From: Joseph H Pratt II <jhpratt2@icloud.com> Subject: AACR report on the Dc Vax L phase 3 trail 5/10/22 NYAS presentation. Date: May 17, 2022 at 4:21:13 PM EDT To: aacr@aacr.org Cc: mfoti@aacr.org
Margaret :Did you get a chance to review the 5/10/22 DC Vax L trial presentation at the NYAS ? I believe the AACR conclusion that the trial failed based PFS is misguided.PFS is not an endpoint. I see Adam Feuerstein recommends NVCR. And NVCR gives AACR alot of funding.These connected dots suggest perhaps corrupted reporting on your part. For the sake of cancer patients , please do not publish the research on nwbo which is written by a media bloggers such as Feuerstain who advocate for the shorts. Thank You. Joe Pratt/ 610 517 4445.alphavestcapital.com By the way, is a fix really happening, as noted below? newman2021
Tuesday, May 17, 2022 3:35:10 PM
Re: None
Post# 474924 of 474939 I talked to AACR. Cancer Discovery CDNews department. Talked to Natalie at 215-440-9300 who said they are aware of the issue and are deliberating to fix it. She doesn't give me a time frame but promised it will be fixed.
"Northwest Biotherapeutics disclosed that their cancer vaccine DCVax-L performed worse than placebo when given to patients with newly diagnosed glioblastoma. In the phase III trial, 232 patients were treated with DCVax-L and 99 received placebo; patients who received DCVax-L had a 10% increased risk of tumor progression compared with those who received the placebo. In addition, those who received the vaccine experienced tumor recurrence after a median of 6.2 months compared with 7.6 months in those in the control group.)"
CHIEF EXECUTIVE OFFICER MARGARET FOTI, PHD, MD (HC) ?American Association for Cancer Research Philadelphia, Pennsylvania
Margaret Foti, PhD, MD (hc), is the chief executive officer of the American Association for Cancer Research (AACR), the first and largest cancer research organization in the world. Under her visionary leadership, membership has grown from about 3,000 members to over 50,000 in 129 countries and territories, and the AACR’s portfolio of peer-reviewed scientific journals has increased from one to ten.
After beginning her AACR career in an editorial position with the journal Cancer Research, Foti progressed through several key editorial and management roles in scientific publishing to become chief executive officer. She launched nine additional major peer-reviewed scientific journals: Blood Cancer Discovery; Cancer Discovery; Cancer Epidemiology, Biomarkers & Prevention; Cancer Immunology Research; Cancer Prevention Research; Cancer Research Communications; Clinical Cancer Research; Molecular Cancer Research; and Molecular Cancer Therapeutics. She also helped launch Cancer Today, a magazine for cancer patients, survivors, and their families and caregivers, as well as Leading Discoveries, a publication that highlights AACR members, programs, and philanthropic initiatives.
A graduate of Temple University, Foti is one of the most influential voices in advancing the field of cancer research, both in the United States and abroad. She was elected president of three professional societies in scholarly publishing and in cancer research. She has also served as a board member, committee member, and consultant to a number of other nonprofit organizations. There is a legacy of young women, minority scientists, and investigators-in-training whose careers have been advanced as a result of her mentorship and support.
Under Foti’s leadership, the AACR has served with distinction as the Scientific Partner of Stand Up To Cancer (SU2C). In this capacity, Foti and the AACR staff have brought significant expertise to their work with SU2C, especially in the scientific peer review of projects, scientific project management, grants administration, communications, and science policy.
Foti’s leadership was instrumental in the production of two landmark annual reports that highlight the critical need for increased annual federal funding for the government entities that fuel progress against cancer: the AACR Cancer Progress Report, which was first published in 2011 and celebrates the advances in basic, translational, and clinical cancer research which have had a major impact on therapeutic development and improved patient care; and the AACR Cancer Disparities Progress Report, which was launched in 2020 with the overarching goal of increasing public understanding of cancer health disparities and of the vital importance of cancer health disparities research to saving lives.
Foti’s contributions have been widely recognized by numerous awards from organizations around the world. Her lengthy list of formal recognitions includes honorary degrees in medicine and surgery from the University of Rome La Sapienza and the University of Catania in Sicily, and an honorary degree in medicine from the University CEU of San Pablo in Madrid. In 2019, she was honored as one of the Women of Inspiration and Influence by the Women Business Leaders of the U.S. Health Care Industry Foundation. She was also recognized with the 2018 Women for Oncology Award from the European Society for Medical Oncology, the 2016 PHL Life Sciences Ultimate Solution Award, the Ovarcome Excellence 2016 Award, the 2016 James Ewing Layperson’s Award from the Society of Surgical Oncology, the 2016 Honorary Member Award from the Oncology Nursing Society, and as a 2015 honoree of “the one hundred” by Massachusetts General Hospital Cancer Center. Additionally, she received the 2015 Children’s Champion Award from the Children’s Hospital of Philadelphia, the 2014 Ellen V. Sigal Advocacy Leadership Award from Friends of Cancer Research, the 2014 Morton M. Kligerman Visiting Professorship Award from the University of Pennsylvania, the 2013 Stanley P. Reimann Honor Award from Fox Chase Cancer Center, and the 2013 Distinguished Partner in Hope Award during the Annual Colorectal Cancer Conference hosted by the Abramson Cancer Center of the University of Pennsylvania. In 2007, the AACR established the first AACR Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research, which is given annually in her name. Her visionary leadership, combined with her steadfast focus on the AACR’s mission, continues to drive the field forward towards the vital goal of preventing and curing all cancers.
"Northwest Biotherapeutics disclosed that their cancer vaccine DCVax-L performed worse than placebo when given to patients with newly diagnosed glioblastoma. In the phase III trial, 232 patients were treated with DCVax-L and 99 received placebo; patients who received DCVax-L had a 10% increased risk of tumor progression compared with those who received the placebo. In addition, those who received the vaccine experienced tumor recurrence after a median of 6.2 months compared with 7.6 months in those in the control group.)"
Margaret, Lisa: Please listen to the 5/10/22 dc vax L lead investigators presentation.PFS is not an endpoint.Joe Pratt/610 517 4445
ATLnsider @ATLnsider I’m extremely disappointed that @CD_AACR didn’t report true results of $NWBO #DCVax trial. On May 10th @ NYAS, trial results were announced & it’s clear for everyone to see that Primary & Secondary endpoints were met. Here’s the email address to complain: cancerdiscovery@aacr.org Image 4:21 PM · May 15, 2022·Twitter for iPhone 19 Retweets 3 Quote Tweets aacr@aacr.or https://www.aacr.org/about-the-aacr/leadership-and-governance/officers/
ae kusterer Sunday, May 15, 2022 8:16:39 PM Re: None PlusOneCoin Icon 0 Post# of 473833 Go Thanks, GermanCol
Post# 473701 of 473734 I think it's time to put to rest all the lies that have been spread, saying that the trail failed, that the “placebo” arm did better than the treatment arm and that interim results were better than the final. None of this is true and actually the trial was a success as predicted.
Based on the final results presentation shared this week by the company (https://virtualtrials.org/dcvax/dcvax.pdf) I prepared the following chart. In order to compare the final treatment arm results with the interim blended blinded data reported in 2018, the survival points for 12, 24, 36 and 46.5 months from surgery were located in this chart. These points were located at 8.9 (12 minus 3.1) months, 20.9 (24 minus 3.1) months, 32.9 (36 minus 3.1) months and 43.4 (46.5 minus 3.1) months because the 2018 interim blended results were measured from surgery, the final results were measured from randomization and the average time difference between surgery and randomization was 3.1 months.
The following table contains a comparison between the final results of the treatment arm for the newly diagnosed GBM (shown in the chart above) and the 2018 interim blended blinded results shared by the company:
** Calculated from JTM interim results publication: https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6 Quote: As of this analysis, 223 patients are>=30 months past their surgery date; 67 of these (30.0%) have lived>=30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. This means that at 46.5 months, 15% (30% / 2) of those patients were expected to be alive.
As a conclusion from this table:
-At 12 months from surgery treatment arm final results were better than blended blinded interim results (91% vs. 89.3%) -At 24 months from surgery blended blinded interim results were better than treatment arm final results (46.2% vs. 45.5%) -At 36 months from surgery treatment arm final results were better than blended blinded interim results (26% vs. 25.4%) -At 46.5 months from surgery treatment arm final results were better than blended blinded interim results (16.5% vs. 15%)
So, for 3 of the 4 points in the table, the final results were better than the results for interim blended blinded results shared in my analysis previous to final results release (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168777187) and just for 1 of them they were better for the interim blended blinded analysis.
And the reason for this is actually good news because this can be explained as follows. At the beginning, the treatment arm started to do better because of DCVaxL, then as progression and pseudo progression (confounding factor) started, patients were taken out of the treatment arm and of the “placebo arm” to start going into the recurrent GBM treatment arm. So the already dead patients started to have higher effect in the treatment arm because there were less patients at risk. Also, important to take into account when analyzing this effect that recurrent GBM treatment arm is measured from recurrence, not from randomization or surgery. Then, after that, with the long term positive effect of DCVax, which is higher for patients that started earlier with the treatment, the treatment arm patients continued doing better and not only counteracted the effect mentioned of having less at risk (that is just a mathematical effect), but also continued doing better and better than what was shown in the interim blended blinded results.
Other very important point to mention is that it was actually very good news that there was no higher separation between the arm for newly diagnosed GBM and the “placebo”, which we know is not a placebo arm. It’s basically the opposite from a placebo arm, it is mainly composed by the treatment arm for recurring GBM. So if it would have been a higher separation between them, GBM arm would have been even better, but recurrent GBM arm would not have been as good as it is.
And here comes the best part. From the presentation: “GBM Is a Particularly Difficult Cancer” “Nearly 100% recurrence rate”, so is even more important to have it approved for recurrent than it is for newly diagnosed GBM and with such a benefit it showed. And that makes even better if the previous OS endpoint was not met because it would have meant bad results for recurrent GBM. Mathematically we can’t have the three endpoints positive at the same time. Maximum 2. Which ones we prefer, we got the best possible for the value of the company
Disclosures: English is not my native language, so sorry if you find mistakes in wording or redaction. This is not investment advice, I am sharing my analysis and opinion based on public information. Take on the markets w/ confidence. E*TRADE's easy to use tools help make trading quicker & simpler. Recent NWBO News Quarterly Report (10-q) • Edgar (US Regulatory) • 05/10/2022 10:02:07 AM Amended Annual Report (10-k/a) • Edgar (US Regulatory) • 05/02/2022 09:05:06 PM TNS Issues New Reports on Stocks with Potential Near Term Catalysts and a Feature Green Energy NASDAQ Report • InvestorsHub NewsWire • 04/12/2022 12:30:00 PM TNS Feature Report and Next Gen Tech and Biotech That Could Change Our Lives • InvestorsHub NewsWire • 03/17/2022 12:00:00 PM Seeking Alpha - ALYI sees substantial interest for new EV taxi program • InvestorsHub NewsWire • 03/04/2022 02:11:16 PM Annual Report (10-k) • Edgar (US Regulatory) • 03/01/2022 05:49:59 PM Northwest stock rises 9% as company begins cancer vaccine production at UK facility • Seeking Alpha • 02/17/2022 02:49:34 PM Biopharma Companies Setting up for a Rebound in the Near Term and a New Blockchain Feature Report • InvestorsHub NewsWire • 02/16/2022 01:00:00 PM SA Breaking News - PURA sees 2022 revenue upside potential to $10M • InvestorsHub NewsWire • 12/15/2021 02:28:27 PM Northwest Biotherapeutics secures $15M financing on stock purchase rights • Seeking Alpha • 11/29/2021 04:11:27 PM Quarterly Report (10-q) • Edgar (US Regulatory) • 11/15/2021 09:41:30 PM IQST Has Catalysts On Deck That Expose A Valuation Disconnect of Roughly 100% - Here's Why That Gap Should Close • InvestorsHub NewsWire • 11/05/2021 02:20:59 PM iQSTEL, Inc. - The Calm Before The Surge (OTCQX: IQST) • InvestorsHub NewsWire • 10/29/2021 06:31:48 PM Star Alliance Intl. Corp. (OTC Pink: STAL) Recent Gold Mine Acquisition NI43-101 • InvestorsHub NewsWire • 10/29/2021 11:08:34 AM IQST - EV & Hi-Tech Company Poised For Potential 4X ROI - Q3 Financials and Short Squeeze • InvestorsHub NewsWire • 10/14/2021 03:34:44 PM CEO Presenting on the Emerging Growth Conference on October 13 Register Now • InvestorsHub NewsWire • 10/11/2021 11:00:00 AM CLS Holdings, (OTCQB: CLSH) New Joint Venture $19 million Sales 61% Growth • InvestorsHub NewsWire • 09/28/2021 11:24:31 AM CEO Presenting on the Emerging Growth Conference on September 29 Register Now • InvestorsHub NewsWire • 09/27/2021 12:35:40 PM CEO Presenting on the Emerging Growth Conference Tomorrow. Register Now • InvestorsHub NewsWire • 09/14/2021 11:00:00 AM CEO Presenting on the Emerging Growth Conference on September 15. Register Now • InvestorsHub NewsWire • 09/13/2021 11:00:00 AM CEO Presenting on the Emerging Growth Conference on September 1. Register Now • InvestorsHub NewsWire • 08/31/2021 11:00:00 AM CLS Holdings, (OTCQB: CLSH) July Sales $1.9 Million 104% increase over July 2019 • InvestorsHub NewsWire • 08/17/2021 11:21:24 AM Quarterly Report (10-q) • Edgar (US Regulatory) • 08/16/2021 08:41:47 PM CEO Presenting on the Emerging Growth Conference on August 4. Register Now • InvestorsHub NewsWire • 08/03/2021 11:00:00 AM WSGF - World Series of Golf Inc VERY BULLISH Signal Continues • InvestorsHub NewsWire • 08/02/2021 01:45:22 PM More NWBO News
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