Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I was beginning to worry about you, Yooo. It's been 3 weeks since you posted. So, good to know you haven't forgotten about us.
As far as the post you replied to, I was only wondering aloud if lenz may be the common denominator in the success of both trials. Obviously, it was the drug being studied in the PREACH-M trial. But as I said before, I wonder if Kevin resigned from Humanigen's Board, to dedicate his full attention to the IIT of their CAR-T, using lenz as intended by one of our patents, such as this one?
"Method of increasing the efficacy of CAR-T immunotherapy using lenzilumab
Patent number: 11673962
Abstract: Methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject, the method comprising a step of administering a recombinant hGMCSF antagonist to the subject, wherein said administering inhibits or reduces the incidence or the severity of immunotherapy-related toxicity in said subject, are provided. An hGMCSF antagonist for use in methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject also are provided.
Type: Grant
Filed: October 2, 2018
Date of Patent: June 13, 2023
Assignee: HUMANIGEN, INC.
Inventors: Cameron Durrant, Dale Chappell"
https://patents.justia.com/assignee/humanigen-inc
I find interesting correlations between the Investigator Initiated Trial (IIT) results that former Board Member Kevin Xie's 'Gracell' just announced, compared to the PREACH-M trial results recently announced for Humanigen's lenzilumab.
Gracell: https://www.sec.gov/Archives/edgar/data/1826492/000110465923126860/tm2332578d1_ex99-1.htm
Humanigen: https://ash.confex.com/ash/2023/webprogram/Paper179706.html
Hello, and welcome to the room, bencozey.
I don't know how you knew there was stock manipulation going on, but then again, it would only be surprising to discover there was no manipulation. So, where are the charges against the brokerages? Don't bother looking. If there are charges, they seldom identify the victimized companies.
What does a serial stock manipulation do the the targeted company? It's usually lethal to the company. Is Humanigen on death's bed? Have you seen the opportunities we have queued up? That certainly signifies management's faith in lenzilumab to me.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173383975
The opportunity to recall our loaned shares is an interesting one, especially if you consider that our float has been reported at 192% of our Outstanding Shares. I've also seen an indication that Humanigen owns 110M of the 119M shares that are Outstanding.
Things aren't always what they appear to be.
The problem is not likely with the low level regulators who have their boots on the ground and are engaged with company staff through constant communication and site inspections. I was engaged with one such site inspector myself, when my staff couldn't provide satisfactory information regarding a process he had observed. He was fully aware of the protocol, and had the competency to accurately determine our compliance.
In the same way, I think our management was sure that we were meeting FDA requirements up until the time we submitted our EUA application. The Lancet and Thorax peer reviews validated the safety and efficacy of lenzilumab. So there was no justifiable reason to deny our EUA application. The FDA knew that. That's why they did not deny the application.
I believe it was just before, or during, the 104 days the FDA sat on our EUA application, that they exercised their discretionary authority to grant themselves a new power, the power to Decline to make a decision. That's what they then did to us. They Declined to make a decision on our EUA, claiming to want additional safety and efficacy data. That decision likely wasn't made by the FDA staff who did the grunt work with management to prepare for a successful submission. It was an arbitrary decision that effectively kept us out of the market, without having to justify their "non-decision."
Now, as we saw in the 'Live Science' article I referenced previously, the medical community is searching for a way to manage inflammation.
https://www.yahoo.com/lifestyle/dont-inflammation-then-youll-die-120009520.html
Lenzilumab has the Method of Action they are searching for. It is locked away from the medical community because of the FDA's abuse of their discretionary authority, using a newly imposed, self-granted power, to Decline to make a regulatory decision on our product.
The more I look at SpringWorks Therapeutics, and the relationship they have with GSK, and many others, the more impressed I am, and the more intrigued I become with the idea of partnering with a forward-moving group of companies, with the track record they are establishing. Even more, I think there could be some group interest in Humanigen's lenz and ifab products.
I sense a lot of potential here, particularly in using lenz as an antibody drug conjugate (ADC).
Look at what SpringWorks is doing in terms of establishing partnerships and collaborations.
https://springworkstx.com/who-we-are/partners-collaborators/
As I recall, the required P-value is .05 or less to show statistical significance. The Hazard Ratio has to be >1.0 (which would indicate the same efficacy as the Standard of Care drug).
During the 104 days that the FDA sat on our EUA, we were showing a Hazard Ratio of ~1.54, a 54% improvement over SOC. In the meantime, Roche submitted an EUA with a Hazard Ratio of 1.44, and had failed to meet the primary endpoint in that trial for about the 3rd time. But they got an EUA for toci, anyway.
The company subsequently provided the establishment of CRP levels as a biomarker. I think that was peer reviewed by Lancet. Humanigen went on to evaluate the LIVE-AIR patients segregated by CRP levels, and demonstrated Hazard Ratios that ranged from 3.0 - 3.4. In yet another lengthy peer review of that data, this one from Thorax, they determined our Hazard Ratio was "only" 2.54.
Toci was awarded an EUA with a Hazard Ratio of ~1.44 because they failed so many trials, that they had established a large database. We were declined an EUA decision, because I'm sure we followed the FDA's guidance in regards to trial size required, but the FDA decided after the fact that they wanted to see more data.
So, millions of people worldwide likely suffered preventable deaths from covid and covid-related indications, since we submitted our EUA application. None of the regulators have been charged with willful or criminal negligence or manslaughter. And we are poised to repeat the process, and allow even more preventable deaths from this new covid variant, which threatens to overwhelm our healthcare system by the end of the month.
Approval can't be arbitrary? We have Hazard Ratios that ranged from 2.5 - 3.4 from our LIVE-AIR trial. Nothing nebulous about the superior results lenz showed in treating covid patients. But the FDA still declined to grant our EUA application. That's what discretionary authority for the FDA allows to happen.
As far as CMML, I think the data I linked in my previous post indicated that current Standard of Care yields a Complete Response rate ranging from 16-21%. I also think that the interim analysis of the PREACH-M study showed a Complete Response rate of 73%. The P-value was 0.02. This reflects my understanding of the data I linked earlier.
I think that level of improvement, complete with establishing biomarkers where there were none, justifies Dr. Thomas' excitement, as well as approval and regulatory incentives, including a PRV, from the Australian regulators.
Last week's presentation to the American Society of Hematology, detailing the patterns of Complete Remission Rates of CMML with Lenzilumab, did not result with the concurrent news of Australian approval, nor of any regulatory awards, such as expedited review or a Priority Review Voucher, that I was hoping to see. Today, there is very little dedicated focus on that topic on the Humanigen investors' X board.
The news was outstanding.
https://ash.confex.com/ash/2023/webprogram/Paper179706.html
The last thing I want to do is to be hopeful about a vaporous catalyst, some opportunity that just doesn't materialize. "I don't see how we could miss" that opportunity to treat CMML patients, even without additional Project Orbis data. To me, this remains one Humanigen's top contenders for regulatory approval.
We just don't learn.
"Hospitals and emergency rooms could be forced to ration care by the end of this month, the Centers for Disease Control and Prevention warned Thursday, saying recent trends in COVID-19 and influenza are now on track to again strain America's health care system."
https://www.yahoo.com/lifestyle/covid-flu-surge-could-strain-155700941.html
"A mysterious respiratory illness among dogs appears to be spreading with cases being reported in two more states."
https://abcnews.go.com/GMA/Living/veterinarians-warn-rising-cases-mystery-dog-illness/story?id=104906650
"‘We Are All Sick’: Infectious Diseases Spread Across Gaza...
While the collapse of Gaza’s health system has made it challenging to track exact numbers, the World Health Organization has reported at least 369,000 cases of infectious diseases since the war began, using data collected from the Gaza Health Ministry and UNRWA, the U.N. agency that cares for Palestinians — a staggering increase from before the war...
The most common diseases raging through Gaza are respiratory infections, Ms. Barkley said, ranging from colds to pneumonia. Even normally mild illnesses can pose grave risks to Palestinians, especially children, older adults and the immunocompromised, given the dire living conditions, she said."
https://www.nytimes.com/2023/12/11/world/middleeast/gaza-health-infectious-disease.html
"Exclusive: US FDA finds control lapses at Moderna manufacturing plant
By Patrick Wingrove
December 15, 2023
Dec 15 (Reuters) - U.S. drug regulators in September found quality control lapses at Moderna’s (MRNA.O) main factory including with equipment used to manufacture drug substance for its COVID-19 vaccine, according to the report obtained by Reuters via a Freedom of Information Act request.
The Sept. 11-21 inspection by the U.S. Food and Drug Administration took place at Moderna’s facility in Norwood, Massachusetts, which is used to manufacture the company’s COVID shot Spikevax..."
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-finds-control-lapses-moderna-manufacturing-plant-2023-12-15/
"Florida’s surgeon general told the FDA that COVID-19 vaccines aren’t safe. The FDA calls that misinformation
Cindy Krischer Goodman, South Florida Sun Sentinel
Fri, December 15, 2023 "
https://www.yahoo.com/news/florida-surgeon-general-told-fda-233900803.html
"The best way to conduct biowarfare is to have your ignorant-ass targeted population further harm themselves with their own medical countermeasures."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173337853
The question is, has our covid Standard of Care, focused predominantly on mRNA vaccines, harmed our innate immune response system, as I suspect that it has?
At least, questions are being asked surrounding this issue.
"Did COVID-19 make us more vulnerable to other illnesses?
Nicole Karlis
Thu, December 14, 2023 at 4:29 AM CST
"...Recent CDC data reports COVID hospitalizations are up 17% and deaths are up 25% from last week...
As Salon has previously reported, severe cases of COVID can trigger a hyperinflammatory response called a "cytokine storm" so intense that it seems to exhaust the T cells and decrease their number. More recently, there has been evidence to suggest this can affect the immune system fighting future infections from both COVID-19 and other diseases as well."
https://www.yahoo.com/news/respiratory-viruses-rise-did-covid-102902780.html
mRNA shots fail to prevent infections. They fail to prevent reinfections. And they fail to imbue an appropriate immune response against future infections.
This can, and should be, avoided. Lenzilumab, used as an adjuvant with a protein-based vaccine, such as Nuvaxovid, can halt this self-inflicted damage to our immune response systems.
I consider Dale's entities to, at least in part, be our financing arm. The share structure was outlined in a filing some years ago, which detailed how corporate insiders would be designated as the nominee owners of Cede shares placed in the accounts, with shares issued to and from the company-controlled beneficial ownership account.
We saw Baudax tried to mask their activity by using merger subs. SpongeTech used certificated shares, originally issued to nominee account holders, who would convert the shares into Cede (digital) form. I was able to identify two such accounts and knew, when the Cede shares in those accounts were converted back into certificate form, that those shares would then be retired. So a company with 2 billion authorized and issued shares, proved that there were a billion shares that could not be certificated, because brokerages could not verify the authenticity of the shares. The corrupt SEC just forced a new Transfer Agent to issue an additional 1 billion shares, and the bankruptcy judge failed to order a list of shareholders, even though that was required in a bankruptcy filing. We got the list, anyway, and the Electronic Blue Sheet trading records, through subpoena power granted to us by the bankruptcy judge.
In all cases above, as the shares were transferred from the companies to the nominees, the transactions would show as buys and sells, when they were actually only transfers of shares between the company-controlled accounts.
That's why in one of my posts, I say, "As our latest Form 4 continues to disappear and reappear, even this morning, we may need to consider who the beneficiary of these shares may be. Baudax is still a contender. But another possibility may be that Novavax will receive these shares in a stock-for-stock merger agreement." I do not accept that our latest Form 4 reflects true sells by Dale's entities. I think those transactions only reflect the accumulation of shares to be transferred in a stock-for-stock merger agreement.
And I discussed our previous recall of loaned shares, and very eagerly anticipate the next recall of our loaned shares. How would that help us, at all, if the company doesn't own the loaned shares?
I have been saying for years that the Form 4's may not be reflecting actual buys and sells.
In fairness, without having access to the Transfer Journal, I can't prove that these shares are just being transferred between company-controlled accounts. But we'll see soon enough, especially if the company recalls their loaned shares, and completes a stock-for-stock merger agreement without issuing new shares.
I have to admit that I don't see what Baudax brings to the table for Humanigen, with the possible exception of inking a deal with TeraImmune before we could. But what secrets lie beneath the surface is anyone's guess. Is there something enticing about their neuro-musculature blocking agent, or an untapped use for Anjeso?
There's got to be something, not just worth buying 500K shares of Baudax, but worth buying those shares WHEN we did, which was when we had (or still have) financial constraints.
I think the real inducement was TeraImmune.
Are we supposed to be surprised by the 8-K Baudax filed this morning?
More importantly, are Durrant, Dale, and TeraImmune's co-founder, Jay Park, surprised?
These are the steps taken to date.
Jay Park accepts a deal to transfer all equity interest of TeraImmune to Baudax in a stock-for-stock acquisition on June 30th, 2023, the last day of Q2.
https://www.baudaxbio.com/news-and-investors/press-releases/detail/267/baudax-bio-acquires-teraimmune-inc
Black Horse acquires 500,000 shares, a 6.9% equity interest of Baudax, on that same date.
https://www.sec.gov/Archives/edgar/data/1178179/000101359423000580/baudax13ga1-07102023.htm
Baudax files a warning 8-K this morning.
"Management has concluded that substantial doubt exists about our ability to continue as a going concern for the next twelve months."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1780097/000119312523293726/d37178d8k.htm
So are Dale, Durrant, and Jay Park SHOCKED by this 8-K?
My opinion is not worth more than yours. But for what it is worth, I see this last step as just a continuation of our carefully-contrived strategy. I hope that this strategy culminates with more fully leveraging our investment in Baudax, and in announcing that we are accepting a stock-for-stock merger agreement, perhaps with Novavax.
But however it turns out, I don't think any of the players are bemoaning the unexpected loss of their equity or investment dollars in less than two quarters from the time they entered into these deals.
An article just published in 'Live Science' concludes with, "Ultimately, what (Dr.) Abdou and others are doing is reframing the way that we see inflammation; not solely as a flaw to be fixed, but rather an incredible force that can be controlled and harnessed for good."
https://www.yahoo.com/lifestyle/dont-inflammation-then-youll-die-120009520.html
To me, the article illustrates the medical communities' search for an immuno-modulator which can already be found in lenzilumab. This long-delayed regulatory authorization is keeping lenzilumab's Method of Action hidden from the medical community that is searching for what lenz offers.
The article demonstrates why I never want to sell out my position in Humanigen. I think the medical community will continue to discover applications for lenz for years to come.
Your position is understandable. I think each board is allowed to have 5 moderators, so you're not preventing anyone from moderating.
Expert Market, not Equity Market.
Yes, I see that you're pretty involved on the other boards, and I don't think you should remain a moderator on this board, with so little participation. But that's just me. After all, you did provide information for us regarding the Equity Market. The single update has been to the FAQ page of the company's site, that Tank brought to our attention. Although, there may be some news regarding the C-SMART trial that Newtg brought up, but I can't explain the clinicialtrials.gov data I see regarding the completion of that trial. I suspect that it references the total 4 arms of that trial being completed.
I continue to post about stuff I see that may be pertinent to us, most recently about a potential use of lenz as an Antibody Drug Conjugate (ADC). And my previous post about Authorized Shares and restructuring didn't make the cut for posting on Twitter. That happens very rarely, and I respect Humanigen's right to make decisions about which of my posts they want to focus on.
Good to hear from you, DTG! Don't be a stranger.
It may have something to do with the cost, or the requirements, of increasing our Authorized Shares or restructuring. The Secretary of State fees, or other state requirements, in California may be less than in New Jersey or Delaware. But that's just a guess, which I will probably regret making.
But I was inordinately pleasantly surprised to see the update. Thank you for finding that for us. It suggests to me that management hasn't written Humanigen off. I haven't thought that they had, but this was the first sign of company care that we have seen since Q1.
I still don't think there is anything suspect here. The company knows that shareholders are at the limits of our patience. But it is extremely unlikely that any of us are bailing at this point, and as long as we still have our shares, AND if the bid gets run-up in the premarket on news day, I think we will be well-rewarded.
I was hopeful that we would see news on CMML approval from Australia, or maybe even in regards to Novavax's use of lenz in their prototype vaccine, today. But things are not running on my scheme or timeline, LOL!
I see that the New Jersey location was deleted.
There's an interesting post on Stocktwits from MRBBBB concerning SpringWorks Therapeutics' drug "Ogsevio." (SWTX)
https://stocktwits.com/MRBBBB/message/553995577
I thought he had probably just posted on the wrong board. But when I looked into (SWTX), I see that they are partnering with companies to pair Ogsevio with antibody drug conjugates, and they are targeting certain cancer tumors. I know that Humanigen has an interest in pursuing the ADC opportunity, and it certainly looks like lenz could be of benefit.
BillStearn, or anybody on Stocktwits, can you see if MRBBBB can substantiate a connection to Humanigen in this regard? Even if the post was misplaced, it still seems like there is an opportunity potential for lenz.
You're right. This is not an all or nothing presentation of our opportunity.
But I've seen reasons to support those possibilities. I believe they are all real. Whatever we don't announce within the next two days, I hope will be announced as we move back to Nasdaq.
I don't see how we could:
Miss getting the continuation decision by the Data and Safety Monitoring Board in the Acute Graft versus Host Disease trial;
Miss being the drug used in the Novavax prototype covid vaccine, which caused European regulators to request more data, and which may have shut down the NVAX shareholders' lawsuit claiming that there was no effective prototype vaccine. The prototype vaccine had to go through a clinical trial, unlike the updated vaccine, which was approved based on non-clinical trial data;
Miss getting EUL or EUA authorization for covid which, if obtained, will open up our market to the prophylaxis use of lenz as a vaccine adjuvant, in addition to the therapeutic use to treat infected patients;
Miss getting an expedited approval to treat CMML from the Australian government, complete with a possible $100M+ Priority Review Voucher;
Miss executing the recall of our loaned shares, which I think will be the biggest ever seen, and will make millionaires of some of us who already have every share of Humanigen stock we have been able to buy;
Miss a business restructuring that will lead the way back to the Nasdaq, with partners who will be handling our distribution and commercialization as they use lenz to strengthen the safety and efficacy of their own products and platforms, such as CAR-T;
Miss saving the lives of millions of people worldwide, who will only suffer preventable deaths under existing standard of care, especially if a new covid variant begins circulating that it far stronger and transmissible than any previous variant;
Miss preventing trillions of dollars in damage to the worldwide economies and societies.
Thank you for asking. And thank management for their steadfast effort to make this happen.
You could be right, Tank, although I would be very surprised that an auditor would sign-off on a 10-K when we have two delinquent 10-Q's. But, one paragraph in each Q, concerning the Baudax/Tera-Immune transaction initiation, and completion, could have both filings made ready.
https://www.sec.gov/Archives/edgar/data/1178179/000101359423000580/baudax13ga1-07102023.htm
I just don't see how we could miss.
Thank you, Newtg.
I was aware of the distinction your source noted.
But rather than, "Two things going on here," I suspect that there may be three things going on.
Share with your source, please, the clinicaltrials.gov site, regarding the C-SMART trial, referenced in the following post.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173360982
I found this:
https://clinicaltrials.gov/study/NCT04534725?term=NCT04534725&rank=1
I wonder if lenzilumab's enhancement of the Novavax prototype vaccine led to the settlement of the litigation against Novavax in this regard, which read as follows:
Novavax, "...made certain purportedly false and misleading statements concerning the Company’s ability to manufacture prototype vaccine on a commercial scale and to secure the prototype vaccine’s regulatory approval."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465923123481/tm2332186d1_8k.htm
Dr. Daniel Thomas, one of the investigators in our CMML trial, will be moderating our presentation at the ASH Conference on Saturday, discussing the Complete Remission rates those cancer patients achieved with lenz.
"1852 Cytokine and Mutation Profiling Reveal Patterns of Complete Remission Rates with Lenzilumab Combination Therapy in Chronic Myelomonocytic Leukemia."
https://ash.confex.com/ash/2023/webprogram/Paper179706.html
This is in stark contrast to what Gilead achieved using magrolimab.
"Gilead To Discontinue Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS"
https://www.gilead.com/news-and-press/press-room/press-releases/2023/7/gilead-to-discontinue-phase-3-enhance-study-of-magrolimab-plus-azacitidine-in-higher-risk-mds
And of course, since our results were already published in the 'blood' journal, our presentation should be well-received.
https://ashpublications.org/blood/article/142/Supplement%201/1847/505640/Lenzilumab-in-Addition-to-Azacitidine-Improves
In addition, we know that this indication offered certain regulatory incentives. Will our demonstrated success result in an expedited approval or the award of a Priority Review Voucher? If so, will Humanigen announce that news this week, ahead of the conference, and perhaps with the announcement of the recall of our loaned shares?
Also, I see that another of our trial doctors, Dr. Saad Kenderian, who was also very excited about lenzilumab's performance in the LIVE-AIR trial, will also be moderating a separate presentation on Immunotherapies.
https://ash.confex.com/ash/2023/webprogram/Session24628.html
I hope shareholders can begin to see the long-awaited benefit of our faith In Humanigen, and in lenzilumab. It certainly looks promising.
Newtg, I can't help but notice that the link you provided indicates there was an update on Nov 30th, which was the date of your post.
"COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; C-SMART study Arm 4: Effect of Lenzilumab in cancer patients with severe COVID-19 infection.
Up to date
(Last updated: 30/11/2023)"
https://www.anzctr.org.au/TrialSearch.aspx#&&conditionCode=&dateOfRegistrationFrom=&interventionDescription=&interventionCodeOperator=OR&primarySponsorType=&gender=&distance=&postcode=&pageSize=20&ageGroup=&recruitmentCountryOperator=OR&recruitmentRegion=ðicsReview=&countryOfRecruitment=®istry=&searchTxt=Lenzilumab&studyType=&allocationToIntervention=&dateOfRegistrationTo=&recruitmentStatus=&interventionCode=&healthCondition=&healthyVolunteers=&page=1&conditionCategory=&fundingSource=&trialStartDateTo=&trialStartDateFrom=&phase=
But the trial review indicates:
Recruitment status Withdrawn
Reason for early stopping/withdrawal Lack of funding/staff/facilities
Participant recruitment difficulties
However, in checking the NIH National Library of Medicine site, I see the status of the trial is "Completed," and that actual enrollment was 441 participants.
https://clinicaltrials.gov/study/NCT04534725
I've looked at the few other boards I have access to, and don't see anything about this. I assume, therefore, that this info was provided on an "invite only" board.
Wherever it came from, could you share this post there, and see if the posters can provide some guidance in this regard? I can't figure it out. What I see looks contradictory.
Thank you!
The Hydrogenone chart continues to display on our ShortVolumes.com site.
http://shortvolumes.com/?t=HGEN
We do have a London subsidiary.
https://www.humanigen.com/subsidiaries
So is this signifying a connection between the companies? Are we in an ETF with them? Or is this just an uncorrected display?
I think the only Bufferin that could be required would be for Durrant, trying to satisfy parties of interest to this filing.
I think it's a static sight, and there is no data compilation needed, so buffering is not an applicable consideration.
Here's a link to the site.
https://www.sec.gov/cgi-bin/browse-edgar?company=humanigen&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
I've been monitoring this site several times each day, for multiple companies, for many years. I've never seen anything like this before.
As our latest Form 4 continues to disappear and reappear, even this morning, we may need to consider who the beneficiary of these shares may be. Baudax is still a contender. But another possibility may be that Novavax will receive these shares in a stock-for-stock merger agreement.
I say that for two new reasons. First, Novavax announced approval of their standard vaccine in South Korea just days ago.
https://ir.novavax.com/press-releases/Novavaxs-Updated-COVID-19-Vaccine-Receives-Emergency-Use-Authorization-in-the-Republic-of-Korea
And we know that S. Korea conducted a safety trial of Humanigen's lenzilumab some time ago.
https://ir.humanigen.com/English/news/news-details/2021/Humanigens-Partner-in-South-Korea-Receives-Ministry-of-Food-and-Drug-Safety-MFDS-Approval-to-Conduct-Phase-1-Study-of-Lenzilumab/default.aspx
In addition, the WHO's Emergency Use Listing (EUL) approval of the standard Novavax vaccine was based on non-clinical data.
However, in regards to Novavax's prototype vaccine, "In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise." It would likely have been the prototype vaccine that used lenz as an adjuvant.
It would be very exciting to see news in this regard, if my assumption about incorporating lenz in the prototype vaccine is correct.
I can't find the specific post I need to clarify the status of the various trials, but I found something close. I believe the person I contacted was with the IMPACT group, conducting the RATinG study of aGvHD.
"IMPACT is going to do an interim assessment of the first 20 patients who get enrolled in their 18 treatment centers.
"The first stage of the trial is expected to treat 20 participants with lenzilumab before conducting an interim assessment of safety, efficacy, and feasibility."
https://ir.humanigen.com/English/news/news-details/2023/Humanigen-Announces-First-Participant-Dosed-in-RATinG-Trial-of-Lenzilumab-for-Early-Treatment-of-Acute-Graft-Versus-Host-Disease-Following-Allogeneic-Stem-Cell-Transplantation/default.aspx
So it may not take long for the data monitoring committee to collect and review data from 20 patients, from 18 sites, and making a recommendation to a second trial stage. Maybe we'll hear something about that CMML patient who progressed to needing aGvHD to be cured of his cancer."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172695604
So I hope we will hear more from this trial.
"And give that discretionary authority to the pharmaceutical companies to self regulate?"
Um, no. I think Self Regulatory Organizations (SRO's) should also be banned.
I totally agree with you, sosjtb, that, "...regulations exist for a reason..." And they should be enforced. There should be no discretionary authority invested in the offices of unelected bureaucrats to ignore the laws created by the elected legislators. NONE. These agencies should follow the laws, as written, unless the legislators change the law.
“As a seasonal slew of respiratory illnesses circulate, it’s Covid that continues to send the most people to the hospital, the Centers for Disease Control and Prevention said Friday.
Covid is still the primary cause of new respiratory virus hospitalizations and death,” CDC Director Dr. Mandy Cohen said at a briefing for reporters Friday.
The virus is responsible for about 15,000 hospitalizations and 1,000 deaths every week, she said."
https://www.yahoo.com/news/covid-drives-hospitalizations-across-country-120000797.html
How many of these hospitalizations and deaths will lenz and the lenz vaccine cocktail prevent? At the least, this is willful negligence by government regulators to approve lenz. Those who are personally benefitting by maintaining the status quo in regards to authorizations and approvals could be guilty of criminal negligence. This includes, but transcends, the remedy of medical license revocation. These people should be arrested, tried, and sentenced for their corruption.
We have got to rescind discretionary authority from government agencies.
I can see where Fauci should be allowed to practice medicine...at a Mens' Federal Medical Center prison.
For the first time since June, I'm seeing data reported by the 'Short Volumes' website regarding Humanigen's stock. For the last session, they reported, "The short sale volume percent (not short interest) for stock ticker HGEN is 68.45% on Dec 01, 2023. The short sale volume is 60,256. The total volume is 88,027. The short sale volume percent is up 68.29% compare to Nov 30, 2023."
http://shortvolumes.com/?t=HGEN
I don't know if Humanigen is providing 'locates' for these short positions, but being on the Expert Market, I don't know who else would. Is this preparatory for the recall of our loaned shares?
Also, the price chart displays data for Hydrogenome Capital Growth, which trades on the London exchange with the ticker HGEN.L. It should not be displayed on Humanigen's site.
In the event that the displayed data is removed, this is what is currently showing for the past 10 days.
The Volume and short volume are limited. It is not including all volumes from all Market.
Date Short Volume Total Volume Percent
2023-12-01 60,256 88,027 68.45%
2023-11-30 98 61,710 0.16%
2023-11-29 16,738 56,449 29.65%
2023-11-27 10 9,803 0.1%
2023-11-20 170 64,808 0.26%
2023-11-17 42,300 52,728 80.22%
2023-11-16 5,800 42,895 13.52%
2023-11-15 100 19,000 0.53%
2023-11-14 370 34,653 1.07%
2023-11-13 55,924 61,677 90.67%
Posters' opinions can be expected to be right or wrong. But it is definitely not nice for a reporting website to display inaccurate information that needlessly confuses an old man trying to maintain some semblance of his mental faculty. And yes, I resemble that remark.
I just hope the accurate portion of this data display portends the imminent recall of our loaned shares.
Interesting, isn't it, that the FDA cleared Gracell's 'GC012F' CAR-T IND application on Nov 27th, and then the next day, they announced that they were investigating the cancer risks linked to CAR-T therapy?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173299876
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173316333
Humanigen's latest patent, dated in June of this year, was to improve the, "Method of increasing the efficacy of CAR-T immunotherapy using lenzilumab
Patent number: 11673962..."
https://patents.justia.com/assignee/humanigen-inc
Is Gracell realizing the reduced toxicities achieved by using lenz in their CAR-T, as described in our patent? Has this opened the eyes of the FDA to the avoidable adverse consequences of other CAR-T's?
Is there hope that using lenz as a covid vaccine adjuvant, which Humanigen has also patented, is yielding the same success for the prototype Novavax vaccine?
Thanks for sharing this link, Tank. It was great to see this receive journal publication ahead of the ASH conference in regards to the PREACH-M study. Although I admit that I enjoyed Dr. Thomas' interviews far more on this subject. His excitement was contagious!
Newtg's article was in regards to lenzilumab representing the 4th arm of the C-SMART trial, which I think we pulled out of when the Australian government declared an end to the prioritization of covid trials.
I'm eagerly awaiting further updates on the aGvHD trial, after the first person was dosed and, as I recall, showed no continuing signs of CMML cancer.
for future reference:
https://ashpublications.org/blood/article/142/Supplement%201/1847/505640/Lenzilumab-in-Addition-to-Azacitidine-Improves
https://www.anzctr.org.au/TrialSearch.aspx#&&conditionCode=&dateOfRegistrationFrom=&interventionDescription=&interventionCodeOperator=OR&primarySponsorType=&gender=&distance=&postcode=&pageSize=20&ageGroup=&recruitmentCountryOperator=OR&recruitmentRegion=ðicsReview=&countryOfRecruitment=®istry=&searchTxt=Lenzilumab&studyType=&allocationToIntervention=&dateOfRegistrationTo=&recruitmentStatus=&interventionCode=&healthCondition=&healthyVolunteers=&page=1&conditionCategory=&fundingSource=&trialStartDateTo=&trialStartDateFrom=&phase=
"Pfizer is sued by Texas over COVID vaccine claims
Jonathan Stempel...
Updated Thu, November 30, 2023
(Reuters) - Pfizer has been sued by Texas Attorney General Ken Paxton, who on Thursday accused the drugmaker of misrepresenting the efficacy of its widely-used COVID-19 vaccine.
In a complaint filed in a Lubbock County state court, Paxton said it was misleading for Pfizer to claim its vaccine was 95% effective because it offered a "relative risk reduction" for people to who took it.
Paxton said the claim was based on only two months of clinical trial data, and vaccine recipients' "absolute risk reduction" showed that the vaccine was just 0.85% effective.
https://www.yahoo.com/news/pfizer-sued-texas-over-covid-204834093.html
There's a 30 degree temperature range forecasted here (Fort Worth, TX area) tomorrow, not too unusual. And Warren is only about 20 miles from my hometown of Youngstown, which I left after high school to join the Army.
But those temperature patterns have been consistent forever. I don't see any reason for those temperature ranges to all of a sudden be responsible for altering the human immune response system.
The best way to conduct biowarfare is to have your ignorant-ass targeted population further harm themselves with their own medical countermeasures. There's only so much you can alter the immune response system, before it is no longer capable of defending us. There's nothing common about a disease, or the treatments, that alters the immune response system.
I find it very suspicious that this phenomenon isn't being studied on a vaccinated vs unvaccinated basis.