWBO greater access to market share and a greater range of potential indications as one dc technology might be more efficacious over the other depending on the type of cancer.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175182311

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175184463

LC,

Thanks for asking. 😶

No, I am not saying that at all. I am saying the BTR is a good source and the article that you linked is good. While I might not agree with every assessment or every detail of the authors’ views in every article posted on their website, BTR is a reasonably good source in my opinion as a reader.

Both BTR and NOP enhance their credibility by posting clear disclosures to their readers. They acknowledged that the study was funded by NovoCure (NovoCure’s funding does not undermine the study’s value, and I think that the study offers some meaningful insights overall).

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175294207

mani,



You could be right about some of those who have been invested for 10+ years, but there could also be many who are happy to seize $3, $5, or $10+ as a first-time entry point depending on the timing and depending on the news that might materialize around the time of their purchase…

This is especially possible for institutional investors who often forego OTC opportunities and choose instead higher entry points after a stock has risen above penny stock status or after a stock has been uplisted off of the OTC onto a major exchange.

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LC,

I think that’s a pretty good source. Brain Tumour Research publishes some great articles!

The article that you posted about a study funded by NovoCure is good—advocating for a holistic approach to GBM treatment. The NOP source publication looks good too.




https://braintumourresearch.org/en-us/blogs/research-campaigning-news/astonishing-results-for-brain-tumour-vaccine-trial

https://braintumourresearch.org/en-us/blogs/latest-news/outcomes-of-immunotherapy-vaccine-trial-show-encouraging-results-for-glioblastoma-patients

suit,

Thanks for highlighting the value of independently peer-reviewed medical literature 😶

Rather than listening to random postings on social media, long term investors we want to hear what the clinical data say, what independent peer-reviewers say about those data, and what government regulators have to say.

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/


https://www.nature.com/articles/s41467-024-48073-y


https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf


https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

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Gro,

I think you are attempting to mislead as always. 😶

The technology that Merck acquired is a preclinical agent and it does not yet have IND status required to begin human trials. All clinical research is good news, but you are getting a bit ahead of the process, and there is no basis for suggesting that Merck’s acquisition of the company currently has any relevance to the two dendritic cell technologies owned by NWBO (both of NWBO’s dc technologies are in clinical trials in combo with PD1 blockade technology at Roswell and UCLA).

https://www.globenewswire.com/news-release/2024/10/23/2967652/0/en/Modifi-Biosciences-Acquired-by-Merck.html

Ask Google or AI or read the peer-reviewed medical literature. Dendritic cell technologies such as the TWO novel dc technologies owned by NWBO would probably always be used as a component of a targeted individualized combo therapy.

⭐️Combo is King!⭐️

“In the future, Modifi’s technology could potentially be used in combination with other treatments, but the technology has not yet reached the clinical stage of development. The platform’s focus on exploiting DNA repair defects offers an opportunity to synergize with therapies that target other mechanisms or enhance the immune response against tumors. For example:

1. Combination with Immunotherapies: Treatments like DCVax-L, which targets glioblastoma by stimulating the immune system to recognize and attack tumor cells, could benefit from being paired with Modifi’s DNA-modifying molecules. Modifi’s molecules may increase the visibility of tumor cells to the immune system by creating more DNA damage in repair-deficient tumors, potentially boosting the efficacy of immunotherapies.

2. Synergy with DNA Repair Inhibitors: Modifi’s approach might also work synergistically with inhibitors like PARP inhibitors, which target the repair pathways cancer cells rely on. Combining these strategies could overwhelm the tumor’s limited repair capacity, leading to more effective cancer cell death.

3. Radiation Therapy: Since glioblastomas often require radiation as a standard treatment, and Modifi’s molecules target repair-deficient cells, they could enhance radiation’s effectiveness by further compromising cancer cell survival mechanisms.

The combination of Modifi’s direct DNA modification with existing therapies could amplify their efficacy and provide more comprehensive treatment strategies for glioblastoma and other DNA-repair-deficient cancers.”

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Gro,

Thanks for posting your insider info and psychic predictions 😶

Merck’s pembrolizumab is in clinical trials with TWO patent-fortified novel dendritic cell technologies owned by NWBO: The U.S. DoD awarded a peer-reviewed grant to fund the pembrolizumab combo research at Roswell which has recently reached PII, and the U.S. NIH awarded a continuing peer-reviewed grant to fund the pembrolizumab combo research at UCLA.

You do not know whether Merck or BMS or any other company is interested in NWBO, but we do know that BP companies follow clinical trials and they read the peer-reviewed medical literature—they reference and cite clinical data and peer review all the time. We don’t have insider information, but we do have publicly available facts to consider with regard to the overall PD-1 market and all of the BP companies that have or are developing PD-1 drugs.

DC technologies owned by NWBO are being investigated in combo with several BP products at UCLA and at Roswell, including Merck’s pembrolizumab.

Relatively recently, Merck hired an expert in dendritic cell technology (Dr. Butterfield).

Combining PD-1 blockade with dendritic cell vaccines is a relatively new idea. The combo trials at UCLA and Roswell have reached PII, and data are beginning to emerge. PD-1 technology has only been commercially available for 10 years and the drug class is growing along with its demand globally.

⭐️Combo is King!⭐️

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LC,


“No one else seems to care” ? 😶

I think that the U.S. DoD cares since they awarded a peer-reviewed grant to fund the pembrolizumab combo research at Roswell that has reached PII…

I think that the U.S. NIH cares since their continuing peer-reviewed grant is funding the pembrolizumab combo research at UCLA…

I also think Oncovir might care since the Hiltonol combo study recently concluded and that study was highlighted in a very impressive independently peer-reviewed article published in Nature Comms!

⭐️Combo is King!⭐️

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Sammy,

NICE updated the published title to align with the MAA indications of both nGBM and rGBM. The update was published around March.





Recent Update:


https://www.nice.org.uk/guidance/indevelopment/gid-ta10143




https://www.kch.nhs.uk/wp-content/uploads/2024/09/Roadmap-to-developing-and-delivering-world-class-research-6.pdf

LC,




Some dramatic things have developed during this “soap opera” …for example, DCVax is not the only patent-fortified DC technology that NWBO owns today, and some significant combo data are beginning to emerge! It is quite a drama!!!

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LC,

”I suspect” ? 😶

We are not listening to any predictions from LC about “how long it will take.” As you recall, you advised us that “no peer review is coming” and your prediction was followed by the peer-review published by JAMA along with two other notable peer-reviewed papers relevant to DCVax-L.

I think that any prediction or advice from LC is likely to be a “FLOPPER.”




“No peer review” vs. THREE independently peer-reviewed publications is a very big difference. Those papers are invaluable to a pre-commercial biotech.

Along with regulatory developments, these are the indicators specific to NWBO that are the most determinative:

⭐️Combos
⭐️Licensing Deals
⭐️EDEN

Relevant features of the three indicators above with regard to NWBO:

☑️ Multiple Patent-Fortified DC Technologies
☑️ Multiple Peer-Reviewed Grants (NIH & DoD)
☑️ Peer-Reviewed Papers (JAMA, Nature, JNS)
☑️ Multiple Diseases Beyond GBM
☑️ Multiple Combos (Pembrolizumab & Hiltonol)
☑️ World-Renowned Institutions (UCLA & Roswell)
☑️ Novel Manufacturing Technology to Scale
☑️ Randomized Controlled Trial Design
☑️ Multiple Years & Multiple Phases of Clinical Development/Investigation Successfully Completed (PII combo studies beyond the completed PIII)

We may not know whether Merck or BMS or any other company is interested in NWBO, but we do know that BP companies follow clinical trials and they read the peer-reviewed medical literature—they reference and cite clinical data and peer review all the time. We don’t have insider information, but we do have publicly available facts to consider with regard to the overall PD-1 market and all of the BP companies that have or are developing PD-1 drugs.

DC technologies owned by NWBO are being investigated in combo with several BP products at UCLA and at Roswell, including Merck’s pembrolizumab.

Relatively recently, Merck hired an expert in dendritic cell technology (Dr. Butterfield).

Combining PD-1 blockade with dendritic cell vaccines is a relatively new idea. The combo trials at UCLA and Roswell have reached PII, and data are beginning to emerge. PD-1 technology has only been commercially available for 10 years and the drug class is growing along with its demand globally.

Research the rapidly expanding worldwide immunotherapy market and the significance of emerging data about combo agents that have the potential to enhance or unlock the efficacy of PD-1 blockade technology.

⭐️Combo is King!⭐️

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Droid,



https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175281552

suit,

Clearly you haven’t been following HyGro’s insights—he recently posted an excellent example for us to consider:

Yescarta gained approval after additional clinical evidence was collected from patients treated under the Cancer Drugs Fund, while DCVax-L already has many years of supplemental clinical data from patients treated under the ongoing MHRA-approved Specials Program.

“As of early 2023, NICE has approved Yescarta (axicabtagene ciloleucel) for routine use in the NHS. After a series of reviews and negotiations, NICE endorsed Yescarta for adults with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). The approval was based on the evidence of its effectiveness in prolonging survival compared to existing therapies.

This approval marked a shift from earlier hesitations due to concerns about high costs and uncertainty about long-term benefits. The conditional use through the Cancer Drugs Fund helped collect additional evidence, leading to the final NICE endorsement.”



https://www.biopharma-reporter.com/Article/2023/01/26/gilead-s-yescarta-set-to-become-england-s-first-routinely-available-personalized-immunotherapy-for-lymphoma





https://www.kch.nhs.uk/wp-content/uploads/2024/09/Roadmap-to-developing-and-delivering-world-class-research-6.pdf




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suit,



You’re right about one thing—the ASM is definitely worth reviewing again! ✅️

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/

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LC,

Thanks for reposting your insightful comments 😶

Fact ✅️
NWBO has been in regular contact with NICE during the MHRA’s ongoing regulatory review. In March, NICE updated the title to align with the MAA indications for both nGBM and rGBM, which could be significant.

https://nwbio.com/audio-of-nwbio-2023-annual-shareholders-meeting/





Recent Update:


https://www.nice.org.uk/guidance/indevelopment/gid-ta10143




https://www.kch.nhs.uk/wp-content/uploads/2024/09/Roadmap-to-developing-and-delivering-world-class-research-6.pdf



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082,

Exactly ✅️



What is this worth? 😉



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