[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  Andrew Caravello, DO [@andrewcaravello](/creator/twitter/andrewcaravello) on x 1073 followers Created: 2025-07-09 14:19:54 UTC $NWBO đ§ DCVax-Direct, the Mayo Trials, and $MRK Multimillion Dollar Validation of This Platform 𧏠The Mechanism: What DCVax-Direct Actually Does DCVax-Direct relies on a time-tested immunological sequence. 1.Unloaded dendritic cells are injected directly into the tumor 2.They absorb tumor antigens on site 3.They mature, migrate to lymph nodes 4.They present tumor-associated peptides via MHC to T cells 5.This triggers systemic immune activation Itâs a smart immune relay, the tumor provides the signal, the dendritic cell translates it, and the immune system learns to attack. This isnât new theory. Itâs old immunology applied with precision. And itâs exactly what Mayo Clinic tested across multiple Merck-backed clinical trials. đ The Mayo Trials: Intratumoral Dendritic Cell Therapy in Action Between 2010 and 2020, Mayo ran three early-phase trials testing autologous dendritic cells injected directly into tumors, the same basic mechanism as DCVax-Direct: X. NCT03325101 Metastatic melanoma Intratumoral DCs with systemic pembrolizumab Co-sponsored by Merck Goal: immune activation, safety X. NCT01239875 Non-Hodgkin lymphoma Intratumoral DCs with or without cryoablation Mechanism-focused, no checkpoint X. NCT03035331 Non-Hodgkin lymphoma Intratumoral DCs with cryoablation and pembrolizumab Goal: synergy from antigen release, DC uptake, and PD-1 inhibition All three trials used the same logic: â˘Dendritic cells delivered intratumorally â˘No lysate pulsing â˘Tumor supplies the antigen â˘Dendritic cells mature, migrate, and train T cells This is the DCVax-Direct model in academic form. đĄ Merck Funded These Trials â Not Hypothetically, Actually Merck didnât just donate Keytruda. They co-funded the studies, supplied drugs, helped design protocols, and ran real-world experiments. They were testing: â˘Whether checkpoint inhibition and dendritic cells worked in tandem â˘Whether intratumoral delivery created systemic response â˘Whether the Direct-style platform logic was viable This wasnât theoretical interest. This was a strategic immunotherapy mapping campaign that mirrors DCVax-Direct to the letter. đ° What Did It Cost? Letâs Be Honest About the Scale These were full clinical studies involving: â˘Leukapheresis and autologous DC prep â˘Intratumoral injection infrastructure â˘Cryoablation support â˘Checkpoint inhibitors (Keytruda) â˘Immune profiling and long-term monitoring Estimated cost per patient: XXXXXXX to XXXXXXX dollars Patient counts: ~27, ~20, and ~30 respectively Maximum total cost for the three trials: XX million to XX million dollars Thatâs not exploratory spending. Thatâs platform-level investment. And this was just the Mayo node. Merck has funded over a dozen dendritic cell trials worldwide in combination with Keytruda (including in glioblastoma, ovarian, and melanoma) testing: â˘Dendritic cells pulsed with tumor RNA or lysate â˘Autologous or semi-personalized setups â˘Checkpoint inhibitor combinations Estimated global investment: XXX million to XXX million dollars over XX years If anyone says Merck wasnât interested in DC-based immune education, that history says otherwise. đŚ Did the Mayo Trials Create the Lysate Library at Mill Creek? No. The Mill Creek lysate library was built separately, most likely from pooled GBM tumor samples. It supports a different use case: â˘Pooled lysate â˘Ex vivo pulsing â˘Intended to accelerate vaccine production for patients without tissue access The Mayo trials tested Direct-style intratumoral delivery. The library supports an allogeneic L model, ex vivo pulsing using shared tumor data. No overlap. No contradiction. Just different arms of the same platform logic. đ What Did the Mayo Trials Show? â˘T cell infiltration: confirmed â˘Systemic immune activation: observed â˘Safety: established â˘Abscopal effects: suggested â˘Commercial follow-up: none â˘Patent conflict: none These trials were built to validate mechanism, not chase market share. Thatâs routine. Pharma sponsors early trials all the time to test pathways. And Mayoâs trials proved that intratumoral dendritic cell delivery works. đ NWBO Owns the Platform Even if Merck paid for the studies⌠Even if Mayo ran the injections⌠NWBO owns the immune engine. Their IP covers: â˘Autologous DCs â˘Pulsed or unpulsed â˘Intratumoral or ex vivo delivery â˘Boosted with cytokines or checkpoint inhibitors â˘Manual or automated via Flaskworks This is not open territory. It is protected ground. Even Mayo, as a respected institution, knows the difference between testing a mechanism and licensing a platform. 𧰠DCVax Use Cases â Direct, Allogeneic, and L Each Have a Place This isnât about picking a winner. Itâs about recognizing the right tool for the right patient at the right time. DCVax is a platform. Not a product. And each configuration serves a different clinical moment. đ DCVax-L: Autologous Lysate Use when: â˘Tumor is resectable â˘System supports full lysate prep â˘Precision is the priority â˘Early-line, newly diagnosed, or regulatory priority path Gives you: â˘Full match to patient tumor â˘High control and reproducibility â˘Long-term memory formation Limitations: â˘Requires surgery â˘Slower manufacturing â˘Not suitable for all geographies or tumor types đ Allogeneic Lysate: Pooled Library Use when: â˘Tumor tissue is unavailable â˘Infrastructure doesnât allow lysate prep â˘Speed is critical â˘You need to scale access Gives you: â˘Semi-personalized immune education â˘Rapid deployment â˘Broad access Limitations: â˘Less precision â˘Relies on population-level epitope coverage â˘May miss personal mutations đ DCVax-Direct: Intratumoral, In Real Time Use when: â˘Tumor is unresectable â˘Lesions are spread or deep â˘Time is limited â˘The patient is in late stage â˘Combo with checkpoint or radiation is desired Gives you: â˘Real-time sampling of tumor antigens â˘Systemic response from local injection â˘Abscopal effect potential â˘Point-of-care readiness Limitations: â˘Less control over antigens â˘Variable immune response without calibration đ§ Final Word NWBO is not building one therapy. Itâs building a framework â a programmable interface between tumors and the immune system. â˘L is for precision â˘Direct is for adaptability â˘Allogeneic is for access All three are valid. All three are needed. And all three already live inside the same engine. 𧞠Final Clarification: Licensing, Alignment, and Inference The Mayo Clinicâs dendritic cell trials â including NCT03360708 (shared glioblastoma lysate), NCT03325166 (melanoma with intratumoral DCs), and NCT03035331 (NHL post-cryoablation) â appear to use autologous dendritic cells prepared identically to DCVax-L. The Mill Creek trials further extended this by actively leveraging the allogeneic lysate bank created in collaboration with Mayo. To date, no formal statement has confirmed a licensing agreement between these programs and Northwest Biotherapeutics. However: â˘The cellular methods used â GMP autologous dendritic cells, pulsed with tumor lysate â fall squarely within NWBOâs patent portfolio. â˘No IP dispute has been filed. â˘NWBO holds the exclusive rights to this class of therapeutic process across multiple jurisdictions. â˘Use of this process, even with pooled or shared lysate, would typically require permission or a sublicensing arrangement, even if not publicly disclosed. Importantly, while the internal process at Mill Creek has not been fully published, all available information, including data from investigator presentations and trial documentation, supports that the dendritic cell generation and lysate application follow the same core method established in DCVax-L: autologous DCs, matured under GMP conditions, pulsed ex vivo with lysate, and reintroduced without genetic modification. This reinforces the presumption that NWBOâs platform underpins the process, regardless of branding. Given this, it is reasonable to infer that these programs are either: â˘Covered under quiet, cooperative arrangements, â˘Proceeding under research-use exemptions, â˘Or operating within a de facto allowance due to shared institutional or collaborative ties. This kind of strategic non-disclosure is not unusual in the biotech industry, particularly in early-stage or mechanism-confirmation trials. đ§ Bottom Line: The mechanism tested in Mayo and Mill Creek validates DCVaxâs versatility, even if it is not branded as such. The absence of conflict speaks volumes. And the trials themselves, especially those with intratumoral administration, provide supportive real-world data that reinforce the systemic mechanism of DCVax-Direct. $LLY $BMY $GILD $PFE $AZN $NVS $JNJ $AMGN $REGN $VRTX $SNY $RHHBY $ABBV $BNTX $CRSP $DNA $EXEL $GSK $INCY $NBIX $MDGL $XBI #DCVax #CancerImmunotherapy #CellTherapy #DendriticCells #AdaptiveImmunity #ImmunoOncology #Glioblastoma #GBM #PrecisionMedicine #NextGenImmunotherapy #TumorMicroenvironment #CheckpointInhibitors #PersonalizedMedicine #RealWorldEvidence #FDA #MHRA #FutureOfMedicine #BiotechInnovation #OncologyResearch #CART #BoschMatrix #NWBO #Flaskworks #ImmunotherapyEngine #Merck #G100 #AbscopalEffect #ClinicalTrials #MillCreek #AllogeneicVaccine #DCVaxDirect XXXXX engagements  **Related Topics** [money](/topic/money) [$nwbo](/topic/$nwbo) [$mrk](/topic/$mrk) [stocks healthcare](/topic/stocks-healthcare) [Post Link](https://x.com/andrewcaravello/status/1942951852875624828)
[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]
Andrew Caravello, DO @andrewcaravello on x 1073 followers
Created: 2025-07-09 14:19:54 UTC
$NWBO đ§ DCVax-Direct, the Mayo Trials, and $MRK Multimillion Dollar Validation of This Platform
𧏠The Mechanism: What DCVax-Direct Actually Does
DCVax-Direct relies on a time-tested immunological sequence. 1.Unloaded dendritic cells are injected directly into the tumor 2.They absorb tumor antigens on site 3.They mature, migrate to lymph nodes 4.They present tumor-associated peptides via MHC to T cells 5.This triggers systemic immune activation
Itâs a smart immune relay, the tumor provides the signal, the dendritic cell translates it, and the immune system learns to attack.
This isnât new theory. Itâs old immunology applied with precision.
And itâs exactly what Mayo Clinic tested across multiple Merck-backed clinical trials.
đ The Mayo Trials: Intratumoral Dendritic Cell Therapy in Action
Between 2010 and 2020, Mayo ran three early-phase trials testing autologous dendritic cells injected directly into tumors, the same basic mechanism as DCVax-Direct:
X. NCT03325101 Metastatic melanoma Intratumoral DCs with systemic pembrolizumab Co-sponsored by Merck Goal: immune activation, safety
X. NCT01239875 Non-Hodgkin lymphoma Intratumoral DCs with or without cryoablation Mechanism-focused, no checkpoint
X. NCT03035331 Non-Hodgkin lymphoma Intratumoral DCs with cryoablation and pembrolizumab Goal: synergy from antigen release, DC uptake, and PD-1 inhibition
All three trials used the same logic: â˘Dendritic cells delivered intratumorally â˘No lysate pulsing â˘Tumor supplies the antigen â˘Dendritic cells mature, migrate, and train T cells
This is the DCVax-Direct model in academic form.
đĄ Merck Funded These Trials â Not Hypothetically, Actually
Merck didnât just donate Keytruda. They co-funded the studies, supplied drugs, helped design protocols, and ran real-world experiments.
They were testing: â˘Whether checkpoint inhibition and dendritic cells worked in tandem â˘Whether intratumoral delivery created systemic response â˘Whether the Direct-style platform logic was viable
This wasnât theoretical interest. This was a strategic immunotherapy mapping campaign that mirrors DCVax-Direct to the letter.
đ° What Did It Cost? Letâs Be Honest About the Scale
These were full clinical studies involving:
â˘Leukapheresis and autologous DC prep â˘Intratumoral injection infrastructure â˘Cryoablation support â˘Checkpoint inhibitors (Keytruda) â˘Immune profiling and long-term monitoring
Estimated cost per patient: XXXXXXX to XXXXXXX dollars Patient counts: ~27, ~20, and ~30 respectively
Maximum total cost for the three trials: XX million to XX million dollars
Thatâs not exploratory spending. Thatâs platform-level investment.
And this was just the Mayo node. Merck has funded over a dozen dendritic cell trials worldwide in combination with Keytruda (including in glioblastoma, ovarian, and melanoma) testing:
â˘Dendritic cells pulsed with tumor RNA or lysate â˘Autologous or semi-personalized setups â˘Checkpoint inhibitor combinations
Estimated global investment: XXX million to XXX million dollars over XX years
If anyone says Merck wasnât interested in DC-based immune education, that history says otherwise.
đŚ Did the Mayo Trials Create the Lysate Library at Mill Creek? No.
The Mill Creek lysate library was built separately, most likely from pooled GBM tumor samples. It supports a different use case: â˘Pooled lysate â˘Ex vivo pulsing â˘Intended to accelerate vaccine production for patients without tissue access
The Mayo trials tested Direct-style intratumoral delivery. The library supports an allogeneic L model, ex vivo pulsing using shared tumor data.
No overlap. No contradiction. Just different arms of the same platform logic.
đ What Did the Mayo Trials Show? â˘T cell infiltration: confirmed â˘Systemic immune activation: observed â˘Safety: established â˘Abscopal effects: suggested â˘Commercial follow-up: none â˘Patent conflict: none
These trials were built to validate mechanism, not chase market share. Thatâs routine. Pharma sponsors early trials all the time to test pathways.
And Mayoâs trials proved that intratumoral dendritic cell delivery works.
đ NWBO Owns the Platform
Even if Merck paid for the studies⌠Even if Mayo ran the injectionsâŚ
NWBO owns the immune engine.
Their IP covers: â˘Autologous DCs â˘Pulsed or unpulsed â˘Intratumoral or ex vivo delivery â˘Boosted with cytokines or checkpoint inhibitors â˘Manual or automated via Flaskworks
This is not open territory. It is protected ground.
Even Mayo, as a respected institution, knows the difference between testing a mechanism and licensing a platform.
𧰠DCVax Use Cases â Direct, Allogeneic, and L Each Have a Place
This isnât about picking a winner. Itâs about recognizing the right tool for the right patient at the right time.
DCVax is a platform. Not a product. And each configuration serves a different clinical moment.
đ DCVax-L: Autologous Lysate
Use when: â˘Tumor is resectable â˘System supports full lysate prep â˘Precision is the priority â˘Early-line, newly diagnosed, or regulatory priority path
Gives you: â˘Full match to patient tumor â˘High control and reproducibility â˘Long-term memory formation
Limitations: â˘Requires surgery â˘Slower manufacturing â˘Not suitable for all geographies or tumor types
đ Allogeneic Lysate: Pooled Library
Use when: â˘Tumor tissue is unavailable â˘Infrastructure doesnât allow lysate prep â˘Speed is critical â˘You need to scale access
Gives you: â˘Semi-personalized immune education â˘Rapid deployment â˘Broad access
Limitations: â˘Less precision â˘Relies on population-level epitope coverage â˘May miss personal mutations
đ DCVax-Direct: Intratumoral, In Real Time
Use when: â˘Tumor is unresectable â˘Lesions are spread or deep â˘Time is limited â˘The patient is in late stage â˘Combo with checkpoint or radiation is desired
Gives you: â˘Real-time sampling of tumor antigens â˘Systemic response from local injection â˘Abscopal effect potential â˘Point-of-care readiness
Limitations: â˘Less control over antigens â˘Variable immune response without calibration
đ§ Final Word
NWBO is not building one therapy. Itâs building a framework â a programmable interface between tumors and the immune system. â˘L is for precision â˘Direct is for adaptability â˘Allogeneic is for access
All three are valid. All three are needed.
And all three already live inside the same engine.
𧞠Final Clarification: Licensing, Alignment, and Inference
The Mayo Clinicâs dendritic cell trials â including NCT03360708 (shared glioblastoma lysate), NCT03325166 (melanoma with intratumoral DCs), and NCT03035331 (NHL post-cryoablation) â appear to use autologous dendritic cells prepared identically to DCVax-L. The Mill Creek trials further extended this by actively leveraging the allogeneic lysate bank created in collaboration with Mayo.
To date, no formal statement has confirmed a licensing agreement between these programs and Northwest Biotherapeutics. However:
â˘The cellular methods used â GMP autologous dendritic cells, pulsed with tumor lysate â fall squarely within NWBOâs patent portfolio. â˘No IP dispute has been filed. â˘NWBO holds the exclusive rights to this class of therapeutic process across multiple jurisdictions. â˘Use of this process, even with pooled or shared lysate, would typically require permission or a sublicensing arrangement, even if not publicly disclosed.
Importantly, while the internal process at Mill Creek has not been fully published, all available information, including data from investigator presentations and trial documentation, supports that the dendritic cell generation and lysate application follow the same core method established in DCVax-L: autologous DCs, matured under GMP conditions, pulsed ex vivo with lysate, and reintroduced without genetic modification. This reinforces the presumption that NWBOâs platform underpins the process, regardless of branding.
Given this, it is reasonable to infer that these programs are either:
â˘Covered under quiet, cooperative arrangements, â˘Proceeding under research-use exemptions, â˘Or operating within a de facto allowance due to shared institutional or collaborative ties.
This kind of strategic non-disclosure is not unusual in the biotech industry, particularly in early-stage or mechanism-confirmation trials.
đ§ Bottom Line: The mechanism tested in Mayo and Mill Creek validates DCVaxâs versatility, even if it is not branded as such. The absence of conflict speaks volumes. And the trials themselves, especially those with intratumoral administration, provide supportive real-world data that reinforce the systemic mechanism of DCVax-Direct.
$LLY $BMY $GILD $PFE $AZN $NVS $JNJ $AMGN $REGN $VRTX $SNY $RHHBY $ABBV $BNTX $CRSP $DNA $EXEL $GSK $INCY $NBIX $MDGL $XBI
#DCVax #CancerImmunotherapy #CellTherapy #DendriticCells #AdaptiveImmunity #ImmunoOncology #Glioblastoma #GBM #PrecisionMedicine #NextGenImmunotherapy #TumorMicroenvironment #CheckpointInhibitors #PersonalizedMedicine #RealWorldEvidence #FDA #MHRA #FutureOfMedicine #BiotechInnovation #OncologyResearch #CART #BoschMatrix #NWBO #Flaskworks #ImmunotherapyEngine #Merck #G100 #AbscopalEffect #ClinicalTrials #MillCreek #AllogeneicVaccine #DCVaxDirect
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