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Clinical and Economic Benefits of Lenzilumab Plus Standard of Care Compared with Standard of Care Alone for the Treatment of Hospitalized Patients with Coronavirus Disease 19 (COVID-19) from the Perspective of National Health Service England
https://www.dovepress.com/clinical-and-economic-benefits-of-lenzilumab-plus-standard-of-care-com-peer-reviewed-fulltext-article-CEOR
Humanigen Announces Peer-Reviewed Publication Demonstrating the Potential Clinical and Economic Benefits of Lenzilumab from the Perspective of the NHS
https://ir.humanigen.com/English/news/news-details/2022/Humanigen-Announces-Peer-Reviewed-Publication-Demonstrating-the-Potential-Clinical-and-Economic-Benefits-of-Lenzilumab-from-the-Perspective-of-the-NHS/default.aspx
-In a weekly cohort of 4,754 newly hospitalized patients, addition of lenzilumab to standard of care (SOC) could result in over £5.5 million in cost savings weekly
-Lenzilumab plus SOC resulted in per-patient cost savings between £8,462 and £17,277 (net savings of £1,162 - £9,977) depending on patient population
-The number of COVID-19 cases continues to remain high with approximately 20,000 patients currently hospitalized in the UK,2 demonstrating the urgent need for both clinically effective and cost-effective variant-agnostic treatments for hospitalized patients
SHORT HILLS, N. J.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced a peer-reviewed publication in ClinicoEconomics and Outcomes Research outlining the potential clinical and health economic benefits of lenzilumab, if authorized or approved for use in the United Kingdom.
“As COVID-19 continues to place significant burden on the National Health Service (“NHS”), this paper demonstrates there is an opportunity to realize significant cost savings for healthcare systems of the UK while improving outcomes for patients. As a variant-agnostic treatment, lenzilumab may offer both a clinically effective and cost-effective option against current and emerging variants,” said Adrian Kilcoyne, M.D., Chief Medical Officer, Humanigen, the lead author of the publication.
The publication demonstrated, in all cases, lenzilumab plus SOC improved all specified clinical outcomes compared with SOC alone. Additionally, patient selection, utilizing CRP<150 mg/L as a biomarker, optimized both clinical and economic outcomes.The observed cost savings are mainly driven by fewer bed days, days on invasive mechanical ventilation and ICU days.
The greatest per-patient cost savings were for patients aged <85 years, CRP <150 mg/L, and receiving remdesivir of £10,427 (net savings of £3,127 after expected lenzilumab acquisition costs); and for Black patients with CRP <150 mg/L of £17,277 (net savings of £9,977).
“During these unprecedented and challenging times, we are preparing to commercialize lenzilumab, if authorized or approved, as a single day treatment and a potential driver of clinical and economic value to patients and the healthcare system,” said Edward Jordan, Chief Commercial Officer, Humanigen.
This peer-reviewed publication highlights the significant costs of treating hospitalized COVID-19 patients and the economic benefits of potentially improving survival without ventilation, reducing ventilator use, hospital days and ICU days which may be associated with adding lenzilumab to standard of care.
Lenzilumab is an investigational product and is not approved or authorized in any country.
VERU is up about 200% on a very questionable trial of only 150 patients. Placebo had a mortality rate of 45% which makes no sense. If VERU can go up 200% on trial results that have virtually no chance at getting an EUA then HGEN might go up 2,000% if/when it gets stat sig for a second time.
The primary endpoint population of the ACTIV trial are patients with a CRP<150mg/L + <85yo + on remdesivir. That population had 243% efficacy in the LIVE-AIR trial on the primary endpoint. Stat sig in the ACTIV trial is a given on the primary endpoint. Stat sig on mortality is a real possibility. The LIVE-AIR had stat sig on mortality with the 336 patients with CRP<150mg/L and <85yo. There is still no effective treatment for newly hospitalized patients. Lenzilumab is a game-changer. Data will be our savior.
Herd immunity isn't going to happen. Covid will be here forever just like the flu. But no matter how much Covid mutates, lenzilumab's variant agnosticity means lenz will always work because it is host-directed i.e. it treats the patient's immunological response to Covid instead of targeting the actual Covid virus. Lenzilumab has a long future ahead.
It is amazing how closely we still track the XBI on low volume days. It made sense when we were part of the XBI. At times HGEN was the XBI's largest holding. But we still very closely track the XBI since being kicked out of it. It has to be sector-wide based algorithms. It has been frustrating since HGEN's plummeting share price seemed so unjustified between November and February. Fortunately, the XBI has likely already hit rock bottom and it will continue to ascend for the foreseeable future. The XBI hit a high of 174.79 on February 9th, 2021. The XBI hit a low of 80.34 on March 14th, 2022. That was a rough 13 months. The XBI is currently 96.00. It would be nice for it to get back to the 130s or 140s.
Compare their two charts below. You could paste one on top of the other and they would be near identical. For instance, look at 10:21 this morning on both charts. That is not a coincidence.
https://www.cnbc.com/quotes/HGEN
https://www.cnbc.com/quotes/XBI
Tim stated 85,000 treatments already available. At $10,000 each, that is $850 million or approximately 4 times HGEN's market cap.
Humanigen April 2022 IR Presentation
https://s28.q4cdn.com/539885110/files/doc_presentations/2022/HGEN-Corporate-Deck-04-01-22-Final.pdf
https://www.humanigen.com/
March 24, 2022, Updated NIH COVID-19 Treatment Guidelines
Updated NIH COVID-19 Treatment Guidelines include updated results and interpretation from lenzilumab LIVE-AIR study now published in The Lancet Respiratory Medicine. The updated interpretation of LIVE-AIR concludes “Lenzilumab improved ventilator-free survival in participants with hypoxemia who were not receiving MV, with the greatest benefit among those with lower CRP levels”, based on the increased incidence of ventilator-free survival observed in patients with CRP <150 mg/L (90% vs 79%, HR 2.54; 95% CI, 1.46–4.41; P=0.0009). Currently, lenzilumab is not yet authorized or approved but is available via compassionate use in some countries (U.S., ex-U.S.). Guidelines state that while GM-CSF is believed to be a key driver of lung inflammation in COVID-19 pneumonia, operating upstream of other pro-inflammatory cytokines and chemokines, NIH interpretation of clinical data show that lenzilumab is the only GM-CSF inhibitor to demonstrate a benefit in the treatment of COVID-19. Lenzilumab may mitigate inflammation by inhibiting this signaling axis upstream of IL-6 and IL-1 and thus minimizing downstream production of numerous pro-inflammatory mediators involved in the pathogenesis of COVID-19.
Geert Vanden Bossche's prediction's have consistently been correct about Covid issues that other "experts" have been incorrect about. The below prediction is scary.
Elisa2Summer
https://stocktwits.com/Elisa2Summer/message/448394341
I was irritated by this discussion about the 60 days + asked ir about it. here is the answer.
1- Our public guidance is top line data would be out late Q1/early Q2.
Database lock occurs once all the data has been entered + verified. Database has multiple data points for each patient. The protocol follows patients for 60 days. The primary endpoint is measured through day 29. It is important to gather all the data through day 60 to lock the database. We spend a tremendous amount of effort tracking down missing data the most important of which is the patient still alive. As these patients have been discharged it is a challenge to confirm if the patients are alive or not.
2 - For LIVE-AIR we were able to freeze the database at Day 29 to come up with the top line data. For ACTIV-5 NIH is in control of the database. We haven’t given any guidance on database lock but the Day 60 data is needed to lock the database.
I can confirm enrollment is complete and the team is working to gather all the endpoints.
I recognize the anxiety around the top line release but safe to say we are working with the NIH to make sure all the data is collected and entered. Top line data will be released when it is available.
@ItsVeryJerry
Mortality rate for hospitalized patients rising in Finland? 1/3 over 80 are dying vs 1/10 for previous waves. Is this reinfections, severity , waning vax, or something else. Either way doesn’t fit the ‘getting milder’narrative @fitterhappierAJ @NToola9 https://t.co/njXeBFM3ju
— Jerry Q*👁️🗨️ (@swandivr) March 30, 2022
Today is the one year anniversary of topline data being released for the LIVE-AIR trial. While the share price is a fraction of what it was a year ago, I keep becoming ever more optimistic. Covid seems like it will likely be endemic. There is still no good treatment for severe patients. And anti-GM-CSF's future is much larger than just Covid. The future is bright for the next month, the next year, and the next decade.
Eric Feigl-Ding @DrEricDing
⚠️BA2 DOMINANT—Welp—CDC reports the #BA2 subvariant is now 54.9% of all cases as of March 26th. ➡️This matches our forecast of March 26th BA2 dominance **right on the nose**—for equilibrium plateau point. Wastewater plateaued too. Surge coming in April.
— Eric Feigl-Ding (@DrEricDing) March 29, 2022
Forecast HT to @JPWeiland pic.twitter.com/BHo3LrNJMg
@humanigen
LIVE-AIR Results featured on the cover. The Lancet Respiratory Medicine, March 2022, Volume 10, Issue 3, Pages 221-312, e25-e33 #lenzilumab https://t.co/b8vzZIu2Vf
— Humanigen, Inc. (@humanigen) March 29, 2022
Stimulating severe COVID-19: the potential role of GM-CSF antagonism
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00539-7/fulltext#%20
One of the key components of the detrimental hyperinflammatory response in COVID-19 is granulocyte-macrophage colony-stimulating factor (GM-CSF), which is an immunomodulatory cytokine that might help to clear respiratory microbes by stimulating alveolar macrophages, but when in excess can cause damage. Its concentrations are low or undetectable in healthy individuals, yet many conditions can cause a rapid increase its concentration.1 Increased circulating concentrations of GM-CSF have been described in patients with COVID-19 compared with healthy controls.2 In the later stages of lung disease in COVID-19, excessive GM-CSF production can contribute to the dysregulated immune response in severe COVID-19,3 in which, upstream of IL-1 and IL-6, activated T cells target neutrophils and macrophages.4 Agents that interfere with its actions have high plausibility for benefit, not just in COVID-19, but in other acute inflammatory conditions, such as acute respiratory distress syndrome or sepsis.5
In The Lancet Respiratory Medicine, Zelalem Temesgen and colleagues6 report on a multicentre, placebo-controlled clinical trial of hospitalised patients with COVID-19, showing that lenzilumab, a neutralising monoclonal antibody against GM-CSF, is associated with improved survival without invasive mechanical ventilation at 28 days. Lenzilumab is a monoclonal antibody that directly binds GM-CSF and is being tested for conditions such as chronic myelomonocytic leukaemia and B-cell lymphoma.
Of 520 randomly assigned patients who were hypoxic or who required oxygen, but who did not require invasive mechanical ventilation, 479 patients were included in the modified intention-to-treat analysis. Patients in the lenzilumab group showed a 6% absolute increase in survival without ventilation at 28 days compared with the placebo group (198 [84%] of 236 patients vs 190 [78%] of 243 patients; hazard ratio [HR] 1·54 [95% CI 1·02–2·32], p=0·040). This difference on the outcome of survival without ventilation was primarily driven by more patients in the placebo group requiring invasive ventilation (49 [20%] patients) than those in the lenzilumab group (26 [11%] patients; HR 0·52 [0·32–0·82], p=0·0059). Key secondary outcomes, such as mortality, ventilator-free days, intensive care unit days, or recovery time, along with adverse events were not significantly different between the two groups.
This study population had lower baseline C-reactive protein (CRP) concentrations than the cohorts in RECOVERY and REMAP-CAP—trials where IL-6-targeted therapy has shown the largest benefit.7, 8 Exploratory sensitivity analyses suggested greater benefit of lenzilumab in patients with CRP concentrations less than the median value of 79 mg/L; further study of a CRP-guided approach, possibly targeting patients with lower CRP concentrations, earlier in their disease course, or of a different disease phenotype, could therefore be warranted. Whether biomarker-driven immunotherapy with stratification of patients can guide individualised use of immunomodulatory treatments in COVID-19 needs to be explored.
Drugmakers, scientists begin the hunt for long COVID treatments
https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-scientists-begin-hunt-long-covid-treatments-2022-03-25/
After producing vaccines and treatments for acute COVID-19 in record time, researchers and drugmakers are turning to finding a cure for long COVID, a more elusive target marked by hundreds of different symptoms afflicting millions of people.
Leading drugmakers, including those who have launched antiviral pills and monoclonal antibodies for COVID-19, are having early discussions with researchers about how to target the disease, five scientists in the United States and UK told Reuters.
Companies including GlaxoSmithKline (GSK.L), Vir Biotechnology (VIR.O) and Humanigen (HGEN.O) confirmed they had spoken to researchers on trials using their current treatments against long COVID. Others including Pfizer (PFE.N) and Roche (ROG.S) said they are interested but would not elaborate on plans.
Researchers, biotech companies and public health experts say major pharmaceutical companies are integral to getting a proven treatment for the disease, which currently afflicts more than 100 million people, according to the World Health Organization.
"When you look at the numbers for heart failure, for diabetes, etc, that is the ballpark we are talking about," said Amitava Banerjee, a leading researcher on a long COVID trial.
Long COVID, with some 200 reported afflictions that include fatigue, chest pain and brain fog, is defined by symptoms that last longer than 3 months. It sidelines people who have had both mild and severe COVID-19, including children. In the United States, it is estimated to have affected 1-in-7 working age adults.
Sandi Zack, 53, a former elementary school teacher from the Atlanta area who can no longer work, described symptoms including extreme fatigue, dizziness, pain and heart palpitations since contracting COVID in December 2020.
She has sought help from a range of specialists and tried a variety of drugs to ease her symptoms including steroids and the antidepressant fluvoxamine.
“We’re all still out here,” she said. "Hoping, and waiting.”
There are fewer than 20 clinical trials underway testing drugs, a handful of which have moved beyond early stages, according to interviews with more than a dozen independent and government-backed scientists and a Reuters review of a global clinical trials database.
Scientists hope their research will uncover the causes of long COVID, a major hurdle in finding targets for new drugs or identifying existing medicines that may work as treatments.
“We are getting to the stage where we are getting traction, and for people suffering, we are getting treatments tested,” said David Strain, a University of Exeter Medical School lecturer whose research has informed which treatments will be tested in a major British trial. “Hopefully we will have things we can we offer them to get their lives back to normal in the near future.”
Big pharmaceutical companies are looking for disease-specific biomarkers that would allow them to assess the value of tested medicines, experts say.
“What they’re struggling with is a case definition for long COVID,” said Dr. Amy Proal, an expert in post-viral diseases at the PolyBio Research Foundation in Mercer Island, Washington. She said she has held confidential meetings with two venture capital groups and one major pharmaceutical company.
Possible underlying causes researchers are studying include damage from the original infection, lingering reservoirs of virus in the body, an autoimmune response, in which the immune system attacks its own cells, and a dysregulated immune response causing excess inflammation that damages small blood vessels or nerves. It could be a combination of those or other factors, they say.
SEARCHING FOR A CURE AND FUNDING
One major UK-funded trial led by University College, London, will test four drugs among 4,500 long COVID patients.
They include antihistamines loratadine and famotidine, the gout and heart inflammation treatment colchichine - all available as generics - and Johnson & Johnson's (JNJ.N) blood clot preventer Xarelto (rivaroxaban).
All have data from preliminary studies in people suggesting they could work against some of the possible disease targets for long COVID, such as inflammation and blood clots.
Banerjee, lead researcher on that trial, said the drugs will target several potential underlying mechanisms of long COVID while seeking to understand more about them.
“It’s challenging, because we’re going for a hazy target,” he said in a phone interview. “People on the industry side are trying to figure it out too.”
U.S-based Axcella Therapeutics is working with the University of Oxford in the UK on a drug developed for nonalcoholic steathohepatitis (NASH), a liver disease marked by dysregulated metabolism, inflammation and scarring.
In long COVID, the hope is the drug will restore the normal function of mitochondria - the energy factories of cells. Poorly functioning mitochondria may explain the crushing long-term fatigue so many patients experience.
As lead researcher Dr. Betty Raman put it, if COVID damaged the battery, the drug aims to restore that battery, so cells can perform their normal functions without using up too much energy.
PureTech Health (PRTC.L), another U.S. biotech, is running a midstage trial of an experimental pulmonary fibrosis treatment aimed at preventing long-term lung scarring linked with COVID.
In Seattle, researchers at the University of Washington and the Fred Hutchinson COVID Clinical Research Center are testing Resolve Therapeutics' experimental treatment targeting fatigue in long COVID patients.
The drug works by dissolving certain RNA in the blood that has been linked with increased inflammation in patients with autoimmune diseases such as Lupus and Sjogren's syndrome, said Dr. James Andrews, a rheumatologist at the University of Washington who is leading the trial.
Scientists who believe the root cause of long COVID could be lingering virus are keen to test whether existing COVID-19 treatments or vaccines could have an impact.
Moderna (MRNA.O) is donating its vaccine for early trials in the UK testing whether it can help kickstart the immune system and ease long COVID symptoms, the company said in an emailed statement.
Funding has been a struggle for some companies.
Berlin Cures Holding AG, a German biotech, secured only enough money for the first stage of testing of its autoimmune drug - previously used for heart failure - that has shown promise in a handful of patients when used experimentally.
“People call us and they cry on the phone," Chief Operating Officer Peter Goettel told Reuters. "Some people want to sell their house to give us donations, just to get a shot.”
Insiders Buy These 2 Stocks at Discounted Prices — Analysts Say They Have Over 200% Upside Potential
https://finance.yahoo.com/news/insiders-buy-2-stocks-discounted-194703999.html
Next up in Humanigen, a $250 million dollar biopharmaceutical research company, whose leading drug candidate, lenzilumab, is under investigation in three late-stage clinical trials. Lenzilumab is a potential cancer treatment; two of its trials are evaluating it against acute GvHD and chronic myelomonocytic leukemia, while the third, the SHIELD study, will test lenzilumab as a preventative treatment for CAR-T-related toxicities.
Most importantly, however, Humanigen is moving forward with the ACTIV-5/BET-B study, a clinical trial of lenzilumab as a treatment for COVID-19. The company announced earlier this year that it has achieved target enrollment in the ACTIV-5/BET-B study, which is a follow up to last year’s LIVE-AIR Phase 3 study.
The NIH is sponsoring the ACTIV-5/BET-B follow-on, and has advanced the study from a Phase 2 exploratory to a Phase 2/3 treatment investigation. That modification of the study will enable Humanigen to use it as a confirmatory study in a push forward with a Biologics License Application for lenzilumab as a COVID treatment. Top line data is expected in the next quarter.
Investors should note that company management – and some of Wall Street’s biopharma experts – are sanguine about lenzilumab’s ability to treat COVID, regardless of the variants. Management noted in a recent conference that a patient’s risk of going on a ventilator or dying from the virus was not impacted by which variant caused infection. This is an important finding, that can support lenzilumab as a COVID treatment.
Turning to Humanigen’s other clinical projects, the SHIELD study is on schedule and getting started in the first half of this year. The company has announced that it is in alignment with the FDA on the registration phase of the trial. Initial data is expected for release in December of this year.
Two other trials, the Phase 2/3 RATinG and the Phase 2 PREACH-M, are also getting underway in the first part of this year. The company is in the enrollment stage of RATinG, a clinical trial of lenzilumab against acute GvHD. It has begun dosing patients in the PREACH-M trial against Chronic myelomonocytic leukemia. Both of these trials are expected to reach later stages before the end of 2022.
Humanigen shares have been falling steadily for the past 12 months; the stock is down 80% in that period. However, while the shares are down, CSO and Board member Dale Chappell made a stir and swung the sentiment deep into the positive range with his recent purchase of 1 million shares for a total of $3 million.
This stock has also caught the attention of Oppenheimer's 5-star analyst Kevin DeGeeter who sees Humanigen positioning itself for future gains.
“HGEN reiterated top-line data readout from ACTIV-5/BET-B study of lenzilumab in COVID-19 in late 1Q22 or early 2Q22. Management considers >20% reduction on the risk of patients progressing to mechanical ventilation or death as clinically differentiated from competitor compounds. Regulatory filings for lenzilumab in treating hospitalized COVID-19 patients are on track pending ACTIV-5 readout. Separately, we view Phase III development of lenzilumab on prophylaxis of CAR-T neurotoxicity as intriguing…. We view the top-line readout from ACTIV-5/BET-B study in late 1Q22/early 2Q22 as the most important upcoming milestone for HGEN,” DeGeeter noted.
DeGeeter is bullish here, and gives the shares an Outperform (i.e. Buy) rating. His $16 price target suggests an upside of 337% for the year ahead. (To watch DeGeeter’s track record, click here)
All in all, Humanigen boasts a unanimous Strong Buy analyst consensus rating, based on 3 recent stock reviews. The shares are selling for $3.66 and their $23.67 average price target indicates an upside of 547% from that level.
Mild COVID-19 imprints a long-term inflammatory eicosanoid- and chemokine memory in monocyte-derived macrophages
https://www.nature.com/articles/s41385-021-00482-8
Thus, previous SARS-CoV-2 infection imprints a pro-inflammatory macrophage phenotype, that mounts exaggerated chemokine- and IFN responses, but likely exhibits impaired T-cell stimulatory and pro-resolving capacities. This was in line with previous studies identifying a dysfunctional, pro-inflammatory monocyte activation for up to 12 weeks after SARS-CoV-2 infection7,13 and additionally suggested the long-term persistence of a pro-inflammatory macrophage state following mild disease. Changes in gene expression of post COVID-19 MDM were amplified by inflammatory stimuli, suggesting a “trained” state that lasted for at least 5 months post infection.
(From Jerry)
That almost had to be Dale buying on Friday. It is conceivable that he bought 3+ million shares on Friday. It won't be surprising if he continues buying large quantities of shares on Monday and Tuesday. On Tuesday night, we would get the Form 4 for the 3 days of buys.
"A novel lead variant was identified inside the gene encoding granulocyte-macrophage colony-stimulating factor (GM-CSF), CSF2. GM-CSF was a crucial cytokine in the synthesis and differentiation of myeloid cells such as neutrophils, macrophages, and monocytes.
The authors previously demonstrated that the circulating GM-CSF levels were linked to the severity of COVID-19, indicating its role as a pharmacological target in severe illness."
https://www.news-medical.net/news/20220311/Novel-genetic-relationships-with-severe-SARS-CoV-2.aspx