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What do you mean with our last week in purgatory? You mean something could move the stock price?
You're a good man, eb, and I appreciate your continued support. But the amended Asset Purchase Agreement was probably the best news we could have received. I look forward to hearing from Michael North on how Taran and Humanigen may be integrated, and I suspect that Filip Dubovsky may have a key role in the expansion of our Milestone Events, which I think will shock the investment community...and the short sellers who have bet against us. Also, I credited Dubovsky for a possible role in the Pfizer covid trial, but Michael Shuster is who I should have credited. I hope this is our last week in purgatory.
Hang in there Jay. You have been through it before and I'm sure no one here understands what you see here. Keep it going; I love your determination.
nothing is happening
As I indicated in the link I provided, the date for the Combined Hearing is June 13th.
I'm fully aware of the warning that existing shareholders may not receive a distribution from the Liquidating Trustee.
But I am convinced that the co-exclusive licenses held by Sanofi and Novavax, will prove to be a game-changer for Humanigen shareholders. I actually think Novavax has received funds they can use to pay their licensing fee to Taran, which could fully satisfy the Unsecured Creditors, and that Taran will possibly offer an exchange of equities to Humanigen shareholders.
There is just not enough information for me to speculate on whether Sanofi will also provide licensing fees to Taran, and how Humanigen shares may be converted to Taran shares, nor how to tell what the outcome will be of a possible combination of Sanofi, Novavax, Humanigen, and Taran.
But, in light of the warning about potentially no distribution to Humanigen shareholders, coupled with my commitment to have a reasonable basis for my conclusions, I am saying that I expect a successful conclusion to our CH11.
What meeting on June 13th? No notice went out. Company is done
Novavax just hit another new 52 week high of $22.24 today.
Can someone make me a summary of what is going on and what could happen with $HGEN?
Novavax just eliminated the possibility of recipients topping-out on awards granted to them under their 2015 Stock Plan. This will positively impact Dubovsky, who I think we'll see named as our Chief of Development. Their June 13th Stockholders Meeting coincides with our June 13th Combined Hearing.
"AMENDMENT TO PROXY STATEMENT DATED APRIL 29, 2024, FOR THE NOVAVAX, INC. 2024 ANNUAL MEETING OF STOCKHOLDERS TO BE HELD ON JUNE 13, 2024."
https://www.sec.gov/Archives/edgar/data/1000694/000110465924068426/tm2416428d1_defa14a.htm
See pg 3, The Combined Hearing
https://reorgdocumentlibrary.broadridge.com/Client/Client?data=0524/N03355/444863/c
Well, Novavax did end up making a 52 week high yesterday. I'm hopeful that they will be using lenz as a vaccine enhancement, and that we see them make an all-time high, which would be over $300 per share, and maybe result in filling my open sell orders at $200 before the orders expire early in July.
"... it was the Combined Plan and Disclosure Statement that vested sole discretion into the Liquidating Trustee to declare a Record Date for a Distribution to Existing Equity Holders."
As I recall, it is the SEC that proposes which Bankruptcy Trustee they want. In my previous experience, the Trustee and the bankruptcy judge discussed the rampant naked shorting of the victimized company that was forced into bankruptcy, and decided not to accumulate a required list of the victimized shareholders, just due to the excessive scope of the problem. Subsequently, the SEC entered into a Settlement Agreement with the Bankruptcy Trustee to deregister the shares, which required the judge's approval.
We obtained the required list of NOBO/OBO shareholders by subpoena. We also argued against the Settlement Agreement, and the judge denied that Agreement.
My point is that Bankruptcy Trustees have a vested interest in accommodating the SEC, by whom they are recommended as Trustees. I think that presents a conflict of interest, and the Trustees should be nominated by a disinterested party (the Consumer Financial Protection Agency, for example). A second point is that shareholders have significant power that can be granted to them by the judge.
I've been reticent speak too much since Liquidation was declared, and that guidance was provided to advise shareholders that no distribution to them was anticipated.
However, it is evident that Humanigen's circumstances have changed (or are changing), to the point where I expect that a distribution will be made to existing equity holders. We see support in that regard by the amended Asset Purchase Agreement, which will significantly expand the Milestone Events, and payments to the Unsecured Creditors.
We see Dubovsky altering his career path from Novavax's President of R&D, as we see Sanofi begin their spin-off, at the same time that we see both companies acknowledge their co-exclusive licensing agreement, which I suspect will be for lenz. I think it is these changes that will ignite the significantly expanded Milestone Events, and will also trigger Humanigen's recall of their loaned shares.
I see Gilead trading near 52 week lows today, while Novavax is trading near 52 week highs.
I suspect this illustrates why management did not want to give Gilead exclusive rights to use lenz. Rather, if I'm right, we'll see that lenz is the product co-exclusively licensed to Sanofi and Novavax. And hopefully, Dubovsky has helped to demonstrate that lenz improves the efficacy of azacitidine in treating, or preventing, Myelodysplastic cancers, perhaps significantly beyond what he and Pfizer demonstrated in their trials.
Of course, we know that Gilead gave up on their effort in this regard, after spending almost $5B to buy magrolimab, which failed to show improved efficacy, and in fact, resulted in increased mortality.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174481489
If North knows what he is getting into by establishing communications with investors and key shareholders of Humanigen's stalking horse bid winner, then he must know about Taran's strategy going forward, and believe that there is sufficient value to warrant the investment he will be soliciting.
And, since our bankruptcy judge has kept us in a CH11 proceeding, he should be equally informed about Humanigen's prospects and strategy as it relates to shareholder value.
Existing equity holders were excluded from voting on the Combined Plan and Disclosure Statement. However, it was the Combined Plan and Disclosure Statement that vested sole discretion into the Liquidating Trustee to declare a Record Date for a Distribution to Existing Equity Holders. The Declaration of a Record Date would not adversely affect the superior claim holders in any way. In fact, it could add value to their claims, if certain Causes of Action are implemented.
Existing equity holders should be permitted to Object to an arbitrary denial of our Preservation of Rights. I see no reason why the judge, rather than the Liquidating Trustee, should not retain the authority to Declare a Record Date, if requested by the Debtor.
There may be something we could learn from Sanofi's acquisition of Inhibrx, Inc. I see some similarities in the set-up of the acquisition. It's beyond my pay grade.
https://www.sec.gov/Archives/edgar/data/1121404/000119312524150383/d843856dex991.htm
“in which they note a Deagel study which projects the US population to decline by as much as 200M by 2025. “
That’s 2/3rds of the US population in the next 6 months, I’m guessing that was written wrong?
Hello, D
First of all, let me say that I appreciate your continued consideration of my posts. The issue of how the bankruptcy concludes, in my opinion, should now consider whether Humanigen still meets bankruptcy parameters, especially in regards to liquidation. I don't think they do. I think we should see our status changed from liquidation, back to reorganization, from which we should emerge with our share structure intact.
Something else I have long believed is that we are engaged in biowarfare. I view the illegal mass migration of non-Europeans into the US in support of that claim. That claim is also reinforced by the tens of thousands of Chinese nationals who have entered our country illegally. These immigrants are not susceptible to the covid strains designed based on national DNA databases. A good discussion of this topic is based on an interview by Matthew Smith of Doug Casey, in which they note a Deagel study which projects the US population to decline by as much as 200M by 2025.
"Research into Disease X also requires gain-of-function utilization, to possibly produce another novel coronavirus, which I think could be the Pangolin Coronavirus GX_P2V..."
More recent discussion suggests that "Disease X" could actually prove to be a version of H5N1 bird flu, which could be, or will become, genetically modified. Dr. Kelly Victory, one of my favorites, conducted an excellent interview of Dr. Brian Hooker, PhD, on this subject of "H5N1 Bird Flu: New Pandemic Gets New mRNA Vaccine," starting at minute marker 09:30 in the following video.
It begs the question, since Humanigen has no secured debt obligations; no non-tax priority claims; and the unsecured creditors are voting to approve the amended APA in anticipation of a rigorous response toward accomplishing Milestone Events, then why shouldn't the CH11 bankruptcy be discharged with the share structure absorbed, as the company emerges from this reorganization?
An old skeptical challenge to such a Phoenix re-emergence of life, would be to ask, "How did this happen? Did the company discover a cure for cancer or something?" And the answer is likely yes, for cancers such as CMML.
That’s interesting.
It could be the butterfly effect. But my long-standing, pro-bias toward Novavax has me convinced that they and Humanigen have such mutual benefit by partnering, that Filip may very well slip into a Chief position with the Taran/Humanigen entity.
But I'm even more excited about the amended Asset Purchase Agreement, where it was indicated that, "...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."
end of 2nd para, pg 4/5
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
About two weeks later, we got a little mixed messaging in Doc 253, where it was noted that no distribution to shareholders was anticipated, but that same paragraph concluded with the potential of a Record Date being declared, exactly for a Distribution to shareholders (which I think could be for shares of Taran, equal to the number of our Humanigen shares).
see 1st para, pg 3
https://reorgdocumentlibrary.broadridge.com/Client/Client?data=0524/N03355/444863/c
Yeah it’s the butterfly effect .
Is Filip Dubovsky retiring as Novavax's President of R&D, after recent patent grants, including some that were Granted in February and March, 2024?
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924064680/tm2415419d1_8k.htm
https://patents.justia.com/assignee/novavax-inc
Will he be joining in the Sanofi spin-off company, perhaps merged with the Humanigen/Taran entity, and Novavax?
"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.
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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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