Sunday, December 01, 2024 7:31:20 PM
Have you read the 10Q about the expanded trial? The following is the trial which covers four refractory types of cancers: lung, breast, bladder, and melanoma.
Why did they run this four types of cancers as tumor-agnostic trial? The reason is simple. These four types of refractory cancers have immunosuppression dominated by myeloid-derived suppressor cells (MDSCs) and Celecoxib, a COX-2 inhibitor can overcome the immunosuppression resulting from MDSCs. Given the fact that there is a collaboration between NWBO and Roswell and LP specifically mentioned about this trial, without doubt LP and Roswell should have a good discussion about the trial.
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
https://clinicaltrials.gov/study/NCT04093323
That dendritic cell treatment aims at a set of targets on abnormal blood vessels that are associated with tumors. As such, that dendritic cell treatment is anticipated to be tumor-agnostic and potentially applicable to most types of solid tumors. The expansion of the trial scope that has been approved is to add refractory lung, breast and bladder cancers to the trial in addition to refractory melanoma.
The forward path for $NWBO couldn't be more clear. The company is going to run tumor-agnostic trials with indications categorized according to their immunosuppressive characteristics. Here is a collaboration trial between Merck and Daiichi which was terminated early for insufficient evidence of clinical efficacy. Five types of cancers were targeted. It is no brainer that Merck and Daiichi would front $NWBO big cash and start a trial ASAP. It will be a trial that most likely will deliver the results within several months.
Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include an evaluation of efficacy of this combination in the following tumor types:
Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded
Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as defined by irRECIST while on therapy
Non-small cell lung cancer
Ovarian cancer
Gastrointestinal Stromal Tumor (GIST)
Squamous cell cancer of the head and neck
A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
https://clinicaltrials.gov/study/NCT02452424
Recent NWBO News
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- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 04/21/2026 04:15:08 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 04/16/2026 09:25:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/07/2026 04:30:50 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 01/15/2026 10:06:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2026 10:14:59 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2025 09:43:27 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2025 09:26:03 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/19/2025 09:15:48 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:44:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2025 04:28:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/14/2025 06:22:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
