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Actually everything outside of BP saving the company does hinge on incomplete orphan trials and IITs for Covid and Car-T that haven’t even been initiated. No BP is going to touch it until ACTIV-5 data is released and even if a BP does put up the cash for IIT then that’s still years away from completion. Asthma and Arthritis are old news and have been tested with monoclonals time and time again. This is recycled news and even if lenz offers benefits over other similar molecules in those regards, it’s still years away from showing any efficacy in them. No one is buying this drug for their portfolio for Asthma or Arthritis
Actually everything outside of BP saving the company does hinge on incomplete orphan trials and IITs for Covid and Car-T that haven’t even been initiated. No BP is going to touch it until ACTIV-5 data is released and even if a BP does put up the cash for IIT then that’s still years away from completion. Asthma and Arthritis are old news and have been tested with monoclonals time and time again. This is recycled news and even if lenz offers benefits over other similar molecules in those regards, it’s still years away from showing any efficacy in them. No one is buying this drug for their portfolio for Asthma or Arthritis
I don't agree that everything hinges on incomplete trials. Even as it stands right now, we may not have exactly beaten ACTIV-5's data with one hand behind our back, but we have kept up with them. The ""one hand behind our back" analogy is quite accurate, when you consider ACTIV-5 excluded half of the patients we included, who accounted for much of our success. And we rightly included those patients. As denoted in our CRP biomarker peer-review, our objective was to examine, "C reactive protein utilisation, a biomarker for early COVID-19 treatment..." Ordinal scales 6 and 7, beyond LIVE-AIR's patient inclusion criteria, is late stage disease progression, and patients in those ordinal levels can't represent LIVE-AIR's evaluation of the early treatment of lenz.
https://thorax.bmj.com/content/thoraxjnl/early/2022/07/05/thoraxjnl-2022-218744.full.pdf
And there is still evidence that we may well show statistical significance, based on our 2.25 Hazard Ratio from our third quartile patients with CRP levels of 75 to <137mg/L (from the above-linked peer-review).
On a different subject, you may not see any BP interest in us, but Durrant does, for competitors who are advancing their arthritis and asthma portfolios. It seems logical that insiders would be accumulating shares, to the degree possible, if a BP partnership is on the horizon. Yet, our float is only some 3M shares less than our OS. So any accumulation has obviously been in the form of buying Cede shares.
This company is screwed for a long time. They have no drugs coming to market in the near term and everything is hinging on trials that have not yet been completed. Aside from their orphan indications, which are a ways off, IIT for Covid and Car-T are the best they can hope for. I do not see any BP interest in any other regard. No BP is going to even come close to this until they see the NIH data as well. This is either going to be a massive hole that they need to dig out of for years, and odds are against them, or they are going bankrupt. Insiders not buying before blackout is a clear indication that nothing positive is coming or expected in the near term
I would not be surprised to see that the reason management has bloated our float is to realize the potential to partner with a Big Pharma, or two, who have a desire to add lenz to their arthritis and asthma therapy portfolio.
I've hesitated to mention this earlier because it may involve Cede shares beneficially owned by Humanigen and/or insiders, and I think I have wasted my time on that discussion. But I'm tired of seeing aspersions regarding insider sells, when I think things may not be what they seem to be. And it is frustrating, also, that I can't prove the alternative with the information that is public.
Regardless, it would be great to end Q3 with positive news.
Thank you for that. Interesting reading.
For what it is worth, pandb, I think our ATM is completed with our Outstanding Shares at 103.7M. That total is a little higher than the 99,004,931 shares outstanding the company estimated it would be after concluding our $75M controlled equity offering, which was based on a share price of $2.62.
"Common stock outstanding immediately following the offering 99,004,931 shares, assuming sales of 28,625,954 shares of our common stock in this offering at an offering price of $2.62 per share..."
https://www.sec.gov/Archives/edgar/data/1293310/000121465922005268/r412220424b5.htm
But, it is impossible to know that what the Transfer Agent reports as our OS is accurate, in my opinion. And I like that.
Noticed the public float is 103M. That's up from 67m. Is this to just to keep the lights on for another few months? Need some major positive news. Bagholding just in case, although sub .20 this month, then under a dime by the end of the year is more likely.
Please pin Humanigen's Covid-19 resource page.
https://www.humanigen.com/covid-19-1
I've seen a number of derogatory remarks from shareholders and antagonists who fault management for pursuing covid treatment, over what was, before then, our intended pathway. I could not disagree with that sentiment more than I do.
But let's look forward instead of back. The covid of today is not what it was. It may currently result in fewer hospitalizations and deaths. But that can't de-emphasize the critical importance of lenz going forward. Even now, covid is claiming 2,100 lives per day around the globe.
"28-Day Deaths
58,812"
Covid has caused worldwide
"Total Deaths
6,517,721"
Just in the United States, covid has caused 1,051,277 deaths.
https://coronavirus.jhu.edu/map.html
No, the covid of today is not what it was. It continues to mutate, and is now targeting our innate immune response system. It continues to mutate, and is now altering clinical disease presentation. Covid today is a far more insidious virus than it was, but perhaps not as insidious as it will become.
The other indications Humanigen is refocusing on are important. But are they claiming 2,100 lives per day around the world? Do those indications threaten the human innate immune response system? Do they cause doctors to treat phantom indications?
LIVE-AIR findings for lenz need to be validated, somewhere.
Hopefully, it will be validated in the United States, even if that is only with a secondary successful trial outcome from ACTIV-5.
But these covid mutations need to be stopped, and lenz has to do it. It's the only intervention that can.
After listening to Durrant's Wainwright presentation several more times, I have lowered his grade to a C.
His concluding statement would have yielded an A. His statement was, "We've also learned a lot about regulatory and governmental affairs. We've also learned a lot about how competitors behave. We believe that we will see a day where our drugs will be approved, and they will improve and save patient's lives."
But I question how much did management really learn about how government regulators work. In the presentation, Durrant was touting government incentives such as orphan drug designation, a priority review voucher, Fast Track, and expedited review. We've heard all of that before. I think that government rhetoric amounts to nothing more than pablum. And Project Orbis? Maybe that doesn't represent a repeat of what I expected from NIH, but that expectation is timely. "The NIH extended trial diverts our attention from the progress the Big Pharmas are making getting their mAbs into clinical trials. Another year, or less, of NIH trial testing could mean we lose our ability to maintain CMC compliance, if we can't financially reserve manufacturing capacity, maintain distribution agreements, or fulfill customer demand. It could mean that the FDA approves a Big Pharma mAb, and closes the EUA door.
Our fate is being wrested from us, with the successful completion of our internal Phase III trial, as the government attempts to commandeer our future." That post was written one year ago.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165875890&txt2find=commandeer
Durrant's assurance that our drugs will be approved is based on more ACTIV-5 data to come, beyond a preliminary finding of insignificant statistical support, to include a Final Report and Conclusion. But a review of our performance against secondary endpoints may be problematic, even if they measure survival, instead of death. Note the following:
Secondary outcome measures:
22, Survival without mechanical ventilation (YAY, right?) Nope. The full measure is, "Survival without mechanical ventilation through Day 29 in subjects with ordinal scores 5 or 6 at baseline. [ Time Frame: Day 1 through Day 29 ]
Subjects with ordinal scores 5 or 6 at baseline with a CRP<150 mg/L at baseline and age<85 years..." So even though it is a survival measure, instead of a mortality measure, and even though it represents our target CRP and age population, it does not draw from patients who were in ordinal scale 4 at baseline (they were excluded from ACTIV-5), and it includes patients who had progressed to ordinal scale 6 at baseline, who would not have been included in LIVE-AIR.
Look at the next secondary endpoint.
23, Survival without mechanical ventilation through Day 29 in subjects with ordinal scores 5 or 6 at baseline. [ Time Frame: Day 1 through Day 29 ]
Subjects with ordinal scores 5 or 6 at baseline with a CRP<150 mg/L at baseline and age<85 years.
Isn't that exactly what the previous endpoint tested? No. There is an additional criteria in conclusion to this endpoint,
"In those subjects who are at ordinal score 7 at baseline, the event is defined as death." Ordinal scale 7 is IMV or ECMO. Why did ACTIV-5 exclude patients in ordinal scale 4, who were most of LIVE-AIR's patients, and why did they include patients in ordinal scales 6 and 7, which were excluded from LIVE-AIR?
https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4
LIVE-AIR tested patients in ordinal scales 4 or 5.
ACTIV-5 tested patients in ordinal scales 5, 6, or 7.
ACTIV-5 was designed to fail.
I did listen to the presentation, and I will likely listen to it again several times.
As far as share price, I agree that announcement of a platform study partner should have a very favorable impact on share price.
But nothing will compare to favorable topline data from ACTIV-5. We did the work to earn that positive TLD. We only need to update our previously submitted EUA application for an EUA. We don't need a partner to resubmit the application. Once we have resubmitted the EUA, I would welcome a partner. And I would LOVE to partner with a Big Pharma who has manufacturing capability.
I think you grossly underestimate the impact potential of favorable news on our share price. I would be disappointed if the impact was 100X, immediately upon announcement of favorable TLD.
I AGREE WITH YOU BUT YOU REALLY SHOULD LISTEN TO THE PRESENTATION I THINK HE DID A GOOD JOB. THE ONLY ISSUE IS I DON'T THINK SHARE PRICE IS GOING TO INCREASE UNTIL WE SHOW PROF AND HAVE A PARTNER TO CONTINUE THE TRAIL. THEY HAVE A SOUND STRATEGY BUT IT'S GONNA TAKE A WHILE TO PROVE OUT AND I'M NOT SURE INVESTORS ARE GONNA WAIT THAT LONG SORRY TO SAY SOME WILL MISS OUT. BUT AT THESE PRICES ITS WELL WORTH THE HOLD. EASY 10X POTENTIAL IN 12 MONTHS OR LESS...
With the presentation by Durrant just concluded, I grade Durrant a B-.
He spoke more about the financial impact opportunity associated with a Priority Review Voucher (PRV), than he did about the opportunity of a favorable outcome from ACTIV-5. Some of us remember losing out on a PRV previously, for Chagas disease.
In my opinion, he should have reiterated our game plan in the event of a successful conclusion to ACTIV-5. Will we move forward, in that event, with the resubmission of our EUA application? Or, will we rely on a partner and their platform study to secure an EUA and full FDA approval?
I just don't sense that NIAID is feeling any pressure to produce topline data that is reflective of a trial that even remotely reflects key aspects of LIVE-AIR's trial design, when it comes to testing patients in ordinal scale 4 (room air), or when it comes to excluding patients in ordinal scale 7 (mechanical ventilation).
I should know better than to comment after just the initial viewing of the presentation. But I do it anyway, as I think a successful conclusion to ACTIV-5 is well within reason, and therefore, an EUA is equally within reason. I want shareholders, not partners, to reap the benefit of that Authorization.
TODAYS PRESENTATION SEPT 2022 PIPELINE W/ CATALYST
:https://s28.q4cdn.com/539885110/files/doc_presentations/2022/HGEN-IR-Deck-2022-09-08.pdf
? Great presentation. HGEN IS NOT DEAD! The preliminary topline results from the Accelerating COVID-19 (“ACTIV-5”) and Big Effect Trial, in the “B” arm of the trial (“BET-B”), referred to as the ACTIV-5/BET-B trial did indicate that lenzilumab demonstrated a positive trend in mortality. The company continues to support National Institutes of Health’s (“NIH’s”) further analysis of the data and are still waiting for more data from the trail. As stated before “Given the positive results from the company’s LIVE-AIR study and the survival trend observed in the ACTIV-5/BET-B study, we have interest from a global group of leading institutions and research networks to include lenzilumab in a large-scale, multinational studies of COVID-19. Tocilizumab and baricitinib demonstrated mortality benefit following inclusion in such studies despite having failed to do so in smaller studies. We are exploring the requirements for inclusion in these studies and plan to provide an update before the end of 2022. Also* Continuing enrollment in the PREACH-M CMML study in Australia, Initiating the SHIELD Phase 3 registrational CAR-T study in the US, they have Initiating the RATinG Phase 2/3 potentially registrational aGvHD study in the UK and Initiating the C-SMART (COVID in cancer patients) study in Australia.
Please check out their pipeline: https://ir.humanigen.com/English/events-and-presentations/default.aspx
Current Market Cap 24.049M
HGEN is extremely undervalued and an incredible opportunity at these prices.
Today's scheduled Wainwright presentation, at 4PM Eastern, is linked below as a reminder.
https://journey.ct.events/view/d74dea38-b7c3-4aef-9227-7025d41cf878
The subject matter of today's presentation is in regards to lenzilumab's ability to reduce circulating cytokines, as well as markers of systemic inflammation.
These are the exact topics I heard Mayo's doctor Zami Temesgen discuss previously in the video linked here.
The company updated their website so that the Hazard Ratio I noted no longer appears on chart 11 of the new Sept slide deck presentation.
However, I was delighted to see that the updated slide deck does indicate that Covid remains in our pipeline of indications for lenz. In fact, and interestingly, it seems page #3 may represent both Phase III trials. I hope that we will see Morris stand firmly behind the LIVE-AIR results. And it will be interesting to hear of any update to the preliminary findings of ACTIV-5, if that is what is being signaled by this slide.
https://ir.humanigen.com/English/events-and-presentations/default.aspx
There will probably be more traders than ever interested in S/R as more and more of them are drawn in to flip for profit at these price levels. So Price Change Parity will once again come into play. Returns will be potentially very lucrative, once we establish more than a 1 1/2 cent daily trading range, and the share price differential between HGEN and CYDY continues to narrow.
Other issues are prominent now, such as how our innate immune response system is being targeted by Covid variants with mutating accessory proteins. In my opinion, safeguarding our immune system by modulating its response, as lenz does, makes lenz a "MUST HAVE" to prevent untold damage to our bodies natural defense mechanism.
Another issue of more prominence is the possible sabotage of our ACTIV-5 trial, which clearly was populated by patients in a more advanced stage of disease progression.
While I know and appreciate your perspective regarding S/R, I think you are very intelligent, and I'd like to hear your thoughts on these larger issues.
We’ll have to see where the S/R is playing as we get closer towards the end of the year, of course.
Regardless of where you stand on this, the share price has been so atrocious of late, I see the opportunity to present at a couple conferences this month lifting the share price, and if they can hit a couple unexpected speculative jabs within it, then perhaps more to build on.
Do you have Covid, or don't you?
What should be a simple determination, may not be that simple after all. Maybe that explains why my wife twice tested positive for Covid while she was in the hospital, and once even transferred into a Covid wing, only to find that she supposedly did not have Covid.
The PNAS study linked in this thread found the following regarding accessory proteins.
"This work suggests that while spike mutations may enhance receptor binding and entry into cells, mutations in accessory proteins may alter clinical disease presentation. "
Attendees who are quite familiar with the company are, like us shareholders, going to want to know about the future of lenz as a covid therapeutic. I can only think of one good reason for the company to be mum on the subject...they have to be.
Silence, as a result of choice, is not acceptable. I expect almost the same passion, defense, and conviction from Dale and Durrant, that I have, only far more. Morris, not so much.
My point was simply that these conferences are usually a nothing burger.
Anyone who will be there that actually cares, or will care, about HGEN already is quite familiar with the company and its drugs.
I wonder how much further down the share price will go in the next few months due to tax loss selling?
Little biotechs don't generally develop a therapeutic that demonstrated a Hazard Ratio of 3.04 over Standard of Care, in regards to saving lives and preventing mechanical ventilation.
chart 11 of the slide deck
https://ir.humanigen.com/English/events-and-presentations/default.aspx
You would think, however, that in discussing the trial history of lenzilumab, the company would not just mention the incomplete histories of the PREACH-M and the RATing studies, and just act as though LIVE-AIR never happened.
The company should at least proudly recognize the accomplishment as found in the Thorax peer review, even though I recall they reported a Hazard Ratio of 2.56. That is still a major accomplishment in the fight against Covid.
I see no reason to cower from our accomplishment, just because captured regulatory agencies fail, as yet, to recognize what this little biotech has achieved.
That's what little biotechs do - they attend conferences. THey are networking events for the CEOs as much as anything else.
Many CEOs use these events to find their next job. Based on the track record here, our CEO may need one and would have trouble finding another gravy train job.
"Humanigen to Participate in H.C. Wainwright and Cantor Investor Conferences in September 2022"
https://www.newsfilecorp.com/release/136074/
Fundamental value of HGEN = $0.00 absolute zero.
And it will move there as time passes, just as a set of car keys falls from the hand of a drunk trying to get into their car on a cold winter night descend to the pavement.
Gravity - physical or financial - works hard 24/7.
"As the spike protein is the immunodominant antigen, the emergence of variants has raised concerns regarding the breadth of protection of the SARS-CoV-2 vaccines. However, it is important to note that many of the variants of SARS-CoV-2 possess mutations in one or more of the accessory proteins. The impact of such mutations outside of the spike protein on the pathogenesis of these variants remains understudied."
https://www.pnas.org/doi/10.1073/pnas.2204717119
The PNAS paper is the only one I've read that alerts us of the need to expand drastically beyond our focus on spike proteins, to include addressing the need to counter the threat to our innate immune response system, posed by accessory proteins. And once again, I think lenzilumab is uniquely qualified to meet that need by binding GM-CSF ahead of accessory proteins, such as it does with spike proteins and receptor cells.
I think the PNAS paper is very important to us.
Hi, Newtg
I want to revisit my previous reply to your post.
Our peer review indicated, "Patients must have been hospitalised with a clinical ordinal score of 4 or 5 (oxygen saturation [SpO2] ≤94% on room air or in need of supplemental oxygen in the form of low-flow oxygen, or both..."
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext
But inclusion into the ACTIV-5 trial allowed patients with (ordinal score 5, 6, or 7). Those are patients in a significantly advanced stage of disease progression than the LIVE-AIR patients.
https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4
The issue gets complicated, but the above encapsulates the gist of my point.
What happens when targeting variant spike proteins isn't enough anymore?
The Proceedings of the National Academy of Sciences (PNAS) has just published a peer-reviewed study regarding how the evolving, "SARS-CoV-2 variant spike and accessory gene mutations alter pathogenesis...
Each variant possesses mutations throughout its genome, but little is known about their effect on pathogenesis. Specifically, we are interested in the accessory genes of SARS-CoV-2, which have been shown to affect viral pathogenesis through interference with the host innate immune response...
The continued spread of the virus is largely driven by the emergence of viral variants, which can evade the current vaccines through mutations in the spike protein. Although these differences in spike are important in terms of transmission and vaccine responses, these variants possess mutations in the other parts of their genome that may also affect pathogenesis. Of particular interest to us are the mutations present in the accessory genes, which have been shown to contribute to pathogenesis in the host through interference with innate immune signaling...
The functions of the accessory ORFs of SARS-CoV-2 involve modulation of several different host pathways including antagonism of the innate immune response...(Genome Open Reading Frames) ORF3a, ORF6, and ORF7a have been shown to be antagonists of the innate immune system.."
https://www.pnas.org/doi/10.1073/pnas.2204717119
Lenzilumab is the only therapeutic I'm aware of with patented technology that works directly on modulating immune response.
"Speed matters. The Omicron variant and its rapid-fire subvariants, each coming just a couple months after the last, was a warning that our pharmaceutical research-and-development processes might be too slow. Note that the U.S. Food and Drug Administration just last week green-lit Omicron-specific vaccine boosters—a full 10 months after the initial Omicron variant first became dominant...
Our vaccine R&D is too slow even when it’s narrowly focused on the spike. What happens when it needs to broaden its scope to combat a virus that’s learning to mutate across its structure?
There’s another wrinkle. These accumulating mutations across the novel-coronavirus—on the spike and not on the spike—could start to mess with the polymerase chain-reaction tests we use to detect and track the virus."
https://www.yahoo.com/news/yet-another-curveball-covid-mutation-084446293.html
Another FDA non-decision which sidelines a vaccine alternative therapeutic, this one with the backing of platform study data.
EIGR provides update on EUA for COVID-19
Eiger BioPharmaceuticals Provides Update on Status of Planned Peginterferon Lambda COVID-19 Emergency Use Authorization Application
Tue, September 6, 2022 at 5:00 AM
In this article:
EIGR .. -31.05%
PALO ALTO, Calif., Sept. 6, 2022 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, today provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA).
Following a cooperative and extensive pre-EUA information exchange with FDA regarding the Phase 3 TOGETHER study of peginterferon lambda for COVID-19, the agency has indicated that it is not yet able to determine whether the criteria for the submission of an application and issuance of an EUA are likely to be met. FDA has indicated that it will consider any new information and data from the TOGETHER study to support an EUA as well as the company's plans for the further development of peginterferon lambda for COVID-19. Eiger remains in active dialogue with FDA and will provide additional information to the agency that the company believes could be supportive of an EUA.
"We appreciate the active dialogue with FDA and remain committed to continued engagement with the agency to obtain the necessary alignment to submit our EUA application for peginterferon lambda," said David Cory, President and CEO, Eiger. "Given its unique mechanism of action and the ongoing need for effective COVID-19 therapeutics, making peginterferon lambda available for patients remains a priority for Eiger."
The company has recently generated new data and analyses from the TOGETHER study that it plans to discuss with FDA, including further statistical modeling and efficacy analyses of the study's primary and secondary endpoints in patients treated within three days of symptom onset. The endpoint of hospitalization due to COVID-19 and all-cause mortality for patients treated within three days of symptom onset is consistent with the endpoint used to authorize other therapeutics for emergency use and is summarized below:
Patients Treated Within 3 Days of Symptom Onset
Population Hospitalization due to
COVID-19 / All-Cause
Mortality
Hospitalization / Mortality
due to COVID-19
Hospitalization due to
COVID-19
Intent to Treat (ITT) N=1,1541 RRR2 0.58
Pr3 0.991 p=0.026 RRR 0.62 Pr 0.996
p=0.014 RRR 0.62 Pr 0.996 p=0.014
1 n=567 (peginterferon lambda), n=587 (placebo)
2 Relative Risk Reduction
3 Probability of superiority; threshold for superiority = 0.976
The original efficacy analysis of the data generated from the TOGETHER study was based on dosing peginterferon lambda within seven days of symptom onset.
In addition, Eiger plans to provide new additional analyses of long-term follow-up data, including rates of rebound and incidence of long COVID, as well as an indirect comparative analysis of mortality and hospitalizations in vaccinated patients when treated with peginterferon lambda compared to other therapeutics authorized for emergency use.
The company is working with the TOGETHER investigators on the publication of a manuscript in a peer reviewed journal.
About Peginterferon Lambda
Peginterferon lambda is an investigational late-stage, first-in-class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections and has been well-tolerated in clinical studies.
Peginterferon lambda is to be administered as a single subcutaneous injection so that it can be prescribed and administered at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness that can lead to hospitalization and death.
IFN lambdas are critical for maintaining a balanced antiviral response in the respiratory tract. They are induced at lower viral burden before type I IFNs to limit the initial infection by inducing viral resistance to cells and helping them deal with the virus load. IFN lambda lacks the strong pro-inflammatory effects of type I IFNs and are tissue-protective and anti-inflammatory. Administration of IFN lambda has been shown to suppress viral replication while stopping 'cytokine storm' from developing.
Eiger is developing peginterferon lambda for the treatment of HDV infection. Peginterferon lambda has been administered to over 4,000 subjects in 28 clinical trials of HBV, HCV, HDV and COVID-19. Peginterferon lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency, and Fast Track and Breakthrough Therapy Designation by FDA for peginterferon lambda in HDV.
Eiger licensed worldwide rights to peginterferon lambda from Bristol-Myers Squibb.
About TOGETHER Study
TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with COVID-19. TOGETHER is the largest placebo-controlled study in COVID-19 and has evaluated 11 different therapeutic agents for non-hospitalized COVID-19 patients. This evaluation of peginterferon lambda versus placebo was the second largest study to date of a COVID-19 therapeutic. Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID-19, and were randomized within seven days of symptom onset. High-risk criteria were defined by patients having at least one of the following, including but not limited to: > age 50, diabetes, hypertension, CV disease, lung disease, kidney disease, obesity, etc. The study enrolled patients regardless of vaccination status or variant strain of SARS-CoV-2. The primary endpoint was a clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of peginterferon lambda versus placebo. The Data Safety Monitoring Board provided independent oversight for the trial and had previously discontinued other therapeutics due to observed futility. The TOGETHER study recruited from 12 sites in Brazil and 5 sites in Canada.
It is called a placebo. HGEN has a pipeline of placebos.
The NIH Covid-19 Treatment Guidelines STILL find that there is insufficient evidence, "...to recommend either for or against the use of GM-CSF inhibitors for the treatment of hospitalized patients with COVID-19." This, despite that they recognize, "Data from a double-blind randomized controlled 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://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/gm-csf-inhibitors/
Further, the guidance panel recognized that the LIVE-AIR study population, "...primarily included patients on room air or low-flow oxygen..."
This was clearly stated in our trial inclusion criteria.
Inclusion Criteria: SpO2 ≤ 94% on room air...
https://clinicaltrials.gov/ct2/show/NCT04351152?term=lenzilumab&draw=2&rank=3
But the ACTIV-5 trial excluded patients on room air. Why, when they knew LIVE-AIR primarily included patients on room air?
Inclusion Criteria #6: requiring, just prior to randomization, supplemental oxygen
https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4
Our peer review reconfirmed that the LIVE-AIR trial included patients on room air.
Participants: Patients must have been hospitalised with a clinical ordinal score of 4 or 5 (oxygen saturation [SpO2] ≤94% on room air or in need of supplemental oxygen in the form of low-flow oxygen, or both;
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext
But the ACTIV-5 trial excluded patients on room air. Why, when they knew LIVE-AIR primarily included patients on room air?
The company did a peer-reviewed post hoc study on using CRP as a biomarker to identify the patients that would best respond to lenz.
Participants Hospitalised COVID-19 participants
(N=520) with SpO2 ≤94% on room air...
https://thorax.bmj.com/content/thoraxjnl/early/2022/07/05/thoraxjnl-2022-218744.full.pdf
But the ACTIV-5 trial excluded patients on room air. Why, when they knew LIVE-AIR primarily included patients on room air?
NIAID sponsored a trial on our co-therapy, remdesivir. The ACTT trial included patients with:
SpO2 < / = 94% on room air
https://clinicaltrials.gov/ct2/show/NCT04280705
But the ACTIV-5 trial excluded patients on room air. Why, when they knew ACTT included patients on room air?
This is sabotage, pure and simple. Both the NIH and NIAID are on the record with acknowledging that room air patients were included, even primarily included in all previous trials. The IG, or the company, needs to refer these findings to the FBI for prosecution.
So happy they stop talking and claiming nonsense on Covid.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Financial Statements and Exhibits. Exhibits
On August 31, 2022, Dr. Adrian Kilcoyne informed Humanigen, Inc. (the “Company”) of his resignation from his position as Chief Medical Officer of the Company, effective September 28, 2022. The Company thanks Dr. Kilcoyne for his contributions and wishes him the best in his future endeavors.
Claim? 100% if YOUR claims have been WRONG!!
Hello HGEN'ers, long time no see. I sold all HGEN positions the day the EUA was denied and haven't touched it until today. Decided to dip my toe back in the water. I still believe that Durrant & Chappell can do something with the company and find it undervalued with only a 23m market cap. But I'm not disillusioned to think a reverse split isn't on the table if they want to stay on the big boards. I'll probably start adding slowly over time and plan on a multi-year hold. I genuinely feel bad for the investors that decided to ride it out.
I was glad to see that post. "Globalrisk13" strikes me as a Shtrubel-Down-Under, but that's okay. (Shtrubel writes for TipRanks). Linking that interview of Dale by Joe Diaz was a great move. I think Diaz is pretty much first-in-class at what he does with Lytham, and Dale did great, especially since he filled in for Durrant on that fireside chat. And Dale made it easy to understand the science behind lenz, which neutralizes GM-CSF, preventing myeloid cells from activating, which would become cytokine factories.
Thanks for sharing the link here
I believe that it was in regards to the FDA's 104 days to make a determination in our LIVE-AIR trial (notice that I didn't say "to make a decision in our trial," because they didn't), I posted that, "HHS needs to have their Inspector General investigate the reason for the FDA delay, and have the FBI file charges if they find collusion in the approval process.
We have agreements with both the Department of Defense (CRADA agreement), as well as the Department of Health and Human Services (BARDA agreement)."
https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-the-Addition-of-BARDA-and-Expansion-of-CRADA-with-the-U.S.-Government-to-Develop-Lenzilumab-for-COVID-19/default.aspx
The NIAID/NIH trial was designed using a more severely ill patient population, and a more severe primary endpoint, than used in LIVE-AIR. For those reasons, their trial cannot be accepted as confirmatory to the LIVE-AIR trial.
The Department of Defense entered into a CRADA agreement with the company so that lenz would be in their armamentarium to protect the country against a biological attack, such as from coronavirus, or future viral or bacterial agents.
If the company doesn't want to sue NIAID/NIH, then they should at least review our case with the FBI. "Elected or appointed officials are entrusted and expected to protect the interests of the people with integrity. When that trust is betrayed, the security and stability of our government is put at risk."
https://ucr.fbi.gov/ten-years-after-the-fbi-since-9-11/just-the-facts-1/public-corruption-1
Anybody can make a claim.
But I try to source the basis for my statements. I provide links to support what I say.
If all ACTIV-5 patients were on ECMO, would you believe that their trial accurately demonstrated the efficacy of lenz? Of course not, the patients were at an advanced stage of disease progression. That wouldn't be a legitimate basis to confirm or refute what LIVE-AIR reported.
But, in excluding patients on room air, ACTIV-5 DID test patients who were at a more advanced stage of disease progression than the LIVE-AIR patients.
Both the LIVE-AIR trial for lenz, and the ACTT trial for remdesivir, included patients in their trials who were on room air (ordinal scale 4 patients). How can the ACTIV-5 trial of remdesivir+lenz accurately evaluate the cocktail of remdesivir+lenz, if they excluded room air patients by requiring supplemental oxygen use (ordinal scale 5 patients).
If so it will be pennies on the dollar and several years from now. Not relevant to current decisions regarding whether to buy sell or hold HGEN.
I hope they win and shareholders get some $ back
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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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