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"Michael North
Co-Founder, CEO; Chairman of Galaxy Magnesium
1mo
I have agreed to serve Taran Therapeutics as Strategy Advisor. Taran is a leader in the field of monocolonal antibody therapies, and I provide communications with prospective investors and key stakeholders. I work directly with the chief executives of the company, Cameron Durrant and Michael Schuster, helping to formulate its mission, vision, and long-term investment strategy. This is especially meaningful to me, because of my long commitment to the life sciences, specifically to making fundamental therapies that penetrate to root causes widely available."
https://www.linkedin.com/posts/michaelnorth_i-have-agreed-to-serve-taran-therapeutics-activity-7183247229166534657-j50L
Michael W Schuster, MD
Hematology Oncology, Hematology
https://doctors.stonybrookmedicine.edu/provider/Michael+W+Schuster/2250408
Schuster seems to have had a role in the following Pfizer clinical trial
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
https://clinicaltrials.gov/study/NCT04842604?intr=NCT02367456.&rank=1
"T cells, cancer and immunity"
I've only listened to the first half, so far, of this latest video posted by Dr. John Campbell, in which he and Professors Angus Dalgleish and Robert Clancy are discussing 'T cells, cancer and immunity.'
You'll have to check Youtube for Dr. Campbell's video for "T cells, cancer and immunity." I can't get the link to work.
To me, listening to the three of these gentlemen is the next best thing to listening to an investor presentation from Dale or Durrant. Without knowing it, I think John, Gus, and Robert are actually talking about the Methods Of Action for Humanigen's Lenzilumab and Ifab. At the least, I always feel that I develop a better understanding of the role I anticipate that our products will play, as we gain regulatory approval and authorization, and gain CMC and commercialization from partners such as Sanofi and Novavax.
Its a great price.
Does anyone have any idea as to why almost 458,000 shares of Humanigen traded today ? The stock is valued at .000 and change - so what's the point ?? Thanks for any illumination you can provide.
"The "significant expansion" of Milestone Events, beyond those regarding the partner-sponsored clinical trials for CMML, aGvHD, and CAR-T, could come from Sanofi and/or Novavax."
Today, Shah Capital filed an Amended 13D for their Novavax holdings.
"Item 4. Purpose of Transaction.
Item 4 is hereby amended to add the following:
On May 20, 2024, the Reporting Persons announced that in light of recent developments at the Issuer, they have determined to withdraw their preliminary proxy statement and campaign against the re-election of the Class II directors at the Issuer’s upcoming annual meeting. The Reporting Persons have long advocated for the Issuer to explore potential strategic partnership opportunities and believe that the Issuer’s recent announcement of its entry into a co-exclusive licensing agreement with Sanofi is a long-awaited step in the right direction."
https://www.sec.gov/Archives/edgar/data/1000694/000119380524000687/e663637_sc13da-novavax.htm
Sanofi, one of Humanigen's oldest shareholders (going back to Kalobios) has announced their intention to spin-off their healthcare division, and they and Novavax have acquired co-exclusive licenses to...use lenz as a vaccine enhancement? I believe so.
There are several developments I was hoping Humanigen would have expanded upon last week, because they all point to the likelihood of our success. And even more than news regarding regulatory approval, which would qualify as a Milestone Event, I especially anticipate the recall* of the company's loaned shares, with that news.
Particularly interesting is the filing of The Official Committee of Unsecured Creditors of Humanigen, Inc. Initial estimates were that this group could receive from
about $172K - $8.5M.
"The Creditors’ Committee initially objected to
the sale to Taran (the “Sale”) but ultimately reached a settlement with the Debtor and Taran
pursuant to which certain terms of the Sale and the APA were amended as described on the record
at the hearing before the Bankruptcy Court on February 14, 2024. The settlement amended the
APA to, among other things, significantly expand the events that will trigger the contingent
“Milestone Payments” and increase the amount of those payments under the APA."
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
Achieving a Milestone Event, in and of itself, would enable Humanigen to pay the full $44.1M owed to the Unsecured Creditors, and open the door to the restoration of financial reward for shareholders.
*Shareholder value will be greatly enhanced by Humanigen's recall of the loaned shares. I had news of a different type of recall myself, from my auto manufacturer. But, my out-of-pocket expense is going to be several thousands of dollars to repair my car. Not the type of recall I was hoping for.
The "significant expansion" of Milestone Events, beyond those regarding the partner-sponsored clinical trials for CMML, aGvHD, and CAR-T, could come from Sanofi and/or Novavax. Novavax filed the following in this regard.
"Item 1.01 Entry into a Material Definitive Agreement.
Collaboration and License Agreement
On May 10, 2024, Novavax, Inc. (the “Company”) entered into a collaboration and license agreement (the “Collaboration and License Agreement”) with Sanofi Pasteur Inc. (“Sanofi”) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Company’s current standalone COVID-19 vaccine products, including the Company’s NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (“COVID Mono Products”),
ii) A sole license to develop and commercialize combination products containing a potential combination of the Company’s COVID-19 vaccine and Sanofi’s seasonal influenza vaccine (“COVID and influenza Combination Products” or “CIC Products”),
iii) A non-exclusive license to develop and commercialize combination products containing both the Company’s COVID-19 vaccine and one or more non-influenza vaccines (“Other Combination Products” and together with the COVID Mono Products, CIC Products, and Other Combination Products (“Licensed COVID-19 Products”), and
iv) A non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include the Company’s Matrix-MTM adjuvant (as described below, the “Adjuvant Products”).
Under the Collaboration and License Agreement, the Company will receive a non-refundable upfront payment of $500 million. In addition, the Company will also be eligible to receive development, tech transfer, launch, and sales milestone payments totaling up to $700 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products. In addition, the Company is eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four Adjuvant Products and $210 million for each Adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924060444/tm2414089d1_8k.htm
It's a shame, Chaplain. We just keep seeing new effects of the damage caused by the virus, AND, caused by the medical countermeasures to the virus, as seen in this young lady's case.
Better HEALTH, a whole lot more WEALTH, and no more STEALTH.
Thanks, Chaplain. I'm pretty sure that management submitted lenz for consideration in treating long covid. I hope lenz will be authorized for it. It's not just for the pain and the chronic fatigue, I'm concerned plaque will become more inflamed, and further lead to restricted blood flow and more clotting, especially with a long stent in my left leg. Lenz has shown how it makes therapeutics more effective, and I think it will likewise lead to improving a variety of indications.
"This biological decrease in energy is specific to those with PEM and not seen in other chronic illnesses."
I have to disagree. In addition to Long Covid, I think this post-exertional malaise (PEM) is also caused by mitochondrial issues associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). I was hoping that lenz would have demonstrated success in treating Long Covid, and that it would help me with ME/CSF. I'm still hopeful.
https://www.newsbreak.com/news/3336545657202-long-covid-can-destroy-your-ability-to-exercise-or-do-simple-tasks-now-we-may-know-why?_f=app_share&s=i16&pd=0EVqRbCy&lang=en_US&send_time=1715800027&trans_data=%7B%22platform%22%3A0%2C%22cv%22%3A%2224.19.0.27%22%2C%22languages%22%3A%22en%22%7D
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392668/
https://share.newsbreak.com/6wpl3vck LONG COVID EFFECTS
Chances are that I misinterpreted the meaning of the 'Covid Mono vaccine,' and that mono, in this sense, means monovalent.
"On May 10, 2024, Novavax, Inc. (the “Company”) entered into a collaboration and license agreement (the “Collaboration and License Agreement”) with Sanofi Pasteur Inc. (“Sanofi”) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Company’s current standalone COVID-19 vaccine products, including the Company’s NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (“COVID Mono Products”)..."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924060444/tm2414089d1_8k.htm
But the term "co-exclusive license" poses the question, who is the licensor? I think Taran will be revealed as the licensor.
I received the proxy material this morning from my broker, even though it is assumed that I would vote against the Combined Plan and the Disclosure Statement. The hearing has been set for June 13th, 2024.
The Hearing will not interfere with Taran's licensing the use of the patented vaccine enhancement, using lenz, to Novavax and Sanofi.
Nor will the Hearing derail progress in the various on-going clinical trials for CMML, aGvHD, and Mayo Clinic's CAR-T. In fact, success in these trials will cause a sharp increase in price for shares of Humanigen, (or the merged entity with Taran), and will result in the company's recall of their loaned shares.
"No new CMML medications with novel mechanisms of action have been approved in over 30 years..."
LENZI is not the only drug that can cure a particulare health or disease.
lots of drugs treat these types very rare CMML stuff which no profit it's very expensive and only insurance would pay for the drugs.
as for corvid, these blood cancers drug reduce inflammation but so do a lot of other drugs. the FDA application was not for treading corvid or anti-viral health treatments.
and in theology you need live blood to reanimate the dead to live again in horror movies. blood itself is some magical liquid. and drug itself
blood has all the nutrients that keeps an animal or person healthy. your blood conatins t-cells that fight bacteria and viruses and the problem occurs when you blood is deficient in blood cells that fight the bacteria or virus. so you drink blood from healthy animals or humans that contain the cells that you are dificient. it makes sense. why it work.
Drinking blood of animals or humans have known to cure or relieve many blood diseases. So if Lenzi works it not a surprise.
http://hauntedohiobooks.com/news/blood-drinking-and-entrail-baths-slaughterhouse-cures/
FAITH IN THE BLOOD CURE
The blood is drank [sic] principally for consumption and debility and for diseases and complaints of a kindred nature. But there have been some cases of almost miraculous cures, it is stated, particularly among children, of scrofulous diseases and diseases of the bones.
a lot of people would not have died if they didn't take the astra zeneca vaccine or taken the mRNA vaccines.
althought it's only .005% resulted in death..in percentage its very small
but in actual numbers in pop. 300,000,000 * .005= 1.5 million people died percentage it is very miniscule and concetrated on particular groups..athletes or people with certain allergies to this vaccines. mRNA like suddent deaths either these athletes are taking certain protein supplement etc
there 3 reason a drug is not FDA approved
1. the drug doesn't work..not efficacy
2. the side effect is death like the mRNA vaccines not worth risk, the risk of the drug is worse than the disease itself
3. Not enough data or patients sampling over a 5 year time period not enough data
As for as I know. there is no cure for leukemia or many blood cancers and lenzi doesn't work which why it was no approved for this application. in fact no company has a drug that can cure leukemia.
The Lenzi molecule was originally clinically trialed for a rare blood cancer and problem is it was no effective and doesn't cure blood cancer? less than. 0001% of the pop have this type of rare blood disorder like the drug disorder Count Dracula has. Viral inflammation is much more higher with corvid infection but was not part of the original FDA application approval or clinical trials The use of LENZI was the side effect or reducing inflammation by viral infections. it's anti-viral drug not anti-cancer drug.
Either the company use new trials to show the molecule is effective in reducing inflammation for viral infection or not enough data to prove it is effective in reducing viral infection deaths.
Either way if the drug does work and the public is not given the opportunity to use the drug, than that would be another issue of the FDA. but the lenzi drug like many drugs need 5-10 years of clinical trials to prove it works or has no severe side effects to solve a particular health issue. obviously for blood cancer, lenizi application may not be effective as other drugs already in the market for treating blood cancers due to the fact there is not a lot of people with these rare blood disorders and not much market for the drug
A Covid Mono vaccine? Do we already have the therapeutic form with lenz?
"On May 10, 2024, Novavax, Inc. (the “Company”) entered into a collaboration and license agreement (the “Collaboration and License Agreement”) with Sanofi Pasteur Inc. (“Sanofi”) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Company’s current standalone COVID-19 vaccine products, including the Company’s NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (“COVID Mono Products”)..."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924060444/tm2414089d1_8k.htm
I did not take a covid vaccine, and took comfort in my contracting mono (mononucleosis, or Epstein Barr virus,) as a teenager, to provide antibodies from T cell memory. I did have a blood test which detected EBV.
But aside from the name distinction, the symptoms of chronic fatigue and inflammation (I still can't wear my cowboy boots), seem to be very similar for EBV and Long Covid (and Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
https://www.cdc.gov/me-cfs/about/index.html#:~:text=People%20with%20ME%2FCFS%20have,concentrating%2C%20pain%2C%20and%20dizziness.
This insidious virus demands the authorization and approval of lenz. Some of us would prefer not to be fodder for the goal of depopulating the world until it is our time to do so.
https://share.newsbreak.com/6vtipmmh NEW VARIANT SPREADING
The important thing is that you got a green checkmark, instead of the signature shit-faced (have you seen his profile pic, very appropriate) 💩🤡 emojis you got for a previous post. Good job!
sanofi is no longer a shareholder.
In Sweden, all public companies have list of shareholders in public view.
Right now even in Bankruptcy, the court and nobody knows who actually owns hgenq? there is only list of people who filed to complain and they can get that .047/share lawsuit. those are the former disgruntled shareholders before hgenq filed for bankruptcy and is the last in line to get anything in bankruptcy court. if the fake creditor commitee who claim to be ripped out of 44 million don't get a dime, what makes you think peon shareholders will get anything? shareholders are not liable for any crimes or liabilities of the company or management.
https://share.newsbreak.com/6vefr7bz
MERS COV2 in Saudi Arabia 🇸🇦
"What would it take to monetize these Milestone Events? It would take receiving a BLA from the FDA for CMML, and related indications in the US. I think Sanofi, with their deep pipeline of oncology products and processes, would be an excellent partner for us in oncology, once they complete the spin-off of their healthcare division in the coming months."
Sanofi, one of Humanigen's first shareholders, issued four Press Releases in between April 17th - May 2nd, 2024.
https://www.sec.gov/Archives/edgar/data/1121404/000119312524129331/d793882d6k.htm
And as we know, Sanofi is planning to spin-off their healthcare division. So, a lot going on there. Did they overlook something?
"Novavax and Sanofi Announce Co-exclusive Licensing Agreement to Co-commercialize COVID-19 Vaccine and Develop Novel COVID-19-Influenza Combination Vaccines
May 10, 2024
>Agreement provides individuals with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards
>Provides Novavax with cash and an equity investment totalling approximately $1.2 billion (upfront payment of $500 million and up to $700 million in additional development, regulatory and launch milestones), plus tiered royalties
>Novavax is entitled to additional launch and sales milestone opportunities of up to $200 million, plus mid-single digit royalties, for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax's Matrix-M™ adjuvant technology
>Accelerates potential for development of a novel COVID-19-Influenza combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially offering individuals enhanced convenience and protection"
https://ir.novavax.com/press-releases/2024-05-10-Novavax-and-Sanofi-Announce-Co-exclusive-Licensing-Agreement-to-Co-commercialize-COVID-19-Vaccine-and-Develop-Novel-COVID-19-Influenza-Combination-Vaccines
These developments have enabled Novavax to remove their 'going concern' warning. "Liquidity and Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern within one year after the date that the financial statements are issued and contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business."
see pg 7
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000100069424000031/nvax-20240331.htm
I'm hoping for news this week that Humanigen's patented methodology was used to enhance Nuvaxovid, and that we will see our restructuring completed with a discharged CH11, and some type of licensing, partnering, or a business combination announced.
if stolen property is traded many times does the person who it was originally stolen from it still claim it.? that is a legal question. it's not theirs if they know it was stolen or if the asset has a lien on it. even if the paid fair value but the asset was purchase it has a lient on it, it's not really there that is why nobody wanted to bid on the hot assets. it's like buying a used car that has lien on it or creditor lien on it. if you buy stolen property not only do you lose the stolen asset you paid for, you also lose the money you use to buy the stolen or hot asset that has a lien on it. but US gov't has proven it may not be the case of stolen Russian assets and think they can sell stolen private property and sell it to pay for ukraine war.
it's grey area in legal world. whether the US gov't or any person can 'steal' assets and sell it. and the buyer doesn't really own it. because the property was stolen it doesn't matter if the gov't stole it or anyone who stole it. if someone has a claim on it, an dasset is hot, any buyer risk losing the asset and losing the amount they paid for the stolen property.
The only legal argument or csse or dispute hgenq equity owners have is whether the assets were sold at below market value or was not sold at 'FAIR MARKET VALUE' in a closed auction which nobody was allowed to bid and restricted auction. the auction was setup that nobody in their right mind would bid on it and most buyers would rather pay 'fair value' than buy assets in a fire sale that is disputed and has ligitation on it. If a buyer buys from taran then that is hgenq shareholders cannot sue the buyer who bought it from taran if taran sold the assets at 'fair market value' even if taran bought it for free. or if it was stolen. property
I'm not questioning whether LENZI has value or not. It probably has value because if hgenq had no assets taran would not waste time or $2 million to buy the 'assets' for free.
In many biotech startup with only stage 1, they have no value and only 2-4 employees. and if they go bankrupt there is no auction to sell as there is nothing sell. they just liquidate and shut down the business.
and file a corporate dissolution with the corporate registry. Any unsecured creditors are left holding the losses as a write off loans or dead accounts receivables. there is no court hearings no creditor committee as these companies have no assets to seize other than some furniture in some shared office.
Unless Dale lost his Appeal, Humanigen is positioned to enter into a stock-for-stock merger with Taran. If Dale lost his Appeal, Taran could just outright buy Humanigen's shares. I don't think it's likely that Dale lost his Appeal, or Durrant would have submitted a Tender Offer, instead of an Asset Purchase Agreement.
You're not recognizing the value of Humanigen owning ~90% of the shares they issued, leaving a float of 192% of our OS. If lenz is gaining market access, whether through authorization or approval, or through its IND use by Gracell and Novavax, that news, announced with the Taran merger, will be the trigger for Humanigen to recall their loaned shares.
the $5 million legal fees hgen the corporation spent on this case or lawsuits is not for legal expense, the money was to pay off the SEC, pay off the FDA, pay of the Judges etc. to ignore the stock scam or robbery. and walk free.
taran or the owner of taran is also the 90% owner of hgenq shares or the controlling shareholder of hgenq. that is why hgenq didn't object to selling taran lenzi ip for nothing.
main reason no bids from other pharma companies, they usually don't bid on assets with a lien on it, which was the promissory not to hgeneq shareholders.
if the hgenq shares are dissolved and liquidated, taran no longer owes hgenq shareholders anything and the promissory not is void and invalid if the company no longer exist. a dead money has no legal status in the courts and can no longer sue taran. if the company is liquidated and dissolved
any lawsuit by former hgenq shareholders would be a separate civil case which takes years and may not have a case. and case denied by omnibus hearing. there is no case for hgenq shareholders to sue taran. you have the courts and SEC working against minority hgenq shareholders you cannot sue them and basically screwed. legally the controlling shareholder of hgenq sold assets for nothing. to taran or himself. these guys know the legal system to screw shareholders in this stock scam, they got everything paid off , you know what I mean.
taran didn't even have to give hgenq shreholders anything or that schmuck insurance or the promissory not. legally, the fake creditors committee owns the company. technically. it's like that fake baloney lawsuit the guilliani was sued for 'defamation ' for llike $100 million and he declares bankruptcy so he doesn't have to pay a dime of that lawsuit. same with Trumps conviction of 'rape' there is no rape. it was consensual sex and stormy daniels was an escort. there is no shame what Trump did, who cares if Trump as 5 mistresses they were consenting and willing females. back in the good old days, rich guys like Trump would have 5 wives, nine lives, alright. mormons can have 10 wives but the gov't banned polygamy like its some kind of 'crime' the status of man was how many wives he had..but gov't banned it.
At this moment based on the legal facts. shareholders own no assets and even the promissory not of payment to hgenq shareholders can be voided if the shares are liquidated and dissolved. to get any money from taran, shareholders would have to file another civil case against taran, in a civil case. taran legally doesn't owe hgenq any compensation with the stolen ip asset they paid nothing for. but that is for juror to decide, the chapter 11 court or judge doesn't care about civil case or criminality charges by the SEC, it's not his job but based on chapter 11 processes, technically, the assets are sold and hgenq shareholder no longer own the ip lenzi patents and entitled to nothing. and no compensation based on chapter 11 law.
That really does promise to be good news for Taran and Durrant!
But, it would be far better for them to trade Taran shares for Humanigen shares, as I think they will. It makes no sense for Taran to deal themselves out of the recall of Humanigen's shares. I hope Durrant announces the stock-for-stock merger now.
Sounds like more great news for Taran and Durrant if Lenz is involved.
"Novavax shares soar on license deal with Sanofi at lofty valuation
By Sriparna Roy
May 10, 2024"
https://www.reuters.com/business/healthcare-pharmaceuticals/frances-sanofi-covid-19-vaccine-deal-with-novavax-statement-2024-05-10/
I am obviously very happy about this announcement, as these two companies have been the subjects of several of my posts. Now if we could only confirm that the efficacy of the Novavax vaccine was indeed enhanced by Humanigen's patented methodology.
Lenzilumab's sabotage was done by the design of the NIAID/NIH ACTIV-5 clinical trial. All the while, billions of Genetically Modified Organisms (GMO's, aka 'vaccines,') were administered to the populations mainly of the US, the UK, and Australia. mRNA vaccines were not administered in China.
Lenz will gain market access through it's ability to prevent CMML, and to enhance CAR-T and protein-based covid vaccines.
it's because big pharma doesn't want 'cheap' drugs that compete with their advance synthetic drugs to treat viral infections. Lenzi is probably cheap to make since it's may be from natural sources and don't need expensive lab to manufacture. where as natural remedies are much cheaper to make. It business, it's called shutting the competition either buy buying them out to prevent cheaper alternative 'competition.' leniz probably has side effects like all drugs or not as effective as other drugs. lots of drugs does the same thing as Lenzi which is treat an virual infection or treat people with blood diseases. or blood disorders. people with AIDS used to die or death sentence in the 1980's but with these expensive Aids anti-viral cocktails where a patient takes multiple drugs to replicate a person immune system, a person like magic johnson can live with aids like long term disease and don't die from Aids anymore if they take the cocktail of expensive anti-viral drugs. like a cocktail it only works if you take multiple drugs like mixing two colors to get one color
Lenzi type of medicine is derived from natural sources? could be blood from another animal, Drinking blood has been known for centuries to cure a lot diseases. like smoking magic mushrooms to cure alcoholism and mental illness and chewing cocoa (cocaine') leaves to reduce depression side effects are some people go insane taking magic mushrooms and get addicted and violent snorting cocaine but it works. and works. big pharma prevents the public to access 'natural remedies' via the FDA gov't telling the public what drug they can have accesss to..This almost unconstitutional what the FDA and gov't is doing.
Either the FDA is deliberating not approving it of humanigen deliberatedly sabotage it's FDA application not approved due to 'technicalities' in statistical variations.
I don't care whether it was the covid trial, or the CMML study, seasoned clinical trial investigators were SHOCKED by how quickly, safely, and effectively lenz saved the lives of severely ill patients. I'm specifically talking about Mayo Clinic's Dr. Claudia Libertin, in the video-taped trial review meeting with fellow investigators on the covid LIVE-AIR trial, as well as Dr. Daniel Thomas, Clinical Hematologist, Royal Adelaide Hospital, Associate Professor, Adelaide Medical School, The University of Adelaide, who presented the interim results of the CMML study.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext (I can't access the video archive)
https://medicalresearch.com/cancer-_-oncology/preach-m-trial-humanigen-study-evaluates-lenzilumab-and-azacitidine-for-cmml/#:~:text=The%20preliminary%20results%20from%20the,cells%20with%20RAS%2Dpathway%20mutations.
Lenz is practically miraculous. That was evidenced by the reactions of the clinical trial investigators (no, there are not "lots of drugs" that cause those reactions from the investigators) , and confirmed by both the Lancet and Thorax peer-reviews.
So yes, lenz works. Will lenz be approved? Yes, by necessity only. Regulators have a vested interest in saving the covid market for Pfizer and Moderna, and for their share of royalties from the approval of these products.
"However, in our breaking investigation, we found hundreds of millions of dollars in payments also flow the other way. These are royalty payments from third-party payers (think pharmaceutical companies) back to the NIH and individual NIH scientists."
NOTE: I do NOT advocate for Fauci's assassination.
https://www.sammyboy.com/threads/fauci%E2%80%99s-royalties-and-the-350-million-royalty-payment-stream-hidden-by-nih.321335/
Management is ALL about getting regulatory approval, even if overseas, and saving patients' lives, as well as rewarding shareholders.
Chapter 11 courts are not real courts but rather administrative processes.
If this was a real court case where you had jurors and judges for criminal case
Charge: Larceny
larceny: theft of personal property.
Where the conviction is determined by 10 jurors, someone is guilty and going to jail. but not in fake court trials like chapter 11 where there is no interviewing the person charged, no verify fake evidence and claims. nothing is taking as real in a real court. Even the people educational claims is investigated to be true or not. bank accounts are interviewed. etc. but chapter its more of administrative and due to low priority crime, bankruptcy fraud is not a top priority.
There so many of these biotech companies with zero revenue other than research and development of new drugs.
As for LENZI, it's been researched and developed for clinical trial since 2015.
If the FDA is costing drug companies that much money to get approval it increases cost of health care. Either the drug works or not.
1. Why is Lenzi not approved
2. Will Lenzi ever be approved
All these biotech with zero sales and unapproved drugs rely on investors to keep the business operating. Even with only 4 employees it cost annual burn rate is 5 million.
However a lot of these biotech firms was not about getting FDA approval or getting the drug to commercialization. The entire plan was to sell to investors and then go bankrupt and not raise additional shares. HGEN could have easily raised additional investement if it was not for the legal liabilities and shareholder lawsuit which was like near 40 million. It cannot get any investor to put money into the company but that was the plan to declare chapter 11 and auction the ip asset for nothing. and start another biotech company and sell hopium to new investors again. But in the process, the drug itself is not sold to the public for use due to no FDA approval even if the drug does have efficacy and works. There are probably lots of drugs like lenzi that does the same thing in immune boosting drugs. The same reason Dracula drank human blood to cure his blood cancer or some kind of blood disease.
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Moderators DTGoody 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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