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I think we HAVE TO SEE the (lenz-enhanced?) Novavax vaccine fully FDA approved this week, with the understanding that Novavax will provide additional clinical trial data in accordance with their postmarketing commitment (PMC) requested by the FDA. The reason I say this is because the current batch of the vaccine evidently expires at the end of this month. It is currently being used some by Long Covid patients. And with Jay Bhattacharya now appointed as Director of the NIH, I don't think there is any way in hell he is going to want to see the CDC recommend alternative products to Novavax's protein-based vaccine.
"I just hope that the next step the CDC recommends will lead to abolishing the administration of Genetically Modified Organisms, especially to infants and toddlers."
Thank God for Bobby's consideration in this regard.
"RFK Jr. eyes reversing CDC's Covid-19 vaccine recommendation for children
Adam Cancryn
Tue, April 22, 2025
HHS Secretary Robert F. Kennedy Jr. is weighing pulling the Covid-19 vaccine from the government’s list of recommended immunizations for children, two people familiar with the discussions told POLITICO.
The directive under consideration would remove the Covid shot from the childhood vaccine schedule maintained by the Centers for Disease Control and Prevention and widely used by physicians to guide vaccine distribution, marking Kennedy’s most significant move yet to shake up the nation’s vaccination practices."
https://www.yahoo.com/news/trump-administration-may-pull-covid-200234356.html
One of our prospective partners, Novavax, released the following notice today.
"Item 7.01. Regulation FD Disclosure.
On April 23, 2025, Novavax, Inc. (the “Company”) issued the following statement:
We believe that our Biologics License Application (“BLA”) is approvable based on conversations with U.S. Food and Drug Administration (“FDA”), as of our Prescription Drug User Fee Act date on April 1 and through today.
We have recently received formal communication from the FDA in the form of an information request for a post marketing commitment (“PMC”) to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465925037728/tm2512925d1_8k.htm
I think the only way Bobby can comply with the decision of the Advisory Committee on Immunization Practices (ACIP), is to dismiss all of the current Committee members, and appoint his own ACIP staff, if there is any reason to even have this Committee. The harm this Committee has done is practically unfathomable. In fact, I can't believe they have applied any acceptable scientific methodology to their conclusions. The current members can be found here.
https://www.cdc.gov/acip/membership/index.html
I think the current ACIP members should be stripped of their licenses and accreditations. They should also be investigated for willful or criminal negligence. It seems highly unlikely that they could have gotten everything so wrong, if it wasn't agenda-driven.
And if Bobby is going to dismiss a lenz-enhanced vaccine candidate, without looking at the clinical trial data because of a pre-conceived notion that targeting a single antigen will not work for a viral infection, then he is no different than the FDA staff that Declined to review our EUA request, which should have been approved in September 2021.
Meanwhile, lenz-preventable-deaths just go on and on. Excess deaths for certain indications continue running at 80% above pre-pandemic levels. And we have no effective medical countermeasures in the event of certain biowarfare attacks that lenz could help prevent and to treat.
We never lost them as they are still in our accounts. The problem is getting them trading again and most likely that A.I. is correct on it's assumption. I doubt they are going to give any legacy shareholders any of the pie.
"Thenatsy
@Mansour1797593
Hi Mr jay hope y r doing well,I read on ihub that there was a bla.whats BLA?? R we going to have our shares back to trading? Tnx"
A BLA is a Biologics License Application submitted to the FDA for approval of a new product. Here's a good AI-generated explanation.
"AI Overview
A Biologics License Application (BLA) is a formal submission to the U.S. Food and Drug Administration (FDA) to request approval for marketing a biological product. This application, which is part of the FDA's Biologics License Applications (BLA) Process (CBER), is a comprehensive dossier that includes information about the product, its manufacturing process, and clinical trial data.
Here's a more detailed explanation:
Purpose:
The BLA is used to obtain approval for the commercial distribution of a biological product, such as vaccines, gene therapies, monoclonal antibodies, and other complex products derived from living organisms.
Content:
A BLA typically includes detailed information about the product's formulation, manufacturing process, non-clinical studies (preclinical research), clinical trial data, safety profiles, and labeling.
Evaluation:
The FDA's Center for Biologics Evaluation and Research (CBER) reviews the BLA to ensure the biological product meets the FDA's standards for safety, efficacy, and quality.
Approval:
If the FDA approves the BLA, the manufacturer is granted the license to produce and market the product for its approved uses, according to the Food and Drug Administration (.gov).
In essence, a BLA is a crucial step in the process of bringing a biological product to the market in the United States, ensuring that it meets the FDA's rigorous requirements for safety, effectiveness, and quality."
The FDA also has a site if you need more information.
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber
I'm doing okay, and thank you for asking. However, I hope we're both doing great after our BLA approval.
I suspect that Humanigen, Inc., consolidated operations into Humanigen Australia, and became a part of Taran in a stock merger. I also think there are 110M shares in our market that Humanigen did not issue. If a stock merger was concluded, those loaned or naked shorted shares will be forced to cover.
That's my opinion. The verifiable facts are that Humanigen, Inc., went out of business, and their shares were dissolved.
However, I think my assessment if fairly accurate. I can't see how Judge Shannon would have just given our assets to Taran without an equity provision for existing shareholders.
AI
Why this probably won’t help old HGENQ holders directly
In Humanigen’s Chapter 11, the court-approved plan extinguished common shares and sold the core assets (like Lenzilumab) to Taran Therapeutics. So even if Taran (or somebody else) later pursues any of the above paths, they’d be issuing new shares in a new corporate vehicle. Old HGENQ tickets, as they stood, don’t automatically morph back into something tradable on NASDAQ.
I really hope I'm wrong. I wish we could somehow get our shares back.
Thanks for the information, Guys.
Humanigen's still listed under the ticker HGENQ, but the stock’s basically canceled, right?
And it looks like Humanigen Australia is also owned by Taran.
Even if they submitted a BLA and got it approved, is there any scenario where our shares come back to life?
Interesting, Jay. Thanks for your latest thoughts and observations.
What does this mean? Is there some really happening here? Please 🙏 let something positive happen for us shareholders!
Due to the favorable activity in the bankruptcy court case, geared toward resumed investor communications, the submission of requisite securities filings, the engagement of Goldman Sachs, the apparent restructuring of Humanigen Australia into Taran Therapeutics, these are all signs indicating funds have been received associated with the likely full regulatory approval of Lenzilumab to treat CMML, from overseas regulatory agencies.
Add to the CMML progress, the FAST TRACK designations for the Novavax and Sanofi covid and covid/influenza vaccines, with the imminent FDA decision on the Novavax BLA, we could easily be seeing positive market-moving news on both sides of the ponds.
Humanigen has a BLA submission in? I didn't know that . I take back all the negative comments . This is great
I don't know much about some of the subject matter you brought up. I just hope that the next step the CDC recommends will lead to abolishing the administration of Genetically Modified Organisms, especially to infants and toddlers. Currently Authorized or Approved covid vaccines in the US are:
"Specifically, FDA has authorized the following for emergency use:
Moderna COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) for individuals 12 years of age and older
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age
The following COVID-19 vaccines are approved by FDA:
Comirnaty (2024-2025 Formula)
Spikevax (2024-2025 Formula)"
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines-2024-2025
Preliminary data was just released on the SHIELD-Utah study. It showed, "...Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine."
https://ir.novavax.com/press-releases/2025-04-15-SHIELD-Utah-Study-Shows-Novavaxs-COVID-19-Vaccine-Induces-Lower-Reactogenicity-Symptoms-Compared-to-mRNA
I'm hoping that Humanigen Australia, acquired by Taran Therapeutics, will significantly build upon those findings in the BLA submission for Lenzilumab, detailing the comparative quality of life benefits revealed by successfully meeting the primary endpoint of Survival Without Ventilation (SWOV). I'm expecting significant reductions in covid reinfection rates, Severe Adverse Events (SAE's), and in excess deaths.
http://www.pacificroyalties.com/resources/taran-therapeutics/
Interesting jay. The saddest thing is we have a billionaire more interested in genetically modified mosquitoes handling our health care. Its deranged and pedophelic behavior but I don't have the cash to fight it.Lenzilumab would work on any kind of inflammation, not only Covid pneumonia.dont sell it short. Just can't catch a break though lenz will end up in dust bin , too hard to make and expensive. Catabolic steroids will suffice for the plebes
"I’ve always felt that something was amiss."
I’ve always felt that something was amiss. Either substantial fraud by the HGEN people or malfeasance by those controlling the Covid narrative.
— MDS (@mds582) April 17, 2025
I stumbled onto your posts several months ago and I support your positivity.
MDS, I borrowed the "sock puppet" term from RFK, Jr., who used it to describe certain FDA employees. "RFK Jr. says Deep State ‘is real,’ called FDA employees ‘sock puppet’ of industry."
https://www.politico.com/news/2025/04/11/rfk-jr-hhs-fda-deep-state-00286826
As you likely know, the FDA Declined to review our EUA application, based on Humanigen's LIVE-AIR trial. I'm hoping for full regulatory approval of a BLA.
Looking for LenziluFAB 1, Sock Puppets 0. 👍️ Humanigen management.
"US CDC advisers begin review of vaccine guidelines after months-long delay
Mariam Sunny and Sneha S K
Updated Tue, April 15, 2025 ...
(Reuters) -The U.S. Centers for Disease Control and Prevention's outside expert panel began a two-day meeting on Tuesday after a nearly two-month delay and expects to review guidelines for several vaccines including recommendations for the next generation of COVID-19 shots...
Following discussions, the panel will vote on Wednesday about usage recommendations for several vaccines...
Louisiana Republican Bill Cassidy, a U.S. senator and physician from Louisiana, said Kennedy had promised to honor decisions by the CDC's ACIP without changes.
It will also discuss updated COVID shots and whether to narrow recommendations on who should receive them for the 2025-2026 season to a smaller group of people.
The agency currently recommends that individuals aged six months and older should be given an updated COVID-19 vaccine, regardless of previous inoculations for the disease."
https://www.yahoo.com/news/us-cdc-advisers-review-vaccine-100318364.html
Watching carefully.
I bought the 4 million shares as a complete lotto and I was completley surprised I was able to get the shares for the trips the day they assigned the Q to it.
If this works out that would be awesome, but I am just as doubtful as you are about this ever seeing the light of day again. I mean during the bankruptcy case the courts cancelled the shares. With that said they are still listed in my Brokerage account. So, until they disappear, and Jay remains positive who knows what can happen here even though I remain skeptical?
I do enjoy Jays unwavering Faith in this, and for his sake and my sake I am rooting for him and hoping a miracle can happen here and he ends up being right about everything.
If Humanigen does take this symbol back and registers it once again everyone still holding this is going to make some incredible gains.
If that happens, I will not destroy the stock and will put up very small lots if I am given the opportunity to sell this again.
I'm Hoping for the best but expecting the worst.
Have a Great Weekend!!!
There's plenty of contractors, like Tim Morris was, that can serve as functionaries at the Chief level, if needed, which I doubt. I'm vastly under qualified at anything beyond the mid-management level, and unqualified at any level now that I have no energy for much of anything.
My objective isn't really to give anybody hope. I'm just sharing the opinions I derive from the circumstances I observe. The LIVE-AIR trial investigators presented the evidence clearly in their discussion and data presentation, as noted in my pinned post, "The definitive evidence for Regulatory Approval of Lenzilumab."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175678449
That evidence, along with the Lancet and Thorax peer reviews, is why shareholders should be hopeful for a just outcome, especially since the trial design of the ACTIV-5 trial was clearly shown to have been designed to fail.
I have not heard an utterance of lenzilumab since the bankruptcy unfortunately. Novavax has never mentioned the name either .
I can understand trying to give hope to a guy with 4 mm shares but geez...
Meanwhile the principal players are trying to avoid prison and will most likely in the least be enjoined from being associated with public companies in the future Maybe you can run the ship jay
You wouldn't necessarily see what testing is being done, nor how effective the product is, if it is being used under IND authorization, which is the case. But count me in that group that would like to see evidence that supports my conclusion, which I think is reasonable, and not a wild stretch of imagination.
A patent is one thing. There is zero evidence they ever have more than a patent. No testing or published research, nothing... your suggestion the drug is included in a BLA is a wild stretch of imagination ..you are entitled to your own opinion though
Why else would Humanigen have developed and patented a covid vaccine enhancement, which I don't think would even work for an mRNA vaccine, leaving the Novavax vaccine as the sole beneficiary for lenz?
"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
Interesting take .. I don't believe lenzilumab has anything to do with that vaccine . What makes you believe it does?
Is lenz just too good to be true?
"April 10, 2025
As we have previously stated, we believe that our Biologics License Application (BLA) for our COVID-19 vaccine included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We have not yet received an official response from the U.S. Food and Drug Administration regarding the status of our BLA."
https://ir.novavax.com/press-releases/Update-on-Status-of-Novavaxs-COVID-19-Vaccine-BLA
"When asked if the delay resulted from "personnel being shuffled" at the FDA, Kennedy attributed it to the vaccine's composition. He said Novavax's single antigen approach "has never worked" for respiratory illnesses."
https://www.reuters.com/sustainability/boards-policy-regulation/novavax-shares-tumble-after-us-health-secretary-raises-concerns-over-covid-shots-2025-04-10/
This is only going to showcase Lenzilumab's method of action, which makes it variant-agnostic. Add to that the quality of life improvement demonstrated by LIVE-AIR'S Survival Without Ventilation (SWOV) primary endpoint, which should show significantly reduced Serious Adverse Events, we have the biggest stage imaginable to spotlight Lenzilumab's true safety and efficacy. It's showtime, and the stage is ours.
It was pure luck getting this position unless it gets cancelled LOL. They day they added the Q to the ticker it allowed for buying even though it was on the expert market. I seen volume going back and forth on the trips and placed a bid and landed 4 million shares at .0003. Then immediately afterwards a basher has showed up here for weeks telling us we needed to sell our shares before they would get locked away in our brokerage firm. LOL I knew this was an interception that they weren't expecting and were pissed off about. I will never let go of these shares unless it gets deleted or becomes trading again.
I am sure it will be much higher if it ever is allowed to trade again.
Not for nothing but when an individual investor holds about 4% of a company and another about 10%, you can pretty much bet that it's over
It's obvious to me that management convinced Judge Shannon to unlock our potential by leveraging our success with CMML by placing the key in Taran's hands. The amended Asset Purchase Agreement was crucial. This allowed AFS and our prospective partners to position us to capture the covid market+. I remain convinced that this is the strategy and our pathway to success.
If we get re-listed this will be the turnround story of a lifetime! One we can tell our Grandchildren about! If it happens we could be looking at Generational Wealth!
I pray that you are right about all of this JAY!!!
I am still holding my 4 million shares, and I sure would hate to see them get cancelled.
From Copilot on your question:
It seems like Taran Therapeutics acquired all rights to lenzilumab during Humanigen's Chapter 11 bankruptcy proceedings2. This means that even if Humanigen (HGEN) gets relisted, the company would not automatically regain rights to lenzilumab unless some new agreement or legal action occurs.
As for the shares, relisting could potentially breathe some life into the stock, but the absence of lenzilumab as a key asset might limit its growth prospects. Investors would likely focus on what new strategies or assets Humanigen could bring to the table post-relisting.
Do you think Humanigen has other avenues to explore, or is lenzilumab the heart of the matter for you?
Thanks for your post.
I’m seriously just curious about this.
Taran took all the rights to lenzilumab, so even if HGEN gets relisted, what’s the point?
Honestly, if HGEN does get relisted, do you think our shares would come back to life and there’d be a chance for us to get the rights to lenzilumab back?
Chat Co Pilot:
What would Taran Therapeutics have to do in order to get HGEN relisted again?
For Taran Therapeutics to relist Humanigen (HGEN) on a major stock exchange, several requirements would need to be met:
Financial Stability: The company must demonstrate strong financial health, including meeting minimum net income or shareholder equity thresholds.
Stock Price: The share price must exceed the exchange's minimum requirement, often around $1 for Nasdaq or NYSE.
Compliance: Filing accurate and timely financial reports is essential to meet regulatory standards.
Corporate Governance: The company must adhere to governance requirements, such as having independent directors and an adequate audit committee.
Market Capitalization: The total value of publicly issued shares must meet the exchange's minimum valuation criteria.
Relisting is a complex process and requires significant effort to rebuild investor confidence and meet all regulatory and financial benchmarks2. Would you like to explore more about relisting processes or similar companies?
Unfinished business includes what GS will be doing for us. Will they underwrite our next (and first) issuance? Will Geoff Winkler/AFS be able to work with the liquidating trustee so that he can finish up before his July deadline? I really hope so. Will we first need to ally with Taran before partnering with Novavax, and entering into a joint merger with Sanofi? Are all such alliances predicated upon regulatory authorization from the US, UK, French, or Australian regulatory agencies? I turned 70 last month, and as multi-year strategies progress to quarterly timeframes, it is still difficult to remain patient. I want to see this come to fruition, and have time to establish my affairs and more fully enjoy my remaining time.
External turbulence will subside, and we'll be stronger. I went through two corporate restructurings, and can empathize with the horrific consequences this is causing so many people. The difference is that two medical companies I was working for were highly successful, and got bought out. That is not the case for what I see happening now.
It's BLA time. I want to see some regulatory approvals!
Let me know if any good news happens, Jay. My loss/forfeit was NOT modest, and like you, I know it is totally due to FDA malfeasance. So any good news would be appreciated. All the distractions of bankruptcy and Dale's SEC issues tries to make light of the real criminality.
What is amazing to me is how Durant was able to snatch up in bankruptcy a drug worth billions (in your mind )for 2 mm bucks. The deal of the century.This RFK is not doing much other than cost cutting so far . He is more interested in yellow#5 than anything like lenzilumab
The only dollar shortage I'm focused on is my own, and it is not because Dale and Durrant caused forfeit of my modest investment. Just the opposite effect will be realized by their effort on our behalf, and I anticipate financial abundance as the result. Government corruption and Big Pharma corporate greed are the culprits depriving me of a lifestyle that will surpass any level that I have achieved to this point. I know the value of my investment, and will strive to be prudent in capturing that value to the best of my ability. I look forward to re-entering my $200 sell orders for about half of my shares when permitted to do so. I hope not to oversell below that price, and I look forward to maintaining a position here above the $200 price level, as well.
Unfortunately humanihen was a day late and dollar short with the "pipeline "Durant and dale carnegie are going to be in a clink soon for theft
“Despite spending $1.9 trillion in annual costs, Americans are getting sicker every year. In the past four years alone, the agency’s budget has grown by 38% — yet outcomes continue to decline,” he continued, emphasizing the need to “shift course.”
https://www.breitbart.com/politics/2025/04/03/report-rfk-jr-fires-faucis-wife-christine-grady-from-nih-bioethics-department/
Bravo, Bobby! And yet, there is more efficiency gain.
HHS "Departmental agencies, including the Food and Drug Administration, Centers for Disease Control and Prevention and National Institutes of Health are slated to cut 3,500, 2,400, and 1,200 employees, respectively.
Ultimately, the current 82,000 full-time employees will be reduced to 62,000, according to last week's announcement."
https://www.usatoday.com/story/news/politics/2025/04/03/rfk-hhs-staff-cuts-mistake/82801001007/
The bottom line is that, for a host of indications, including those that will improve as Humanigen's product pipeline rolls out, excess deaths are running ~80% higher than they were trending prior to the pandemic. Certain HHS agencies and personnel abet this preventable loss of life for their Big Pharma sponsors, and I hope this is just the beginning of the process to enforce accountability and fairness, and to Make America Healthy Again.
In my opinion, we were both operating under license of the IND authorization of lenzilumab, with stated intentions of obtaining regulatory approval of our BLA's, and with successful Phase III trials.
I question whether our first regulatory approval will come from our LIVE-AIR trial to treat covid, or from our partnership with Novavax, or from our partnerships with the South Australian Health and Medical Research Institute (SAHMRI), or from the IMPACT stem cell transplant centers across the United Kingdom. I expect that the PREACH-M and RATinG trials will show truly stellar results in the treatment, and perhaps in the prevention, of CMML and/or GvHD.
https://ir.humanigen.com/English/news/news-details/2023/Humanigen---Lenzilumab-Being-Studied-as-a-Potential-First-Treatment-in-Thirty-Years-with-a-Novel-Mechanism-of-Action-for-Chronic-Myelomonocytic-Leukemia-CMML-an-Orphan-Form-of-Leukemia/default.aspx
https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Clinical-Trial-Collaboration-to-Evaluate-Lenzilumab-in-Acute-Graft-Versus-Host-Disease/default.aspx
That's great wish it had anything to do with our former company
One of our prospective partners, Novavax, released an Item 7.01 8-K regarding their PDUFA date for an FDA decision on a BLA. It reads, in part, as follows:
"Novavax can confirm that April 1, 2025, was the U.S. Food and Drug Administration (“FDA”)’s Prescription Drug User Fee Act date for our Biologics License Application (“BLA”) seeking the approval of our COVID-19 Vaccine. As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval. As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA. "
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465925031099/tm2511339d1_8k.htm
This slight delay is hitting NVAX stock price.
An approval of a BLA will rock the market, and I think an FDA approval is an inescapable conclusion.
I'm looking forward to Geoff Winkler and the AFS team's, "...communication with investors;" to include the producing of the, "...quarterly
report and requisite filings."
Now that April is finally here, I'm also looking forward to beginning to see BLA's approved for Humanigen's lenzilumab to treat various indications.
Thanks for taking the time to look that up, homie
So did Dale Chappell finally get snatched from his cushy Swiss prison and thrown into Max security New Jersey prison getting trains ran or what?
Who am I that your patrons seem so interested in disparaging me? I don't blame you for doing it, since it appears you make the same false claim every time you change your nickname. It's just a sorry way to make money.
The government of the SEC has given them the license to steal.
Its essentially a government regulated fraud operation.
You have to pay gov't fee to steal like those ripoff short fees and paying interest in shorted money. pay to steal and rip off investors?
Corporate embezzlement
1. management sells assets for 10% of what it's worth to third party entities and gets paid buy buyer
2. management buy assets for 1000% what it's 'fair' market value' is and gets kickbacks
3. fund manager invest in worhtless equities, and gets kickbacks from investment dealer.
all these cases are 'very hard' to prosecute by SEC or FBI if nobody whistle blows or complains to the cops.
like a rape case, if the victim doesn't file charges or report it. there is no case
crime co operation. nobody knows about it like the 1 billion in alledged 'stolen' bitcoins. they say they didn't know who hacked into the exchange and 'stole the bitcoins...cops and FBI don't care if the corportion or the bank don't report the 'crimes' of stolen company assets.
there is no case of bank or exchange don't report the crime' since it's a insider job.
they even go to news to talk about, you actually believe they don't know who stole 1 billion in bitcoins? and that easy steal bitcoins.?
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Moderators cowtown jay |
Humanigen, Inc. is a clinical-stage biopharmaceutical company developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, GM-CSF neutralization and gene-knockout platforms. As a leader in GM-CSF pathway science, we believe that we have the ability to transform CAR-T therapy and a broad range of other T-cell engaging therapies, including both autologous and allogeneic cell transplantation. There is a direct correlation between the efficacy of CAR-T therapy and the incidence of life-threatening toxicities (referred to as the efficacy/toxicity linkage). We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. Clinical correlative analysis and pre-clinical in vivo evidence points to GM-CSF as the key initiator of the inflammatory cascade resulting in CAR-T therapy’s side-effects. Pre-clinical in vivo data on the neutralization of GM-CSF using antibody or gene KO indicates that it is not required for CAR-T cell activity. Our strategy is to continue to pioneer the use of GM-CSF neutralization and GM-CSF gene knockout technologies to improve efficacy and prevent or significantly reduce the serious side-effects associated with CAR-T therapy.
We believe that our GM-CSF pathway science, assets and expertise create two technology platforms to usher in next-generation CAR-T therapies. Lenzilumab, our proprietary Humaneered® anti-GM-CSF immunotherapy, has the potential to be used in combination with any FDA-approved or development stage CAR-T therapy, as well as in combination with other cell therapies such as HSCT, to make these treatments safer and more effective. In addition, our GM-CSF knockout gene-editing platform has the potential to create next-generation CAR-T therapies that may inherently avoid any efficacy/toxicity linkage, thereby potentially preserving the benefits of the CAR-T therapy while altogether avoiding its serious and potentially life-threatening side-effects.
The company’s immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, was recently announced to evaluate the use of lenzilumab with Yescarta®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. The company is also developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, T cell engaging, and immunotherapy treatments to break the efficacy/toxicity linkage including the prevention and/or treatment graft-versus-host disease (GvHD) in patients undergoing allogeneic HSCT. The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline.
June 15, 2020
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia
https://clinicaltrials.gov/ct2/show/NCT04351152
Anti-GM-CSF antibodies expected to show better effect in Covid-19 than cytokine-specific targets
July 27, 2020
https://discoverysedge.mayo.edu/2021/06/22/cancer-to-covid-19/
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