Key Points:
- After the passing of John McCain NWBO's, DCVAX-L did not make the news in the United States it should have
- The 2017 blinded data on DCVAX-L continues to be relevant among academics and in journal articles
- New phase I clinical trials are scheduled to begin with the Mayo Clinic
- August 29, 2018, Dr. Marnix Bosch presented on DCVAX-Direct in Boston
- Cognate is ramping up production, the author lists his reason why he believes this is relevant to NWBO
- The author details why the current SEC investigation may not be as worrisome as Adam Feuerstein and some IHUB posters believe
John McCain (Picture courtesy of NY Times)
Its been a very busy two weeks in terms of news related to NWBO which could easily get lost among the numerous posts on IHUB. I wanted to review some of the items I found the most interesting, because I believe there are some important things which happened this week. But, first I want to start off with condolences to the McCain family for the loss of their father, husband and United States Senator John McCain. McCain passed away after losing his battle with brain cancer, specifically Glioblastoma on August 25, 2018. It seemed a good opportunity for DCVAX-L to make headlines in the media. Instead DCVAX-L was essentially ignored by news channels and doctors appearing on news channels. One would have expected the type of news coverage in the United States as Tessa Jowell received did in the U.K. regarding NWBO's treatment for Glioblastoma. In the U.K. when Tessa Jowell died, NWBO's DCVAX-L study was listed in the news several times. (https://www.theguardian.com/society/2018/may/29/brain-cancer-vaccine-could-extend-lives-patients-years-dcvax-tessa-jowell, https://www.belfasttelegraph.co.uk/news/uk/brain-cancer-vaccine-could-extend-lives-of-patients-by-years-36958244.html, https://www.independent.co.uk/news/health/brain-cancer-vaccine-tessa-jowell-tumour-patients-clinical-trial-a8374886.html,https://www.braintumourresearch.org/media/news/news-item/2018/05/30/outcomes-of-immunotherapy-vaccine-trial-show-encouraging-results-for-glioblastoma-patients) But here in the United States there appears to have been radio silence and I would have expected more news organizations to pick up on the current treatment regarding DCVAX-L. I believe this was an opportunity missed by NWBO in the wake of the current SEC investigations.
Tessa Jowell (Picture Courtesy of ITV.Com)
In my last article on DCVAX-L "Scientific Community Notices Positive Effects of Northwest Biotherapeutics DCVAX-L as Share Price Falls" https://steemit.com/nwbo/@moonknight1977/scientific-community-notices-positive-effects-of-northwest-biotherapeutics-dcvax-l-as-share-price-falls I stated the medical community was starting to accept and learn about the benefits of DCVAX-L. This also becomes evident in the Research Article "The Induction of Immunogenic Cell Death (ICD) During Maintenance Chemotherapy and Subsequent Multimodal Immunotherapy for Glioblastoma (GBM)" http://www.iozk.de/aktuelles/iozk_glioblastoma_immunotherapy_austin_oncology_report_2018.pdf published on July 18, 2018 .
Listed in the introduction the authors state "In spite of multimodal treatment consisting of neurosurgery, radiotherapy and chemotherapy, the prognosis is poor (In patients with Glioblastoma) with a Medium Overall Survival (OS) of only 15 months." The authors then go on to mention advances in current Glioblastoma treatment "recently a large phase III clinical trial integrating DC Vaccination during first line treatment, or in cross-over at time of disease progression, demonstrated improved long-term survival. Moreover, meta-analyses pointed out the significant effect of active specific immunotherapy on OS compared to intra-institutional historical control patients."
The large phase III study was conducted on DCVAX-L and based on blinded information released during ASCO 2018, regarding 2017 data. "Due to the crossover design, nearly 90% of the total 331 patients in the trial have received DCVax-L treatment. For the total 331 patients (both arms of the trial combined) the median survival as of this analysis was 23.1 months from surgery. With the standard of care (SOC) today (surgery, radiation and chemotherapy), median survival for newly diagnosed Glioblastoma is 15-17 months." https://www.nwbio.com/nwbio-announces-scientific-publication-interim-survival-data-phase-3-trial-dcvax-l-glioblastoma-brain-cancer/
On August 20, 2018, listed on ClinicalTrials.gov a new phase I study on Dendritic Cell Therapy for Brain Metastetases From Breat or Lung Cancer was announced. Northwest Biotheraputics will Sponsor the study collaborating with the Mayo Clinic in Jacksonville, Florida. The chief investigator for this trial is doctor Alfredo Quinones Hinojosa, MB, who performed over 2,500 brain surgeries. https://clinicaltrials.gov/ct2/show/NCT03638765?
Doctor Alfredo Quinones Hinojosa, MB (Picture courtesy of CNN.Com)
Then on August 29, 2018, Dr. Marnix L. Bosch, Chief Technical Officer for Northwest Biotherapeutics presented in Boston, Massachusetts on the "DCVAX: Clinical Development of Dendritric Cell-Based Immunotherapy for Cancer." (https://www.nwbio.com/wp-content/uploads/2018/08/I-O-Summit-Presentation-FINAL.pdf ) Dr. Bosch references the study "Cytokines Produced by Dendritic Cells Administered Intratumorally Correlate with Clinical outcome in Patients with Diverse Cancers." concluded "In this study, we showed that aDCs are safe, feasible treatment option for patients with solid tumors. We also identified specific cytokines that, when secreted by the aDCs, lead to stabilization of disease, resulting long term survival." Overall, this is very good news but the stock price drops the next day after this is presented anyway.
What I also found most interesting was what appeared on page 5 of the presentation (https://www.nwbio.com/wp-content/uploads/2018/08/I-O-Summit-Presentation-FINAL.pdf) a listing for the DCVAX-Prostate as a 35 patient completed phase II trial. This trial was not listed on the June 5, 2017, ASCO presentation https://www.nwbio.com/NWBio_ASCO_Update_On_Trials_6-5-17.pdf or Dr. Bosch's August 31, 2017 presentation in Boston https://www.nwbio.com/Boston-slides-31Aug2017-v0.5.pdf. Or the ASCO 2018 video https://www.nwbio.com/dcvax-personalized-dendritic-cell-vaccines/ I believe this begs the question to be asked "Why now?"
(Picture courtesy of Contractphrama.com)
On August 14, 2018, Nicola Ambler authored the following article "Preparing For Commercialisation with the Right CDMO." An interview with J. Kelly Gangel, CEO and Chairman of the board, Cognate Bioservices, inc and Kelly Ganjel stated “We have several big things in the works that will address multiple aspects of product development and manufacturing that I wish I could discuss at the moment but can’t. All I can say is please stay tuned.” https://www.phacilitate.co.uk/article/preparing-commercialisation-right-cdmo
The reason this article on Cognate ramping up production is so speculatively interesting is listed in NWBO's 10-Q dated March 31, 2017 "In addition, the Company’s (NWBO's) programs require a large amount of capacity in these specialized manufacturing facilities, and require that the large capacity be dedicated exclusively to the Company’s programs. " https://www.sec.gov/Archives/edgar/data/1072379/000114420417027650/v466994_10q.htm This was summarily changed in all the following 10-Q's listed by the company. However, one has to speculate is the "Big Things" in "Manufacturing and Product Development" a result of those resources exclusively dedicated to NWBO. (If NWBO is still Cognate's largest client, this could be a good chance.) This is just my opinion and guess of course and unfortunately we don't know.
But now the rhetorical question which I shall leave for the reader becomes which side do you come down on: Based on the evidence presented above just in the last two weeks "Is NWBO a company that has mailed it in?" or "Is NWBO a company just ramping up production?"
The next section is entirely my opinion and it is on a topic which is brought out by IHUB posters on a regular basis. The June 30, 2018 10-Q listed the following "The Company has been cooperating with the SEC investigation. As hoped, the investigation is winding to a conclusion. After investigation of a broad array of issues over the past two-plus years, the SEC Staff has informed us preliminarily that they have concerns in regard to two issues, relating to the Company’s internal controls over financial reporting and the adequacy of certain disclosures made in the past. We have previously disclosed material weaknesses in our internal controls. As for disclosures, we believe our disclosures complied with applicable law. Despite our belief that the Staff should close the investigation, there can be no assurance that the Staff will not recommend some action involving the Company and/or individuals."
On August 14, 2018, Adam Feuerstein commented on twitter "$NWBONew 10-Q includes updated disclosure on the ongoing SEC investigation. It’s not good for Linda P. and crew, but confirms my past reporting about misleading disclosures." ~~~ embed:1029487309970923521. Several IHUB posters also took up the opportunity to jump on NWBO. While I agree no SEC investigation is ever good. However, I would ask that we break down and dissect exactly what was written line by line in the 10-Q: twitter metadata:YWRhbWZldWVyc3RlaW58fGh0dHBzOi8vdHdpdHRlci5jb20vYWRhbWZldWVyc3RlaW4vc3RhdHVzLzEwMjk0ODczMDk5NzA5MjM1MjEuIFNldmVyYWwgSUhVQiBwb3N0ZXJzIGFsc28gdG9vayB1cCB0aGUgb3Bwb3J0dW5pdHkgdG8ganVtcCBvbiBOV0JPLiBXaGlsZSBJIGFncmVlIG5vIFNFQyBpbnZlc3RpZ2F0aW9uIGlzIGV2ZXIgZ29vZC4gSG93ZXZlciwgSSB3b3VsZCBhc2sgdGhhdCB3ZSBicmVhayBkb3duIGFuZCBkaXNzZWN0IGV4YWN0bHkgd2hhdCB3YXMgd3JpdHRlbiBsaW5lIGJ5IGxpbmUgaW4gdGhlIDEwLVE6fA== ~~~
Company has been cooperating with the SEC investigation. (SEC investigation is Bad/ Cooperation Good)
The investigation is winding to a conclusion. (Good)
SEC Staff has informed us of issues...adequacy of certain disclosures made in the past. (Is this the reason for their silence? What are the exact disclosures? )
As for disclosures, we believe our disclosures complied with applicable law. (That's Good)
Despite our belief that the Staff should close the investigation, there can be no assurance that the Staff will not recommend some action involving the Company and/or individuals. (Essentially its out of our hands. That's not so Good.)
Linda Powers (Picture courtesy of WSJ.Com)
I would argue at this point there are no two better individuals to argue regarding the law than two attorney's for NWBO; Linda Powers who went to Harvard and Les Goldman who went to the University of Michigan. Remember, NWBO (Powers and Goldman) have had all lawsuits against them dismissed or settled without adverse effect. They are (in my opinion) essentially undefeated in the areas surrounding law. They (NWBO/ Powers/ Goldman) would not say anything in a legal document such as a 10-Q which they were not certain of, and it is because of this I lay a lot of emphasis on their sentence "As for disclosures, we believe our disclosures complied with applicable law." However, because the SEC is the deciding body and is taking their time resolving the matter they cannot say with an exact amount of certainty this will be resolved in their favor. I emphasize, this is my opinion only.
Final Thoughts
Unfortunately this leaves us with so many more questions now going unanswered "Why didn't DCVAX-L make it into the news following John McCain's death?" "If research articles are quoting the blinded numbers presented at ASCO 2018 and new phase I studies are being launched and the academic community is taking notice, why is the share price continuing to fall?" "Why did NWBO choose to list the previously absent DCVAX Prostate phase II on their slide show at this time?" and "Is the production and manufacturing development at Cognate for NWBO or a new client?"
We anxiously stay tuned.
Author's note: This article is all my opinion and should not be relied upon for predictive behavior or outcome of any stock or its drug approval status by the FDA. It is all my opinion. You can follow me on Twitter @TheMoonknight77 where I mainly follow NWBO, send prayers for cancer patients and post Steemit articles on topics which I enjoy. Yes I am NWBO Long and a share holder.