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$8.00 tomorrow?
Humanigen Inc. - European Commission Report of the COVID-19 Therapeutics Sub-Group
https://s28.q4cdn.com/539885110/files/doc_presentations/2021/October/Final-Report-of-COVID-19-therapeutics-subgroup-for-European-Commission-Oct.-22-2021.pdf
There has been sustained buying throughout today. That is a good sign.
Lenzilumab is variant agnostic so its efficacy will not be affected by mutations.
Humanigen announces preparation of Phase 1b study of ifabotuzumab in solid tumors following presentation of Phase 1 study results at EANM‘21
https://ir.humanigen.com/English/news/news-details/2021/Humanigen-announces-preparation-of-Phase-1b-study-of-ifabotuzumab-in-solid-tumors-following-presentation-of-Phase-1-study-results-at-EANM21/default.aspx
-An abstract showing tumor specific targeting at all known tumor sites in glioblastoma patients, with no normal tissue uptake of ifabotuzumab, from a Phase 1 study will be presented at EANM‘21
-A Phase 1b study of ifabotuzumab in non-CNS solid tumors (such as breast, colorectal, lung, and pancreatic cancer) is planned to start in early 2022
BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company, today announced its research partners will present Phase 1 results from a study of ifabotuzumab in glioblastoma multiforme (GBM) at the Annual Congress of the European Association of Nuclear Medicine (EANM’21) and plan to initiate a follow-on Phase 1b study in non-CNS solid tumors in early 2022. EANM is the largest organization dedicated to nuclear medicine in Europe and represents more than 9,000 specialists from 41 different countries.
The abstract will be presented virtually by Principal Investigator Prof. Andrew Scott, Head, Tumor Targeting Laboratory, Olivia Newton-John Cancer Research Institute; Director of the Department of Molecular Imaging and Therapy, Austin Health; and Professor, School of Cancer Medicine, La Trobe University. The abstract (OP-0854) entitled: “Phase I safety and bioimaging trial of ifabotuzumab in patients with glioblastoma” has been published in the EANM‘21 abstract book and was chosen to be included in a TOP 3 trials session at EANM’21 that will take place from 3:05-4:35pm Central European Standard Time on October 22, 2021.1
“The biodistribution characteristics demonstrated in the Phase 1 GBM study indicate ifabotuzumab has ideal characteristics for a range of therapeutic options including the creation of an antibody-drug conjugate,” said Prof. Scott. “Our preclinical studies with antibody-drug conjugate forms of ifabotuzumab have shown promising results. We hope to take this payload delivery approach into the clinic in the next 1-2 years.”
The Olivia Newton-John Cancer Research Institute plans to conduct a Phase 1b dose-escalation and imaging study in non-CNS solid tumors that is scheduled to begin in early 2022. This will be led by Prof. Andrew Scott and Prof. Hui Gan, Clinical Research Lead, Olivia Newton-John Cancer Research Institute and Director, Cancer Clinical Trials Center, Austin Health.
“We are excited by the potential ifabotuzumab holds to create a novel cancer therapeutic that delivers cytotoxic agents to tumor cells while minimizing toxicity to normal tissue,” said Cameron Durrant, Chairman and CEO of Humanigen. “We look forward to supporting our valued partners in Australia as they advance research of ifabotuzumab into solid tumors.”
About Ifabotuzumab
Ifabotuzumab is a proprietary Humaneered® monoclonal antibody that binds the EphA3 receptor, which plays an important role during fetal development but is not thought to be expressed nor play a significant role in healthy adults. EphA3 is a tyrosine kinase receptor, aberrantly expressed on the tumor vasculature and tumor stroma in many solid tumors including melanoma, breast cancer, lung cancer, colorectal cancer, GBM and prostate cancer, making it an attractive target for a range of cancers.
Humanigen has completed a Phase 1 study in multiple hematologic malignancies that suggest it is well tolerated with mild-to-moderate infusion reactions that can be managed by stopping infusion, or using medications to treat reactions (chills, fever, nausea, hypertension, and rapid heart rate).
In 2021, a Phase 1 safety and bioimaging study of ifabotuzumab, supported by Cure Brain Cancer Foundation, and Humanigen, showed specific and reproducible targeting of the tumor and its microenvironment, with no normal tissue uptake, in all patients. Future development plans, in conjunction with our research partners in Australia, are intended to confirm highly specific tumor uptake in non-CNS solid tumors with the intention of creating an antibody-drug conjugate by linking ifabotuzumab to a cytotoxic (cell-killing) agent.
It feels like we are officially out of the $6.00-$6.50 rut. It is nice that this upward movement is happening on no news. Good news will send the share price soaring.
Humanigen Announces Late-Breaking Presentation at the CHEST Annual Meeting Highlighting C-Reactive Protein as a Biomarker for Identifying Patients Most Likely to Benefit from treatment with Lenzilumab
https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Late-Breaking-Presentation-at-the-CHEST-Annual-Meeting-Highlighting-C-Reactive-Protein-as-a-Biomarker-for-Identifying-Patients-Most-Likely-to-Benefit-from-treatment-with-Lenzilumab/default.aspx
-Baseline C-reactive Protein (CRP) <150 mg/L identified as the strongest predictor of response to lenzilumab in hospitalized COVID-19 patients
-In this population age <85 years, lenzilumab improved likelihood of survival without ventilation by 3-fold and reduced mortality by 2-fold compared to standard treatment that included remdesivir and steroids
BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced a late-breaking (LB) presentation of results from the Company’s randomized, double-blind, placebo-controlled LIVE-AIR Phase 3 study at the CHEST Annual Meeting 2021, which is being hosted by the American College of Chest Physicians® (CHEST) virtually from October 17th to October 20th. CHEST includes more than 19,000 physicians, nurses, and respiratory therapists among its members, including more 15,500 U.S-based members and 3,500 members from more than 100 other countries.
The presentation will be delivered by Zelalem Temesgen, MD, Professor of Medicine at Mayo Clinic and Principal Investigator of the LIVE-AIR Phase 3 trial, highlighting the potential utility of CRP as a means to optimize outcomes with lenzilumab in hospitalized COVID-19 patients. The LB abstract entitled: “C-Reactive Protein as a Biomarker for Improved Efficacy of Lenzilumab in COVID-19 Patients: Results from the LIVE-AIR Trial” has been published in the journal CHEST®and can be accessed via this link.1
Lenzilumab has not been authorized or approved for use in any indication by any regulatory agency.
“Our analysis of LIVE-AIR data using CRP<150 mg/L as a cut-off suggests that early use of lenzilumab in COVID-19 patients upon hospitalization can significantly reduce progression of these patients to a hyperinflammatory state that independent research has already shown results in higher rates of invasive mechanical ventilation and death,” said Dale Chappell, Chief Scientific Officer of Humanigen.2 “Our LIVE-AIR study data show lenzilumab reduces CRP levels, and improves clinical outcomes, and this analysis suggests utilization of CRP as a biomarker may offer an effective way to optimize lenzilumab treatment in hospitalized COVID-19 patients, if authorized or approved for use. In our LIVE-AIR trial, 78% of the LIVE-AIR study population had a baseline CRP less than 150mg/L, representing a substantial population.”
Exploratory analysis of LIVE-AIR results in patients with CRP<150 mg/L and aged <85 years of age, which represented 74% of patients with an evaluable CRP at baseline, show lenzilumab improved the likelihood of survival without ventilation by more than 3-fold (OR 3.04; 95% CI: 1.68-5.51, nominal p=0.0003) compared with placebo and mortality was improved by more than 2-fold (OR: 2.22; 95%CI: 1.07-4.67, p=0.034). Response to lenzilumab was observed in the first through third quartiles of baseline CRP with the greatest response observed in those patients treated earlier in the inflammatory process (<41 mg/L, HR:8.33; 41-<79 mg/L, HR:1.60; 79-<137 mg/L, HR: 2.12; >137 mg/L, HR: 1.17)
Overall, the LIVE-AIR study achieved its primary endpoint of survival without ventilation measured through day 28 following treatment (HR: 1.54; 95%CI: 1.02-2.32, p=0.0403).
About use of CRP to identify immune phenotypes in hospitalized COVID-19 patients
Numerous studies in COVID-19 have published data showing CRP levels are strongly associated with severity of disease and worsening clinical outcomes such as respiratory failure and death.2,3,4,5 As an example, last year, independent researchers established an operational definition of COVID-19 hyperinflammation (COV-HI) from emerging evidence that there was an association between biomarkers of inflammation such as CRP and severe disease. To test this hypothesis, these UK-based researchers conducted a retrospective longitudinal cohort study of 269 consecutive patients admitted to study hospitals in March 2020. Results of the study support the concept that a subset of COVID-19 that meet the definition of the hyperinflammatory phenotype, 82% of which met the criteria due to elevated CRP (CRP>150 mg/L), suffer from worse outcomes than those who do not. The study also showed 74% of those requiring elevated respiratory care met the definition of COV-HI by the time they needed the additional support. In addition, meeting the definition of COV-HI (CRP > 150 mg/L) was significantly associated with next-day escalation of respiratory support or death supporting the concept that therapeutic intervention prior to CRP > 150 mg/L may be necessary to provide an adequate therapeutic window in order to prevent progression to mechanical ventilation and death.4
While the LIVE-AIR results, reported above, suggest an improved treatment outcome for patients treated with lenzilumab with CRP<150 mg/L, other studies of immunotherapies like tocilizumab show a differential benefit in patients with CRP>150 mg/L. A large observational study in Spain showed tocilizumab was associated with decreased risk of death (adjusted hazard ratio 0.34, 95% confidence interval 0.16–0.72, p 0.005) and ICU admission or death (adjusted hazard ratio 0.39, 95% confidence interval 0.19–0.80, p 0.011) among patients with baseline CRP >150 mg/L but not among those with CRP ≤150 mg/L.6 Another study of tocilizumab reported the primary endpoint (the proportion of patients who required noninvasive ventilation or intubation or who died at day 14) was achieved in the overall patient population as a result of the disproportionate benefit seen in patients with CRP>150 mg/L, as no benefit was reported in patients with baseline CRP<150 mg/L. Likewise, a survival benefit was observed at day 90 in this same study for those treated with tocilizumab who had baseline CRP>150 mg/L, but not for those with baseline CRP <150 mg/L.7 This suggests CRP as a biomarker may help physicians to determine which immunotherapeutic may be most beneficial for a particular patient.
UK COVID update: More than 49,000 new cases, highest in 3 months
UK COVID update: More than 49,000 new cases, highest in 3 months
— BNO News (@BNOFeed) October 18, 2021
- New cases: 49,156
- Average: 44,145 (+1,276)
- In hospital: 7,662 (+576)
- In ICU: 832 (+26)
- New deaths: 45
- Average: 124 (+2)
@ScottGottliebMD
https://twitter.com/ScottGottliebMD/status/1449803423906418691
UK reported its biggest one-day Covid case increase in 3 months just as the new delta variant AY.4 with the S:Y145H mutation in the spike reaches 8% of UK sequenced cases. We need urgent research to figure out if this delta plus is more transmissible, has partial immune evasion?
@BNODesk
UK COVID update: Biggest one-day increase in cases in nearly 3 months, up 30% from last week
— BNO News (@BNOFeed) October 17, 2021
- New cases: 45,140
- Average: 42,869 (+1,509)
- In hospital: 7,086 (no update)
- In ICU: 806 (no update)
- New deaths: 57
- Average: 122 (+3)
C-REACTIVE PROTEIN AS A BIOMARKER FOR IMPROVED EFFICACY OF LENZILUMAB IN PATIENTS WITH COVID-19: RESULTS FROM THE LIVE-AIR TRIAL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8503207/
PURPOSE: The hyperinflammatory cytokine storm (CS) of COVID-19 is mediated by GM-CSF leading to release of downstream inflammatory chemokines, cytokines, and corresponding markers of systemic inflammation (C-reactive protein, CRP). The LIVE-AIR study demonstrated that treatment with lenzilumab, an anti-GM-CSF monoclonal antibody in patients hospitalized with COVID-19, safely improved the likelihood of achieving the primary endpoint, survival without ventilation (SWOV) by 1.54-fold (HR: 1.54; 95%CI: 1.02-2.32, p=0.0403) compared with placebo. An exploratory analysis in patients with CRP <150 mg/L and aged <85 years was conducted to determine the effect of lenzilumab when administered prior to advanced inflammation.
METHODS: LIVE-AIR was a phase 3 randomized, double-blind, placebo-controlled trial. Patients with COVID-19 (n=520), ≥18 years, and ≤94% oxygen saturation on room air and/or requiring supplemental oxygen, but not invasive mechanical ventilation (IMV), were randomized to receive lenzilumab (600 mg, n=261) or placebo (n=259) via three intravenous infusions administered 8 hours apart. Participants were followed through Day 28 following treatment.
RESULTS: Overall, baseline demographics were comparable between the two treatment groups: male, 64.7%; mean age, 60.5 years; mean BMI, 32.5 kg/m2; median CRP, 79 mg/L; CRP was <150 mg/L in 78% of participants. Participants received steroids (93.7%), remdesivir (72.4%), or both (69.1%). Lenzilumab (n=159) improved the likelihood of SWOV by 3.04-fold in participants with CRP < 150 mg/L and age < 85 years (3.04; 1.68-5.51, nominal p=0.0003) compared with placebo (n=178). Response to lenzilumab was observed in the first through third quartiles of baseline CRP (<41 mg/L, HR:8.33; 41-<79 mg/L, HR:1.60; 79-<137 mg/L, HR: 2.12; >137 mg/L, HR: 1.17). The incidence of IMV, ECMO, or death was reduced (OR: 0.31; 95%CI: 0.15-0.63, p=0.002) and mortality was improved by 2.22-fold (OR: 2.22; 95%CI: 1.07-4.67, p=0.034). In these participants, lenzilumab decreased CRP as early as Day 2 following treatment, compared with placebo which was further decreased by 38% on Day 28 compared with placebo (24.4±3.4 mg/L vs 39.1±4.9 mg/L).
CONCLUSIONS: Lenzilumab significantly improved SWOV in hospitalized, hypoxic participants with COVID-19 pneumonia with the greatest benefits in SWOV and survival in patients with CRP<150 mg/L and age <85 years. Inhibition of GM-CSF, an orchestrator of CS, early in the hyperinflammatory response improved outcomes in COVID-19. NCT04351152
CLINICAL IMPLICATIONS: CRP, a routine laboratory test can be used to determine in which patients, and at what times, lenzilumab treatment may provide the greatest clinical benefits and outcomes.
We aren't going to find out about lenz's authorization from a program schedule. When it says "Lenzilumab authorization" it isn't saying that it happened. It is going to be a presentation that advocates for authorization.
Closing at $6.49 feels good. It is HGEN's highest closing price since September 23rd. The daytraders had the $6.40's locked in as their selling point. They are going to have to recalibrate or move onto greener pastures.
Here is a link to Durrant's presentation at the LD Micro Event. It was prerecorded on October 4th. I haven't listened to it but there supposedly isn't much new. However, Durrant says that they are close to submitting to the FDA new data from 200 additional patients. People are theorizing that it is the Mayo clinic eINDS patients. Another theory is that is the Australia patients. Most seem convinced it can't be ACTIV-5 patients.
https://me21.mysequire.com/recording?session_id=9121d7d9-29e2-43da-9ae4-53a8c900a554
A couple of new press releases just came out about XBI's ownership of 8.7 million shares of HGEN. I believe this has been known for weeks. XBI owned ~3 million shares pre-crash and upped it to ~8 million shares post-crash.
https://d18rn0p25nwr6d.cloudfront.net/CIK-0000093751/be971b8a-f3c6-4e2e-984a-f3af1a819aea.pdf
https://d18rn0p25nwr6d.cloudfront.net/CIK-0000093751/be971b8a-f3c6-4e2e-984a-f3af1a819aea.pdf
Humanigen’s Budget Impact Model Demonstrates Lenzilumab’s Potential Positive Economic Value in Hospitalized COVID-19 Patients
Oct 11, 2021
https://ir.humanigen.com/English/news/news-details/2021/Humanigens-Budget-Impact-Model-Demonstrates-Lenzilumabs-Potential-Positive-Economic-Value-in-Hospitalized-COVID-19-Patients/default.aspx
*Overall analysis demonstrates treatment with lenzilumab may result in both clinical and economic benefits in the majority of hospitalized patients
*Potential clinical and economic benefits are greater in certain patient populations
BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced that a manuscript describing its budget impact model for the treatment of patients hospitalized with COVID-19 is available on medRxiv (link). These results highlight the value of selecting the right treatment for the right hospitalized patients during this time of unprecedented pressure on health systems.
The cost to care for a COVID-19 patient in the ICU can significantly exceed $100,000 and average costs for patients on invasive mechanical ventilation in ICU amount to $78,245 per patient.1 Lenzilumab is an investigational product and is not currently authorized or approved in any country.
Looks like I was wrong about investors coming back after the 30 day wash sale requirement was up.
Clinical Benefits and Budget Impact of Lenzilumab plus Standard of Care Compared with Standard of Care Alone for the Treatment of Hospitalized Patients with COVID-19 in the United States from the Hospital Perspective
https://www.medrxiv.org/content/10.1101/2021.10.06.21264651v1
Here are some lenzilumab science-related articles for those wanting to do due diligence. Lenzilumab is a GM-CSF inhibitor. The "M" in GM-CSF is macrophage. Lowering GM-CSF is the key to stopping the cytokine storm.
Covid
https://www.bbc.com/news/health-56352128
https://immunology.sciencemag.org/content/6/57/eabg9873
https://directorsblog.nih.gov/2021/04/13/mapping-severe-covid-19-in-the-lungs-at-single-cell-resolution/
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30267-8/fulltext
https://www.nature.com/articles/s41586-021-03569-1
https://www.pharmaceutical-technology.com/news/humanigen-lenzilumab-improves-survival/
CAR-T
https://www.nature.com/articles/s41408-021-00459-7
https://www.nature.com/articles/s41421-021-00255-4
https://www.targetedonc.com/view/lenzilumab-plus-axi-cel-achieves-responses-in-100-of-patients-with-dlbcl-with-limited-toxicity-in-small-study
https://www.healio.com/news/hematology-oncology/20210422/lenzilumab-before-cart-induces-high-response-rates-without-severe-toxicities
Investors who sold when the stock crashed on 9/9/21 will be able to buy again on Monday without triggering wash sale rules. There is a good chance that we get back to the $7s next week.
#lenzilumab BET-B study has been approved in South Korea just now.
— gbe_estory (@EstoryGbe) August 30, 2021
50 out of 400 patients will be selected in Korea.$hgen $telcon $kpmtech #remdesivir vs #lenzilumab pic.twitter.com/HMVZpUvjAL