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The secret sauce is in the process, not so much the biological starting materials. 'The process is the product' is the often quoted phrase.
The Take-home Message For Controlling The Process And CQA.
1
2 Be the owner of all the knowledge regarding the process.
3
4
5
Ryta Power
July 28, 2020
Today, Jim is a six-year survivor of a glioblastoma multi-forme brain tumor. His thinking is clearer, his short-term memory is improving, and he is able to participate and understand conversations with much more ease.
Due to Covid, Jim has had to to cease his physiotherapy and this impacts Jim positively because he does not like exercising. Unfortunately, it does not help his mobility. So we are hoping that we will reach a stage where we can commence Physio again. A big thank you to my family and to the friends who have kept in touch by phoning, texting or visiting.
Kristyn Power
3:17 a.m. · Jul.31, 2020
GBM dx on July 28, 2014... 6 year anniversary! Go Dad! Thanks #DCVax-L and #NWBO!! I can’t wait for more people to access this treatment!
Kristyn Power
6:24 a.m. · Aug.1, 2020
We got the results from Dad’s MRI today: “Opinion - Stable postoperative appearance. “ Things continue to be good
#NWBO #DCVax
GBM dx on July 28, 2014... 6 year anniversary! Go Dad!
— Kristyn Power, CFA (@KristynPower) July 31, 2020
Thanks #DCVax-L and #NWBO!!
I can’t wait for more people to access this treatment! pic.twitter.com/K57mBNgQFi
For the first time I find information about Robin Swart and his relationship with Advent Bioservices, although I follow the evolution of Sawston closely.
Robin Swart
Principle at Independent
Emmer Green, Berkshire, United Kingdom
.....................
Enterprise Architect
Company Name: Advent Bioservices Contract
Dates Employed Jul 2019 – Apr 2020
Employment Duration 10 mos
Location Cambridge, England, United Kingdom
Transformation of a brownfield ex-Industrial site in the process of conversion to a medical laboratory for a Cell Therapy Start-Up (Contract Development and Manufacturing Organisation [CDMO]).
Included Site Survey, Interim IT Infrastructure design and deployment, followed by further evolution to IT Operational Readiness for a state-of-the-art facility for multiproduct GMP production.
About
Highly experienced in both IT and Communications, wide industry knowledge and experience, capable in dealing with global customer and teaming activities.
Specialties:
Technology and Business Strategy alignment
Enterprise Architecture
Data Modelling
Communications Products and Services
Future Networks: Software Defined Networks (SDN) & Network Function Virtualisation (NFV)
Globalisation and Localisation
Knowledge Management
Industry Standards Compliance
Consolidation and Convergence
https://www.linkedin.com/in/robinswart/
A week ago the Mill Lane Sawston website https://www.mill-lane-sawston.co.uk/ was : is coming soon
Today https://www.mill-lane-sawston.co.uk/ is : password-protected=login
anyone?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=154084831
I do think they have a special advisor that has written numerous and oft used FDA regulation text books and whom is considered a strong authority on the subject. I’d imagine LP listens intently to what this expert has to say regarding data lock, and consults his input as to when it might finally be the right time to move forward with that important milestone.
Victoria (Tory) Lake, RAC
Regulatory Affairs Consultant at Sound Regulatory Consulting, LLC
Regulatory Affairs Consultant
Company Name: Sound Regulatory Consulting, LLC
Dates Employed Jul 2013 – Present
Regulatory Affairs Director
Company Name: Fred Hutchinson Cancer Research Center
Dates Employed 2003 – Jul 2013
Company Name: Northwest Biotherapeutics, Inc
Total Duration 6 yrs
o Title: Associate Director, Regulatory Affairs
Dates Employed 2000 – 2002
o Title: Regulatory Affairs and Quality Assurance Manager
Dates Employed 1998 – 2000
o Title: Senior Research Technician
Dates Employed 1996 – 1998
hankmanhub,
I agree with biosectinvestor that they seem to be anticipating something binary.
The last couple of months I did a lot of DD and occasionally you get useful and “sensitive” information.
In the coming days, I expect additional information from one of the authorities involved in this trial.
It all seems to be connected.
69 authors!
Published: 29 May 2018
First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma
Linda M. Liau, Keyoumars Ashkan, David D. Tran, Jian L. Campian, John E. Trusheim, Charles S. Cobbs, Jason A. Heth, Michael Salacz, Sarah Taylor, Stacy D. D’Andre, Fabio M. Iwamoto, Edward J. Dropcho, Yaron A. Moshel, Kevin A. Walter, Clement P. Pillainayagam, Robert Aiken, Rekha Chaudhary, Samuel A. Goldlust, Daniela A. Bota, Paul Duic, Jai Grewal, Heinrich Elinzano, Steven A. Toms, Kevin O. Lillehei, Tom Mikkelsen, Tobias Walbert, Steven R. Abram, Andrew J. Brenner, Steven Brem, Matthew G. Ewend, Simon Khagi, Jana Portnow, Lyndon J. Kim, William G. Loudon, Reid C. Thompson, David E. Avigan, Karen L. Fink, Francois J. Geoffroy, Scott Lindhorst, Jose Lutzky, Andrew E. Sloan, Gabriele Schackert, Dietmar Krex, Hans-Jorg Meisel, Julian Wu, Raphael P. Davis, Christopher Duma, Arnold B. Etame, David Mathieu, Santosh Kesari, David Piccioni, Manfred Westphal, David S. Baskin, Pamela Z. New, Michel Lacroix, Sven-Axel May, Timothy J. Pluard, Victor Tse, Richard M. Green, John L. Villano, Michael Pearlman, Kevin Petrecca, Michael Schulder, Lynne P. Taylor, Anthony E. Maida, Robert M. Prins, Timothy F. Cloughesy, Paul Mulholland & Marnix L. Bosch -Show fewer authors
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6#Ack1
Same name?
I would have to say Tasty Green Wafers has it even though he has never officially posted it. He has been saying "never" for about 4 years.
inveterate and Pharmboy46,
Job done, IMO.
Dr. Anthony E. Maida, Ph.D., was Senior Vice President - Clinical Research of Northwest Biotherapeutics. He originally joined the company in June 2011, as Chief Operating Officer. During 2013, Dr. Maida moved into the position of SVP, Clinical Research, reflecting his focus on the Company’s Phase III clinical trial program in the US, in which he had been playing a central role throughout 2012 and 2013 to date.
https://wallmine.com/otc/nwbo/officer/1643164/anthony-maida
This month Fanny Schömann started a new position as an Office Manager at Mannin Research GmbH.
Office Manager
Company Name:
Mannin Research GmbH Part-time
Dates Employed Jul 2020 – Present
Location Leipzig, Saxony, Germany
Head Of Operations
Company Name:
Northwest Biotherapeutics GmbH
Dates Employed Aug 2013 – Jul 2020
Employment Duration 7 yrs
I continue working for NWBio on a consultant basis.... working with the head of the company on day to day tasks, such as travel management, preparing meetings and calls, overlooking the contracts with clinics for the clinical trial. Also responsible for the book keeping and all tax relevant matters.
https://www.linkedin.com/in/fanny-sch%C3%B6mann-28557a11/
Anthony Maida, Ph.D started a new position as Chief Clinical Officer - Translational Medicine at Mateon/Oncotelic, Inc.(3 weeks ago)
Experience
Nuclear RNA Networks
Chief Scientific Officer - Translational Medicine
Company Name Nuclear RNA Networks Part-time
Dates Employed Jul 2020 – Present
Mateon/Oncotelic, Inc.
Chief Clinical Officer - Translational Medicine
Company Name Mateon/Oncotelic, Inc. Full-time
Dates Employed Jul 2020 – Present
Location Irvine, California, United States
Northwest Biotherapeutics, Inc.
Senior Vice President - Clinial Research
Company NameNorthwest Biotherapeutics, Inc.
Dates Employed Jun 2011 – Jul 2020
Employment Duration 9 yrs 2 mos
https://www.linkedin.com/in/anthonymaida/
About
Dr. Maida, an expert in immuno-oncology, currently serves as Chief Scientific Officer - Tranlational Medicine at Nuclear RNA Networks a company focused on the interpretation of relationship of transposalble elements and disease. Dr. Maida was formerly Senior Vice President - Clinical Research at Northwest Biotherapeutics, Inc. Prior to joining Northwest Dr. Maida served as Vice President, Clinical Research and General Manager, Oncology, World-wide at PharmaNet, Inc. Prior to joining PharmaNet Dr. Maida served as Chairman, Founder and Director of BioConsul Drug Development Corporation and Principal of Anthony Maida Consulting International, servicing pharmaceutical firms, venture capital, hedge funds and Wall Street. Dr. Maida’s skill set includes the leading execution and oversight of finance, operations, research, clinical and scientific development, regulatory and manufacturing for the development of various oncology immunotherapies. Over the past 25 years Dr. Maida has served in a number of executive roles, including, Chairman, CEO, COO, CSO, CFO and business development. Over recent years Dr. Maida has raised, or assisted in financings, nearlyof $200 million for emerging biotechnology companies. Dr. Maida serves as an advisor, consultant and technical analyst for CMX Capital, LLC, Sagamore Bioventures, Roaring Fork Capital, Toucan Capital, North Sound Capital, The Bonnie J. Addario Lung Cancer Foundation and vFinance; the later three companies are located on the East Coast. Additionally, Dr. Maida has been retained by Abraxis BioScience, Inc., Northwest BioTherapeutics, Inc. and Takeda Chemical Industries, Ltd. (Osaka, Japan). Dr. Maida holds a Ph.D. in Immunology, a B.A. degree in Biology, a B.A. Degree in History, a MBA and a MA in toxicology. He is a member of the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), the Society of Neuro-Oncology (SNO), the Society for Immunotherapy of Cancer (SITC), and the American Chemical Society. Dr. Maida holds a patents and patent applications associated with various therapeutic modalities and approaches.
Does anyone know if that is a new position?
A new employee.
Daniel Moore, MCITP, MCSA, ITIL V3
Director of Information Technology at Northwest Biotherapeutics.
IT professional working in the D.C. area with over 14 years of experience. I have worked on multiple Windows platforms ranging from XP, Vista, 7, 8, 10, Server 03, 08, 12, and 16.
I have provided support for:
Exchange
MS Office , 365
Printers
IOS/Droids
Hardware
Software
Network
Servers
Asset Management
Ghost
ITIL - Incident & Problem Management
Cisco Prime configuration
Director Of Information Technology
Company Name
Northwest Biotherapeutics Full-time
Dates Employed Jul 2020 – Present
Employment Duration 1 mo
LocationBethesda, Maryland, United States
https://www.linkedin.com/in/daniel-moore-mcitp-mcsa-itil-v3-9359b012/
It would be nice to know how close we are to a licensed Sawston
With investment being made into the organisation and new build projects on the horizon, this is the ideal time to join the team and establish yourself as a key team member
Mike Scott
Chief Operating Officer at Advent Bioservices & Visiting Professor, Anglia Ruskin University
1d • 1 day ago
Advent Bioservices is seeking a Validation Lead. If you have the experience and want to join a vibrant team as we build our business, please get in touch.
JOB VACANCY: Validation Lead
We are looking for a GMP experienced validation/qualification professional to progress their career with us in the exciting area of cell & gene therapies. With investment being made into the organisation and new build projects on the horizon, this is the ideal time to join the team and establish yourself as a key team member. As Validation Lead you will work across GMP manufacturing, Quality Control laboratory facilities and the Cryostorage facility to ensure that all aspects of validation comply with relevant regulations.
Job Summary
In this role, you will be supporting the validation of equipment, facilities, utilities and processes in accordance with GMP requirements. You will be preparing and maintaining validation plans, assisting systems owners with impact assessments and identifying validation requirements as well as the execution of validation protocols (equipment, facilities, utilities, computerised systems and processes). This will include cleanrooms, medical gas supply and computer systems including environmental monitoring-systems.
You will have the following experience/qualifications:
• A Degree (or equivalent) in a Science or related discipline
• Working knowledge of biopharmaceutical or pharmaceutical industry regulations and guidelines that relate to qualification/validation
• Demonstrable experience of validating manufacturing/laboratory equipment, facilities/utilities and processes
• Generation/execution of lifecycle documents (URS, DQ, IQ, OQ and PQ) in a biopharma, pharma or related industry
• Experience of computer validation systems is desirable.
We offer excellent opportunities for career progression along with training and the chance to be a part of a growing organisation. We also offer an attractive base salary and benefits package.
The candidate must have the right to work in the UK.
Interested candidates are encouraged to submit a CV and a supporting letter to recruitment@adventbio.uk
https://www.adventbio.uk/job-validation-lead-scientist
I have doubts this is DCVax. Does anyone here know for sure?
As it’s #EyeWeek just wanted to thank @bootsopticians @westfieldlondon who back in October spotted pressure behind Laura’s eyes which on further investigation showed multiple brain tumours. A quick diagnosis can make all the difference @HeadSmartUK @BrainTumourOrg pic.twitter.com/kSRw86gISw
— shitscaredmum (@shitscaredmum) September 26, 2019
March 10, 2019 by Nicola Nuttall.
So here we are, 4 months after surgery and 2 months into the 12 cycles of chemotherapy we have scheduled......
In terms of treatment, the monthly chemo is hitting her pretty hard but the recent scan does suggest that she may be responding to the treatment which is great news. We're having lots of conversations with the DCVax people and hopefully it won't be too long before we can update you with further news in that area.
May 8, 2019 by Nicola Nuttall.
Yesterday marks 6 month's since Laura's surgery and although some days are rubbish and she's sick and exhausted, other days are amazing.
.......
The DCVax treatment process started but it's had to be put on hold for technical (tumour related) reasons.
We are hoping that soon we'll be in a position to start the process again but in the meantime we're continuing to explore further immunotherapy treatments available internationally.
July 30, 2019
More excitingly, Laura and I are currently in Cologne where we have just started immunotherapy treatment at the IOZK clinic under Professor Van Gool.
This treatment starts with electrohyperthermia treatment and the Introduction of an oncolytic virus to help her immune system to recognise and identify the tumour cells.
We will be returning to Cologne for 5 days every month whilst Laura is still on chemo and when that ends she will return for further sessions where she will receive the dendritic cell vaccine, manufactured from her reprogrammed white blood cells.
Obviously we have no guarantees but we’re optimistic that this is the best course of action for her.
DECEMBER 30, 2019
So looking to the future, Laura has her final round of chemo in January and from February she’ll start the Dendritic cell vaccination protocol in Cologne, she’ll be having her next scan in January too which is always a bit nerve wracking for us.
Without you, we wouldn’t have been able to start the immunotherapy treatment in Germany and for that and for your continued support and love, we are truly grateful
MAY 1, 2020
I am pleased to say that Laura is doing pretty well at the moment, her last scan was in March and although it's still showing a 4mm 'spot' it is at least stable at the moment.
https://www.gofundme.com/f/ngdq37-doing-it-for-laura
Corning is experienced in this field, but getting a useful cell product is another matter entirely.
Flaskworks spun out of Northeastern University with a goal of improving the manufacture of autologous immunotherapeutics. Based in Boston, Massachusetts, Flaskworks collaborates with leading researchers who are developing lifesaving personalized treatments for cancer, autoimmune, and infectious diseases.
Autologous therapies utilize a patient’s own cells, thus each treatment must be individually manufactured introducing significant complexity to the process. With feedback from leading researchers, Flaskworks has developed a suite of systems that enable an automated, closed process for production of individualized treatment.
MicroDEN® System for Dendritic Cell Generation
• Generates up to 25 million dendritic cells per run from monocytes.
• Significantly reduces operator variability in monocyte-to-DC generation yield.
• Eliminates manual cell seeding, cytokine/medium refresh, and harvest.
• Major applications in biologics discovery & characterization (e.g. MLR assays), human, and non-human cells.
https://www.flaskworks.com/#contact
Problem
Due to the rise of personalized therapies, the demand for Dendritic cells has increased. However, the process for generating Dendritic cells has remained laborious, error-prone, and time intensive.
Solution
Flaskworks has produced a device, MicroDen, that revolutionizes the process. MicroDen is compact, easy-to-use, efficient, affordable, and 10x more productive than current methods and devices.
Leadership
President & CEO
Jennifer Rossi
Founder
Shashi Murthy
For more information about Flaskworks, contact Shashi Murthy.
https://www.northeastern.edu/cri/spinouts/flaskworks/
Dangerously close to describing trade secrets, so I think we take note of it, but not discuss it too much!!
Ex, that was 2018! We are 2 years later. I think you're a little behind. Much has changed in those two years!
longfellow95,
I assume you found the information in this patent?
OPTIMALLY ACTIVATED DENDRITIC CELLS THAT INDUCE AN IMPROVED OR INCREASED ANTI-TUMOR IMMUNE RESPONSE
Jun 29, 2016 - Northwest Biotherapeutics, Inc.
https://patents.justia.com/patent/20180187145
I don't think I dreamt it! It's out there somewhere, unless they took it down for fear of revealing trade secrets..
Didn’t LP talk about work and progress towards a closed system manufacturing technology that reduced needs for clean rooms and automates the Dcvax production very significantly, thus reducing production costs and quality?
Anyone remember this?
I want to just reiterate what I said at the beginning. As a company, we fully endorse, and it is our goal, for this technology to be widely available to patients. We don’t want this to be a treatment of last resort. We want this to be a frontline treatment. We’ve worked long and hard to make it practical. There’s only one manufacturing process per patient. We manufacture the whole set of doses for multi-year treatment in one batch. Then we freeze those doses, and we’ve validated the frozen shelf-life for years. So then it’s just an off-the-shelf product out of the freezer, although it’s fully personalized for that patient. So we’ve worked for years and years to try and make this a very practical product to be widely available.
Right now, it’s made by hand. That is a very obviously, expensive process. It’s the same thing that the T cell people are dealing with. And there will be steps in the future, whether it’s economies of scale, whether it’s closing the system and having to have clean rooms with people in space suits making this by hand, which is what it is today,
or full end-to-end automation. So there’s a lot of steps to be done in the future. I would say to anyone who can help us, help us provide funding, provide technical support, help spread the word, help us. We want to get this to everyone. Thank you.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142168678
There is a detailed paper floating around somewhere that came out of the Direct P1, which went into quite a lot of detail about how they had learned the time critical partial maturation, which they had previously referred to as Method B (for better).
And I remember thinking that they were in danger of giving their secrets away in that paper, because it was so detailed.
But I've lost the bookmark somehow.
Don't know if anyone knows the one I'm talking about, and can perhaps put up the link.
Johnnygogo,
I found this summary on a brain tumor patient forum. Hope that helps.
Methylation is driven by two genes: IDH-1 and MGMT Promoter. These two work cooperatively with one another to produce methylation. So, you can have these combinations:
IDH-1 negative (i.e., unmutated) + MGMT Promoter unmutated = complete unmethylation, which gives rise to the most aggressive of tumors.
IDH-1 negative (unmutated) + MGMT Promoter mutated OR vice versa (IDH-1 positive/mutated + MGMT Promoter unmutated) = sort of a half and half methylation, which gives rise to a lesser aggressive tumor
IDH-1 positive (mutated) + MGMT Promotor mutated, which gives rise to a completely methylated tumor, which in turn gives rise to the least aggressive tumor (apart from what other DNA bio-markers might do)
So, that's the genetics side of the story. The actual process side goes something like this...
Both of these genes (IDH-1 and MGMT Promoter) produce enzymes. When one or both of those genes are mutated, they produce flawed enzymes with an entirely new molecule, called 2-hydroxyglutarate. This molecule causes groups of atoms called methyl groups to latch onto the DNA strand (this is the part of the process called “methylation”).
So, along comes an alkylating chemo (like Temodar) which damages the tumor cells' DNA with the objective of killing the tumor cells. If the tumor's status is methylated (meaning that one or both of these genes are mutated), that damage cannot be repaired as easily because of the presence and interference of the methyl groups.
In the case where one or both of those genes are unmutated (giving the tumor an unmethylated status, whether complete or partial), then the absence of that methyl group producing molecule in the enzymes enables the tumor cells to rapidly repair and rebuild themselves, which is obviously not the preferred condition.
So, .....if a tumor is known to be IDH-1 positive, that tumor is methylated to some extent. If we also know something about the status of the MGMT Promoter gene, we can then understand if that methylation is complete or partial.
Hi Flipper, when is that 5 year date line crossed? Just curious.
One can never know. It could be. I understand that it’s close, and a reasonable hypothesis.
Jack2479,
Thank you for the information! I agree 100%.
You said that you visited the Sawston facility late last year and spoke to the team at Advent. Did they told you they want to receive GMP license for a closed production system used to manufacture their lead product?
I ask you because Advent Bioservices is working with Autolomous.
And a month ago Glycostem Therapeutics announced they have chosen Autolomous for the digitisation of the manufacturing and release of Glycostem's NK-cell therapies for clinical trials and beyond.
Glycostem Therapeutics
947 followers
1mo • 1 month ago
Digital, effective, eco-friendly, and powerful – Glycostem will implement Autolomous AutoloMATE platform to digitise manufacturing and release of oNKord®, for clinical trials and beyond. The AutoloMATE platform will be tailormade for oNKord® manufacturing process in our state-of-the-art in-house and GMP licensed facility. This change will drive efficiency throughout the capturing / review and release of manufacturing data and leverage leading edge technologies such as distributed ledger technologies, IoT and AI. Glycostem is reinforcing its commitment to GMP aspects of cellular immunotherapy while supporting difficult to treat cancer patients.
https://www.linkedin.com/company/glycostem-therapeutics/
https://www.linkedin.com/feed/update/urn:li:activity:6673855756040843264/
25th June 2019 - Glycostem Therapeutics BV today announced they have received GMP license for Glycostem’s proprietary closed production system used to manufacture their lead product, oNKord®, an off-the-shelf,allogeneic Natural Killer(NK) cell therapy.
Troels Jordansen, CEO said “This is a key milestone for Glycostem as it allows us to progress with our pivotal clinical trials in Acute Myeloid Leukemia (AML) to be followed by Multiple Myeloma (MM), two life-threatening hematologic malignancies with severe prognostic. But it is also a unique event in the cellular therapy sector as this is the first inspection leading to approval of a closed allogeneic cellular production systemin a class-C cleanroom.This major achievement allows for oNKord® production in class-C clean room which is more cost efficient than in class-A/B clean rooms; both in set-up and running costs.
https://www.glycostem.com/node/172
The production process yields in a high quality of oNKord®based on:
• The ex vivo cultured NK cells have a similar composition and
functionality as in vivo NK cells.
• The system is closed, assuring a low risk of contamination.
• The system is very efficient and effective. The process
generates a superior expansion of NK cells: 5-10,000 fold
expansion is achievable.
• The system produces unprecedented high numbers and also very
pure NK-cells: up to 10 billion per batch that are over 95% pure
and devoid of contaminating T- and B-cells, which frequently
play a role in the mortality associated with allo-SCT and would
be similarly problematic in NK cell infusions.
• The produced NK cells are activated and 'ready to attack cancer
cells'.
• The output has been proven to be highly reliable & reproducible.
Dec. 2018. Over the next 4 years Glycostem in, as part of the consortium led by Prof Ulrike Köhl from Leipzig, work on developing novel methods to manufacture tumour reactive NK cells. The consortium consists of nine academic centres covering basic and translational research, as well as 3 leading biotech companies (Innate Pharma, Miltenyi and Glycostem) and Fraunhofer IZI as a world leading research institute. The objective is to educate top level selected PhD candidates not only in science, but also have a strong focus on business and management activities as well as basic and advanced knowledge in strategies around intellectual property.https://glycostem.com/node/150
Dr Bosch is also on the programme committee of an upcoming (8 to 10 February 2021) cancer conference in Noordwijk aan Zee (Netherlands), and interestingly he is referenced as working for NWBO-UK.
https://cddf.org/events/upcoming-events/cddf-12th-spring-conference-2021/
I don't see anything negative in the authors' reluctance to pass judgement on a trial that has yet to come out with the final results.
Am I missing something?
Marjolein Geurts will complete her neurology residency in January 2019. She works at the University Medical Center Utrecht. During her residency, she strongly focused on neuro-oncology. She has performed a clinical specialization in the Brain Tumor Center at Erasmus Medical Center Cancer Institute (Rotterdam, The Netherlands; supervisor, Professor Martin J. van den Bent) and has worked as a research fellow in The James Comprehensive Cancer Center at The Ohio State University (Columbus, Ohio; supervisor, Dr. Arnab Chakravarti). In addition to her laboratory work, which focuses on microRNAs in glioblastoma, she is also interested in clinical research.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587541/
Article : Immunotherapy in Glioblastoma: Current Shortcomings and Future Perspectives
https://www.mdpi.com/2072-6694/12/3/751/htm
Thank you for the information. I know that he returned to the Netherlands last year. So, I suppose you can communicate with the professor in Dutch?
Ps Dr Bosch is Dutch too
And then when you line up many other indicators, I think it just starts to look quite clear to me, again, just my opinion, but rationally, it starts to just add up, point-by-point-by-point.
We showed that an increased estimated TIL content prior to therapy was associated with prolonged TTP and OS. All very long-term survivors in this trial had estimated TIL content in the top quartile. The correlations between estimated TIL content and TTP and OS suggest that estimated TIL content in the initial tumor specimen may be used to select patients for DC vaccination and may be applicable to other immunotherapies as well. In contrast, TIL content was not associated with survival in patients who were not treated with immunotherapy. Thus, our data suggest that the use of TCR sequencing to predict such survival indices may be directly relevant only for patients undergoing immunotherapy treatments such as DC vaccination.
https://cancerimmunolres.aacrjournals.org/content/4/5/412
I have always believed the partial halt was driven by German ethics in trials as they have the NAZI history with experimentation and take that stuff very seriously. One of my very early posts here was on that subject and my conviction that it was driven by a German ethical concern for placebo patients having their treatment delayed and therefore being potentially harmed by that delay.
Q6: “How do you interpret paragraph 32 of the Declaration of Helsinki?”
Germany refers to the “compelling and scientifically sound methodological reasons” [2] which could justify a placebo control under the condition that “the duration of the placebo treatment is as short as necessary”.
https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0262-9
So agree that changes are possible, but do carry risks.
In order to manufacture DCVax®-L for each individual patient, tumor tissue and a blood product first had to be taken from the patient before the cell-based therapeutic agent could then be manufactured in a complex, multi-stage process.
The number of patients that had to be recruited for the trial from a statistical perspective was reached back in 2015, marking the successful completion of the manufacturing and testing activities at Fraunhofer IZI. https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2017.pdf
there have been multiple references by Fraunhofer over the years to utilizing an "optimized" L product.
The manufacturing process for the immunotherapeutic DCVax®-L has been optimized and implemented as part of a clinical trial conducted by American biotech company Northwest Biotherapeutics, Inc. The therapeutic approach is based on autologous dendritic cells and aims to improve the treatment of glioblastoma, a particularly aggressive type of brain tumor.
https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/AnnualReport_IZI_2017_short.pdf
During the clinical studies, the drug manufacturing process was changed and optimized. At the time of approval, only three patients with the ß0/ß0 genotype had been treated with product manufactured by the commercial process. A comparability exercise between the previous process used for clinical trial material and the commercial manufacturing processes at the quality level had been extensively discussed before the evaluation. Given the well-known sensitivity of gene therapies to changes in the manufacturing process, and resulting uncertainties regarding their impact on drug product potency and clinical outcome, these changes might have contributed to a negative regulatory decision. However, in this particular case, pharmacodynamic parameters and efficacy results were consistent across studies. To address these uncertainties, the Agency decided to impose the following obligations: (i) tight control of the finished product potency attributes and (ii) reevaluation of the acceptance criteria for attributes related to the drug product potency tests using batch release data and clinical results after 6 months follow-up of 20 patients treated with commercial batches. It is up to the company to resolve the issues speedily and launch the product.
https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.1639?af=R
hankmanhub,
here are some recent quotes from iwasadiver:
Wednesday, 05/13/20 12:23:25 PM
The UK is taking over for all new drug approvals from the EMA, right now. DCVax is on the expedited review list with only another 200 or so drugs and it could be as quickly as 4 months.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155605945
Thursday, 05/14/20 07:47:29 AM
The EMA has nothing to do with an already existing MHRA authority to approve drugs for use only in the UK. Then NICE, AWMSG (All Wales Medicines Strategy Group), SMC (Scottish Medicines Consortium), DoH (Northern Ireland’s Dept. of Health) assess for cost guidance, etc.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155622375
Friday, 05/15/20 08:56:38 PM
I think there will be some sort of news before November about an application to the MHRA and an expected timeline for an answer for approval and NICE recommendations
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155671633
meirluc,
I have a few questions?
Do you believe that the last 31-32 patients are all treatment patients?
If your answer is “Yes”, do you agree that there are about 25 placebo patients in the last group of 108 patients? (first 223 patients randomized 2:1 = 149 treatment and 74 placebo. 99-74 = 25)
Do you agree that the last group of placebo patients may have received better surgical treatment than the first 74 placebo patients? (ALA-5 in Europe …etc.!)
Do you agree that at least 60% of placebo patients in this trial are dead after 22 months?
If your answer is “Yes”, at least 15 out of 25 placebos of the last group of 108 are dead and no more than 10 placebo patients are still alive at the time of the interim analysis. That was mid-March 2017 = 22 months after surgery of the last placebo patient (around mid-May 2015.)
Next question:
Do you belong to the group of ihub members who are convinced that the number of cross-over placebo patients increased from 54 to 66 cross-over placebo patients between mid-March 2017 ( interim analysis) and end of May 2017 (Asco 2017)? (From 86.4% to 90% of the ITT group) That is an increase of 12 cross-over placebo patients.
If your answer is “Yes”, I assume that you can only conclude that all placebo patients censored between month 22 and month 36 on the OS curve were progression free at the time of the interim analysis(WOW!!) and all these placebo patients(increase of 12) got recurrence from their brain tumour between mid-March 2017 and the end of May 2017. (10 placebo patients censored between month 22 and month 30 and about 2 out of 7 patients censored between month 30 and month 36 on the OS curve March 2017). Unbelievable!!
Conclusion: Do you agree that none of the last 25 placebo patients (the best group=ALA-5 surgery...etc.) were progression free 36 months after surgery if the above is correct ?
Last question:
If none of the last 25 patients were progression free 36 months after surgery, why do you believe that 8 of the first 74 placebo patients were progression free 36 months after surgery?
NOTE: 86.4% of the ITT population received the experimental DC treatment at some point during the trial at the time of the interim analysis March 2017.( https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6)
I believe that number of 86.4% never changed after March 2017.
OS curve March 2017:
https://investorshub.advfn.com/uimage/uploads/2018/10/22/gddzjCombined_charts_no_notes_revised_-lykiri.jpg