NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

dstock07734: I have a family member who had an operation for colorectal cancer about four weeks ago. I understand she starts 3 months of chemo next week. Some spread to the lymph nodes was noted. If she can be admitted to the trial you have described below, please email the instructions to [e-mail] . I can email you back my cell pne number , so we can talk about the case, if you like. A.E.K.

Re: None

Friday, July 19, 2024 2:07:23 PM

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707068
of 707072
If the collaboration trial with Merck is real, according to the latest rule, it seems like the trial has to be registered in a public accessible website if the trial is to be continued beyond January 30, 2025.

A multi-center, Phase II clinical trial evaluating DCVax-L (autologous dendritic cells pulsed with tumor lysate antigen) and pembrolizumab (an anti–PD-1 monoclonal antibody) for subjects with liver metastases of primary colorectal carcinoma
https://www.rlp-forschung.de/public/facilities/2807/research_projects/22146

Any EU/EEA trial with a foreseen Last patient last visit* after 30 January 2025 is required to transition to the Clinical Trials Information System to comply with Regulation (EU) 536/2014. This needs to be done as soon as possible, since this deadline includes the time necessary for completion of the Member State(s) procedure, which can take up to 3 months. More information here.

If your trial is expected to continue after 30 January 2025: see CTIS: how to get started and how to transition a trial. In case of a multi-country trial, sponsors should ensure the harmonisation of their clinical trial under the Directive through EudraCT, prior to transitioning their trial to CTIS: see Guidance for the Transition of clinical trials.

*This applies to all trials having at least one active site in the EU/EEA ('Active site' in the context of transition trials means that the last visit of the last subject, or other trial-specific interventions with the subject specified in the protocol) as well as to any EudraCT trial for which an additional member state application needs to be submitted.



https://eudract.ema.europa.eu/

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174356517


dstock07734

Re: None

Friday, May 03, 2024 10:59:29 PM

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688907
of 707073
In the PR in 2016 on the collaboration trial between Merck and NWBO, LP said the trial took more than 2 years of planning and work. The PI of the collaboration trial was Markus Moehler. I went through some of his publications between 2013 and 2023 to see if he had been in contact with Merck. I suspect if there are still some people who claimed that this trial never happened. The collaboration between Markus Moehler and Merck reminds me of the interaction between Vivek Subbiah and NWBO.

Linda Powers, CEO of NW Bio, noted that, “More than 2 years of planning and work have gone into developing this Phase II trial program. We are excited to work with a leading team to test the potential synergies of combining broad spectrum DCVax-L and targeted Pembrolizumab to treat a heterogeneous and challenging disease such as metastatic colorectal cancer.”


https://nwbio.com/nw-bio-announces-phase-ii-clinical-trial-program-combining-dcvax-l-and-pembrolizumab-keytruda-for-colorectal-cancer/




2023
The Oncology Biomarker Discovery framework reveals cetuximab and bevacizumab response patterns in metastatic colorectal cancer
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10477267/
M.M. received honoraria for advisory boards or talks by Amgen, BMS, Roche, Merck KGaA, MSD Sharp & Dohme, Lilly Oncology, Servier, Pierre Fabre, Taiho Sanofi and Bayer Pharmaceuticals and serves as officer for the European Organisation on Research and Treatment of Cancer (EORTC), and Arbeitsgemeinschaft internistische Onkologie (AIO).

Standard diametric versus volumetric early tumor shrinkage as a predictor of survival in metastatic colorectal cancer: subgroup findings of the randomized, open-label phase III trial FIRE-3 / AIO KRK-0306
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9889429/
M.M. has received grants and non-financial support from EORTC, grants and non-financial support from AIO, grants and non-financial support from German Cancer Aid, and grants and non-financial support from BMBF, during the conduct of the study; personal fees from Falk Foundation; personal fees from Lilly; grants and personal fees from MSD; personal fees from Roche; grants and personal fees from Pfizer; grants, personal fees, and non-financial support from Amgen; grants, personal fees, and non-financial support from Bristol-Myers Squibb; grants and personal fees from Merck Serono; personal fees from MCI Group; and personal fees from Taiho, outside the submitted work.

2022
Survival after secondary liver resection in metastatic colorectal cancer: Comparing data of three prospective randomized European trials (LICC, CELIM, FIRE-3)
https://onlinelibrary.wiley.com/doi/10.1002/ijc.33881
Markus Moehler: Honoraria or consulting or advisory role: Falk, Nordic Amgen, AstraZeneca, mcI, Frankfurt, Lilly, MSD, MerckSerono, BMS, Pfizer, Roche; Research funding: Amgen, BMS, MSD, Merck Serono, EORTC; Travel, accommodations, expenses: Merck Serono, BMS, Roche, MSD, Amgen.

Early weight loss is an independent risk factor for shorter survival and increased side effects in patients with metastatic colorectal cancer undergoing first-line treatment within the randomized Phase III trial FIRE-3 (AIO KRK-0306)
https://onlinelibrary.wiley.com/doi/10.1002/ijc.33775
Markus Moehler reports potential conflict of interest from Merck Germany, MSD, BMS, Servier, Pierre-Fabre Pharma, Lilly Deutschland, Dragonfly.

2021
Early-Onset Colorectal Adenocarcinoma in the IDEA Database: Treatment Adherence, Toxicities, and Outcomes With 3 and 6 Months of Adjuvant Fluoropyrimidine and Oxaliplatin
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8677996/
Markus Moehler
Honoraria: Amgen, Roche/Genentech, Merck Serono, MSD Oncology, Bristol Myers Squibb, AstraZeneca/MedImmune, Servier, Pierre Fabre, Sanofi
Consulting or Advisory Role: Bayer, MSD, Merck Serono, Amgen, Taiho Pharmaceutical, Pfizer, Roche, Lilly, Servier, BeiGene, BMS
Research Funding: Amgen (Inst), Leap Therapeutics (Inst), Merck Serono (Inst), AstraZeneca (Inst), MSD (Inst)
Travel, Accommodations, Expenses: Amgen, Merck Serono, Roche, Bayer, ASCO, German Cancer Society, MSD, ESMO

Cancer gene related characterization of patterns and point of recurrence after resection of colorectal liver metastases
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8506541/
MM reports grants and non-financial support from EORTC, grants and non-financial support from AIO, grants and non-financial support from German Cancer Aid, grants and non-financial support from BMBF, during the conduct of the study; personal fees from Falk Foundation, personal fees from Lilly, grants and personal fees from MSD, personal fees from Roche, grants and personal fees from Pfizer, grants, personal fees and non-financial support from Amgen, grants, personal fees and non-financial support from Bristol-Myers Squibb, grants and personal fees from Merck Serono, personal fees from MCI Group, personal fees from Taiho, outside the submitted work.

2020
Amphiregulin Expression Is a Predictive Biomarker for EGFR Inhibition in Metastatic Colorectal Cancer: Combined Analysis of Three Randomized Trials
https://aacrjournals.org/clincancerres/article/26/24/6559/83059/Amphiregulin-Expression-Is-a-Predictive-Biomarker
M. Moehler reports personal fees and nonfinancial support from Roche and Servier; grants and personal fees form MSD; grants, personal fees, and nonfinancial support from Merck Serono, BMS, and Bayer during the conduct of the study.

Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7573695/
Dr Moehler reported receiving grants from Merck Serono during the conduct of the study and receiving personal fees from MerckSerono and Roche outside the submitted work.

2019

Consensus molecular subgroups (CMS) of colorectal cancer (CRC) and first-line efficacy of FOLFIRI plus cetuximab or bevacizumab in the FIRE3 (AIO KRK-0306) trial
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6927316/
MM: got honoraria for presentations and advisory board role from: AMGEN, BMS, MSD, Merck-Serono, Lilly, Falk, Pfizer, Roche; DPM: got honoraria for presentations and advisory board role from: Merck-Serono, Roche, Servier, Sirtex, BMS, MSD, Bayer, Boehringer-Ingelheim, Lilly


Immune Checkpoint Inhibitors as Switch or Continuation Maintenance Therapy in Solid Tumors: Rationale and Current State
https://pubmed.ncbi.nlm.nih.gov/31535338/
Markus Moehler reports a consulting/advisory role for Amgen, Bayer, Bristol-Myers Squibb, Eli Lilly, Merck, Merck Sharpe & Dohme, Onyx, Pfizer, and Roche; research funding from AIO-Studien-gGmbH, Amgen, Bristol-Myers Squibb, European Organisation for Research and Treatment of Cancer, Merck, Merck Sharp & Dohme, Roche, Taiho Pharmaceutical, and Transgene; and honoraria from American Society of Clinical Oncology, Amgen, Bristol-Myers Squibb, Eli Lilly, European Society for Medical Oncology, Falk, Merck, Nordic, and Pfizer.


2018
Immuno-oncology in GI tumours: Clinical evidence and emerging trials of PD-1/PD-L1 antagonists
https://pubmed.ncbi.nlm.nih.gov/30196908/
MM: Advisory role: Lilly, Onyx, Roche, Bristol-Myers Squibb, MSD, Amgen, Merck, Pfizer; Honoraria: Falk, Nordic, Amgen, mci, Lilly, MSD, Bristol-Myers Squibb, Merck, Pfizer; Research grants: Merck, Amgen, Bristol-Myers Squibb, Taiho, Roche, MSD, Transgene


2017
Relevance of liver-limited disease in metastatic colorectal cancer: Subgroup findings of the FIRE-3/AIO KRK0306 trial
https://onlinelibrary.wiley.com/doi/10.1002/ijc.31114
M.M. has received honoraria from Falk, Nordic, Amgen, mci, Lilly, MSD, Merck, Pfizer, BMS, ESMO, ASCO and travel support from Merck KgaA, Amgen, Roche. He served on advisory boards for Lilly, Onyx, Roche, BMS, MSD, Amgen, Merck, Pfizer.

Evaluation of survival across several treatment lines in metastatic colorectal cancer: Analysis of the FIRE-3 trial (AIO KRK0306)
https://pubmed.ncbi.nlm.nih.gov/28843184/
MM received honoraria/travel support from Lilly, Amgen, Roche, Merck, MSD, BMS, Pfizer and AstraZeneca.

2016
FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer (FIRE-3): a post-hoc analysis of tumour dynamics in the final RAS wild-type subgroup of this randomised open-label phase 3 trial
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30269-8/abstract
MM reports personal fees and non-financial support from Pfizer, Merck, Roche, and Medac.

Immunotherapy in gastrointestinal cancer: Recent results, current studies and future perspectives
https://pubmed.ncbi.nlm.nih.gov/27039171/
MM’s institution received research support from Amgen, Boehringer, Bayer and Merck Serono. MM advised or lectured to Amgen, AstraZeneca, Bayer, BTG, MSD, Merck Serono, Biontech, Lilly, Nordic, Roche and Taiho.

2015
Inclusion of targeted therapies in the standard of care for metastatic colorectal cancer patients in a German cancer center: the more the better
https://pubmed.ncbi.nlm.nih.gov/25230900/
M Moehler received honoraria for presentations in satellite symposia by Merck and Roche.

Adjuvant Fluorouracil, Leucovorin, and Oxaliplatin in Stage II to III Colon Cancer: Updated 10-Year Survival and Outcomes According to BRAF Mutation and Mismatch Repair Status of the MOSAIC Study
https://pubmed.ncbi.nlm.nih.gov/26527776/
Marcus Möehler
No relationship to disclose

2014
Proteins of the VEGFR and EGFR pathway as predictive markers for adjuvant treatment in patients with stage II/III colorectal cancer: results of the FOGT-4 trial
https://pubmed.ncbi.nlm.nih.gov/25272957/
Competing interests
The authors declare that they have no competing interests.

FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial
https://pubmed.ncbi.nlm.nih.gov/25088940/
MM has received honoraria for lectures or presentations from Merck and Roche.

2013
Single-agent therapy with sorafenib or 5-FU is equally effective in human colorectal cancer xenograft—no benefit of combination therapy
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3587684/
Disclaimer
Carl Schimanski received research funding; Markus Moehler, speech honoraria; and Peter R. Galle, consulting and speech honoraria

Phase I/II trial of capecitabine and oxaliplatin in combination with bevacizumab and imatinib in patients with metastatic colorectal cancer: AIO KRK 0205
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776974/
AH has received research support from Novartis; DA, RH and UTH have received research sponsorship from Roche; DA has received speaker’s honoraria from Roche and Sanofi-Aventis; RH and UTH have received speaker’s honoraria from Roche. The remaining authors declare no conflict of interest.