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Here is a quote from the latest PR from Northwest Biotherapeutics:
“Now that the data from our Phase 3 clinical trial of DCVax®-L have further matured and provided a further encouraging picture of patient survival, and we are ready to move forward with the months of work related to completion of the trial, we are very pleased to have a new war chest of funding for this work,” commented Linda Powers, CEO of NW Bio. “We are also looking forward to proceeding with further DCVax®-Direct trials.”
“We are especially pleased to obtain this funding on a non-dilutive basis, and to seamlessly continue our activities with the UK manufacturing facility under the favorable lease-back.”
„Wir freuen uns, das Jahr mit den jüngsten aktualisierten Zwischenergebnissen aus unserer Phase-3-Studie mit DCVax-L für Glioblastome stark abzuschließen. Diese britische Transaktion bietet uns einen beträchtlichen finanziellen Spielraum an nicht verwässernder Finanzierung“, erklärte Linda Powers, CEO von NW Bio.
„Wir glauben, dass wir mit diesen Erfolgen einen wichtigen Schritt gemacht haben, um dem seit Monaten angestrebten Abschluss der Phase-3-Studie deutlich näher zu kommen“, so Frau Powers weiter. „Wir freuen uns auch darauf, die Phase-2-Studien mit DCVax®-Direct fortzusetzen.“
"We look forward to closing the year with the most recent updated interim results from our Phase 3 DCVax-L trial for glioblastoma. This UK deal gives us considerable financial leeway in non-dilutive financing, "said Linda Powers, CEO of NW Bio.
"We believe that with these achievements, we have made an important step towards coming much closer to the completion of the Phase 3 study, which has been going on for months," Ms. Powers continued. "We also look forward to continuing the Phase 2 studies with DCVax®-Direct."
At the end of the day - don't know how he got the numbers so wrong
about the MGMT Methylated GBM CETEG trial
Gliale Hirntumoren – Aktuelle Therapiekonzepte (GBM Tumors - Current Therapy Concepts)
Klinischer Abend Mittwoch, 05. Dezember 2018 17.00 – 19.00 Uhr
17.35 Uhr
Aktuelle therapierelevante Studienergebnisse (DCVax, CeTeG, NF-14) Prof. Dr. Dietmar Krex Klinik und Poliklinik für Neurochirurgie
https://www.carus-management.de/wp-content/uploads/2018/08/Klin.-Abend-_final_05.12.18.pdf
Flipper,
OK, thanks! and "Stephen W" is Stephen Western!
3) Bumped into - a person - who in effect - was pushing people
OFF DCVax and suggesting the other drug - using the 46.9 month
argument .... and yada yada yada
- Die CeTeG-Studie mit Temodal+CCNU erreicht für methylierte GBM-Tumore ein medianes Überleben von 46,9 Monaten, das ist deutlich besser als die für DCVax genannten 34,7 Monate. Warum also impfen ?
- The CeTeG study with Temodal + CCNU achieved a median survival of 46.9 months for methylated GBM tumors, significantly better than the 34.7 months reported for DCVax. Why vaccinate?
Was kann man jetzt tun?
Viele Patienten werden sich angesichts der guten Zahlen fragen, ob sie sich mit der DCVax-Zellimpfung behandeln lassen sollen. Dazu ist folgendes anzumerken:
- Die Studie ist seit 2015 geschlossen, auch die in Deutschland teilnehmenden Kliniken in Dresden, Stuttgart, Chemnitz, Halle, Hamburg, Heidelberg, Frankfurt, Bonn, Köln nehmen keine Patienten auf.
- Aber selbst wenn eine Klinik nach dem DCVax-Schema behandeln wollte, so geht das nicht, wenn man schon operiert worden ist. Denn es gibt strenge DCVax-Vorschriften, wie das herausoperierte Tumormaterial zu behandeln ist, diese können praktisch nicht eingehalten werden, wenn die OP einige Zeit zurückliegt und woanders durchgeführt wurde. Man muss sich also für eine dendritische Zellimpfung schon vor einer Operation entscheiden.
- Auch wenn die Zahlen als gut erscheinen, so muss man trotzdem auch andere Therapien mit guten Ergebnissen betrachten:
- Die CeTeG-Studie mit Temodal+CCNU erreicht für methylierte GBM-Tumore ein medianes Überleben von 46,9 Monaten, das ist deutlich besser als die für DCVax genannten 34,7 Monate. Warum also impfen ?
(Zusätzlich zum direkten Zahlenvergleich muss man auch die oben beschriebenen speziellen DCVax-Studienbedingungen berücksichtigen: keine Biopsiepatienten, kein Tumorprogress zu Beginn, Einschluss auch der nicht geimpften Patienten.)
- D,L- Methadon als Zusatz zu Stupp. Es gibt zwar keine Studien, aber ermutigende Einzelfallergebnisse, über die ich bereits früher berichtet habe (weiter unten GBM-Aktuell April 2018): Dr. Hilscher nannte 11 GBM-
Komplettremissionen durch Methadon in den letzten 3 Jahren. Auch CeTeG + Methadon ist interessant, auch bei fehlendem MGMT.
- Ganz neu: Gliovax-Studie mit dendritischer Zellimpfung
in Düsseldorf, Bochum, Münster, Duisburg
I found this testimony of the wife of a German patient. Pay particular attention to what she tells in the end. What do you call someone who can not keep secrets?
I'll give you the German version first and then Google Translate.
Dec 1, 2015
Hallo,
mein Mann sollte auch an der DC-Vax Studie teilnehmen. Er hatte sogar schon Monozyten gespendet. Nach der Bestrahlung durch Protonen durfte er allerdings an der Studie nicht mehr teilnehmen.
In Dresden sagte man mir Anfang Oktober, dass ein Aufnahmestop eingeleitet wurde. Wie ich es verstanden habe aber nicht von der Klinik sondern von dem Hersteller.
Ich habe auch nachgefragt, wie lange es denn dauern könnte, bis diese Therapie für alle zugänglich wäre und bekam ein schätzungsweise 5 Jahre zur Antwort.
Wir hatten uns am Anfang auch große Hoffnungen gemacht, da die Verabreichung fast nebenwirkungsfrei sein sollte. Nur gegegentliche Rötungen an der Einstichstelle.
Aber mittlerweile bin ich mir fast sicher, dass mein Mann zu den 33 % Placebopatienten gehört hätte. Somit denken wir, haben wir alles richtig gemacht.
https://forum.hirntumorhilfe.de/neuroonkologie/informationen-erfahrungen-zur-immuntherapie-8422.html
Sentiment,
We know from the SNO data that a total of 28.2% of all 331 patients, or 93, made it past 36 months.
I'm pretty sure it's 94 at this time. See OS curve 2018.
91 patients made it past 36 months and you see 3 censors between 35 and 36 months.
Of 2 of these 3 patients there was recently news available on the web.(good news)
Survival at 3 years for the unmethylated = 162 patients is 14.3%.
14.3% of 162 =23.16.
23 unmethylated patients made it past 36 months and you see 2 LTFU unmethylated censors around 9 months on the last 2018 OS unmethylated curve.
https://pbs.twimg.com/media/DsOGDz_W0AAeYpL.jpg
We know from our analysis (and your great work) that 8 out of 23 unmethylated patients come from the first 223 patients.
15 of these 23 unmethylated patients come from the last group of 108.
It is also my guess that NO CONTROL meth- patients lived to 36 months.
So in that case: 223 – 38 unknown= 185 patients (methylated and unmethylated)(placebo and treatment).
2/3 treatment = 123 patients
55.4% of 123 unmethylated= 68 unmethylated treatment patients.
8 of these 68 made it to 36 months = 11.7% (if you believe that all 8 patients are from the treatment group= DCVAX-L from the start.)
In that last group of 108 patients we have 46 unmethylated patients (83 treatment X 55.4% = 46 unmethylated)
15 of these last 46 unmethylated patients made it to 36 months =32.6% (if you believe that all 15 patients are from the treatment group= DCVAX-L from the start.)
32.6% against 11.7%
I think this is additional evidence that a change took place when the Germans came on board. In the meantime I found more evidence pointing in that direction (data, German comment, reaction Germans on the publication 2017, story Australian GBM patient etc.)
Read this:
Herstellung des Immuntherapeutikums DCVax®-L für Gehirntumorpatienten.
Das Fraunhofer IZI produziert und optimiert ein klinisches Prüfpräparat in Europa, dessen Wirksamkeit im Rahmen einer klinischen Studie der Phase III überprüft wird. Das Immuntherapeutikum DCVax®-L wurde vom amerikanischen Biotechnologieunternehmen Northwest Biotherapeutics Inc. in den USA bereits erfolgreich in klinischen Studien eingesetzt. Dieses Arzneimittel für neuartige Therapien (ATMP) basiert auf autologen Dendritischen Zellen zur Behandlung von Glioblastomen, einer besonders aggressiven Form von Hirntumoren
http://publica.fraunhofer.de/eprints/urn_nbn_de_0011-n-4066911.pdf
Looks like Title updated just yesterday.
However, it occurred to me that perhaps the 2 year survival figure of 46.2% recorded at 3/17 was a derived figure that was based on performance up to 3/17 and predicted the final 2 year survival percentage of the entire trial. In that case, a projection of a 65%-70% survival at 2 years for the last 54 patients could have been factored in and they ended up being only off by 0.2% (46.2% vs. 46.4%)
So it is possible that there are a good number of patients in the trial that hale from the treatment arm who actually never even progressed. And data like that would also be very convincing, I'd think, in indicating real or true efficacy (if not statistical efficacy) of DCVax-L.
“The survival rate is quite remarkable compared to what would be expected for glioblastoma,” said lead author Dr. Linda Liau, professor of neurosurgery at the David Geffen School of Medicine at UCLA and a member of the UCLA Jonsson Comprehensive Cancer Center. “The 20 to 30 percent of long-term survivors in immunotherapy clinical trials are the people in whom we think there may be a particularly strong immune response against their cancer that is protecting them from getting tumor reoccurrence.”
http://newsroom.ucla.edu/releases/personalized-vaccine-increase-long-term-survival-glioblastoma
the second contingent of the last 108 (probably around 54 patients) who at 3/17 were on trial 18-24 months only had at best a 2 year survival rate of about 48%
about 46% of the first 223 patients survived at 24 months
meirluc,
Approximately 60 to 62 patients from the last group of 108 lived at least 24 months after their surgery. See publication 2017 and the data 2018.
Linda should also explain her dealings with the Chinese to shareholders. I have stated what would happen if a bad deal with big pharma happened with regard to my understanding of Direct and I believe the Chinese would be very interested. It seems that Linda now understands the leverage she has by hinting at future Chinese involvement if others refuse to get real. She is playing her cards right. Let's see what happens.
Beneficial owners of more than 5%:
Toucan Capital Fund III (8)
8 Linda Powers of Toucan Capital Fund III and has voting and investment control of the shares of the Company’s held by Toucan Capital Fund III, 4800 Montgomery Lane, Suite 801, Bethesda, MD 20814.
A significant shareholder of the Company is also the owner of various companies that conduct business with the Company, including Luminus Holdings, Inc. (“Luminus”), Novamune, and Advent Bioservices, Inc. (“Advent Bioservices”)
https://www.sec.gov/Archives/edgar/data/1711754/000164033418002253/inmune_s1a3.htm
David Moss
CFO & Co-Founder INmune Bio, Inc.
3mo
“History in the making. First China Merchant Bank US IPO Escrow Agreement”.
Navid Malik’s comment:
Navid Malik Executive Director at THE LIFE SCIENCES DIVISION LTD
“Congratulations David, RJ and team. Very well deserved!”
J. Kelly Ganjei’s comment (my comments:he is playing with words)
J. Kelly Ganjei likes.
J. Kelly Ganjei Chief Executive Officer; Chairman of the Board at Cognate BioServices, Inc.
"I see you had lunch with a potential investor. Nice. I'm guessing you both had the bamboo salad."
· 1 Reply
David Moss:
LOL Kelly. Look forward to seeing you in san diego. Have many more pics to show you if you're keen on meeting our investors...
https://www.linkedin.com/in/david-moss-4b705460/detail/recent-activity/
Marzan,
Dr Liau PET scan method was for differentiating tumor progression from pseudoprogression.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5617282/
reg2015,
Erik Ramos - Special Projects, Northwest Biotherapeutics
Erik Ramos's Email
Manager @ Northwest Biotherapeutics (Past)
Location Darien, Connecticut
Work Strategic Planning Analyst @ Booz Allen Hamilton
Sr. Financial Analyst @ Pepsi Bottling Group
Education 2012 2013 Master of Business Administration (MBA) @ INSEAD
2001 2005 A.B. @ Princeton University
Minority Introduction to Engineering in Entrepreneurship & Science (MITEES) @ M.I.T.
https://rocketreach.co/erik-ramos-email_4961672
• Erik Ramos Special Projects, Northwest Biotherapeutics Inc
Eric R.?????
https://www.linkedin.com/in/erik-r-4405777/
Erik R.
Manager at Northwest Biotherapeutics
Darien, Connecticut
Intrests:
Chinese MBA Club
Standard group
1,453 members
https://www.linkedin.com/groups/4820333/
About this group
The Chinese MBA Club (CMC) is an organization for all MBAs of Chinese origin and MBAs interested in China to share business information and opportunities related to China. With the booming Chinese market and quick expansion of Chinese firms globally, many business opportunities are emerging. CMC aims at supporting MBA talent, companies, governments, and organizations in developing and growing those opportunities. Vision: The Chinese MBA Club wants to become the most influential Chinese MBA organization in the world. Mission: The Chinese MBA Club aims at providing a platform for all MBAs, companies, governments and organizations that have a Chinese background or are interested in China, to exchange business information and create new opportunities for cooperation. It will assist MBA students in terms of academic-related issues, and support MBAs in personal and career development, and in bridging the gap between industry needs and MBA talent. Associates of the club: • All MBAs of Chinese origin • All MBAs with interest in China or Chinese business/firms.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=115361541
Major UK Parliamentary report reveals the very high ongoing costs of brain tumours
A UK Parliamentary committee established in 2005, called the All-Party Parliamentary Group on Brain Tumours (APPGBT), has published a wide-ranging report about the economic and social impacts of brain tumours borne by patients, families and wider society. The report details these financial costs, many of which are 'invisible', stating that the average household affected by a brain tumour will be financially worse off by £14,783 (19,000 USD) per year, versus £6,840 for all cancers.The economic costs of brain tumours among working age people are ranked third highest among the common cancers, behind lung and breast cancer. The report gives recommendations to reduce financial burden to brain tumour patients and their families, as well as identifying ways to improve patient experience.
Brain Tumours A cost too much to bear?
Report of the All-Party Parliamentary Group on Brain Tumours
Inquiry into the economic and social impacts of brain tumours
This is not an official publication of the House of Commons or the House of Lords. It has not been approved by either House or its committees. All-Party Parliamentary Groups are informal groups of Members of both Houses with a common interest in particular issues. The views expressed in this report are those of the group. This report was compiled by the Brain Tumour Research charity which provides the Secretariat to the All-Party Parliamentary Group on Brain Tumours.
Session 3 – Tuesday 26th June 2018
• Dr Navid Malik Non-executive board director, Northwest Biotherapeutics Inc
• Erik Ramos Special Projects, Northwest Biotherapeutics Inc
The APPGBT received expert written evidence from the following:
• Macmillan Cancer Support • Cancer Research UK • CLIC Sargent • Teenage Cancer Trust • Headway—the brain injury association • Children’s Brain Tumour Research Centre University of Nottingham • The Christie Hospital NHS Foundation Trust and Salford Royal NHS Foundation Trust • Brain Tumour North West, Northwest Biotherapeutics Inc
• Dr Alasdair Rooney University of Edinburgh • Tom’s Trust
References
70. Background information on regulations in Japan and the USA provided by Northwest Biotherapeutics, Inc in both written and oral evidence.
https://www.braintumourresearch.org/docs/default-source/default-document-library/public-affairs-and-campaigning-documents/18-11-20-brain-tumours---a-cost-too-much-to-bear_final-report_low-res-singles.pdf?sfvrsn=24&utm_source=e-news&utm_medium=email&utm_campaign=inquiry_report
"Understanding the NICE economic evaluation process."
flipper44,
Thanks for that article about AI.
artificial intelligence (AI)
Here is another article:Let’s Activate Intelligence.
https://www.huawei.com/us/about-huawei/publications/winwin-magazine/31/activate-intelligence
john1045,
good find! Thanks!! I like the title!!!
IN THE NEWS
Campbell Lecturer Details New Directions in Brain Cancer Treatment
December 20, 2018 | Goodman Campbell | Brain Health, Events
Liau also described one of the main challenges is measuring whether an immunotherapy drug is working against a glioblastoma tumor. After injections of these drugs, a tumor may enlarge (“pseudoprogression”) for possibly 6 months before it gets smaller.
Therefore, standard imaging techniques, such as MRI, to assess whether tumors are growing or shrinking in response to treatment are not as sufficient in brain cancer.
https://www.goodmancampbell.com/in-the-news/campbell-lecturer-details-new-directions-in-brain-cancer-treatment
July 30, 2015 at 1:17 pm
Report
My dad is in the DC Vax L trial and just started the cross over arm about 2 weeks ago. He's received 2 injections so far and 1 next week since he's been in the cross over arm.
He started the trial around a year ago and was crossed over 2 weeks ago due to progression. At first Drs thought it was scar tissue but after 3 mris (6 month time frame), it became more clear it was slow tumor growth.
sharpie510,
If you search, you can find the story of these three patients on the web.
After reading their story, I strongly suspect that the three patients who got second resection were all treatment from the start. One of these patients belongs to the last group enrolled in the trial.
All three patients died a few months after second surgery.
Huawei Technologies Research & Development (UK) Limited
Location info - Huawei Technologies Research and Development (UK) Limited
Unit 302, Cambridge Science Park
Milton Road
Cambridge
Cambridgeshire
CB4 0WG
United Kingdom
Location info - Huawei Science Park
Unit 101 Science Park
Milton Road
Cambridge
Cambridgeshire
CB4 0FY
United Kingdom
https://www.cambridgewireless.co.uk/members/huawei-technologies-research-and-development/
SNO-CAP 2018: RECAPPING THE ANNUAL MEETING AND EDUCATION DAY OF THE SOCIETY FOR NEURO-ONCOLOGY
By Tom Halkin | Published December 17, 2018
Finally, Dr. Linda Liau of UCLA, in discussing her 20 years of experience leading studies of the immunotherapy called DCVax, expressed the need for more careful development and selection of trials endpoints. She noted that endpoints relevant for immunotherapy trials may be different from those for other treatments, and that, in general, relevant surrogate biomarkers of progression-free survival and response are desperately needed in the field to expedite trials.
Coincidently, a recent article – authored by Dr. Erik Sulman, who participates in the Defeat GBM Research Collaborative – details more on this topic.
GOV.UK
Department for Business, Energy & Industrial Strategy.
Office for Life Sciences.
Policy paper
Life Sciences Sector Deal 2, 2018
Updated 5 December 2018
https://www.gov.uk/government/publications/life-sciences-sector-deal/life-sciences-sector-deal-2-2018
AV is good at ferreting out ancient history, and he might comment from his own perspective.
Longfellow95,
I found this:
First published March 8, 2018
“Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial”
Bruno Francois,1,2,3 Robin Jeannet,2 Thomas Daix,1,2 Andrew H. Walton,4 Matthew S. Shotwell,5 Jacqueline Unsinger,4 Guillaume Monneret,6,7 Thomas Rimmelé,7,8 Teresa Blood,4 Michel Morre,9 Anne Gregoire,9 Gail A. Mayo,10 Jane Blood,4 Scott K. Durum,11 Edward R. Sherwood,10,12 and Richard S. Hotchkiss4,13,14
FUNDING. Revimmune, NIH National Institute of General Medical Sciences GM44118.
Conflict of interest: M. Morre and A. Gregoire are Revimmune employees.
https://insight.jci.org/articles/view/98960#FN
Anne Grégoire
Director Process Development
Company Name Revimmune
Dates Employed Jun 2014 – Present
Employment Duration 4 yrs 7 mos
Location Paris Area, France
Interests- Following Companies: Toucan Capital, Northwest Biotherapeutics, Cognate Bioservices, ……
https://www.linkedin.com/in/anne-grégoire-86639b57/
Michel MORRE
Chief Science Officer chez REVIMMUNE
https://www.linkedin.com/in/michel-morre-7b6556153/?originalSubdomain=be
Interleukin 7 - Revimmune SAS
Alternative Names: CYT 107; Glycosylated recombinant human interleukin-7 - Cytheris; IL-7; Recombinant human interleukin-7 - Cytheris; rhIL-7; Second-generation CYT 99 007
Latest Information Update: 19 Sep 2018
https://adisinsight.springer.com/drugs/800020133
Longfellow95,
I found information about the “Entreprise Revimmune SAS à Paris”.
The information is in French but I think you can handle that….
Nom : Revlmmune SAS
Date de démarrage d'activité : 17/06/2014
Activité : recherche et développement biopharmaceutiques, incluant le développement de nouvelles molécules, la conduite d'essais cliniques et la commercialisation de ces nouveaux produits, médicaments ou molécules…
Président : Revlmmune, Inc., société du Delaware (Delaware Corporation) de droit américain, sise 4800 Montgomery Lane, Suite 800, Bethesda, Maryland 20814, Etats-Unis, authentification n o 1401874, représentée par Mme Linda Fairing Powers demeurant 9306 Kendale Road, Potomac, MD 20854 Etats-Unis.
Directeur Général : M. James Kelly Ganjei demeurant 10609 River Oaks Lane, Potomac, MD 20854 Etats-Unis.
http://entreprises.lefigaro.fr/revimmune-sas-75/entreprise-803071729
Flipper44,
This is from a GBM patient blog:
e-mail:
In order to produce DCVax-L, two to three grams of tumor tissue are usually required to make the eleven-shot, three year cycle of injections. If the tissue is frozen (only for the UK Specials Program) it must be flash-frozen without any chemicals or preservatives and not preserved in saline or paraffin (most tissue banks preserve tumor tissue in blocks of paraffin). Also, some surgeons use Gliadel wafers. These wafers are soaked with a type of chemo which is meant to poison tumor cells, and are placed in the tumor cavity in the brain when the tumor is surgically removed. If Gliadel wafers were used, then DCVax-L will not be available as a treatment option because the chemo leaching from the wafer will also kill immune cells which enter the tumor cavity to fight residual tumor cells.
NWBO investors are being played like a fiddle.AVII77
3.6 Movement Generation: First Principles
3.6.1 The proposal is a particular specialised type of manufacturing, and hence it is appropriate to consider the assessment of movement generation based on a first principles assessment.
3.6.2 The site is proposed to be operated by a contract manufacturer of medicines, but whilst most conventional drugs are manufactured from their constituent chemicals, the medicines produced are manufactured from human cells, and typically from the patients themselves. The medicines produced are “cutting edge”, and are part of a new class of medicines called Advanced Therapy Medicines.
3.6.3 Every medicine produced at the site will originate from human donor cells, and / or tissues. These will derive either from the patient, or a close relative, but there may be some from a bank of cells made specifically for one type of product including for example stem cell bank from donated umbilical cord blood. Another starting material is organs from the NHS Blood and Transplant Service that is unsuitable for routine transplantation but can be used as a “scaffold” for product development. Such products will be harvested across the UK, and transported to Sawston by specialised courier service.
3.6.4 The work that will be involved in the production of such medicines is undertaken on a small scale across the UK in major hospital, but this facilities would be the first “large scale” manufacturing facility. That said the work at the site is largely similar to that seen at Blood Transfusion Centres with the predominant traffic generation being by car for staff, and any professional visitors, and by the unit’s own vehicles for goods in and out for the most part.
3.6.5 It is anticipated that when fully operational, and in full occupation the site will employ the following levels of staff by skill type, and shift:
i) Manufacturing staff would work on two shifts from Monday to Saturday 07.30 – 16.30 25 staff 15.00 – 23.00 25 staff
ii) Warehouse staff would also work on two shifts from Monday to Saturday 07.30 – 16.30 4 staff 15.00 – 23.00 4 staff
iii) Site security staff on three shifts 07.30 – 16.30 1 staff 15.00 – 23.00 1 staff
iv) 5 scientists for product development on Monday to Friday 09.00 – 17.30
v) 5 office / support staff on Monday to Friday 09.00 – 17.30
3.6.6 Table 3 shows the arrival / departure profiles based on a first principles assessment. The arrival / departure profile assumes that staff will arrive and depart within the quarter of an hour before and after their shift start respectively. As a “worst case” assessment, the profiles assume the following modal split:
Car 94%
Cycle 4%
Walk including public transport 2%
These values are from the Sawston Business Park TA. There were no values provided for by public transport access which are taken as being included within the walk percentages.
3.6.7 The profile also indicates an assessment of parking accumulation which indicates that between 14.45 and 16.45 that there may be a need to accommodate the parking demand of two shifts of 65 vehicles in total. The overall car parking provision including the main car park would be adequate to accommodate the demand by staff, and visitors.
3.6.8 In addition to the staff movements, there are likely to be regular, and irregular goods vehicle movements as follows:
Delivery and pick up 20 per day by transit sized vehicle
Delivery by box van 12 per week
Cryogenic delivery trucks 2 per week (once every 3 days)
Domestic refuse removal 1 per week
Clinical waste removal by box van 3 per week
3.7 Traffic Distribution
3.7.1 The vehicular traffic distribution used for testing purposes if appropriate will be identical to that of the TA prepared for the Sawston Business Park planning application for cars, and goods vehicles as follows:
Cars HGVs
a) To / from Whittlesford Road 20% 0%
b) To / from A1301 then
To / from the north 20% 33%
To / from Sawston 20% 0%
To / from south 40% 67%
Doc logic,
Is this a piece of the puzzle?:
Peripheral blood is a source of easy access to mononuclear dendritic cell precursors. Cord blood is another source of mononuclear dendritic cell precursors. Mononuclear dendritic cell precursors can be isolated from a variety of organisms that can elicit an immune response. These organisms include animals, including, for example, human and non-human animals, such as primates, mammals (including dogs, cats, mice, and rats), birds (including chickens), and their transgenic species.
is there any evidence that even a single dose of DCVax-L has been manufactured by Advent in London?
Currently, I have started a fabulous project where I am going to be involved in performing dendritic cell culture as a treatment in oncology patients.
How much umbilical cord blood does it take to make a dose of DCvax?
Looks like even in 2014 they didn't plan on using Sawston for DCVax.
Longfellow95,
"Following revised business plans, application for MHRA/ HTA license will be Q3 2019."
I suppose it should be mentioned that in last years report, the target for licencing was Q2 2018. So we are almost certainly looking at further mothballing.
I imagine that they want to see what finally happens with Brexit, which may lead to two sets of GMP guidelines, parallel licencing regimes, and set up rules regarding requirements for exporting CGT products into Europe.
Just as well we have the right man onboard in respect of the above in Prof Lowdell.
https://www.terrapinn.com/conference/festival-of-biologics-usa/speaker-mark-LOWDELL.stm
And for their 'revised business plans' to come to fruition.
Philippe Pire
Chief Financial Officer
Results-driven CEO/CFO. 25+ years' business/operational finance experience. Develop global financial strategy, raise capital, manage investments, create sustainable value, implement efficiencies and internal controls, M&A integration, problem solve and IR. M&A experience includes acquisitions and divestitures.
Armed with quantitative and analytical skills, I am well-equipped to address pressing challenges and capitalize on opportunities. Managed teams of 100+ in economically volatile environments, Accustomed to solving multiple issues creatively and under extreme pressure. I actively anticipate when to implement changes in direction, prioritizing and delegating tasks, and motivating others to achieve targeted objectives in a timely and efficient manner.
Key strengths include:
FINANCE
• Lead continuous evaluation of short/long-term strategic financial objectives
• Optimize management of capital sources and their uses
• M&A
• Investor Relations (manage relationships with financial markets; lenders; investors; etc.)
• Timely, accurate analysis of budgets, financial trends and forecasts
• Audit, budget and financial forecasting
• Strategically enhance financial performance and business opportunities
• Seek and negotiate capital raising transactions
• Ensure effective internal controls, compliance with GAAP and applicable regs governing financial and tax reporting
MANAGEMENT/LEADERSHIP
• Develop strategic plan
• Hire, motivate and direct teams of men and women
• Create new organizations and deploy work force
BUSINESS DEVELOPMENT
• Design strategies to achieve, sustain and recapture market leadership and growth
• Expand geographic footprint/wholesale and retail franchise operations in appropriate global markets
• Launch new product lines
• Increase manufacturing capabilities
• Improve brand name recognition
COMMUNICATION
• Liaise with media in connection with PR strategy
Experience
Company Name Cognate BioServices
Total Duration 3 yrs 11 mos
Title Special Advisor, Strategy and Corporate Finance
Dates Employed Mar 2018 – Present
Employment Duration 10 mos
Location Greater New York City Area
I act as special advisor to the senior executive management team, drawing on deep expertise in strategy and corporate finance to drive value creation, growth and optimal allocation of resources.
https://www.linkedin.com/in/philippe-pire-2b700833/
Longfellow95,
Last year there was only a contact person.
Contact: Tina Crombie Head of Business Operations tcrombie@adventbio.uk
https://ct.catapult.org.uk/sites/default/files/publication/GMP%20Manufacturing%20Report%202017%2030_12_17%20FINAL.pdf
This year same contact person Tina Crombie but for the first time a Chief Operations Officer= Philippe Pire.
Tina Crombie Head of Business Operations tcrombie@adventbio.uk 0203 627 9960/ 07905 658843
Philippe Pire Chief Operations Officer ppire@adventbio.uk 0203 627 9960
https://ct.catapult.org.uk/sites/default/files/publication/2018%20GMP%20Manufacturing%20Report_FINAL.pdf
I agree,
Ceci est où l'intrigue se corse.
Longfellow95,
Thank you for the update! Great find!
Longfellow95,
I agree, they are all in on getting this done first time round.
The last clinical results are particularly strong. IMO
Longfellow95,
17 MAY 2012 Northwest Bio Provides Update On DCVax® -L Brain Cancer Trial.
Linda Powers, CEO of Northwest Bio, commented, “Of course, the evolution of this trial to a Phase III trial is no assurance of the outcome, and more than one Phase III trial can often be required for a product approval unless the clinical results are particularly strong. However, we are pleased to make this transition to Phase III, and believe that the package of amendments further enhances an already strong trial, positioning the Company to realize the potential of the DCVax®technology.”
Flipper44,
"Endpoints relevant for immunotherapy may be different from those for other treatments.
----- Hazard Ratio of long term survival vs 1 year OS difference"