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beartrap12,
Jim Power: 30% of the tumor remained, and it was a fast growing tumor.
Kathleen Charles (Katscure) : 20% of the tumour remained and there was three months, six months left to live.
Doc logic,
A PEI document (The Paul-Ehrlich-Institut) shows that the last German treatment patient was enrolled around November 8, 2015.
At the beginning of October 2015 a German patient who had gone through all the pre-treatments (surgery, radiation, chemo, leukapheresis) couldn't get the vaccine. (NOTE: he had no side-effects after surgery and his doctor told him that he had never seen such excellent blood values after brain surgery and chemo/rad.)
On December 1, 2015, her husband said she was almost certain that he would be one of the 33% placebo patients. When I connect the dots I think i understand why she came to that conclusion.
No Ex, it's not for one more cleanroom. It's for an additional "cleanroom" suite.
Phase 1:
Phase 1 of Advent Bioservices’ own new facility in Cambridgeshire includes two completed suites (185m2 i.a. each) comprising B, C and PD/QC labs, offices and storage space. https://ct.catapult.org.uk/sites/default/files/publication/2018%20GMP%20Manufacturing%20Report_FINAL.pdf
Exwannabe,
You wrote:
Sawston construction is delayed. Given that it takes time to certify after construction, operation is a ways out. Only $62K of equipment purchases in Q1.
MAY 2020.
Advent Bioservices is currently in the process of applying for licencing and accreditation from UK authorities including the HTA, MHRA and HFEA for the Sawston site.
https://www.sciencedirect.com/science/article/pii/S1465324920303959
On March 26, 2020, the Company entered into a Loan Agreement (the “Loan Agreement”) with Cambridge & Peterborough Combined Authority (the “Lender”) for a loan of £1.35 million (approximately $1.7 million) (the “Loan”) for the next phase of buildout of the Sawston facility.
https://www.sec.gov/Archives/edgar/data/1072379/000110465920076154/tm2014603-1_10q.htm
In addition, manufacturing of DCVax products is impeded by personnel being under lockdown, and the buildout of the Sawston facility has been delayed by the construction sector shutdown and restrictions. The Company anticipates that such effects of the COVID-19 situation may continue for an extended period of time. However, the Company is exploring possible ways of mitigating these effects, such as employing double shifts for some of the Sawston facility buildout.
https://www.sec.gov/Archives/edgar/data/1072379/000110465920076154/tm2014603-1_10q.htm
Poor Man,
One can ask Fanny Schömann what's going on. She is an employee of the German subsidiary of NWBO and responsible for the book keeping and all tax relevant matters.
Fanny Schömann
Head Of Operations
Company Name
Northwest Biotherapeutics GmbH
Dates EmployedAug 2013 – Present
Employment Duration6 yrs 11 mos
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/
Al Musella
Yesterday
This is probably the most important bill I have ever seen for brain tumor patients as well as people dealing with other life altering diseases not just cancer but ALS, Parkinson's disease and more. We are working on a plan to help it along - don't do anything just yet - I am building up a coalition to help.. then will annoucne when I need you to contact the congressman! (if anyone has experience with this type of advocacy, contact me privately!)
Tone Ruccio
Al Musella what do you think could be hoped for now?
Al Musella
If this bill passes, we should see a few new treatment options for brain tumors very quickly, then a steady stream of new treatments. We will be able to try combinations in a virtual trial (which is why I chose the domain name virtualtrials.com) that will be tracked in a registry until we find the ultimate cocktail. It will vastly speed up the search for the cure. And because there will be many treatment options, and the cost of developing a drug will be cut by over 90%, prices should come way down.
I am pretty sure this works for a decent amount of people. It may not work for everyone but...perhaps that is why we want to see data that goes well beyond the median.
IO therapies have shown great progress for 30 to 40 percent of the population
The one thing we forget to quantify is QOL years.
survivor1x,
Thank you for the reply. I fully respect the privacy reasons. I thought it might be one of the 8+years survivors of the DCVax-L trial who recently shared their story on social media. Obviously not! Still, I am happy to add another long-term survivor of the DCvax-L trial to my list.
survivor1x,
can you give me the first name of the patient you know? ( or initials of patient's name?)
Just curious if he/she is on my list. Thanks!
I would not make any attempt to place odds. I am not investing now as overall I think LP and PFS make it a bad bet today. Once the PFS story resolves I could reconsider.
In contrast, DCVax has achieved clinical benefits (i.e.longer delay in disease progression and longer extension of survival than with standard of care treatment) in over 80% of the patients who have received DCVax in clinical trials to date. Since DCVax is made with biomarkers from the patient’s own tumor, it is automatically tailored to targets that are present on that patient’s cancer.
wow did anybody else notice the SP jump Friday a week ago for Groupon from 1,75 to 21,75 in 1 freaking day... a 12x bagger in 1 day. Investment world is getting nuts
June 10, 2020 09:00 AM Eastern Daylight Time
CHICAGO--(BUSINESS WIRE)--Groupon, Inc. (NASDAQ: GRPN) (“Groupon” or the “Company”) announced today that the Company’s board of directors has approved a reverse stock split of the Company’s common stock at a ratio of 1-for-20, following approval of the reverse stock split by the Company’s stockholders at the Annual Meeting of Stockholders held on June 9, 2020.
The reverse stock split will become effective at 5:00 p.m. Eastern time on June 10, 2020. At the effective time, every 20 issued and outstanding shares of the Company’s common stock will be converted and combined into one share of the Company’s common stock, and a proportionate reduction will be made to the Company’s number of authorized shares of common stock.
Beginning with the opening of trading on June 11, 2020, the Company’s common stock will trade on the Nasdaq Global Select Market on a split-adjusted basis under a new CUSIP number, 399473206. The Company’s trading symbol will continue to be “GRPN.”
The reverse stock split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s common stock, except for adjustments that may result from the treatment of fractional shares as described below.
No fractional shares will be issued as a result of the reverse stock split. Instead, the Company’s transfer agent will aggregate all fractional shares and sell them as soon as practicable after the effective time of the reverse stock split at the then-prevailing prices on the open market. Stockholders who would have been entitled to a fractional share as a result of the reverse stock split will receive a cash payment from the transfer agent in an amount equal to their respective pro rata share of the total proceeds of such sale.
I wonder what happened in Germany around the end of November 2016.
Kati Kebbel
Head of Department GMP Cell and Gene Therapy at Fraunhofer Institute for Cell Therapy and Immunology
Consultant
Northwest Biotherapeutics GmbH
Dates Employed Oct 2013 – Dec 2016
Employment Duration 3 yrs 3 mos
Location Leipzig
Consultant
Key words: qualified person acc. to §15 German Drug Act (AMG); supporting QC and QA related tasks
https://www.linkedin.com/in/kati-kebbel-9654978b/
Gerno Schmiedeknecht
Head of Main Department GMP Cell and Gene Therapy at Fraunhofer Institute for Cell Therapy and Immunology IZI
Regulatory Consultant and Qualified Person
Northwest Biotherapeutics GmbH
Dates Employed Oct 2013 – Dec 2016
Employment Duration 3 yrs 3 mos
Location Leipzig
Qualified Person (QP) according to §15, section 3a, point 1 & 2 German Drug Act. Regulatory consultancy cell therapy manufacturing, quality control and supply.
https://www.linkedin.com/in/gerno-schmiedeknecht-9a289850/
Günter Rosskamp
CEO bei Northwest Biotherapeutics GmbH
Amtsgericht Leipzig Aktenzeichen: HRB 27978 Bekannt gemacht am: 30.11.2016 18:30 Uhr
Die in () gesetzten Angaben der Geschäftsanschrift und des Unternehmensgegenstandes erfolgen ohne Gewähr.
Veränderungen
30.11.2016
HRB 27978: Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig. Ausgeschieden: Geschäftsführer: Dr. Rosskamp, Guenter, Berlin, *04.06.1942.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=156101950
…. and December 15, 2016- famous presentation by Linda Liau-
Sander,
Thank you for the German information!
Longfellow95,
I occasionally follow Oxford Biomedica since Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox. (May 13, 2020.)
Construction was completed at the end of 2019.
That’s the reason I expect Sawston licensing in the second half of June.(four and ½ month after final construction)
Press releases
13/05/2020
Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox
Oxford, UK – 13 May, 2020: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, announced today the successful outcome of their recent UK Medicines & Healthcare products Regulatory Agency (MHRA) inspection, resulting in the issue of a Certificate of GMP compliance for the first two GMP manufacturing suites and supporting area such as warehouse, cold chain facilities and QC laboratories, in its new Oxbox manufacturing facility.
Oxbox is Oxford Biomedica’s new 7,800 m2 commercial manufacturing centre, located in Oxford, UK. Phase I is 4,200 m2 of developed area consisting of six GMP manufacturing suites - four for viral vector production and two for fill-finish, warehousing and cold chain facilities and support laboratories. Construction was completed at the end of 2019. This approval by the MHRA of the first two suites enables commercial production of batches to commence for partner programmes within the coming weeks.
As previously announced the first fill / finish suite is expected to be operational by the end of the year with the other completed clean rooms in the first phase ready for equipment installation as demand increases. Phase II will provide for the flexible expansion of a further six GMP clean room suites.
This world class facility is suitable for the manufacture of a variety of viral vectors and will more than double Oxford Biomedica’s manufacturing capacity, supporting further growth in revenues and partner programmes.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: “We are delighted that despite COVID-19 the MHRA has been able to complete the inspection and sign off of the two suites and supporting areas within our world class Oxbox manufacturing facility. This not only secures facilities for our current and future cell and gene therapy partner programmes but also potentially provides access to the Oxford COVID-19 Vaccine Consortium for production of vaccine should the clinical trials prove to be successful.”
-Ends-
https://www.oxfordbiomedica.co.uk/news-media/press-release/oxford-biomedica-receives-mhra-approval-first-two-manufacturing-suites
longfellow95,
Yes, Mike Scott in center of table.
https://twitter.com/UCLTRO/status/1238161125948166145/photo/1
I expect Sawston licensing in the second half of June.
Join us on 11 March 2020 for an exclusive London Advanced Therapies ATN, powered by MedCity event on ATMP manufacturing in the UK, with leading academic and industry expert panellists.
Why ATMP Manufacturing?
The UK is one of the leading sources of research and development in advanced therapies, with over 900 therapeutic developers, 1,060 clinical trials and 14 approved ATMPs (ARM and BIA 2019). With 25 manufacturing facilities across the UK, we are competitively positioned as a leading global hub in the field, but key challenges remain to be addressed, particularly when it comes to manufacturing at scale.
Investment, funding opportunities, viral vector manufacturing capacity and the right skills and talent are all challenges facing both academia and industry, whose capacity to translate research into clinical products is at critical levels.
This event will bring together leading academic and industry experts to discuss the current state of play in this landscape, along with the challenges and the way forward. We will also look at how to translate current ATMP manufacturing capabilities into clinical excellence, and the important role investment is playing in the race for global leader status.
Agenda
• 16:30 Registration, tea and coffee
• 17:00 Opening Remarks – Dr Francesca Gliubich, Director of London Advanced Therapies
• 17:10 Session 1: The ATMP manufacturing landscape in the UK and the current challenges
•
o 17:10 – Keynote – Ian McCubbin, OBE, Chair RoslinCT and Manufacturing advisory group Innovate
o 17:25 – Panel Discussion
•
o
?
? Prof Uta Griesenbach, Imperial College London
? Matthew Durdy, CBO, Cell and Gene Therapy Catapult
? Dr James Miskin, CTO, Oxford Biomedica
? Prof Farzin Farzaneh, King’s College London
? Peter Coleman, CEO, Cobra Biologics
? Dr Mike Scott, COO, Advent Bioservices
• 18:10 Session 2: Translating the UK ATMP manufacturing capabilities to clinical excellence and the role of investment
•
o 18:10 – Keynote – Dr Eliot Forster, CEO, F- Star and Chairman, MedCity
o 18:25 – Panel Discussion
? Prof Emma Morris, UCL and UCLH
? Dr Jacqueline Barry, CCO, Cell and Gene Therapy Catapult
? Prof Andrew Baker, University of Edinburgh
? Prof Adrian Thrasher, UCL
? Dr Catriona Crombie, LifeArc
•
o 19:10 Closing Remarks – Dr Pamela Tranter, Head, Translational Research, UCL
o 19:20 – 20:30 Networking reception
https://www.medcityhq.com/news-and-events/
Will sherlock
ATMP scientist at Advent Bioservices
https://www.linkedin.com/in/will-sherlock-602878123/?originalSubdomain=uk
Alejandro Barquero
Quality Assurance Officer at Advent Bioservices
https://www.linkedin.com/in/alejandrobarquero/
Nabiha Hussain
GMP Production Scientist at Advent Bioservices
https://www.linkedin.com/in/nabiha-hussain-0088549b/
Han-Yu (Selena) H.
GMP Production Scientist at Advent Bioservices
https://www.linkedin.com/in/hanyuhsieh/
sukus,
Autolomous
Startup
"Autolomous is a company founded by ATMP- and software development experts, who have combined their skills to deliver elegant solutions to the ATMP supply-chain. Autolomous will deliver the digital solutions necessary for ATMP (Advanced Therapy Manufacturing Process) to achieve scalability, allowing more patients to benefit from this life changing benefits. The company is creating a portfolio of software solutions (AutoloMATE) to enable the scheduling of the patient for collection of their cells in a hospital; the transport of those cells to the production site; the tracking of the manufacturing process to meet regulatory obligations of production; the legal release of the medicine; and the scheduled delivery of the patient-specific medicine to the hospital in time to meet the on-going treatment of the patient. Our software will enable increased automation of these processes, reducing the risk of errors and ensuring that the correct product is returned to the right patient."
https://www.terrapinn.com/congress/advanced-therapies/exhibitor-autolomous.stm
Construction of an ATMP manufacturing facility and scale up of production: Advent Bioservices
W.Sherlock A.Barquero N.Hussain S.Hsieh M.Scott
Advent Bioservices, London, London, United Kingdom
Available online 23 May 2020.
https://doi.org/10.1016/j.jcyt.2020.03.331
Background & Aim
In recent years, the UK cell and gene therapy industry has expanded rapidly. Cleanroom space capacity has increased during the last five years to a total of 7,819m2. In 2019, cleanroom facilities in the UK ran at 72% of operational capacity on average with 80% generally considered full. This demand has been driven by the success of the UK in capturing a disproportionately high level of investment and clinical trial activity. Between 2014 and 2019, the UK initiated 112 new ATMP clinical trials which was the highest total figure for any European country. This increase in the number of candidate treatments is projected to increase the production of ATMPs from hundreds to tens of thousands per year by 2028, resulting in strong demand for GMP manufacturing services and expertise in commercialisation and scale-up of manufacture.
Advent Bioservices began activity as a cell therapy contract development & manufacturing organization in 2016 and is in the process of building a state-of-the-art multiproduct GMP production facility outside Sawston in Cambridgeshire, which will allow the scale up of current commercial production and the provision of contract manufacturing services to meet the growing demand for such services in the UK.
Methods, Results & Conclusion
The Sawston facility is located just 7 miles outside Cambridge city centre with excellent transport links to Central London, London Stansted airport and is 4 miles from the M11 motorway. The facility consists of 1700m2 of GMP lab space, 325m2 for process development and an additional 1450 m2 for future expansion. Initial construction work has focused on the building of 2 separate GMP suites with grade B/C classified areas, in house QC testing and office space as well as a multipurpose cryogenic storage unit.
The entire facility will operate under a comprehensive IT infrastructure including eQMS and an eBMR, with a LIMS with secure storage for client documents and paperless systems. Clients operating within these suites will benefit from already validated cleanrooms, in-house environmental monitoring system as well as training, ancillary services and technical support inclusive of process development and validation. Our cryogenic facilities are available to external clients as off-site storage and offer disaster recovery services as per UK regulatory (HTA) requirements.
Advent Bioservices is currently in the process of applying for licencing and accreditation from UK authorities including the HTA, MHRA and HFEA for the Sawston site.
https://www.sciencedirect.com/science/article/pii/S1465324920303959
JTORENCE,
Autolomous will likely figure in the manufacture plan for DCVax-L (blockchain cloud-based needle to needle audit system = the AutoloMATE platform.) when the MAA is submitted to EMA and/or MHRA.
For those who follow Autolomous:
remember this:
4 months ago:
Happy and Excited to announce that we have been working with Advent Bioservices on developing & deploying our AutoloMATE eBMR solution. We look forward to continuing our partnership with Mike Scott and the Advent Team. (https://www.autolomous.com/linkedin)
We are proud to announce Autolomous has been chosen by Glycostem Therapeutics, for the digitisation of the manufacturing and release of Glycostem's hashtag#NK-cell therapies for clinical trials and beyond.
Our deployment to Glycostem Therapeutics represent a significant milestone for , it is our first deployment to a hashtag#Allogeneic hashtag#ATMP manufacturer and our first deployment in Europe, showcasing the flexibility of the hashtag#AutoloMATE platform and the value-add it brings. We are excited to be working with Troels Jordansen, Volker Huppert and the Glycostem Therapeutics team.
I'm proud of the progress the Autolomous team have made, a US deployment is not far behind.
alphapuppy,
thank you for your analysis of the PFS arm!
One question: why 110 patients in your placebo group and 221 patients in your treatment group and not the real numbers? (99 placebo patients and 232 treatment patients in the DCVax-L trial)
Sentiment,
Thank you! And also hmuney thank you!
Daniela A. Bota, M.D., Ph.D and DCVax-L trial: around min.20.
Umibe5690,
Thank you for all your contributions! Much appreciated!
iwasadiver,
Thank you for all your contributions! Much appreciated!
You wrote:
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
RevImmune
T-CELL TECHNOLOGY & DEVELOPMENT
CEO: Linda Powers
https://dirigeant.societe.com/dirigeant/Linda.POWERS.29622905.html
*Our COVID-19 Program
1. We believe IL-7 (CYT107) can prevent patients who are in the hospital for COVID-19 from progressing to having to be treated in the ICU or progressing to needing more than 4L/minute of supplemental oxygen.
2. Both the underlying biology and existing data from CYT107 clinical trials and compassionate use support this belief.
• The biology underlying progression into the ICU is severe and progressive lymphopenia [see figure from Lancet article on ALC in survivors and non-survivors of COVID-19] and a large body of literature has established that IL-7 resolves lymphopenia by expanding T cell populations.
• Data from clinical use of CYT107 have shown encouraging results in sepsis and a variety of viral diseases (PML, HIV, HCV, etc.) – resolving the condition or preventing clinical decline.
3. CYT107 is one of the few potential new treatment options already in advanced clinical development – currently in Phase IIB trials, with accumulated safety data in >440 patients showing an excellent safety profile, and with efficacy data in both sepsis and multiple viral diseases.
https://www.revimmune.com/
https://www.revimmune.com/covid-19-program
Compassionate Use and Clinical Trials of CYT107 for COVID-19
Compassionate use access to CYT107 is being provided to certain hospitals in Italy, Spain, France, Belgium and the US while the clinical trial is being prepared and launched.
What did he say 2 months ago? (March 4, 2020)
THE PRESIDENTIAL YEAR ECONOMY
Russ and Sully discuss the market in a presidential year. Then, Les Goldman discusses a personalized cancer vaccine. Plus, Rob Davidson discusses their new medication that is easy to get into your system faster. Original Air Date: March 4, 2020
https://www.biztvclub.com/tv/search/video/81e22ffedeab807060d0ff8e6bb77795
10 hours ago:
Comment Al Musella
Advances in Neuro-Imaging.
Musella Foundation Brain Tumor Awareness Month Webinar
5/10/2020
This is a must view for anyone interested in brain tumors. It presents a new way to look at MRI images to tell if a treatment is working or not way earlier than the standard MRIs. This technology is available at some major centers now and if not available at your hopsital, there are companies that can outsource the service!
Comment Scott Stier (5 hours ago)
This is an absolutely incredible advancement in brain tumor treatment. Allowing our doctors to differentiate between tumor and pseudo-progression is an important game changer!! Thank you for sharing this important new technique!!
Comment Al Musella ( 5 hours ago)
Scott Stier this should be standard. Especially for optune and immunotherapy So many people stop too early. This might show it helps and allow then to continue
The Musella Foundation For Brain Tumor Research & Information, Inc
2020 Brain Tumor Webinar Series
Sunday - May 10
Kathleen Schmainda, PhD
"Advances in Neuro-Imaging"
Al Musella
May 9
Our next Webinar in the Brain Tumor Awareness Month Series is tomorrow night (Sunday - May 10) at 7 pm eastern. Dr Kathleen Schmainda will be speaking about a new technique for MRIs that she says can tell true progression from Pseudoprogression, and can tell much earlier if a treatment is working or not.. Shoud be interesting and can affect all of us.
May 10
Al Musella Zoom is overloaded... and we had technical problems with the sound so we won't be posting the video. It was a very important lecture so we will record it again sometime this week and post the video of it.. a key point was a way to tell early when a treatment is working or not, such as immunotherapies or optune. It is technology that is available now and should be in use for everyone.
How is that because the recent video from last year she states they are only now understanding the significance of IDH.
Vanessa Arce
Sr. Controller at Northwest Biotherapeutics
Washington D.C. Metro Area
Experienced Senior Controller with a demonstrated history of working in the financial services industry. Skilled in ADP Payroll, ADP Payforce, Payroll Processing, Generally Accepted Accounting Principles (GAAP), and Tax Accounting. Strong accounting professional with a Bachelor of Science - BS focused in Accounting and Business/Management from University of Maryland University College.
Sr. Controller
Company Name
Northwest Biotherapeutics Full-time
Dates Employed Mar 2020 – Present
Employment Duration 3 mos
Location Maryland, United States
https://www.linkedin.com/in/vanessa-arce-606a3318a/
Sunday, 10/22/17
Evaluate
Sunday, 10/22/17 02:31:21 AM
Re: None
Post # of 282119
A couple other Sawston docs I stumbled across (while I was looking for the site acreage):
http://plan.scambs.gov.uk/swiftlg/MediaTemp/1134366-522858.pdf
includes:
Involvement
The following consultants have been involved in the preparation of this application:
DTZ – Planning Consultants
AHP – Architects
PJC - Ecology
MBC Traffic – Transport Consultants
SMP – Consulting Engineers
Consultation
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135592905
longfellow95
Friday, 11/17/17 06:13:53 AM
Re: tencoin post# 143391
Post # of 282119
ahpltd.co.uk/cell-therapy-laboratories/
Quote:AHP are pleased to have been instructed by a leading Bio Science company in the development of a new commercial validated GMP compliant manufacturing facility and state of the art Research and Development Laboratories in South Cambridge. Our client has extensive experience in the development of cell-based therapeutics in the USA and are now developing the first commercial scale manufacturing facility in England.
.
The South Cambridge Site offers the opportunity for further expansion and the vision is for the development of a healthcare campus providing both manufacturing and patient treatment in the same locality.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136271773
scheme
Genetic and Cellular Therapy Laboratories
client
Undisclosed
value
£18m
description
AHP were appointed as lead designer for the refurbishment of an existing distribution depot and associated offices. The refurbishment provided the client with state of the art genetic and cellular therapy, GMP manufacturing facilities in class D, C and B cleanroom laboratories with associated accommodation, including temperature-controlled quarantine storage, microbiology testing laboratories, process development laboratories, cryogenic shipping, secure data storage, administration offices, staff recreation and changing areas.
The design also included 4 rentable ‘hotel’ suites for start-up projects. Each self-contained unit includes laboratory and EM microbiology facilities, and administration space.
scheme
Cell Therapy Laboratories
Royal Free Hospital
client
Royal Free London NHS Foundation Trust
value
£2.1m
description
The scheme comprised increasing University College London’s world-leading cell therapy laboratories facility at the Royal Free Hospital, from four cleanroom labs to ten with multiple cleanroom classifications. The rooms require carefully sequenced air pressure cascade and make use of cutting edge partitioning systems from Italy.
The scheme was developed by an expert design team through extensive workshops with the end user and hospital Trust. The project was split into three phases, organised around the continuing laboratory function within the live hospital environment.
Yes her husband is a billionaire.
CoqDiss 1188X,
I guess it will be available here soon:
https://virtualtrials.com/video.cfm
https://www.facebook.com/Braintumor/videos/10158377546424485/?t=2101
Combining Advances in Surgery and Immunotherapy to Maximize Outcomes for Patients with Malignant Glioma.
Steven Brem
Al Musella
April 29
Our brain tumor webinar series continues this week with Combining Advances in Surgery and Immunotherapy to Maximize Outcomes for Patients with Malignant Glioma
our host will be:
Steven Brem, M.D.
Professor and Co-Director, Penn Brain Tumor Center
Department of Neurosurgery
Hospital of the University of the Pennsylvania
No advance registration is needed. For details and to view the webinar, go to virtualtrials.com/webinar Go about 5 minutes before the event to allow time to sign in. We start promptly at 7pm eastern time! There will be time to ask questions!
Note: the Zoom software has been updated recently to enhance security and they may lock out old versions of zoom. If the website asks you to update Zoom, do it before the webinar. Leave an extra 5 minutes to allow for the update.
flipper44,
Thank you for the additional information. Now I understand why you said this a few months ago:
flipper44
Sunday, 10/06/19 09:16:33 AM
Re: IkeEsqpost# 212316
"Taking some days off from posting, my personal inclination was that this board would ignore the very hopeful sign that Dr. Hahn might be the FDA's next lead. I have no doubt many here know his background is intimately tied to a University that supports Autologous dendritic therapy, and said University indeed worked with Dr. Bosch and DCVax-L on a small but very successful ovarian trial (pilot study). I don't find that lack of discussion on this board strange at all. In fact I expected it to remain under the radar -- which it did."
The Musella Foundation For Brain Tumor Research & Information, Inc
Brain Tumor Webinars.
5/3/2020: SUNDAY 7pm Eastern Time. Topic: Combining Advances in Surgery and Immunotherapy to Maximize Outcomes for Patients with Malignant Glioma.
Steven Brem, M.D.
Professor and Co-Director, Penn Brain Tumor Center
Department of Neurosurgery
Hospital of the University of the Pennsylvania
The Room will open about 15 minutes before the next webinar starts!
The link to the room will appear here when the room open!
longfellow95 Friday, 07/06/18 12:02:31 PM
Re: None
Post #
181412
of 246830
Well, it's gratifying to know that in addition to the extremely well qualified Scientific Advisory Board, there is also an extremely well qualified Steering Committee for the trial, and they are all amongst the list of co-authors.
I had not heard them named previously until LP named them at the ASCO meeting.
Steering Committee:-
Dr. Steven Bremm.
Chief, Neurosurgical Oncology, Co-Director, Penn Brain Tumor Center, Professor of Neurosurgery, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania
Dr. Fabio Iwamoto.
Dr. Iwamoto is a neuro-oncologist whose previous training includes a neurology residency at NewYork-Presbyterian/Weill Cornell Medical Center and a neuro-oncology fellowship at Memorial Sloan-Kettering Cancer Center. For over three years, Dr. Iwamoto was an attending physician and an investigator at the Neuro-oncology Branch, a trans-institute branch of the National Cancer Institute and National Institute of Neurological Disorders and Stroke, in Bethesda, MD. At the intramural NIH, Dr. Iwamoto was a principal investigator in early phase clinical trials for brain tumors and worked with laboratory and computational scientists on several translational projects in brain tumors.
Dr. Iwamoto was recruited to Columbia University as the Deputy Director of the Neuro-oncology Division and is actively developing the clinical and translational research components of this program. He is an expert in the diagnosis, management, and treatment of brain and spinal cord tumors as well as neurological complications of cancer.
Dr. Jian Campian.
https://oncology.wustl.edu/people/faculty/Campian/Campian_Bio.html
Dr. John Trusheim.
https://www.youtube.com/watch?v=hS2u1jvkJY4
https://www.youtube.com/watch?v=QKznRBiE-ew
https://www.futuremedicine.com/doi/10.2217/cns-2016-0032
And a recap on the SAB:-
Dr. Mac Cheever.
Dr. Martin (“Mac”) Cheever is the Director and Principal Investigator of the Cancer Immunotherapy Trials Network (CITN) funded by the National Cancer Institute (NCI). The CITN is a network of immunotherapy investigators who are well established and recognized academic leaders in the field of immunology at 32 leading research institutions across the U.S. Dr. Cheever also spearheaded the multi-year project to evaluate and prioritize the 20 most important investigational agents for immunotherapy and the 75 most promising cancer vaccine targets. Dr. Cheever previously served as the Director of Solid Tumor Research at the Fred Hutchinson Cancer Research Center, and continues to be a Full Member (Professor) there.
Dr. Cheever’s research is focused on cancer immunotherapy, including T cell therapy and the development of cancer vaccines, especially for breast cancer. He co-founded an early biotech company developing cancer vaccines, and served as Vice President of Clinical Research and Medical Affairs for 8 years. In that capacity, he gained extensive experience with design and execution of cancer vaccine clinical trials, FDA related product approval issues and collaboration with major pharmaceutical companies.
Dr. Alfredo Quinones-Hinojosa.
Dr. Alfredo Quiñones-Hinojosa is currently Director of the Brain Tumor Surgery Program at Johns Hopkins Hospital. He is also head of the Brain Tumor Stem Cell Laboratory at Johns Hopkins. In September 2016, Dr. Quiñones will become the “William J. and Charles H. Mayo Professor” and Chair of Neurologic Surgery at the Mayo Clinic in Jacksonville, Florida, in connection with $100 million in major new construction projects being undertaken there, to develop new facilities and integrated services for complex cancers and for neurologic and neurosurgical care.
Dr. Quiñones has published 295 peer-reviewed papers and over 100 book chapters (including invited reviews and letters), and has been the main editor or section editor of nine textbooks. Most notably, Dr. Quiñones is also Editor-in-Chief for one of the most well-respected and widely-read neurosurgical textbooks in the world. Dr. Quiñones is one of the few brain surgeons with multiple research grants from the National Institutes of Health, as well as the Robert Wood Johnson Foundation and the Maryland Stem Cell Foundation. Some of his major accomplishments to date include: 1) elucidating mechanisms by which brain tumors migrate and metastasize, 2) integrating the use of stem cells into local treatment of solid tumors, 3) the concomitant use of nanotechnology and focal beam radiotherapy in the systemic treatment of solid tumors, 4) the development of new imaging software to help identify areas within solid tumors with the greatest malignant potential, and 5) the development of innovative, minimally invasive approaches to brain tumor resection. Dr. Quiñones is the Principal Investigator (PI) or Co-PI on multiple clinical trials, including novel combination therapies for brain tumors (with checkpoint inhibitors and/or various other technologies), and the first trials in the U.S. of certain technologies for more complete surgical removal of brain tumors.
Dr. Quinones has been recognized with the Association of American Medical Colleges Herbert W. Nickens Award, the Johns Hopkins Hospital Department of Neurosurgery, Richard J. Otenasek, Jr, Faculty Teaching Award, the “Neurosurgeon of the Year” award from Voices Against Brain Cancer, a “Health Care Heroes Award,” a Howard Hughes Medical Institute Physician-Scientist Early Career Award and various other recognitions.
Dr. Jerome Galon.
Dr. Galon is the Director of the Integrative Cancer Immunology Lab at INSERM (the French national institutes of health). He is associate Director and co-founder of European Academy of Tumor Immunology (EATI) and board Director of the Society for Immunotherapy of Cancer (SITC). He defined the concept of cancer immune-contexture, and demonstrated the major importance of pre-existing immunity in cancer. He developed the Immunoscore system, which is receiving wide and growing attention throughout the immuno-oncology field as a potentially more accurate system for evaluating tumors and predicting clinical outcomes, taking account of both tumor characteristics and patient immune system factors. Dr. Galon heads a worldwide task force of immunologists and pathologists from 16 countries working on clinical applications and global validation of the Immunoscore system, working together with major organizations such as the Society for Immunotherapy of Cancer (SITC) and others.
Dr. Galon’s contributions have been recognized with numerous awards, including the William B. Coley Award (NY, USA), an international prize which honors the best scientists in fundamental and cancer immunology, the Rose Lamarca Award from the Medical Research Foundation, the Gallet & Breton Award from the National Academy of Medicine, and the Simone & Cino del Duca Cancer Research Award from the National Academy of Science.
Dr. Samir N. Khleif.
Dr. Khleif is the Director of the Georgia Cancer Center, the State cancer center of Georgia at Augusta University. He is a Georgia Research Alliance Distinguished Cancer Scientist and Clinician, and a professor of Medicine, Biochemistry, Cancer Biology and Graduate Studies. He also serves as the Director of the Immuno-Oncology and Immunetherapeutics Program. Dr. Khleif previously served as Chief of the Cancer Vaccine Section at the National Cancer Institute (NCI), and Professor of Medicine at Uniformed Services University of the Health Sciences. He also served as a Special Assistant to the FDA Commissioner from 2006-2009, where he led the FDA Critical Path for Oncology designed to restructure the oncology drug development process.
Dr. Khleif’s research group focuses on the development of novel immune therapies and cancer vaccines, and rational designs for combination immune therapy, based on understanding the molecular mechanisms of the interaction between cancer and the immune system (including cancer-induced immune suppression). His team designed and conducted some of the first cancer vaccine clinical trials, and they are currently developing novel combination approaches to enhance anti-tumor effects. During his tenure at NCI, Dr. Khleif was also detailed to serve for 4 years as the Director General and CEO of the King Hussein Cancer Center in Amman, expanding and strengthening the clinical operations and building that institution into a National Comprehensive Cancer Center of Excellence. Dr. Khleif serves on the board of the Society of Immune Therapy of Cancer (SITC), and he is a member of the National Cancer Policy Forum of the National Academy of Medicine where he leads the Immunotherapy Task Force. Dr. Khleif is the chair or member of many national committees on immuno-oncology and cancer research. He is the recipient of many awards including the National Cancer Institute (NCI) Director Gold Star Award, and the Public Health Service (PHS) Commendation Medal.
Dr. John Smyth.
Dr. Smyth was appointed the first Chair of Medical Oncology in Edinburgh and, over the course of 30 years, has developed multidisciplinary oncology to create the Edinburgh Cancer Research Centre, combining laboratory and clinical research with teaching and training, and serving a population of 2 million. Dr. Smyth’s research expertise is in experimental therapeutics, from drug design through all phases of pre-clinical evaluation and clinical trials, with his major research focus on the development and evaluation of new anti-cancer drugs. He Chaired the Expert Advisory Group for Oncology & Haematology for the Commission on Human Medicines, and served for several years on the UK Committee on Safety of Medicines, as well as on the Scientific Advisory Group for Oncology for the European Medicines Agency (the Europe-wide regulatory body). Dr. Smyth also has extensive experience participating in the independent monitoring of clinical trials of checkpoint inhibitor drugs. His work has also focused on the affordability of cancer related healthcare.
Dr. Smyth has published over 300 papers and been involved in 47 books and chapters. He served as Editor-in-Chief of the European Journal of Cancer for a decade, from 2001to 2010. He is a fellow of the Royal College of Physicians of Edinburgh and London, and fellow of the Royal Society of Edinburgh, and is a past president of the European Society of Medical Oncology and the Federation of European Cancer Societies.
All in all, that is a lot of expertise guiding this trial.
forumreader35
Thursday, 04/11/19 09:21:53 AM
Re: None
Post: 222208
Select Novel Approaches to Glioblastoma—Part 2
Published in Oncology and Expert Opinion / Interview · April 10, 2019
Interview with
Steven Brem MD
Interview by
Aman Shah MD
https://www.practiceupdate.com/content/select-novel-approaches-to-glioblastoma-part-2/76518
Dr. Shah: So, we spoke earlier in part one of this program about some of the new research that you’re doing with DNA vaccines and conjugates with Pseudomonas toxin. Could you tell us some other interesting research you’re doing on novel therapies in neuro-oncology?
Dr. Brem: Yes. We just completed a study with Tocagen, which is a viral therapy, which will also stimulate the immune response and also uses a novel form of chemotherapy where it takes an antifungal drug that is converted genetically to an oncolytic drug. So it’s a very clever approach, and that’s a large multi-center study and that’s being analyzed right now. And we learned at this meeting that their plans to roll out a new trial through the NRG for newly diagnosed using viral therapy and we’ve heard of the poliovirus, we’ve heard of the many viral studies coming from multiple centers in Boston, Houston, and so on, and about viral therapy. And whatever the virus is, they all are oncolytic. They kill the new glioma cell, liberate new antigens, or neoantigens, which are then recognized by antigen presenting cells.
We’ve also been very active in the DCVax, which was started at UCLA but now extended to Penn and other sites. And the interesting thing of that trial, which we reported some preliminary data, is that a large percentage of the patients are now living beyond 3 years, so that is a unique approach in that the patients own tumor creates their very individual vaccine looking at their own panel of antigens. So we’re excited by that approach and we’ll be hearing more about that in the future.
Dr. Shah: Okay, so my understanding of the DCVax is that you have to take the tissue out and then generate something against the dendritic cells within that admixture.
Dr. Brem: Yes.
Dr. Shah: Could you tell us a little bit more about where that therapy stands as of now and what kind of efficacy we're getting?
Dr. Brem: Well, a very large multi-national study was concluded and so that is going to…as the data matures, that will be going to FDA. We hope that that gets approved. We don’t know, but it’s an exciting study.
Dr. Shah: Okay, so talking about getting tumor cells out and generating something against it. It seems that you are also either working on or are involved with CAR T cells in glioblastomas, so please walk us through how that works.
Dr. Brem: Well, that is an exciting effort. It’s being led at the Abramson Cancer Center by Donald O’Rourke and his team, Zed Binder. I’m involved in that group, and it has just been funded by the Abramson Cancer Center as a translational center of excellence, so there’s a huge effort underway with neurosurgery and the Parker Institute, Abramson Cancer Center, Carl June’s Laboratory, many other laboratories trying to develop the next generation of CAR T cell. So we are…we just published a first-in-man phase I human trial that showed biological activity. And now because we’re dealing with a tough foe, the glioblastoma, we’re working on potentiating this by taking down some of the tumor defenses, looking at checkpoint inhibitors, combining it, supercharging the CAR T cell vaccine in a combination therapy, so that will be the next generation. That’s the future.
Dr. Shah: So, my understanding is that perhaps part of the reason why PD-1s have not been as promising in glioblastomas is glioblastomas somehow seem to not be very rich in T cells when you sample them, so there’s something stopping them.
Dr. Brem: There’s stromal barrier and there are inhibitors like TGF-ß, IL-6, the TNF-a, there’s cytokines. Also, we’ve been very interested in looking at macrophage polarization. And I’m part of a group that published this year in Nature Communications led by Yi Fan, who presented at this meeting, showing that if you block IL-6, you could redirect the macrophage from a tumor-suppressing state, the M2 state, to the M1 immunostimulatory state, so we hope to partner with pharma on that and develop the clinical trials based on that discovery.
Dr. Shah: That is fascinating, and of course, the CAR T cell strategy makes perfect sense because you create them in vitro and then put them in.
Dr. Brem: Yeah, so ultimately, we feel by attacking the tumor microenvironment as well as creating a vaccine directed to the antigens on the tumor, we’re going to have really a new class of therapy.
correction:
"in the U.S."
Show me German enrollment and I'll show you the reason for the hold.
Linda Liau:
Recruitment completed in de U.S. (n=331)
2016 MEETING SUMMARY
The 62nd Annual Meeting of the Western Neurosurgical Society was held at the Park Hyatt Aviara Resort in Carlsbad, CA, September 9-12, 2016. WNS President Linda Liau presided.
The meeting was attended by 94 members and professional guests and supported by 27 exhibitors, including Medtronic Spine that for the second time provided support at the Platinum Level; Arbor Pharmaceutical that provided support at the gold level and DePuy Synthes and Haag-Streit that provided support at the silver level. It is the exhibitors who make the meeting possible at the level of registration fee we charge.
2016 Annual Meeting Program on Website
For those of you who were unable to attend the annual meeting this year, the program booklet is available on our Website (westnsurg.org) as a pdf file you can download.