cowtown jay
4 days ago
Lenz is best-in-class for CMML and covid prevention and treatment, clinically proven safe and effective. Maybe we'll still see lenz hit the market as the biggest new blockbuster drug ever. Merging/partnering with Novavax, and then a joint merger with Sanofi, will give us all the firepower we need to realize that tremendous opportunity.
That comment is partially based in fact. Whether the entire statement will prove to be reality remains to be seen. If I was in management, I would partner with Novavax and enter a joint merger with Sanofi. Lenz is the ideal candidate for Sanofi's product pipeline. Sanofi is the 6th biggest pharmaceutical company in the world. We previously saw that Normandy and France, where Sanofi is based, has regulatory authorities that may be receptive to lenz. That makes Sanofi a very big fish in a relatively small pond of regulatory water. I think management has us well-positioned for this opportunity. And since lenz was born in Australia, their Therapeutic Goods Administration might like to crown a home-based therapeutic for myeloid-driven cancers.
If it turns out that we partner with different companies, so be it. That does not diminish the facts, and that's what's important.
https://www.proclinical.com/blogs/2024-7/who-are-the-top-10-pharma-companies-in-the-world-2024#:~:text=1.,being%20the%20launch%20of%20Arexvy.
cowtown jay
4 days ago
Seriously, dlog, instead of being so flippant and dismissive, you ought to prepare yourself to accept the increasingly apparent reality that lenz has the major role in enhancing the Novavax covid vaccine, above and beyond the efficacy of their saponin adjuvant.
I think we are much closer to Regulatory APPROVAL, and market dominance in both the covid and cancer markets, than people realize.
I'm wondering if the part of the District Court case that may remain sealed for now, is because of state and federal criminal investigations into related matters, such as the abuse of discretionary authority by government agencies, and collusion with their Big Pharma sponsors.
cowtown jay
6 days ago
In addition to the FDA granting themselves the ability to Decline to make a regulatory decision on our EUA application, there were a couple of other roadblocks they put up to protect the covid market for their Big Pharma sponsors. For instance, we had submitted our initial EUA application with the then-required 28 day follow-up of clinical data. But that concerned me to the extent that I contacted IR to point out that the FDA had just changed that requirement for companies that had a Phase III trial, like Humanigen had. For us, the FDA was now requiring 60 days worth of clinical data. I think IR got a little perturbed by my handful of emails in a very short time frame, and it was in response to one of those emails that IR called me when they did. Another FDA roadblock that we had to contend with was just the length of time the FDA was taking to approve or deny our EUA. I seem to recall it was something like 147 days before they Declined to make a decision. I was concerned with the financial constraints this delay had caused on our ability to maintain our CMC requirements. Reserving manufacturing space is expensive. IR confirmed that if the Decline was made earlier, we would not have reserved the additional manufacturing capacity that we had.
In terms of the value the ACTIV-5 trial brought to confirming the LIVE-AIR trial results, I knew that contribution would be minimal, at best. I said several times that the ACTIV-5 trial was nothing more than the "commandeering" of the excellent LIVE-AIR trial results. The FDA's exclusion of early-stage patients on room air in hospital ordinal scale 4, 60% of the LIVE-AIR patients, negatively skewed our chance of a successful ACTIV-5 outcome. The FDA's inclusion of late-stage patients in hospital ordinal scales 6 and 7 (8 is death), doomed any chance of a successful trial outcome.
Our only chance of any confirmation of the LIVE-AIR trial would have been if management was permitted to segregate the data from the patients in ordinal scale 5 of the ACTIV-5 trial. That would be the only confirmation that management could hope for from the designed-to-fail ACTIV-5 trial. I have not seen that data reported separately, and I have to assume that management was not permitted to report that stand-alone data.
It was morally reprehensible to design the ACTIV-5 trial to fail, and to cause tens of millions (and counting) preventable deaths.
cowtown jay
1 week ago
If you're looking for specific references to lenzilumab, look no further than the PREACH-M and the RATinG trials.
"June 9, 2023) - Humanigen, Inc. (Nasdaq: HGEN) today extended previously reported results by presenting additional, statistically significant hematologic improvements and reductions in inflammatory markers from lenzilumab, its investigational drug, in a Phase 2/3 trial of treatment-naïve participants with chronic myelomonocytic leukemia and RAS-pathway mutations."
https://www.newsfilecorp.com/release/169164
"August 7, 2023) - Humanigen, Inc. (OTC Pink: HGEN), a clinical-stage biopharmaceutical company, today announced successful dosing of the first participant in the RATinG trial of lenzilumab for the early treatment of acute Graft versus Host Disease (aGvHD), conducted by IMPACT, a world-class accelerated clinical trial network delivering innovative research for stem cell transplant patients in major centers in the UK.
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#:~:text=The%20RATinG%20trial%2C%20a%20Phase,stem%20cell%20transplant%20(HSCT)
These are advanced trials, very promising, from outside of the FDA/NIH purview.
cowtown jay
1 week ago
"NIH clinical trial will test precision medicine treatments for myeloid cancers
Researchers will seek to accelerate the discovery of more tailored treatments for these aggressive cancers of the blood and bone marrow."
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-will-test-precision-medicine-treatments-myeloid-cancers
Humanigen's PREACH-M trial has focused on myeloid-driven cancer, such as CMML.
"Humanigen, Inc. (Nasdaq: HGEN) today extended previously reported results by presenting additional, statistically significant hematologic improvements and reductions in inflammatory markers from lenzilumab, its investigational drug, in a Phase 2/3 trial of treatment-naïve participants with chronic myelomonocytic leukemia and RAS-pathway mutations."
It looks to me that Humanigen focused on earlier stages of disease progression, as well as later stages, for those RATinG trial patients who may develop aGvHD from subsequent bone marrow transplants.
https://www.newsfilecorp.com/release/169164
I have been anxiously awaiting regulatory approval of lenzilumab to treat CMML, awarded by Australia's Therapeutic Goods Administration. This is a real chance to cross the finish line first, and potentially inform researchers in related areas of study.
cowtown jay
2 weeks ago
I hadn't heard that, but it's interesting.
I would expect that Dale would ignore any such advice from investors. Why would they even suggest that? What business is it of theirs?
Unless...unlike me, there are investors who KNOW that Black Horse was merely the nominee for shares beneficially owned by the company, which I have merely concluded to be the case. So did Sanofi, possibly our oldest shareholder, suggest bailing out, and then capitalizing on the share price reduction, by buying an increased number of shares?
It's just total speculation, based on your comment.
cowtown jay
2 weeks ago
You might recall that the overwhelming number, practically all, of the shares in the Black Horse entities were HGEN shares. However, I've seen no evidence that Dale was the beneficial owner of enough shares to be recognized as the largest shareholder. I seem to recall seeing that 12% of the Black Horse shares were held by non-affiliated entities. I suspect that the majority of those shares are beneficially owned by the company, to be used in the course of business, such as to conduct a merger, assuming that the SEC was ordered to release a freeze of those shares, if one was in place.
cowtown jay
2 weeks ago
"For some reason, SC&H updated their notice..." It would make sense to me if this was in regards to Taran's assumption of the >$500K "sunk cost" of our CMC and inventory expense, in exchange for the covid and device patent rights. Patent rights haven't been assigned to Taran yet, and they may not be. A move as I described could make us debt free, and just represent the enactment of our merger, yielding shares to us under our new ticker, which could bring us out CH11, and put us back on the OTC until we regain Nasdaq compliance.
cowtown jay
2 weeks ago
I'm looking to Sanofi, and to the governments of France and Normandy, to spearhead our forward progress in terms of getting lenz into the market for the prevention of covid.
"Sanofi keeps Novavax afloat with $1.2B bet on its vaccine platform
By Kevin Dunleavy May 10, 2024"
https://www.fiercepharma.com/pharma/sanofi-keeps-novavax-afloat-12b-bet-its-vaccine-platform
I think the PREACH-M and the companion RATinG trials will lead to regulatory approval from the Therapeutic Goods Administration in Australia for the treatment of CMML, and the prevention of aGvHD.
With so much of the world's population having exposure to covid, I think we have the opportunity to treat covid infections much earlier in the disease progression, before patients exceed 41mg/L of CRP.
shajandr
2 weeks ago
Matrix-M is a vaccine adjuvant, a substance that is added to various vaccines to stimulate the immune response.[1][2][3] It was patented in 2020 by Novavax[4] and is composed of nanoparticles from saponins extracted from Quillaja saponaria (soapbark) trees, cholesterol, and phospholipids.[5][6][7] It is an immune stimulating complex (ISCOM), which are nanospheres formed when saponin is mixed with two types of fats.[8]
https://en.wikipedia.org/wiki/Matrix-M#cite_note-8
Nott anything to do with the failed lenz crap, dude. Nuffin. And nuffin about any lenz-crap in the IND or any of the FDA filings. Only place is in your head, dude. It is called a "fever dream" or delusion.
cowtown jay
2 weeks ago
"The COVID-19 IND for Novavax’s COVID-19 vaccine is not impacted by the clinical hold."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924108950/tm2426249d1_8k.htm
GAITHERSBURG, Md., October 16, 2024 – Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax’s Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside of the U.S. who received the vaccine in January 2023. The trial completed in July 2023 and the participant reported the SAE in September 2024.
cowtown jay
3 weeks ago
I think the FDA may be somewhat out of the loop in terms of the material value of any information they provided to the District and the Appeals courts.
For some reason, SC&H updated their notice that they advised Humanigen regarding their sale to Taran on September 25, 2024.
https://www.schgroup.com/press-release/scamph-capital-advises-humanigen-in-sale-to-taran-therapeutics/
This was the day before the publication date regarding Humanigen's covid and lenz/covid vaccine update on September 26,2024.
https://patents.justia.com/assignee/humanigen-inc
Featured on Taran's website is a link to an Executive Summary written by Pacific Royalties. They note that, "Only disciplined application of monoclonal antibody therapies has kept these (covid-related death) numbers from being much larger.
When — not if — a new outbreak occurs, Taran will be among the first with the experience and resources to begin addressing that need quickly." It should be noted that Taran does not have the covid patent rights...yet.
http://www.pacificroyalties.com/resources/taran-therapeutics/
The disciplined application of which monoclonal antibody saved lives that would otherwise be lost? It's obvious that they are referencing lenz.
But lenz isn't authorized to treat mild to moderate covid.
https://www.cms.gov/monoclonal
It would have to be administered by the "disciplined application" of an IND authorization, which lenz has.
https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx
And I believe Novavax has used the patented lenz/vaccine cocktail under this IND authorization to keep the covid and covid-related deaths from being much higher. I hope the data accumulated under the Novavax IND use of lenz has justified regulatory authorization or approval of lenz from one of the Regulatory bodies worldwide recognized by the bankruptcy court judge to meet a Milestone Event.
cowtown jay
3 weeks ago
It was four years ago today that my wife died. I believe that lenz could have saved her, if the medical community was aware of the safety and efficacy of lenz, and of what it is is capable of doing.
Today, we are closer than we have ever been to regulatory Authorization and Approvals. I still contend that the key ingredient to our success will be necessity. I have tried, somewhat unsuccessfully on this platform, to present various publications detailing the Serious Adverse Events associated with the mRNA vaccines. For those interested in this subject, there is a compilation of the worldwide SAE research on the Youtube site of Dr. John Campbell.
I believe that Novavax and Sanofi are aware of the 10's of millions of lives that can be saved by utilizing their lenz-enhanced protein-based covid and Covid Influenza Combination vaccines. I eagerly await imminent news from the private sector to capitalize on this unmet need, and to stop the unnecessary loss of life, obscured and ignored by Regulators.
shajandr
3 weeks ago
CONgratulations! You no longer own any shares as the corporation has been liquidated and dissolved (Humanigen no longer exists) and all shares were cancelled.
So, Jay has STEVE MNUNCHIN working on getting the former shareholders of 15,000 of the now-GONE shares shares in the similarly-defunct SPNGQ at an imaginary share ratio of 100-to-1, meaning HGENQ former shareholders will gett 100 imaginary shares of non-existent corporation SPNGQ for every imaginary share of non-existent corporation HGENQ.
What this would mean, if it were to occur, is that your $1,800 loss on 15,000 shares of HGENQ would transform into an $1,800 loss on 1,500,000 shares of SPNGQ. It sounds much better to tell friends, family, and yourself that you lost $1,800 on 1.5 million shares than losing the same amount on a paltry 15,000 shares.
PLUS, Jay has an entirely unwarranted belief, contrary to facts and reason, that STEVE MOSKOWITZ will finally finish the SPNGQ 10-K from 2009 and STEVE MNUNCHIN will CONvince the SEC to cease the endless "flyspecking" of the imaginary 10-K, so that these old, cancelled shares in long-defunct SPNGQ (also liquidated in bankruptcy many years ago in Judge Berstein's US Bankruptcy Court) will be relisted as imaginary shares and soon comprise part of the QQQ (NASDAQ 100) as faked sales of soap-infused sponges become the hottest pennyscam theme since the marijuana craze. As a kicker, SPNGQ will also announce it is going into the pergola-building business as a new, additional line of business, as well as selling facades for manufactured homes to make the drab, boxy houses look like the Alamo from the street. Soonly, STEVE MOSKOWITZ would announce during one of his live interviews on CNBC that STEVE MNUNCHIN has accepted the yobb of Chairman of the Bored at the revived SPNGQ and will also be the head of the soon new-to-be AI self-driving electric vehicle division of Spongetech as it rolls~OUTT its first self-driving electric wheelchair and skateboards.
My friend, the news is GOOD. The future of the non-existent shares in defunct and evaporated Humanigen is extremely bright. It is likely, indeed virtually certain, that say 15,000 imaginary shares of HGENQ will be worth many million$ of USD quite soon. PLUS, shareholders will also be entitled to a free lifetime supply of soap-infused sponges in addition to million$ in dividend income annually. Shareholders will also be eligible for deep discounts on pergolas and Alamo facades.
My advice to you, as your new financial advisor, is to hold on to the imaginary shares of non-existent Humanigen and become rich thereby. This is the same path taken by the former SPNGQ bagholders who never sold. Besides, what other option do you have? Just relax and enjoy the life of luxury that comes with the incredible wealth of having imaginary shares in a non-existent company - the upside is UNLIMITED. To Da Moon!!!
This is how the pennystock markets work and how pennyvestors build wealth by buying pennystocks. It is your good fortune to hold the imaginary shares in HGENQ/SPNGQ. The image in the mirror is what it looks like to be fabulously rich! Enjoy!
cowtown jay
3 weeks ago
It's been suggested that my promoting of lenz as a covid therapeutic, and as a covid vaccine enhancement, is "unhealthy" for me, and for readers of my posts, despite the failed effort to guide me, "...toward reason and clarity..."
Let's take a look at the demonstrated health benefit of lenz. The Lancet peer review reported the following.
"... approximately 60% of LIVE-AIR patients were on room air or low-flow oxygen support for which the use of tocilizumab or baricitinib is not recommended. In this context, LIVE-AIR raises the possibility that lenzilumab might be positioned for use before ICU admission and progression of respiratory failure requiring high-flow oxygen and non-invasive or invasive ventilation.
In summary, LIVE-AIR showed that lenzilumab treatment of hospitalised patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile similar to that of placebo."
See the conclusion of the Discussion
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext
The Thorax peer review provided additional data on lenz patients stratified by CRP levels.
WHAT THIS STUDY ADDS
? In LIVE-AIR, elevated baseline plasma CRP was
the most predictive feature for progression
to invasive mechanical ventilation or death
(OR, 0.15; 95% CI 0.07 to 0.29; nominal
p<0.001). Participants with baseline CRP <150
mg/L represented 78% of the LIVE-AIR study
population and demonstrated the greatest
improvement in SWOV with lenzilumab,
through day 28 (HR: 2.54; 95% CI 1.46 to 4.41;
p=0.0009).
https://thorax.bmj.com/content/thoraxjnl/78/6/606.full.pdf
I hope that Humanigen's updated covid patent was Published just ahead of an announcement from Novavax that lenz successfully enhanced their covid vaccine, which Sanofi will also use in their Covid Influenza Combination vaccine. "On May 10, 2024, as part of its commitment to developing a diverse portfolio of best-in-class vaccines, Sanofi announced that it had entered into a co-exclusive licensing agreement with Novavax, a biotechnology company headquartered in Maryland, US. The terms of the agreement include (i) a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea, where Novavax has existing partnership agreements); (ii) a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and (iii) a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi took a minority (<5%) equity investment in Novavax."
First Half Overview
https://www.sec.gov/Archives/edgar/data/1121404/000112140424000016/exhibit992-2024halfyearman.htm
The alternative covid vaccines in the US are mRNA based, and available for use in infants as young as SIX MONTHS OLD. The following video is a discussion of a recent publication titled 'Changing Views toward mRNA based Covid Vaccines in the Scientific Literature: 2020 - 2024,' which appeared in the Polish Annals of Medicine. If you have an interest health-based 'reason and clarity,' you might want to pay attention to the alternative to a lenz-enhanced Novavax covid vaccine.
(or search Youtube, Dr. John Campbell, 'Changing Views toward mRNA based Covid Vaccines in the Scientific Literature: 2020 - 2024')
In addition, legal effort by the SEC that helped to stop lenz from getting into the market, should have required a higher standard than they themselves recognized.
"The SEC emphasized that there was “a lower bar here than a traditional preliminary injunction” because all that needed to be shown was “an inference ... that there was a violation of the securities law."
see the embedded filing, pg 16/49
https://law.justia.com/cases/federal/appellate-courts/ca3/23-2776/23-2776-2024-07-09.html
Tens of millions of lives have been lost by keeping lenz off the market, and forcing patients to use the mRNA vaccines. That loss continues. The SEC has allowed themselves, likely willingly (since they may have their own vested interests), to be manipulated by the FDA.
This is a travesty of truth and justice on a worldwide proportion.
,
cowtown jay
4 weeks ago
I'm glad that Dale may have filed a motion to expedite the hearing, if he did. 'Time' has always been an important factor to me, when it comes to realizing our success. I want to more than just restore a sense of normalcy to my life. I want to experience abundance beyond that which I have ever achieved. And I'd like to do that before my birth certificate expires.
A motion to expedite is basically a "shit or get off the pot" demand. The Temporary Restraining Order should never have advanced to a preliminary injunction. The standard the SEC used to obtain the preliminary injunction essentially gives the SEC carte blanche to do as they will. Who is safe from malicious prosecution when this is the standard:
"During the hearing, the Court repeated that, for there to be injunctive relief, “the SEC must show either a likelihood of success on the merits or that an inference can be drawn that a party has violated the federal securities laws.” (J.A. at 18.) The SEC emphasized that there was “a lower bar here than a traditional preliminary injunction” because all that needed to be shown was “an inference ... that there was a violation of the securities law[.]” (J.A. at 20.) After hearing the parties’ arguments, the Court found that “the SEC has certainly met that there’s a likelihood of success” that Chappell violated the insider trading laws “and if not[,] at minimum they have showed an inference that can be drawn” that he violated them.
see the embedded filing, pg 16/49
https://law.justia.com/cases/federal/appellate-courts/ca3/23-2776/23-2776-2024-07-09.html
The only "significant concern" the FDA had about the LIVE-AIR clinical trial was the threat it represented to Pfizer, BioNTech, and Moderna, and to government entities and scientists who rely on Big Pharma largesse in the form of providing operating funds and royalties to them, and to the global health organizations who want to control the word's population, and shackle medical care professionals.
Sweet Jesus, the NIH, NIAID, etc., pretended that the LIVE-AIR trial, led by Mayo Clinic, didn't even exist. The statistical significance of lenzilumab's efficacy was astounding! A demonstrated Hazard Ratio as high as 8.2 in early stage disease progression.
"Exploratory analysis for the effect of lenzilumab on SWOV was conducted by the CRP baseline quartile. Response to lenzilumab was observed in the first through third quartiles of baseline CRP with the greatest lenzilumab treatment effect observed in the first quartile (CRP
cowtown jay
4 weeks ago
I have a basis for believing that there is a lenz-enhanced covid vaccine. The most recent patent Publication Date for a lenz/vaccine cocktail is dated about 1 1/2 months ago.
"METHODS FOR TREATING CORONAVIRUS INFECTION AND RESULTING INFLAMMATION-INDUCED LUNG INJURY
Publication number: 20240317846
Abstract: The present invention provides methods for treating a subject infected with 2019 coronavirus (SARS-CoV-2) comprising administering to the subject a therapeutically effective amount of a GM-CSF antagonist or a therapeutically effective amount of a GM-CSF antagonist and a second drug, including an anti-viral agent, an anti-SARS-CoV-2 vaccine, and serum containing human polyclonal antibodies to SARS-CoV-2.
Type: Application
Filed: March 4, 2022
Publication date: September 26, 2024
Applicant: HUMANIGEN, INC.
Inventors: Cameron DURRANT, Dale CHAPPELL"
https://patents.justia.com/assignee/humanigen-inc
cowtown jay
4 weeks ago
"Novavax would like to clarify that while it has anticipated the COVID-19 vaccination market in the U.S. will be similar to last year, it has neither updated nor reaffirmed its full year 2024 financial guidance issued on August 8, 2024."
A covid vaccine update is likely to be dependent on Sanofi.
"On May 10, 2024, as part of its commitment to developing a diverse portfolio of best-in-class vaccines, Sanofi announced that it had entered into a co-exclusive licensing agreement with Novavax, a biotechnology company headquartered in Maryland, US. The terms of the agreement include (i) a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea, where Novavax has existing partnership agreements); (ii) a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and (iii) a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi took a minority (