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.
Again, nothing to do with our company. I suggest you dig into Epiq Corporate restructuring, as this apparently is the company being used during chapter 11
Easy come, easy go.
"Moderna has scored $2.48 billion in R&D and supply funding from the U.S. government for its program."
https://www.fiercepharma.com/pharma/after-nearly-1b-research-funding-moderna-takes-1-5b-coronavirus-vaccine-order-from-u-s
"Moderna halts plans to build Kenya vaccine plant as Covid shot demand plunges
PUBLISHED THU, APR 11 2024...
The biotech company said it has not received any vaccine orders for Africa since 2022 and has taken more than $1 billion in losses and write-downs related to the cancellation of previous orders from the continent.
https://www.cnbc.com/2024/04/11/moderna-halts-kenya-vaccine-plant-plans-as-covid-shot-demand-plunges.html
The lack of demand for mRNA covid vaccines in Africa is noteworthy.
"This study shows that the highest number of cases per million population was recorded in Europe, while the trend of new cases is lowest in Africa. The mortality rates in different continents were as follows: North America 4.57%, Europe 3.74%, South America 3.87%, Africa 3.49%, Oceania and Asia less than 2%."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8157209/#:~:text=Results%3A%20This%20study%20shows%20that,cases%20is%20lowest%20in%20Africa.
It's frustrating to me, as a US citizen, to see our tax dollars squandered in support of deadly mRNA vaccine development. It's even more frustrating to me, as a US investor in Humanigen, to see Lenzilumab side-lined from the opportunity of being used as a covid traditional-vaccine-enhancement and therapeutic treatment, despite Lenzilumab's superior safety and efficacy peer-reviewed trial results.
I was glad to hear Dr. Kelly Victory interview Ed Dowd recently. Ed is a former portfolio manager at Blackrock, and I believe they may still maintain a position with Humanigen.
I've come to enjoy reading clinical trial reviews, and following the logic the trial investigators use in writing their findings. But Ed opened a new perspective on the logic he uses to make investment decisions, such as in biotech (continuing with Humanigen)? I like the way in which Ed explained his estimation of excess deaths, which brought a sharp focus on the astounding increase in excess deaths in the younger population. And another thing I really like is that he didn't just focus on covid. He noted the developments in neurological and cancer indications, as well.
I think lenz has tremendous opportunities in preventing and/or treating all three indications. I've been saying that for several years. And I really appreciated hearing a financial guy express his conclusions in this regard.
I know it will be back down tomorrow, but it sure looks nice seeing this up 89,900%
I Can't wait until we achieve these gains for real when it gets re-listed on the OTC.
.01 to Dollars will make an awesome retirement party for me!
Regarding Dr. McCullough's congressional testimony about a lack of recommended covid treatment protocols, we know that in 2021, the NIH did recognize the substantial improvement lenzilumab demonstrated in treating hospitalized covid patients.
""Preliminary data from a double-blind, placebo-controlled randomized trial of lenzilumab did show a significant improvement in the primary endpoint of ventilator-free survival through Day 28 among those who received the GM-CSF inhibitor."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165682015
Since then, and as now, there has been no justification for the US and UK Regulators to negligently permit thousands of preventable deaths every week. Those deaths should be added to the number of "excess deaths" due to the mRNA vaccines, because keeping lenz off the market is only to protect the covid profits from the Pfizer and Moderna mRNA vaccines (and the financial investments in those companies made by the US and German governments).
"Sanofi needs to spin-off their healthcare sector, and we saw the S-8 regarding the Securities to be offered to employees in employee benefit plans filed today."
Other Sanofi news hitting the wire today was in regards to their on-going trial to treat Parkinson's Disease.
"A Type 2 diabetes medication called lixisenatide appeared to slow the progression of Parkinson's disease symptoms in a small, mid-stage trial funded by the French Ministry of Health and others, the New England Journal of Medicine reported on Thursday."
https://www.morningstar.com/news/marketwatch/20240404312/diabetes-medication-appears-to-slow-progress-of-parkinsons-disease-in-french-backed-trial
Loss of motor control completely changes the quality of life for affected patients. I hope lenz may have a role in improving the efficacy of Sanofi's lixisenatide.
If, by some miracle, certain of the conclusions I have drawn develop as I surmised, then the counter-parties to those events need to complete their tasks, in addition to Humanigen doing the same. Baudax needs to complete their CH11, and hopefully sell Tera-Immune to us. Novavax may need to get additional regulatory approval or authorization to use lenz as their prototype vaccine enhancement. Sanofi needs to spin-off their healthcare sector, and we saw the S-8 regarding the Securities to be offered to employees in employee benefit plans filed today.
Humanigen has never been stronger that we are now. And the world will be a better place as we step into our rightful covid and oncology positions.
With all of HGEN/Lenz exposure overseas you would think overseas traders who can still buy shares here would be buying them up. I have seen other EM tickers trading much higher on the EM based on rumors and speculation of a reverse merger.
GVSI with 2.2 billion shares outstanding was trading at .05 based on reverse merger rumors while on the EM.
If there was anything here, overseas investors/traders would be buying…they aren’t. That a big sign we are done IMO.
Doesn’t mean it’s worthless though.., someone in the coming years will probably want the shell…who knows.
I don’t think Durrant is going to go after the hedge funds who shorted since he may need them in the future and that’s just the way the game is played. Hedge funds will always win at the expense of shareholders.
Why isn't management providing any insight then, as to the plan forward? Not a peep, nothing for shareholders.
And no CH7. So the bankruptcy court judge does not agree with your assessment of Humanigen's prospects and future. The company is restructuring, under CH11. Give it a minute.
Sanofi filed an S-8 securities Registration Statement today. I think Sanofi may be our most-tenured shareholder, and that their oncology market could be enhanced by lenzilumab, such as we have seen in CMML. Sanofi previously announced plans to spin-off their healthcare sector, and I am excited about the partnership opportunity this could provide to Humanigen/Taran.
https://www.sec.gov/Archives/edgar/data/1121404/000119312524086673/d803515ds8.htm
The filing notes that, "The information required by Item 1 and Item 2 of Part I of Form S-8 is omitted from this filing..."
The type of information withheld, if I am reading the prospectus instructions correctly, can be found on pages 5-7 in the following link.
https://www.sec.gov/files/forms-8.pdf
You don't seem to grasp it, the company is done, no website, no product.
You're missing the point I was making, which is that worldwide, the majority of the covid vaccines are non-mRNA-based, and I think they represent a large market for our patented method of vaccine enhancement. There is nothing "off-topic" about that, even if some staff of government agencies, such as NIH or USAMRIID, continue to promote mRNA vaccines, which pose increased risk of deadly consequences, not only to this generation, but to the unborn of the next, as well.
Applicant:Humanigen
Owned by: Taran
"What do these companies have to do with HGEN?"
Most vaccine manufacturers don't use mRNA technology, they use traditional methodology, and incorporate an inactive form of the virus, for example. That's what Novavax does, and they are the only non-mRNA vaccine manufacturer authorized in the US.
The majority of the overseas vaccine manufacturers should be candidates to use lenz as an enhancement to their vaccines. We patented the process for this application, as I've shown before.
"METHODS FOR TREATING CORONAVIRUS INFECTION AND RESULTING INFLAMMATION-INDUCED LUNG INJURY
Publication number: 20230109208
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 8, 2021
Publication date: April 6, 2023
Applicant: HUMANIGEN, INC.
Inventors: Cameron DURRANT, Dale CHAPPELL"
https://patents.justia.com/assignee/humanigen-inc
It is not accurate to consider the subject of vaccine enhancement as "off topic." Quite the contrary, vaccine enhancement is THE MAIN OPPORTUNITY I am hoping to see Humanigen capture.
...Come on man, The webpage is gone. The product is gone. Management is gone.
The only argument the antagonists have is always centered around the fact that none of the developments I fully expect to see realized have, as yet, come to pass. Instead, there is, "Not a peep from management."
I haven't seen anything disproven that was in the Top Line Data of the LIVE-AIR trial. Not only were those trial results verified by the Lancet peer-review, they were bolstered by the Thorax peer-review, based upon patient stratification by CRP levels.
I would link, for the 100th time, Humanigen's home page, with access to the Lancet and Thorax peer reviews, but I am now getting an error message trying to do so.
"Looks like this domain isn't
connected to a website yet"
https://www.humanigen.com/
All the tabs associated with the home page are accessible (Other, News, Events, etc).
https://ir.humanigen.com/English/news/default.aspx
I wonder if the Home page is getting a facelift.
What do these companies have to do with HGEN? Was there a PR I missed about a partnership? It's over pack it up. Not a peep from management.
No you don't have to worry about anything. You are 100% wrong and continue to be 100% wrong with no indication that you will be right. Continuing to make the connection between Lenz and Humanigen is incorrect also. There is no connection other than the CEo and a deal that has closed. Continuing to tout something daily where you are proven wrong daily suggests you have questionable credibility
And what? Am I supposed to be worried about that? That's the nature of postulating, based upon the reasoning of what is observed.
People are entirely free to think what they will, or to not think about Humanigen, at all, if that's what they want to do. But to me, it's a big deal to suffer the abuse of discretionary authority, by the very government intended to prevent the abuse of their citizens. By all means, that is true in the financial sense, where the SEC routinely ignores illegality by everyone, except for the alleged violations by the principals of the victimized companies.
But in a profoundly worse sense, as I learned here, agencies such as NIAID, the NIH, and the FDA, intentionally abuse their discretionary authority, with full knowledge of the immoral loss of life that would be prevented, were these agencies to discharge their duties faithfully. And, "...every day that goes by (I am right)," about families suffering the needless loss of a loved one.
Our share structure was designed to counteract the naked shorting of our shares, and to severely punish the perpetrators, even in the absence of fiduciary duty by the SEC. This defensive mechanism will result in the recall of Humanigen's loaned shares, or, it may be effected simply by a merger. Regardless, it should not even be a contingency for which management had to plan, and meticulously execute over a period of years. Our management has fought more battles than we'll ever know about, perhaps like in regards to our venture in Wuhan.
I think pieces are continuing to fall into place, which may include Tera-Immune, Novavax, and Sanofi, plus mergers or partnerships, including those based on the PREACH-M and RATiNG trials. Of course I'd like to know WHEN these developments will occur. But I have no reason to waste my time writing posts about how meaningless these developments will be to Humanigen.
The shares have not been recalled and every day that goes by you are wrong each and every day
What benefit will Taran get from the recall of the loaned shares?
Taran holds the IP rights, and Humanigen is likely holding ~90% of all the shares the company issued, with a float of 192% of the OS.
Let's just see how the reorganization develops. Humanigen is sure to maintain majority control, if necessary.
All this is meaningless because Humanigen doesn't own Lenz anymore
In May of 2021, #DR. PETER MCCULLOUGH, who testified about a lack of covid treatment options in front of both the national, as well as the Texas legisative oversight committees, questioned why there were no defined covid treatment protocols established. He specifically questioned where guidance was offered by The Mayo Clinic.
see the discussion from minute marks 14:30 - 15:30.
https://www.bitchute.com/video/gDXcWb4tgAkj/
I can assure Dr. McCullough that Mayo clinical trial investigators were fully engaged in the effort to bring a safe and effective covid therapeutic to market. Several of their trial investigators, working with Humanigen, led a Phase III trial of Humanigen's Lenzilumab, concluding with tremendous success (HR 1.54).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8635458/
I think that #Dr. John Campbell, an English doctor I greatly admire for his fact-based research and reporting, would be even more impressed with Humanigen's reporting of outcomes based on CRP levels, which Humanigen established as a biomarker. Those results were peer-reviewed by Thorax, as shown on page 5.
"Effect of CRP<150 mg/L on SWOV and secondary endpoints in
LIVE-AIR
In participants with baseline CRP <150 mg/L, lenzilumab
improved the likelihood of SWOV compared with placebo
(HR: 2.54; 95% CI 1.46 to 4.41; nominal p=0.0009;"
https://thorax.bmj.com/content/thoraxjnl/early/2022/07/05/thoraxjnl-2022-218744.full.pdf
Humanigen's home page reflects this information, as well as the peer-review by Lancet.
https://www.humanigen.com/
Additional review established Hazard Ratios of between 3.0 - 3.4.
It has been my belief that the FDA's refusal to authorize lenzilumab (lenz) amounted to willful negligence, if not criminal negligence. Mr. Andrew Bridgen, MP, went even further. I ask #Texas Attorney General Ken Paxton to consider Mr. Bridgen's letter to Scotland yard in this regard. Texas Medicaid funds should not be used for mRNA vaccines that are resulting in more excess deaths in one year, than the number of soldiers killed in all American wars combined.
https://twitter.com/ABridgen/status/1765069935603306651/photo/1
So the shares survived the chapter 11? They were not wiped out?
After July 1, 2024 when the chapter 11 is complete, HGENQ is just a 'shell company' and it doesn't own any LENZ patent, no employees, no assets other than 'promissory note', and still some liabilities which may still be payable, why would hgenq pay any creditor. the company has no business operations. HGENQ is essentially a shell company or derivative, or option with an expiry date. it has no business and no customers after july 1 2024 The least the legal defense can do is the shell company has ZERO liabilities. but it can still have liabilities. A shell company with liabilities as pointless as the creditor can never get any money from a shell. you cannot even sue a shell company.
After July 1, 2024 when the chapter 11 is complete, HGENQ is not just a 'shell company' it doesn't own any LENZ patent, no employees, no assets other than 'promissory note', and still some liabilities which may still be payable, why would hgenq pay any creditor. the company has no business operations. HGENQ is essentially a shell company or derivative, or option with an expiry date. it has no business and no customers after july 1 2024
LOL 4 million of them went to me when they should have gone to him. The day we got the Q assignment it opened the stock up to be purchased in which I got 4 million shares at .00027. After that day in December he has been here under many different allisias telling us to sell this doomed stock. I got 1 million shares up for sale at .40 cents if he wants them? 😂
You may have heard about potential safety concerns with 1st generation #CAR-T therapies. While new regulatory considerations unfold, there are already exciting biotech developments underway to present alternatives. #LNP #mRNA can be used as the transformative drug substance to equip cells with new chimeric antigen receptors! The pace of novel cancer treatment is not slowing down.
Researchers from the Fraunhofer Institute for Cell Therapy and Immunology recently partnered with scientists from Precision NanoSystems Inc. to publish this fascinating paper: "Lipid Nanoparticles Outperform Electroporation in mRNA-based CAR T Cell Engineering."
In this work, they showed that:
1) LNPs outperform electroporation in delivering CAR-mRNA to T cells
2) LNPs result in less cytotoxicity and slower T cell proliferation, enhancing the safety profile of CAR T.
3) the functionality of LNP-engineered CAR T cells is comparable to those modified through viral vectors, but with reduced T cell exhaustion.
4) LNPs offer a scalable and cost-effective alternative for CAR T cell engineering, presenting a promising avenue for safer and more efficient cancer treatments.
📓 Check out the article: https://lnkd.in/eiW6pHuE
In case you missed it: a March issue of American Society of Gene & Cell Therapy's Molecular Therapy journal featured a model of an LNP in recognition of this team's recent publication and breakthrough work.
Reni Kitte, Martin Rabel, Reka Geczy, Stella Park, Stephan Fricke, Ulrike Köhl, Sandy Tretbar
You have a 10 million short position. Wow that is indeed a good news . If there is a turnaround .. agreed there is a very small chance . But if it does, we know what’s going to happen . That explains your posts .
So now you want to throw $1k at “worthless shares”? Why would you waste that money on something worth nothing?
wanted 10,000,000 shares hgenq
bid: .000001
reply here if you have it.
Only ' market' orders gaurantees a fill are filled for sell orders
Bid is .000001 Ask: .25
if anyone has 10 million shares for sale you can post here. you get like $1000 for better than nothing. Bid of .000001 which is $10 as the last price sold was .000001
There remains the indication for which lenzilumab was intended, and in which it has demonstrated tremendous promise. And I hope that lenz will be very successful in treating cancers, such as CMML.
But there remains two realities. First is, that the world has no safe and effective covid preventative. And secondly, there is no variant-agnostic therapeutic for covid, let alone one that could imbue an appropriate immune response against future infections.
The fact that excess deaths are attributed to mRNA vaccines, WHICH ARE STILL BEING ADMINISTERED AND ENCOURAGED, is another reason that the Novavax vaccine, in it's best form, has to be brought to market, with it's lenz enhancement. In less than a year, excess deaths from mRNA vaccines have cost more lives than all the soldiers lost in all the battles, combined, in the US.
And we are welcoming illegal immigrants by the tens of thousands, even though their countrymen have already been discovered operating biotechs on our soil, designed to spread covid and a variety of lethal diseases across our land.
The tracks on which the train has left don't just run one way. And at the least, we need to be prepared for when the train returns.
As for LENZI, it's a hemo drug. and was developed even before corvid, it is to treat the symptoms of corvid not a vaccine. it's like one drug as multiple uses. The weight loss drug was a actually a drug to treat medical condition but the side effect also reduced weight loss.
it's not in the news. but virus is now just a flu
Corvid now a severe flu that is manageable and not in the media as much. it's now a contained infection or manageable infection. 4000 /day hospitlazations just in the US alone on average on march 9 2024. As for vaccines, unsure if people who work in the medical field still wearing mask and getting vacccines.
Nvax is down around 5 year lows with an approved product, covid is over. You don't even hear about boosters anymore, the train has left
I think management is working on the application of their lenz/vaccine/anti-viral patented process. Novavax is the only US-based covid vaccine manufacturer with a traditional vaccine, which I think would be compatible for use with lenz as an enhancement.
If Humanigen has about $4M worth of lenz in-process of being manufactured, that might be enough for a re-formulated version of lenz to be administered either orally or subcutaneously, along with millions, even tens of millions, of Nuvaxovid vaccines.
I can only tell you what I think management may be working on. This is it, in large part.
Awesome, any update from our company? What's management working on to get us out of bankruptcy?
Novavax issues a second set of stock options in two weeks.
https://www.sec.gov/cgi-bin/browse-edgar?company=novavax&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
On March 11th, Novavax issued the following Press Release (which I didn't see highlighted by the FDA's site).
https://ir.novavax.com/press-releases/Canada-National-Advisory-Committee-Publishes-Recommendation-for-Use-of-Novavaxs-Nuvaxovid-TM-XBB-1-5-COVID-19-Vaccine
https://newsfilter.io/
The gov't regulated media has unwritten code saying they cannot bash or say the vaccine is bad or get sued by the gov't or state for 'misinformation'. that is the reason. You had doctors get fired for telling people not to get vaccinated as they think it was 'unnecessary' it's unncessary for most people if they have a healthy immune system and can create that anti-dotes without a vaccine just like flu vaccine but corvid is different that the is very selective virus and for some people the effect is severe like peanut allergy for some 5-10% people, corvid is very bad and can cause death without a vaccine and symptoms are not the same for everyone. some people have no symptoms and just get sniffle while some lose their taste while other don't. not everyone reacts to this virus have same symptoms or side effects like children under 12 had no symptoms while the elderly over 70 had much bad side effects i
Regarding "Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)."
"Early reports from studies with patients with long COVID suggests a constellation of symptoms with similarities to another chronic medical illness-myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). A review study comparing and contrasting ME/CFS with reported symptoms of long COVID may yield mutualistic insight into the characterization and management of both conditions."
https://pubmed.ncbi.nlm.nih.gov/33925784/
I listened to an interview of Dr. Pierre Kory, who discussed Long Covid (which he says is mainly Long Vax), and says that what we're calling Long Covid is the same, or about the same, as ME/CSF, and he mentioned that Epstein-Barr was another similar indication. And I got to thinking about lenzilumab being considered for this, at one point. But more specifically, I wondered HOW lenz may be effective in treatment of this indication. Despite the similarities of Long Covid to mono, how would lenz improve CFS in patients with HLA from mono?
But he also said something of more importance to Humanigen and the shareholders. As we noted in real time, both Lancet and Thorax took exceptionally long times to complete the publications of their peer reviews, even though the results of both were stellar. Dr. Kori also noted issues regarding the medical journals, and went so far as to state his opinion that this is now where the degradation of the medical field starts. Further, he went on to say that RFK, Jr., said that he would summon the chief editors of the medical journals into his office, if elected, and file RICO charges against them, if they didn't restore integrity to their publications.
So, I think this could be further evidence of management's conviction, and lenzilumab's safety and efficacy, if Dr. Kori is right. Management may have had to fight to get fair and honest assessments of lenzilumab's performance. Something caused the extremely lengthy review times, and lenz is a profit killer for Pfizer and Moderna.
I had earlier reported an interview of Steve Kirsch, whose study revealed that autism is totally caused by vaccines, and has been, for years.
What these doctors are saying is important.
However, Tucker conducted both interviews. I think it's irrelevant to the information being conveyed by the doctors. But in this post, I included an NIH corroborative study to help focus on the subject.
The $3 million dollar SEC settlement for people who bought the shares between May 16 2020 to july 13 2022 doesn't make sense either
https://11thestate.com/cases/humanigen-investor-settlement
most bought the shares between on average price was $2 so a measily .047/share for if they sold their shares. they get peanuts of 10,000 shares is only $470 - 235 legal fee--that is only $235 and some get even less. and for people with less than $100, they won't even waste time filing the claim. to get $80/ these mutli million settlements may be hit to companies but for the individually ,its peanuts. like facebook violating privacy with 50 million dollar settlemetns but each person get only $35 waste of time for an individual to spend 3 hours filling form et to get $35 2 million people wasting time to get $35 each
Starstone seeking releif and actually paid $5 million management insurance policy and now full paid out. Supposedly, the $3 million is in some Law firms escrow account. Likely they deny all claims from shareholders who send in the claims as there is no way to confirm who bought it. and how gets first . it's like 100 people want 20 million in claims but only 1.5 million after legal fees. Now how they confirm who and how it gets paid is another question. so $2 million has been advance to humanigen and maybe that is where Taran go the 2 million to bid for the assets. I don't see any $2 million payment from starstone in humanigen balance sheets. Either way Humanigen doesn't look like there is any insurance payment, no revenues. and case closing soon. For 2 million in legal fees, humanigen shareholders didn't even get bone. Why bother with chapter 11 and spend $2 million in legal fees. Only reason was to close the case clean. and walk fee. No person would spend this kind of money in legal fees over 1 million to declare bankruptycy sold assets for free and still owe money.
Taran paid only paid net $1,265,831 for all the assets cash, liquid receivables with it's $2 million dollar bid as the assets had a asset value of 736,470. HGEN reported the sale as 'revenue' when it is not really revenue. but capital loss. it's asset were sold like 99% loss. HGEN can claim 100 million in capital loss . Investors valued the assets at over 100 million when ipo so technically a loss if FDA didn't approve their patent. But for some reason the CFO won't report the over 100 million as capital loss. As shell company with over 100 million capital loss it can be sold just tax purpose but management seems to have another agenda. The assets of hgen was valued at over 100 million when it ipo in nasdaq. now the assets are worth 0 that is capital loss of 100 million.
Followers
|
326
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
43436
|
Created
|
01/31/13
|
Type
|
Free
|
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/
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |