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Just posted:
Joel Danziger : Treatment Update.
The start of the treatment process has been delayed slightly due to the manufacturing company's schedule. Its being rescheduled from December to the New Year.
Joel Danziger : Treatment Update.
It’s been a very difficult couple of months trying to weigh up the pros and cons of the different types of Dendritic Cell Vaccine treatments on offer, both here and in Germany. We’ve had detailed consultations with Professor Ashkan, at King’s College Hospital; with the Cambridge based bio tech company who manufacture the vaccine; and with IOZK, the German clinic who offer their version of the vaccine.
We’ve come to the conclusion that the UK based offer is the best option for Joel. This is in terms of minimising disruption to his university life as well as there being very promising results from recent clinical trials, in terms of prolonging life. The first stage of the manufacturing process has now started and Joel has a number of appointments with King’s College Hospital London starting in early December for the second stage of manufacturing.
This is all rather scary given that we haven’t raised all of the funds needed. But time is of the essence, whilst Joel is currently stable. So, we therefore need a further BIG push on the fundraising to be able to complete Joel’s treatment.
Thanks again for all of your support and please continue to help us to HelpJoelLiveLonger.
10baggerz,
Thank You!!
Facebook- Ian Runacres( Joel Danziger's dad)
Ian Runacres
September 11, 2019 ·
The most shocking thing that could happen to a parent. My son, Joel, has just been diagnosed with brain cancer. We were given the news yesterday, following the removal of a tumour, last week. Joel will soon be starting lengthy chemo and radio therapy, to try to keep the cancer at bay. Today, Joel has set up a Just Giving page, for the Teenage Cancer Trust. There's a branch at the Christie Hospital, where he will be attending. If you'd like to help, then this is a nice way of showing it.
https://www.justgiving.com/fundraising/joel-danziger?fbclid=IwAR3SQSQPpqK_Nss-Vw1pIHxaL9woam5Nx1AUnbJgm0g9Q25mob97P38Psd8
Ian Runacres
May 3, 2020
I’m conscious that I haven’t posted an update about Joel’s brain cancer for a while and I know that some people feel a bit awkward about asking. Also, Joel is quite private about it all, so I don’t like to keep going on about it on social media, too much, however I thought a quick update might be appreciated. Joel is currently on his last round of 6 months of chemotherapy, plus he’s self injecting a daily immune boosting drug, as a covid19 precaution. The current debate is whether to continue for another 6 months with the chemo, as his compromised immunity is a big issue with covid19, plus the chemo is only about 20% effective anyway. Joel is keen to carry on, though. We’ve also been exploring what might come next, as the treatment he’s had to date is effectively only palliative. The most promising treatment is called Dentritic Cell Vaccine. Basically it’s a personalised cancer killing vaccine is made from residual tumour. There is some evidence that it prolongs life, (years, but not decades). So, we’re trying to find out if there’s enough of Joel’s tumour left, following the NHS histology and, if so, whether it’s been frozen properly. Even then the cost is jaw-droppingly expensive. Something like £200k to £250k, it seems. So, we have quite a bit to consider, even if it’s possible. Hopefully we should find out over the forthcoming weeks. In the meantime Joel worries that each headache is an indication of the tumour growing back, which is very scary for him. Having said that, he’s reconfirmed his place at Kings to do English, this autumn and has his accommodation secured. I just hope he can make it and I hope that lockdown restrictions don’t jeopardise his plans. Until then, we’ll keep wandering along the Mersey, as you can see.
Ian Runacres
August 13, 2020
It's now almost a year since my son Joel was diagnosed with Glioblastoma - the most lethal of all brain cancers. Life expectancy is only 18 months on average. Almost no one survives beyond five years.
The NHS have been absolutely amazing over the last year and Joel has had surgery to remove as much of of the tumour as possible. This was followed by intensive radiotherapy, chemotherapy and immunotherapy. The NHS have continued Joel's treatment all through the covid restrictions, but it is now all concluded and was only really palliative anyway.
We've done loads of research and the only proactive treatment recommended by leading oncologists and neurosurgeons is called Dendritic Cell Vaccine. This is a personalised cancer killing vaccine manufactured from your own residual tumour tissue. Trials have shown positive efficacy in prolonging life. But, it is prohibitively expensive at around £400,000.
We are therefore trying to raise the funds ourselves. If you are able to donate please do so via Joel's Go Fund Me page:
http://gofundme.com/helpjoellivelonger
please post the replay or transcript of the 11/18 @ 8 am Cognate meeting with EDGE. thanks.,
“We work with innovative companies that develop technologies to take living cell tissue from patients and change those in a way to treat a disease,” Will James said.
“We might take living tissue and genetically modify it to better fight cancer,” he said during the online meeting. Or, he said, “It might involve taking white blood cells in a tumor and multiplying those and returning them to the patient to better fight cancer.”
AN INTERVIEW WITH J. KELLY GANJEI, CEO AND CHAIRMAN OF THE BOARD, COGNATE BIOSERVICES, INC
NICOLA AMBLER AUG.14, 2018
What is the one thing you’d recommend clients do when evaluating a CMO partner?
Having been on the other side of the table, as a company in development, I would evaluate, in person, what efforts are being made to address commercialization and try to understand the mindset of those who are responsible for making and releasing your product. Developing, and maintaining a commercial mindset is not easy to achieve, and is highly critical, especially in context with the rapid development cycles we’re witnessing today. Products must be manufactured with a higher level of compliance at earlier stages and elements like simplicity, closed systems, modular automation and validation are more important earlier on. If you’re going to develop a product with a CMO that doesn’t have a commercial mindset, you’re most likely going to have to go back to the drawing board when you’re seeking FDA approval. To summarize, face to face relationships are critical.
https://www.phacilitate.co.uk/article/preparing-commercialisation-right-cdmo
biosectinvestor,
see my post Monday 11/09/2020. https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159380673
Lykiri Monday, 11/09/20 12:09:56 PM
Re: Lykiri post# 328421 0
Post #
328443
of 331815
Quote:
MDNA: PLANNING FOR INNOVATIVE HYBRID REGISTRATION TRIAL FOR MDNA55…
10/20/2020
By David Bautz, PhD
NASDAQ:MDNA
Business Update
Phase 3 Plan for MDNA55 Program
On October 15, 2020, Medicenna Therapeutics Corp. (NASDAQ:MDNA) provided an update for the MDNA55 program following an ‘End-of-Phase 2’ meeting with the U.S. FDA. The FDA has guided for the company to proceed with a Phase 3 registration trial of MDNA55 in patients with recurrent glioblastoma (rGBM) that harbor no IDH1/IDH2 mutations. There are two noteworthy points regarding the proposed trial:
1) The trial will utilize a matched external control group for 2/3rd of the control arm.
2) Patients will be randomized 3:1 to receive MDNA55 or standard of care (SOC). SOC will consist of physician’s choice (temozolomide, bevacizumab, lomustine, etc.)
This is the first instance we are aware of where a company has been encouraged to utilize a substantial external control arm for a cancer trial and could represent a paradigm shift in the way trials are conducted for diseases that have a significant unmet need for improved therapeutics. In addition, the use of a sizeable external control arm will decrease the number of patients required in the trial, which will help to defray costs and could expedite the time to complete the trial. With a 3:1 randomization it will also allow for more patients to receive MDNA55 than would be possible with a standard 1:1 randomization.
We estimate a total of approximately 150 patients will be enrolled in the treatment arm, with approximately 50 patients enrolled in the control arm. Another 100 patients will be enrolled into the external control arm, with records for those patients derived from previous clinical trials that have been conducted since January 2016. Patients included in the external control arm will have characteristics similar to those enrolled in the treatment and control arms and will be identified in a manner similar to that used for the company’s analysis of the Phase 2 clinical trial that utilized a synthetic control arm (discussed below).
We expect that the positive ‘End-of-Phase 2’ meeting with the FDA will invigorate Medicenna’s efforts to identify a suitable partner to advance the program, as we do not anticipate the company initiating a Phase 3 program for MDNA55 without a collaboration agreement with a larger pharmaceutical company in place.
https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2020/MDNA-Planning-for-Innovative-Hybrid-Registration-Trial-for-MDNA55-article/default.aspx
So what's the news...???
HUGE news for $NWBO yesterday and not a single mention in the twitterverse. #GBM #glioblastoma
— Carlo Rago, PhD (@rago_carlo) November 19, 2020
Bring on the jobs: It was just announced that Cognate BioServices, Inc. is seeking a 15-year Jobs PILOT from EDGE.
Quick refresher on what that is—in a PILOT (payment in lieu of taxes) we reduce the property tax we charge for a few years to get projects that would have either gone somewhere else or wouldn't have happened at all. In return, a company commits to create or retain jobs, pay good wages, invest in Memphis, and contract with minority and women-owned firms.
Once this PILOT is approved, it will enable the company to create 561 net new jobs at an average wage of nearly $64,000 with a capital investment of almost $213 million.
The locations proposed for this project currently produce around $524,000 in City of Memphis and Shelby County property taxes each year. The estimated annual property taxes will be nearly $1.18 million during the PILOT term and $4.4 million afterwards.
This is great news during a year when we haven’t had enough of it to share. I’m excited about this project and what those jobs and investment will mean for Memphis.
Have a great weekend!
Yours,
Mayor Jim Strickland
anders2211,
I agree. All good points.
Some of us think that NWBO has been trying to shift endpoints ever since summer of 2015. And that was what the mystery FDA talks were all about. So not that surprising.
Linda Liau responds to investor concerns regarding 12/15/16 Seattle presentation. In an email exchange between an investor and Linda Liau, Dr. Liau offers clarification regarding her comments from the presentation.
Quote:
Question
Dear Dr. Liau: In your video last week (and also last year), your comments seemed quite positive about the patients living longer, but last week you also seemed to say that DCVax would not be able to get FDA approval. Is that what you really meant? How could that be the case if patients are living longer? Would love to have clarification on this issue
Thank you in advance for your time .
Xxxxxx xxxxxxxx
Dr. Liau's answer
Hi Xxxxxx,
Yes, the patients do seem to be living longer with DCVax; and no, I did not mean to say that DCVax would not get FDA approval. I was making the point that, whether or not the study fits a particular category endpoint, there should be a way to get approval if the data shows that the entire group of DCVax patients (in both arms) does better than concurrent/historical controls who have not gotten DCVax.
Hope this clarifies the issue.
Thanks,
LL
Linda M. Liau, M.D., Ph.D., M.B.A.
Professor & Vice Chair of Neurosurgery
Director, UCLA Brain Tumor Program
UCLA Department of Neurosurgery
Sent from my iPhone
The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma.
Kaizenman,
Thank you!
APPLICATION OF COGNATE BIOSERVICES, INC. FOR EXPANSION PAYMENT-IN-LIEU-OF-TAX BEFORE ECONOMIC DEVELOPMENT GROWTH ENGINE INDUSTRIAL DEVELOPMENT BOARD OF THE CITY OF MEMPHIS AND COUNTY OF SHELBY, TENNESSEE 2020
AstraZeneca
In 2019, Cognate announced the acquisition of Cobra Biologics, a leading CDMO specialized in providing development and manufacturing services for plasmid DNA and viral vector. With its acquisition of Cobra Biologics, Cognate now has facilities in the United States (Baltimore and Memphis) and Europe (Keele, United Kingdom and Matfors, Sweden). This past June, Cognate announced that its Cobra Biologics facility in Keele, UK signed a supply agreement with AstraZeneca to provide GMP manufacture of an adenovirus vector-based COVID-19 vaccine candidate.
Cognate’s Memphis facilities have been at the center of recent industry collaborations for the development and manufacture of cell-based products and therapies. Representative collaborations and programs include:
• 2019 Caladrius Biosciences: Cognate uses its Memphis facilities to manufacture CLBS14, a cell therapy of Caladrius, a late-stage therapeutics development biopharmaceutical company pioneering advancements of cell therapies in select cardiovascular and autoimmune diseases.
• 2019 Astero Bio Corporation: Cognate’s Memphis facilities serve as a beta site for new technologies developed by Astero, a leader in the development of innovative tools for cryo-preserved biologics.
• 2018 Terumo BCT: Using its Memphis facilities, Cognate incorporates into its innovation labs the existing and future technologies of Terumo, a leading technology provider in the cell-therapy market.
Cognate’s clients include Atara Biotherapeutics, Inc., a developer of atherapeutic product designed to treat Epstein Barr virus, one of the most common humanviruses in the world, and Northwest Biotherapeutics, Inc., a developer of a patient-specific treatment for Glioblastoma multiforme (“GBM”),the most aggressive and lethal form of brain cancer.
Indeed, Cognate manufactured product for the world’s largest GBM clinical trial. Though Cognate is not the only CDMO in the United States, only a select few have the knowledge, experience and qualified personnel required to manufacture a living cell product from its inception until the moment when it is administered to a patient.Cognate is one of them. The live cell specimens that form these products require careful monitoring, adjustments, quality control, analysis and testing.
ae kusterer,
Thank you! Great find.
APPLICATION OF COGNATE BIOSERVICES, INC. FOR EXPANSION PAYMENT-IN-LIEU-OF-TAX BEFORE ECONOMIC DEVELOPMENT GROWTH ENGINE INDUSTRIAL DEVELOPMENT BOARD OF THE CITY OF MEMPHIS AND COUNTY OF SHELBY, TENNESSEE 2020
Cognate’s clients include Atara Biotherapeutics, Inc., a developer of atherapeutic product designed to treat Epstein Barr virus, one of the most common humanviruses in the world, and Northwest Biotherapeutics, Inc., a developer of a patient-specific treatment for Glioblastoma multiforme (“GBM”),the most aggressive and lethal form of brain cancer.
Indeed, Cognate manufactured product for the world’s largest GBM clinical trial. Though Cognate is not the only CDMO in the United States, only a select few have the knowledge, experience and qualified personnel required to manufacture a living cell product from its inception until the moment when it is administered to a patient.Cognate is one of them. The live cell specimens that form these products require careful monitoring, adjustments, quality control, analysis and testing.
Thank you KaOsiris!
Yes, but they may not actually provide approval or buy-in, they may just let it go for more than 60 days without any response or comment.
hankmanhub,
IkeEsq Sunday, 02/03/19 01:24:29 PM
NWBO 2018 Annual Shareholders Meeting
February 2, 2019 at 13:30 EST
1050 Connecticut Ave, NW, Washington D.C.
Question #10: Is there ongoing dialog with the FDA regarding formation of the SAP and will you wait to unblind until after the SAP is approved?
Answer (LP): "Definitely 'yes' we won't unblind until the Statistical Analysis Plan has been approved by all regulators. FDA and other, four regulators. We intend publicly as a company policy, which is pretty standard for companies, we don't talk about our communications that are ongoing with FDA or other regulators. We only say results, so I can't comment on interim communication type things, but in case there is any [lack of] clarity about remarks earlier about the SAP, it is an actual submission to the regulators. Like when you apply for an IND, that's Initial New Drug, application to get a clinical trial approved or when you apply to get a new product approved. You make an actual submission to get your SAP reviewed and approved."
2020 Think Tank on Neuro-Oncology Clinical Trails.
November 6th, 2020
https://www.soc-neuro-onc.org/UploadedFiles/SNO%202020%20Think%20Tank%20Meeting%2011-2-2020.pdf
9:50-10:05 am
Statistical Considerations for the Use of External Control Data in Oncology Trials
Pallavi Mishra-Kalyani, PhD, US Food and Drug Administration
Btw, there were a few people on the LL Galbraith teleconference from nvcr
Looks like Advent appointed a warehouse manager this month, based on my semi-regular LinkedIn searching.
We are on the look out for new people! We currently have vacancies for two GMP Production Scientists and an IT Support Analyst
(apprenticeship option also available).
MDNA: PLANNING FOR INNOVATIVE HYBRID REGISTRATION TRIAL FOR MDNA55…
10/20/2020
By David Bautz, PhD
NASDAQ:MDNA
Business Update
Phase 3 Plan for MDNA55 Program
On October 15, 2020, Medicenna Therapeutics Corp. (NASDAQ:MDNA) provided an update for the MDNA55 program following an ‘End-of-Phase 2’ meeting with the U.S. FDA. The FDA has guided for the company to proceed with a Phase 3 registration trial of MDNA55 in patients with recurrent glioblastoma (rGBM) that harbor no IDH1/IDH2 mutations. There are two noteworthy points regarding the proposed trial:
1) The trial will utilize a matched external control group for 2/3rd of the control arm.
2) Patients will be randomized 3:1 to receive MDNA55 or standard of care (SOC). SOC will consist of physician’s choice (temozolomide, bevacizumab, lomustine, etc.)
This is the first instance we are aware of where a company has been encouraged to utilize a substantial external control arm for a cancer trial and could represent a paradigm shift in the way trials are conducted for diseases that have a significant unmet need for improved therapeutics. In addition, the use of a sizeable external control arm will decrease the number of patients required in the trial, which will help to defray costs and could expedite the time to complete the trial. With a 3:1 randomization it will also allow for more patients to receive MDNA55 than would be possible with a standard 1:1 randomization.
We estimate a total of approximately 150 patients will be enrolled in the treatment arm, with approximately 50 patients enrolled in the control arm. Another 100 patients will be enrolled into the external control arm, with records for those patients derived from previous clinical trials that have been conducted since January 2016. Patients included in the external control arm will have characteristics similar to those enrolled in the treatment and control arms and will be identified in a manner similar to that used for the company’s analysis of the Phase 2 clinical trial that utilized a synthetic control arm (discussed below).
We expect that the positive ‘End-of-Phase 2’ meeting with the FDA will invigorate Medicenna’s efforts to identify a suitable partner to advance the program, as we do not anticipate the company initiating a Phase 3 program for MDNA55 without a collaboration agreement with a larger pharmaceutical company in place.
Learn anything interesting from the session on using external controls?
“Most of our power for the study in the SOC arm was going to come from what they (FDA) calling External Controls…….”
3:30-3:40 pm Point/Counterpoint: Why Current Standard of Care for
GBM is Not a Major Impediment to Progress
John Sampson, MD, PhD, Duke Cancer Center
If they really have had around 250 non-trial patients this year, they might actually have decent revenue to report
The Company has been unable to undertake compassionate use cases during part of March and during Q2, due to lockdowns, travel restrictions and hospitals focusing most of their personnel and resources on COVID-19 patients. In addition, manufacturing of DCVax products is impeded by personnel being under lockdown, and the buildout of the Sawston facility was delayed in starting due to the construction sector shutdown and restrictions, and the duration of the work will be substantially longer due to the contractors having to operate under social distancing arrangements. The Company anticipates that such effects of the COVID-19 situation may continue for an extended period of time.
exwannabe,
This one?
The $9B Question: Is the Cost of Drug Development Killing Us? Can Digital Health Save Us?
sharpie510,
Thank you!
hankmanhub,
IMO, Linda Liau make it more clear in this presentation:
Linda M Liau, MD, PhD, MBA - Perspectives on Glioblastoma (1994-2019)
12:00-12:05 pm Pharmacodynamic Endpoints: Tumor Microenvironment Based Robert Prins, PhD, Brain Research Institute, UCLA
Anyone have a list of professionals that are on the Steering Committee of the trial, as well as Scientific Advisory Board?
CORRECTION: I copied the wrong session. I apologize!
9:50-10:05 am Statistical Considerations for the Use of External Control
Data in Oncology Trials
Pallavi Mishra-Kalyani, PhD, US Food and Drug Administration
Looks like the meeting I previously posted about - SNO Clinical Trials Think Tank - is free to attend and there will be opportunities to ask questions.
https://www.soc-neuro-onc.org/WEB/About_Content/News_Pages/SNO_Think_Tank.aspx
Conference is on 11/6 and the FDA have a number of people attending/presenting. The session that caught my eye is “statistical considerations for the use of external control data in oncology trials”.
9:20-9:30 am Introduction to Externally Controlled Studies and Opportunities in Drug Development: Irmarie Reyes-Rivera, PhD, Associate Group Head, RWD Oncology
These presentations will also be recorded and available for viewing at the conclusion of the course on the SNO website.
I think that is the one that I missed, the one before the slide entitled 'Survival of Whole ITT Population From Surgery'.
Dr Bala,
I missed that slide too. I only saw the bottom of the slide: 90% of all 331 patients in Phase III trial were treated with DCVax-L at some point.
Maybe this slide?: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155681462
Thanks Dr Bala. Great job!
Yes you missed a slide that was displayed for a very short time.
The one that 90% of the patients received DCvax-L.
Pavlosvr and Evaluate,
Thanks! I agree.
I sent an email to Allison Joost this morning:
Dear Allison Joost,
I have a question in regards to Abstract/Poster Presentation 787 (Phase III Clinical Trial to Test the Safety and Efficacy of Autologous Tumor Lysate-Loaded Dendritic Cells in Patients with Newly Diagnosed Glioblastoma).
1. Will Late-Breaking Abstract 787 be released Monday, Nov. 9 at 8 a.m. EST or is LB Abstract 787 withdrawn per Authors?
2.The authors shown are: Marnix L. Bosch, MBA, PhD; Linda Liau; Keyoumars Ashkan.
If there is an oral presentation: would this be via Zoom presentation?
Are all 3 of above authors available during the presentation or Q&A?
Hi XXXX,
Thank you for reaching out. Abstract 787 will be released on Monday, Nov. 9 at 8 a.m. EST as part of the JITC Supplement. As for your second question, this abstract was offered a poster presentation in our virtual poster hall. However, the authors have not submitted a poster yet, and if there is not a submitted poster, it will not be displayed in the virtual poster hall. If a poster is submitted, the presenting author does have the option to record audio with the poster, as well as be available during specific ePoster Viewing Sessions where attendees can interact with them.
Please let me know if you have any other questions.
Thank you,
Allison Joost
Senior Program Manager, SITC
Well... whilst It would not surprise me if I am either ignored or DI hides behind the "silent period" line [my last request for information was ignored], strictly speaking there is no excuse for them not to be able to provide this information.
Can I issue a press release about my abstract?
Yes, you may issue a press release about your abstract; however, any planned press releases and media alerts must have been reviewed and approved in advance by SITC Communications staff and they must follow the Embargo Policy. Please provide a minimum for two business days for review. Drafts should be emailed to communications@sitcancer.org.
When is the deadline to withdraw my abstract?
The deadline for regular abstract withdrawal is Sept. 30, 2020. The deadline for late-breaking abstract withdrawal is Oct. 15, 2020. If you would like to withdraw your abstract between the submission deadline and this date, you must submit your request in writing to education@sitcancer.org. Upon receipt of your request SITC will make the change and send a confirmation once the withdrawal has been completed.
This morning I sent an email to Regan Gaskin, MPA | Clinical Research Administrator (The University of Alabama at Birmingham) asking if any changes have been made to the posted schedule.(37th Annual J. Garber Galbraith, M.D., Scientific Session and Lecture)
I got this reply:
Hello XXXX,
No changes have been made to the posted schedule.
Best,
Regan Gaskin, MPA | Clinical Research Administrator I
Office of Clinical Research – Shared Services
Departments of Neurosurgery, Otolaryngology, Urology and Oral Surgery
UAB | The University of Alabama at Birmingham
Usually the authors for poster presentations are present to answer questions. Don't know how this is going to work in a virtual setting.
SITC
November 2020
IMMUNE MONITOR
A Message from the President
Dear Colleagues,
Only a few days remain before The Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020) begins on Nov. 9, 2020. This will be our first virtual meeting, and I anticipate that all the preparation and hard work will produce the best possible meeting experience for our members and our many colleagues who will join us from around the globe. I also want to extend a warm welcome to the more than 1,300 researchers and clinicians who joined the SITC family in 2020 and I look forward to working together with you in the future.
The Annual Meeting is the highlight of the year for our society and there are always many reasons to attend, but the focus is on the new and exciting data from research spanning across the entire spectrum of cancer immunotherapy. Oral and poster presentations will cover a broad range of topics including tumor immunobiology, the tumor microenvironment, mechanisms of response and resistance to immune modulators, novel immunotherapy strategies in the clinic, and emerging clinical data from new agents and combinations.
On behalf of the society, I extend our congratulations to this year’s nominees for the Presidential Award, who will present their work on Friday, Nov. 13, beginning at 1:30 p.m. EST. These abstracts were selected from a large group of submissions and represent the work of highly motivated and talented early career investigators. This year’s nominees are:
• Defne Bayik, PhD – Cleveland Clinic
• Emily Hsiue, MD – Johns Hopkins University
• Nils-Petter Rudqvist, PhD – The University of Texas MD Anderson Cancer Center
• Michal Sheffer, PhD – Dana-Farber Cancer Institute
To mitigate some of the disadvantages of a virtual meeting, opportunities were created within the meeting to enhance connections with presenters. I invite you to attend the virtual poster sessions starting Nov. 9 at 8 a.m. EST hall. In these sessions, attendees can chat in real time with poster presenters during the following designated poster presentation hours:
• Odd-numbered posters: Wednesday, Nov. 11, from 5:15–5:45 p.m. EST, and Friday, Nov. 13, from 4:40–5:10 p.m. EST
• Even-numbered posters: Thursday, Nov. 12, from 4:50–5:20 p.m. EST, and Saturday, Nov. 14, from 1–1:30 p.m. EST
For a complete look at this year’s abstracts, please visit the Journal for ImmunoTherapy of Cancer (JITC), our society’s open access, peer-reviewed online journal, to view the abstract supplement that will be published as a preprint on Monday morning. Also, we extend our congratulations to JITC Editor-in-Chief Pedro J. Romero, MD, and the countless other editors, reviewers and contributors, on the recent news that the journal increased its impact factor to 10.252! This is a remarkable accomplishment in such a short period of time, and Dr. Romero has initiated an ambitious agenda to further increase the value and impact of the Journal.
The SITC Annual Meeting would not be the same without The CheckPoints party, so join in to hear them on Friday, Nov. 13, at 6 p.m. EST (through ZOOM) for a special happy hour. Don’t forget to order your limited edition T-shirt and CheckPoints Mask to support the Forward Fund.
Finally, please remember that everyone registered for SITC 2020 can now explore the SITC 2020 virtual environment. The preview continues prior to the opening of our pre-conference programs on Monday morning. Please click here to set up your profile, access the virtual exhibit hall and plan your schedule for next week.
Thank you all for your commitment to SITC. Look forward to seeing you online next week!
Sincerely,
Mario Sznol, MD
SITC President
Sojourner55,
thanks!
Late-Breaking
Plenary 1A
LTBK-02 - Phase III Clinical Trial to Test the Safety and Efficacy of Autologous Tumor Lysate-Loaded Dendritic Cells in Patients with Newly Diagnosed Glioblastoma - Withdrawn per Author
Friday, November 20, 2020 11:55 AM – 12:05 PM EST
Live Abstract Speaker(s)
LINDA M. Liau, MD, PhD, MBA
University of California Los Angeles
There's likely a good reason that the updates to the clinical trial sites have been handled in the manner they have... and by that, I mean it's been in the best interests of the company, the trial, and therefore, shareholders that the updates, or lack of them, have been handled as they have been.
The reasons may not seem clear to us now, but in time, I would think they will be.
exwannabe,
i agree!
European Medicines Agency (EMA) vs. U.S. FDA
The EMA inspects clinics and labs to make sure medicines are being tested and produced correctly.
The EMA is not involved in research and development (R&D), nor is it involved in clinical trials.
What Is the European Medicines Agency (EMA)?
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health. The EMA does so by the use of medications in European countries. The EMA is the European Union’s equivalent to the U.S. Food and Drug Administration (FDA). However, the EMA is sometimes called the European Medicines Evaluation Agency or EMEA, although this is not its official name.
KEY TAKEAWAYS
• The European Medicines Agency (EMA) is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines.
• The EMA serves the EU, EEA, Iceland, Norway, and Liechtenstein.
• The EMA practices pharmacovigilance to ensure the safety and efficacy of medicines.
• The EMA is not involved in clinical trials or R&D.
• Individual countries can choose to approve drugs that the EMA has not approved.
Understanding the European Medicines Agency (EMA)
European Medicines Agency (EMA) originated in London in 1995. It serves a population of more than 500 million people in the EU. The EMA’s mission is to protect the health and well-being of both people and animals living throughout the 28 EU member states, along with those in the countries located in the European Economic Area (EEA). One of the agency’s primary priorities is to provide critical new medications to patients who need them in a timely manner.
When a pharmaceutical company wants permission to sell a drug in certain parts of the world, it must get permission first from the EMA. If the EMA grants approval, the drug can be used throughout the European Union, Iceland, Norway, and Liechtenstein. The EMA also monitors the safety of medicines after they have been approved, through a process called pharmacovigilance.
The EMA has established joint task forces with the heads of other medicine agencies to explore the costs and benefits and how to probably utilize big data.
Special Considerations
The definition of pharmacovigilance by the EMA is “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.” Medicine safety and efficacy is limited to results from clinical trials. This means that the medicine has been tested in a relatively small number of people and must be consistently monitored by healthcare providers throughout its use.
European Medicines Agency (EMA) vs. U.S. FDA
The EMA inspects clinics and labs to make sure medicines are being tested and produced correctly. The EMA is not involved in research and development (R&D), nor is it involved in clinical trials.
The FDA and EMA collaborate through “clusters” to share safety information on issues such as medication safety, biosimilars, cancer medicines, orphan medicines used to treat rare diseases, medicines for children, and blood-based products. A biosimilar is a biological medicine very similar to another approved biological medicine. Biological medicine is medicine where the active ingredient is a living organism. Lantus is a good example of bio-medicine. It is a man-made form of the insulin hormone.
While the EMA and FDA are similar, they do not always approve the same drugs, and the EMA is perceived as being less strict than the FDA in its approval process, meaning that some drugs are approved in Europe that are not approved in the United States. Also, the EMA does not approve all drugs that are used in EU countries; individual countries may choose to approve drugs that the EMA has not approved.
The EMA does not decide whether a medicine can be marketed, and it does not develop or change drug laws, or directly influence medicines’ prices or availability. It is the European Commission that actually approves, denies, suspends or revokes marketing authorizations. The EMA’s role is to scientifically evaluate marketing authorizations for medicines.
Instead of updating the status to. “Restarted”, why do these European clinical trial sites not change the status instead to “Trial Completed; awaiting Top Line Data”?
IMO the status “restarted” gives the false impression that the trial is ongoing again and starting to enroll or provide more treatments to patients. I would prefer to see that trial is done, and that all that remains is submitting TLD.
3.10. Temporary halt of a trial
146. A temporary halt of a trial is a stoppage of the trial which is not envisaged in the approved protocol and where there is an intention to resume it.
147.
A temporary halt can be:
— a substantial amendment, or
— part of an urgent safety measure as referred to in Article 10(b) of Directive 2001/20/EC. In this case, the notification of the temporary halt of a trial should be made immediately and, at the latest, in accordance with the deadline set out in Article 10(c), second sentence, of Directive 2001/20/EC, within 15 days from when the trial is temporarily halted.
148. The reasons and scope, e.g. stopping recruitment or interrupting treatment of subjects already included, should be clearly explained in the notification (in case of substantial amendment, see Section 3.7) or in the ex post information (in case of urgent safety measures, see Section 3.9).
149. The restart of the trial should be treated as a substantial amendment providing evidence that it is safe to restart the trial.
150. If the sponsor decides not to recommence a temporarily halted trial he should notify the national competent authority of the Member States concerned within 15 days of his decision in accordance with Article 10(c), second sentence, of Directive 2001/20/EC (see Section 4.2).
4.2. Procedure for declaring the end of the trial
4.2.1. General rules
159. The sponsor has to make an end of trial declaration when the complete trial has ended in all Member States/third countries concerned. The end of the clinical trial is defined in the protocol (see Section 4.1).
160. This declaration has to be made to the national competent authority and the Ethics Committee of all Member States concerned within 90 days of the end of the clinical trial.
To this end, the form published in Volume 10 of EudraLex — The Rules Governing Medicinal Products in the European Union (54) should be used.
161. The notified Member States are responsible for entering this information into the EudraCT database.
The trial was on partial clinical hold for a period of time in regard to screening of new patients for enrollment; however, the patients already in the trial continued to be treated in accordance with the trial protocol, without interruption. In December 2016, the Company announced that to date the regulators had not agreed to remove the partial hold, and the Company had determined that it would not enroll the last 17 of the planned 348 patients. Thereafter, in February 2017, the FDA lifted its partial hold. The Company had self-imposed a hold on screening in countries outside the US, this remains in place in agreement with the regulators, and the Company will not enroll the last 17 patients as announced in December 2016.
37th Annual J. Garber Galbraith, M.D., Scientific Session and Lecture
"Brain Tumor Immunology & Immunotherapy"
Galbraith Lecturer:
Linda M. Liau, M.D., Ph.D., M.B.A.
Professor and W. Eugene Stern Chair, Neurosurgery Department
Director, UCLA Brain Tumor SPORE
David Geffen School of Medicine at UCLA
Closed case presentations begin at 8:30 a.m., and the open Scientific Session begins at 10 a.m.
Friday, November 6 at 8:30am to 5:30pm
Virtual Event