NorthWest Biotherapeutics Inc (NWBO)

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In the 2024 NCI budget proposed by Dr. Monica Bertagnolli, she mentioned the following specifically about brain caner.

https://www.cancer.gov/about-nci/budget/congressional-justification/fy2024-nci-congressional-justification.pdf

New Treatments for Brain Cancer

Despite substantial public and private investment, the survival rate for adult glioblastoma (GBM) remains dismal and new treatment approaches are needed. GBM presents substantial biological challenges to be addressed in preclinical studies that support testing of therapies in the clinic. In 2021, NCI launched the Glioblastoma Therapeutics Network (GTN), a national multi-institutional collaborative effort with the goal of taking novel therapeutic agents from preclinical studies in models of GBM into pilot clinical studies that include biomarkers of effects. GTN grantees are currently conducting collaborative pilot projects and initiating clinical studies. This research advances the Cancer Moonshot goal of speeding progress against the deadliest cancers.

What intrigues me the most is the part about "pilot clinical studies that include biomarkers of effects". As a way of investigation, I went through all the clinical trials on Glioblastoma sponsored by NCI including the ones in which NIC was the collaborator. Here are all the trials started late 2019 until late 2022. Note that I didn't include the DCVax-L combo trial here. I searched each trial trying to see which one includes the biomarkers of effects in its primary or second ending points. None could I find! I mean zero!

Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT05281731?cond=NCT05281731&draw=2&rank=1

Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT04397679?cond=NCT04397679&draw=2&rank=1

Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT04590664?cond=NCT04590664&draw=2&rank=1

Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT05095376?cond=NCT05095376&draw=2&rank=1

Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial
https://classic.clinicaltrials.gov/ct2/show/NCT04825275?cond=NCT04825275&draw=2&rank=1

Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT05236036?cond=NCT05236036&draw=2&rank=1

AB154 Combined With AB122 for Recurrent Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT04656535?cond=NCT04656535&draw=2&rank=1

Natural Progesterone for the Treatment of Recurrent Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT05091866?cond=NCT05091866&draw=2&rank=1

Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT04977375?cond=NCT04977375&draw=2&rank=1

Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT04661384?cond=NCT04661384&draw=2&rank=1

Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
https://classic.clinicaltrials.gov/ct2/show/NCT04216329?cond=NCT04216329&draw=2&rank=1

Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
https://classic.clinicaltrials.gov/ct2/show/NCT04817254?cond=NCT04817254&draw=2&rank=1

Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
https://classic.clinicaltrials.gov/ct2/show/NCT05432804?cond=NCT05432804&draw=2&rank=1

A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
https://classic.clinicaltrials.gov/ct2/show/NCT04145115?cond=NCT04145115&draw=2&rank=1

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
https://classic.clinicaltrials.gov/ct2/show/NCT05099003?cond=NCT05099003&draw=2&rank=1

Now take a look at the current combo trial. I can find biomarker related measures everywhere. I even find the exact word "Biomarker analysis"

The association between biomarkers and clinical outcomes (PFS and OS) will be evaluated using Cox regression. Changes in markers pre- and post- treatment will be assessed using paired t-tests.

https://classic.clinicaltrials.gov/ct2/show/NCT04201873?cond=atl-dc&draw=2&rank=1



The writing on the wall couldn't be more clear. If DCVax-L is not the cornerstone of the Moonshot program, at least DCVax-L is going to be an important part of the Moonshot program.

The transient window of opportunity is going to be gone. Anyone who has dry powder should seize the opportunity.

Again the above is purely my speculation. Take it for fun if you don't like it.