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Interview with VP of Data Science Research on COVID-19 Studies with Humanigen
https://www.biosymetrics.com/blog/blog-interview-with-vp-of-data-science-research-on-covid-19-studies-with-humanigen
BioSymetrics partnered with Humanigen in 2021 to investigate whether subsets of patients in the company’s Phase 3 study of lenzilumab for severe COVID-19 responded differently to the drug. Below is an interview with BioSymetrics’ VP of Data Science Research, Victoria Catterson, PhD, about the work and subsequent publications.
Question: Findings from Humanigen's Phase 3 study of lenzilumab in patients with severe COVID-19 were recently published in the Lancet Respiratory Medicine and more papers are pending in other peer-reviewed journals. BioSymetrics partnered with Humanigen in support of these studies. Can you summarize what BioSymetrics did as part of this collaboration??
Victoria: The successful Phase 3 clinical trial showed higher likelihood of survival without mechanical ventilation (SWOV) for patients treated with lenzilumab. SWOV is an endpoint which captures not only survival, but also quality of life of the surviving patients, and is therefore a strong marker of effectiveness. We applied our Clinical Insights workflow, from our phenotypic-driven drug discovery platform, to investigate whether there were some subsets of patients in the trial cohort who responded particularly well to lenzilumab. This type of patient stratification can unlock precision medicine, where therapeutics are chosen for an individual patient based on attributes of their specific case, rather than drugs being used for a disease cohort.
Question: Some of the BioSymetrics analysis prompted Humanigen to do further study on the dataset. Can you describe what that was, and how it impacted further study design and outcomes?
Victoria: Our analysis found that when controlling for the effect of multiple variables at the same time, the strongest predictor of SWOV was not patient severity, age, or even treatment, but the patient’s initial level of C-Reactive Protein (CRP). CRP is a biomarker indicating inflammation in the body, and normal, healthy levels are under 10 mg/L. The inflammation caused by COVID-19 can drive these levels very high: the median value in the trial population was 79 mg/L, and 25% of the cohort had values over 137 mg/L. While no one in this patient population had a “healthy” level of CRP, our findings showed that those with initially lower CRP were more likely to survive.
This prompted follow-up investigation focusing specifically on the interaction of lenzilumab and CRP. When stratifying patients according to CRP, those in the lowest quartile (<47 mg/L) showed the highest benefit of lenzilumab, with over 8 times the chance of SWOV if given lenzilumab versus placebo. At the other end of the CRP scale, those in the highest quartile (>137 mg/L) showed the most modest benefit from lenzilumab, with only a 17% increased chance of SWOV over those on placebo.
The main take-away is that lenzilumab demonstrated efficacy across the whole cohort, but we uncovered the particularly strong effect in those with lower CRP in this cohort. Future trials can be structured to confirm the effect seen here, pointing the way to the use of CRP as a biomarker to personalize the use of lenzilumab.
Question: What would you hope other pharma companies might take away from the work conducted with Humanigen, and how that might be applied to more studies in COVID-19??
Victoria: At BioSymetrics, our mission is to use phenomics-driven drug discovery to translate human disease biology and advance precision medicines to ultimately improve people’s lives. Many diseases that were previously thought to be monolithic conditions have been refined into subtypes, such as when different genes within the same pathway trigger similar symptoms. We believe that the future is precision medicine, where we take account of the patient’s specific history, symptoms, demographics, genomics, and any other relevant factors in order to determine a treatment plan tailored to them.
If you have longitudinal electronic health records (EHRs), genomics, medical images, notes, or some combination of health data, we can use our platform to uncover the phenogroups, or clusters of patient attributes, within an overarching disease diagnosis. Further stages of the platform can then focus drug discovery on one or more of these phenogroups. We believe that phenomics-driven drug discovery leads to a more targeted therapeutic, with more specific patient criteria for trial recruitment, and ultimately a higher chance of success at clinical trial.
Question: What other work is BioSymetrics doing currently in COVID-19??
Victoria: We have a broad program of work in COVID-19, starting with patient stratification for Janssen in 2020 while they were determining criteria for their vaccine’s trial enrollment. Prior to the pandemic we were actively working on Acute Respiratory Distress Syndrome (ARDS) in partnership with Northwell Health (the largest hospital network in New York), which positioned us well to expand into COVID-ARDS as it became the highest cause of mortality in COVID-19 patients. We have recently performed phenogrouping on COVID-ARDS patients and compared them with non-COVID-ARDS, highlighting that some phenogroups are similar between the two diseases, but COVID-ARDS also presents differently in a large proportion of patients.
Finally, we have explored the genomics of susceptibility to severe COVID through a partnership with Sunnybrook Hospital in Toronto, which led to a follow-on study linking the genomics and EHR phenogroups, to uncover biomarkers for precision use of COVID therapeutics.
For more information on the Humanigen collaboration and results, you can read the Phase 3 study of lenzilumab in the Lancet Respiratory Medicine and an analysis of CRP levels from the study on medRxiv.
All I care about is the ACTIV-5 data. Nothing else matters. GM-CSF is the key to Covid so the ACTIV-5 data will replicate the LIVE-AIR data. If the ACTIV-5 data is similar to the LIVE-AIR data, an EUA will be automatic.
The primary endpoint of the ACTIV-5 is patients with CRP<150mg/L and <85yo. That population had 196% efficacy in the LIVE-AIR trial. Stat sig is all but guaranteed in the ACTIV-5.
https://www.bbc.com/news/health-56352128
Smart money is loading up at $.70 for a second run.
"CytoDyn expects to file the BLA for leronlimab for the treatment of HIV with FDA in the first quarter of 2022," stated Dr. Nader Pourhassan, President and CEO of CytoDyn.
The share price will hit $.80 on Monday, $.90 next week, and $1.00 in January. This stock is resilient. It always bounces back.
I just bought back into CYDY at $.70. I feel dirty.
This is brutal. But I'm not worried. All that matters is the ACTIV trial data. If the trial hits stat sig, an EUA will be automatic. And the ACTIV trial will hit stat sig. The LIVE-AIR trial had 196% efficacy with the ACTIV's primary endpoint. Not getting stat sig would be a big surprise.
ACTIV-5 data in March. EUA in April.
Humanigen to Present at Investor Conferences January 7 and 13, 2022
https://ir.humanigen.com/English/news/news-details/2022/Humanigen-to-Present-at-Investor-Conferences-January-7-and-13-2022/default.aspx
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 Cameron Durrant, chairman and chief executive officer of Humanigen, will present at two healthcare conferences in January 2022. The company and its management are also expected to meet with investors, analysts, bankers and potential partners during the conferences next week. All presentations and meetings will be held virtually. Dr. Durrant will provide updates on recent interactions with regulatory authorities from the United States, United Kingdom and European Union. Dr. Durrant also will provide updates on the enrollment for the ACTIV-5/BET-B clinical trial of lenzilumab in hospitalized COVID-19 patients (NCT04351152), the strategy and potential timing of an amendment to the Emergency Use Authorization (“EUA”) of lenzilumab for COVID-19 to the U.S. Food and Drug Administration (“FDA”) and the timeline for the response to written questions received from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”). Lastly, Dr. Durrant will describe the company’s clinical development pipeline, including foreign COVID-19 trials with lenzilumab and the studies in CAR-T, aGvHD and CMML.
Details of the presentations and link to webcasts are as follows:
H.C. Wainwright BIOCONNECT Virtual Conference - January 10 – 13
The prerecorded presentation will be available beginning Monday January 7, 2022, 7:00 AM ET
Link to webcast: https://journey.ct.events/view/69fd2a11-6a62-43f3-86a4-17f12adbdda3
40th Annual JP Morgan Healthcare Conference
The live presentation will be given Thursday, January 13, 2022, 7:30 AM ET
Link to the webcast: https://jpmorgan.metameetings.net/events/healthcare22/sessions/39967-humanigen/webcast?gpu_only=true&kiosk=true
Solebury Trout Management Access Event
Humanigen is also participating in the Solebury Trout Management Access Event, being held virtually between each of January 10-13 and January 18-20, 2022. Parties interested in 1x1 meetings with management are invited to register for a private meeting at https://troutaccess.com/investor.php/c/SoleburyTrout1x1ManagementAccessEvent2022
The mushroom investors are going to bring this stock back to 40 cents quickly. And then a good chance for an EUA when the data arrives. An EUA would increase the share price 20-fold or more. I am loving this stock.
Lenzilumab Treatment Response in Hospitalized COVID-19 Patients Correlates with C-Reactive Protein Levels
https://ir.humanigen.com/English/news/news-details/2022/Lenzilumab-Treatment-Response-in-Hospitalized-COVID-19-Patients-Correlates-with-C-Reactive-Protein-Levels/default.aspx
-Multi-variate analysis of LIVE-AIR Phase 3 data demonstrates that elevated baseline C-Reactive Protein (“CRP”) is the most predictive feature for progression to invasive mechanical ventilation (“IMV”) or death and may be a useful biomarker to guide therapeutic intervention
-Patients with baseline CRP<150 mg/L who received lenzilumab had a more than 2.5-fold higher likelihood to survive without IMV than patients who received placebo (p<0.001)
-Findings suggest hospitalized COVID-19 patients who are early in the hyper-immune response, with lower baseline CRP levels (CRP<150 mg/l), achieve even greater clinical benefit from lenzilumab treatment
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’ with its lead drug candidate, lenzilumab, announced that a manuscript detailing the results of an analysis of CRP levels from the LIVE-AIR Phase 3 study is available on medRxiv (https://www.medrxiv.org/content/10.1101/2021.12.30.21267140v1) . The results indicate the greatest clinical benefit of lenzilumab treatment may be achieved in hospitalized COVID-19 patients with lower baseline CRP levels, which typically occur earlier in the progression of the disease.
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is an early upstream mediator and orchestrator of the hyperinflammatory immune response following SARS-CoV-2 infection and serves to activate and expand inflammatory myeloid cells. Increases in CRP are driven by elevations of myeloid cell derived downstream cytokines. Highly elevated levels of CRP (>150 mg/L) may indicate a stage of the hyperinflammatory immune response by which sufficient myeloid activation has already occurred, rendering GM-CSF neutralization less adequate to prevent further disease progression.
This analysis and publication provide evidence that a biomarker-driven approach utilizing baseline CRP levels to guide therapeutic intervention and patient selection may improve outcomes in patients hospitalized with COVID-19.
“We are encouraged by these results” said Dr. Dale Chappell, Chief Scientific Officer, Humanigen. “In the context of other GM-CSF targeting therapies having failed to progress in development for COVID-19, these results confirm the importance of patient selection and understanding disease processes when designing clinical trials. Importantly, ACTIV-5/BET-B, a potentially confirmatory Phase 2/3 study, utilizes CRP<150 mg/L to define the primary analysis population.”
Dr. Cameron Durrant, Chief Executive Officer, Humanigen, added, “The PREACH-M study in chronic myelomonocytic leukemia being conducted at 5 centers in Australia has begun dosing patients. Both the SHIELD study in CAR-T and the RATinG study in acute Graft versus Host Disease (aGvHD) are planned to begin enrolling in the first half of 2022, in the US and the UK respectively. Additional COVID studies which will be completed or initiated in 2022 include the NIH-sponsored ACTIV-5/BET-B study in the US and Korea and the C-SMART study being conducted in Australia. All are late-stage, clinical studies. Further strengthening the Humanigen pipeline is our Phase 1 program focused on ifabotuzumab in solid tumors.”
I just bit the bullet and sold for tax purposes. The December decline in share price made it too tempting. There doesn't seem to be any potential positive catalysts for several months so I'll likely be fine waiting 30 days to buy back.
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A Phase 2/3 Randomized, Placebo-Controlled, Open-Label, Multi-Center Trial of Lenzilumab to Improve the Safety and Efficacy of CAR-T Cell Therapy in Adults with Relapsed or Refractory Large B-Cell Lymphoma (The SHIELD Study)
https://ashpublications.org/blood/article/138/Supplement%201/1758/480686/A-Phase-2-3-Randomized-Placebo-Controlled-Open?searchresult=1
Abstract
Background: Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive sub-type of non-Hodgkin's lymphoma(Liu, et al. Am J Hematol 2019). All three approved CD19-directed CAR-T therapies (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel) are associated with toxicities, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) that can be severe, resulting in non-relapse mortality, ICU admission, and significant non-drug related health resource utilization which represent barriers to access and adoption (Nabhan, et al. J Clin. Pathway 2017). Studies have shown that early elevation of granulocyte-macrophage colony-stimulating factor (GM-CSF) levels 1-day post CAR-T infusion correlates with severe ICANS (Rossi, et al. EMA Workshop 2016), which is a negative prognostic factor for overall survival (Karschnia, et al. Blood 2019). It has been proposed that upon contact with the tumor, CAR-Ts produce GM-CSF, which serves as a communication conduit between the specific immune response of CAR-T and the off-target inflammatory cascade produced by myeloid lineage cells, causing myeloid cells to expand and promote the production of other downstream proinflammatory chemokines (MCP-1, IL-8, IP-10), cytokines (IL-1, IL-6), and other markers of systemic inflammation (CRP, Ferritin) (Sterner, et al. Blood 2019). Moreover, IL-6 is predominately released by tumor cells in a contact-independent manner (Barrett et al. Blood 2016), which helps explain why the prophylactic administration of tocilizumab is not effective in reducing the overall incidence of CRS or ICANS, as this cytokine is downstream in the inflammatory cascade. Further, the prophylactic use of tocilizumab has been shown to increase the incidence of all-grades and grade >3 ICANS (Locke, et al. Blood 2017). Lenzilumab is a novel Humaneered ® monoclonal antibody that neutralizes GM-CSF and has demonstrated potential to reduce the hyper-immune mediated cytokine storm induced by SARS-CoV-2 infection and significantly improve the likelihood of survival without ventilation in hospitalized COVID-19 patients, as reported in the LIVE-AIR phase 3 study (Temesgen, et al. medRxiv 2021). Methods: Eligible patients are adults (≥ 18 y) with relapsed or refractory DLBCL or are chemorefractory. Prior therapy must have included an anti-CD20 monoclonal antibody and an anthracycline-containing regimen. Patients will undergo leukapheresis and may receive optional corticosteroid bridging therapy. Patients will then receive lymphodepleting chemotherapy on Days ?3 to ?5 followed by infusion of lenzilumab on Day 0, 6-hrs prior to CAR-T infusion. Approximately 40 accredited sites across the U.S. certified to administer the three commercially available CAR-Ts have been engaged to participate in this 2-part study. In Part 1, all patients will receive lenzilumab 1800mg via a single 2-hour infusion prior to CAR-T administration. The objective of Part 1 is to evaluate the optimal regimen and assess whether a second dose of lenzilumab post-CAR-T infusion is required. A translational assessment of GM-CSF axis suppression, levels of CAR-T cells in blood, other inflammatory markers and lenzilumab PK/PD will be evaluated, along with the incidence and severity of CRS and ICANS, objective response rates (ORR) and rates of complete response (CR) by Day 28 to select the optimal regimen to carry forward into Part 2. The objective of Part 2 is to confirm whether lenzilumab can improve the toxicity and tolerance of CAR-T while maintaining or improving efficacy and durability of response. Up to 250 patients will be randomized 1:1 to receive lenzilumab or placebo with CAR-T per standard of care. The primary endpoint of the study is incidence of grade >2 CRS and/or ICANS by Day 28, with a key secondary endpoint of CR at 6-months in patients without grade ≥ 2 CRS and/or ICANS at Day 28 (Toxicity-free CR). This design and sample size yields 90% power to detect a 50% reduction in the primary outcome measure. Secondary endpoints include incidence of all grades and grade >3 CRS and/or ICANS, respectively; ORR and CR at 1, 3, 6, 12 months; durability of CR; progression-free survival, overall survival and health related quality of life using validated patient reported outcome measures. In addition, the study will explore the CRS and ICANS grading criteria that have been utilized with each of the approved CAR-Ts.
This is an easy stock to be invested in if you have a long term mindset. Lenzilumab is a great drug. I realize investors in every drug company say that about their drug but with lenzilumab, it is true. GM-CSF inhibition will certianly be used for many indications in the future. Lenzilumab has been shown to be an effective GM-CSF inhibitor with no safety issues. The stock is seriously undervalued even if Covid doesn't work out. HGEN stock is literally trading at pre-Covid levels.
But a Covid EUA is coming. Virtually all currently authorized mAbs are useless against Omicron. Lenz has 154% efficacy for patients with CRP<150mg/l. Lenz is variant agnostic so it will have the same efficacy against Omicron as previous variants. Lenz is the most obvious way to treat newly hospitalized Omicron patients. While there is no guarantee that lenzilumab will get the EUA this winter, I think the chances are better that it will than won't.
So HGEN is a safe long term investment because of the the growing potential for GM-CSF inhibition but has a high chance of going 5x-20x in the next few months if lenz gets the Covid EUA. It is an easy choice to stay invested. I just went back to 100% invested in HGEN.
Here is a post from Corundum from another board that explains how today's volume went from 3.9 million shares right before close to over 23 million shares a few minutes after close:
So I believe I have the numbers figured out. 3.9 million shares traded before the close. This may have included some that the MM needed to complete the XBI rebalance. Most of the rebalance was already allocated to other parties, possibly including other family funds. Between 16:00 and 16:00:58 the initial MOC came in at 10.4 million shares, leading the 16:00:58 shares traded figure to be at 14.3 million (see above posts with Level 2 data). The 10.4 million shares for MOC included 8 million (7,977,249) sold/transferred to other funds/investors as pre-planned. In addition, 749,055 for a LABU rebalance got recorded at 16:00:58 (Humanigen shares sold -- but not all of the LABU amount). The remaining 1.65 million shares were true MOC, which is consistent with the heavy transactions occurring in the last 30 minutes of the day, and consistent with quad witching, etc. In the next 2.5 minutes, Nasdaq recorded an additional 9.3 million in transactions, almost all of which was double booking. There is the XBI offset (7,977,249) the LABU offset (899,055 total shares), the LABU sales missed in first MOC (150,000), one transaction of 225,222 that might have been related to the XBI rebalance (if so, the true MOC excluding rebalance might have been 225,222 higher than 1.65 million)and a few small after hours sales (17,000) that might have been caught up in a restatement of MOC. So you had 3.9 million shares prior to close, 8 million XBI rebalance (offset by exact count of 7,977,249 = 8 million reported 2 minutes after close), 900,000 LABU rebalance (duplicated by another 900,000 in three transactions), 1.65 million true MOC, 225,000 transaction not sure. Equals 23.575 million total reported with the price not really moving much because it is a rebalance. There may have been rounding effects in the 3.9 million and 14.3 million figures above that lead my numbers to be slightly more than 23.5 million. Best guess overall.
The latest XBI holdings showed the XBI owning 7,977,249 shares of HGEN. A trade was posted today at 16:02:05 for 7,977,249 shares. Seems HGEN might no longer be part of the XBI. If true, I think that is a huge positive. XBI has been a thorn in HGEN's side for the last 10 months. HGEN is back to controlling its own destiny instead of being controlled by the XBI's movement.
LENZILUMAB IN HOSPITALIZED BLACK/AFRICAN-AMERICAN COVID-19 PATIENTS: LIVE-AIR PHASE 3 STUDY RESULTS
https://journals.lww.com/ccmjournal/Fulltext/2022/01001/23__LENZILUMAB_IN_HOSPITALIZED.26.aspx
Background: Black/African Americans (B/AA) are twice as likely as Whites to develop COVID-19, possibly due to disparities in healthcare access and genetics. Mutations in the angiotensin converting enzyme gene enabling greater SARS-CoV-2 replication may be overexpressed in B/AAs leading to increased viral load, morbidity, hospitalizations, and mortality. The hyperinflammatory cytokine storm accompanying SARS-CoV-2 infection is mediated by GM-CSF releasing downstream inflammatory chemokines, cytokines, and inflammatory markers including C-reactive protein (CRP), predictive of clinical worsening. This analysis of LIVE-AIR explored the efficacy of lenzilumab in its B/AA population.
Methods: LIVE-AIR was a randomized, double-blind, placebo-controlled trial of 479 (mITT population) hospitalized COVID-19. Patients, ≥18 years old with oxygen saturation ≤94% on room air or requiring supplemental oxygen (low-flow or high-flow), but not invasive mechanical ventilation, were randomized to receive lenzilumab (1800?mg, n=236) or placebo (n=243) via three IV infusions, every 8 hours, within 12 hours of randomization. A secondary analysis of the primary endpoint, survival without ventilation (SWOV), by race/ethnicity and baseline CRP level was assessed at Day 28.
Results: Participants were racially and ethnically diverse: 3.1% Asians, 14.8% B/AA, 38.6% Hispanic/Latino. The likelihood of SWOV was significantly improved by lenzilumab across races and ethnicities compared with placebo (HR: 1.54; 95% CI: 1.02, 2.32; p=0.0403; N=479) and in patients with baseline CRP< 150?mg/L, < 85 years of age (HR 3.04; 1.68, 5.51; p=0.0003; n=337). The likelihood of SWOV in B/AAs trended higher than the overall population (HR: 2.68; 0.89-8.12; p=0.0811; n=71) and was significantly and disproportionately improved in those with baseline CRP< 150?mg/L (HR: 8.96; 1.09-73.55; p=0.0412; n=51). Serious adverse events were similar across treatment groups.
Conclusion: In LIVE-AIR, with a B/AA representation comparable to the US population and usually under-represented in trials, lenzilumab improved the likelihood of SWOV across races and ethnicities of COVID-19 patients; however, B/AA with baseline CRP< 150?mg/L exhibited a markedly greater improvement. Biological, genetic, and social factors contributing to these differences requires further investigation.
https://twitter.com/Gab_H_R/status/1471550460003815427/photo/1
Denmark Warning sign
Omicron vs Delta Hospitalizations Warning sign
Please tell me, what do you see?
Here are some lenzilumab science-related articles for those wanting to do some due diligence. Lenzilumab is a GM-CSF inhibitor. The "M" in GM-CSF is macrophage. Yada, yada, yada.
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
The Warren Buffett quote "buy when there is blood in the streets" applies to HGEN right now. It is at rock bottom. It is virtually risk free at this price. The share price will likely return to $5.25-$5.75 next week. That is a 10%-20% profit in one week's time.
Sentiment has changed but the facts remain the same. Lenz has 154% efficacy with CRP<150mg/L and 733% efficacy with CRP<41mg/L. Lenz is variant agnostic. Lenz had zero safety issues in its trial. The EUA is coming. This month's Type B Meeting with the FDA will be fruitful.
@humanigen
Data from S. Africa shows rapid rise in cases of #Omicronvariant is now leading to rapid rise in new hospitalizations--doubling every 5 days. Data is part of rationale @CMO_England cited for implementing "Plan B" in UK. Highlights the need for #variantagnostic treatments https://t.co/87EILkRuce
— Humanigen, Inc. (@humanigen) December 8, 2021
California-Based Biopharma Advances Lead Asset in COVID-19, Other Indications
Source: Streetwise Reports (12/8/21)
https://www.streetwisereports.com/article/2021/12/04/california-based-biopharma-advances-lead-asset-in-covid-19-other-indications.html
Results of the LIVE-AIR trial, evaluating Humanigen Inc.'s (HGEN:NASDAQ) lead asset lenzilumab in hospitalized patients with COVID-19 pneumonia, completed earlier this year, were published in a recent issue of the British medical journal Lancet Respiratory Medicine, reported ROTH Capital Partners analyst Tony Butler in a Dec. 2 research note. Lenzilumab is an antibody that neutralizes the cytokine GM-CSF.
Butler reiterated LIVE-AIR's results, writing that "the conclusion of the study demonstrated that lenzilumab treatment of hospitalized patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile similar to that of placebo."
In other news, Humanigen has a type B meeting with the U.S. Food and Drug Administration (FDA) this month to discuss additional LIVE-AIR data. Three months ago, the FDA denied Humanigen emergency use authorization of lenzilumab in the same patient population.
Also in the U.S., the biopharma is working to submit a biologic license application for lenzilumab with the FDA while the ACTIV-5/Big Effects trial of lenzilumab is underway, Butler indicated. The population of the study, sponsored by the National Institutes of Health and in the enrollment stage, will be hospitalized, hypoxic COVID-19 patients but only those with a C-reactive protein of less than 150 milligrams per liter.
"It is possible this type B meeting may serve as a prelude to an advisory panel for lenzilumab and/or that the FDA may wait until a readout from the ACTIV-5/BET-B trial before taking further action concerning the use of lenzilumab in COVID-19 in the U.S.," Butler explained.
Outside the United States, Humanigen continues to pursue approval of lenzilumab. In the United Kingdom (U.K.), for instance, the biopharma has a meeting this month with the Medicines and Healthcare products Regulatory Agency concerning further information it requested in conjunction with Humanigen's conditional marketing authorization application. The company plans to respond to the request formally in Q1/22.
Also, Humanigen's marketing authorization application filed with the European Medicines Agency is still under review.
Butler pointed out Humanigen is testing lenzilumab in indications other than COVID-19, and has three such multisite trials on tap. One, the PREACH-M study, for which patient recruitment is underway at five Australian sites, will evaluate the efficacy of combination treatment, lenzilumab plus azacitidine, in patients with chronic myelomonocytic leukemia.
The other two trials, SHIELD and RATinG, are slated to commence in H1/22. SHIELD will evaluate the use of a combination therapy of lenzilumab plus commercially available chimeric antigen receptor T-cell therapies in patients with non-Hodgkin's lymphoma. About 250 patients will be enrolled from 30 sites.
RATinG will evaluate lenzilumab in patients who have undergone allogeneic hematopoietic stem cell therapy and have an intermediate to high risk of developing acute graft versus host disease. The trial will span 22 sites in the U.K.
ROTH has a Buy rating and a $19 per share price target on Humanigen. Its current share price is about $5.57.
According to The Chest Journal publication, the 25% of patients in the lenzilumab's LIVE-AIR trial that had the lowest CRP levels had a hazard ratio of 8.33 in the treatment arm. Those were the 119 patients with a CRP level below 41mg/L. A hazard ratio of 8.33 means that those patients had 8.33-fold efficacy or 733% efficacy. 733% efficacy is absolutely insane. The obvious conclusion is that all patients who become hospitalized with Covid should be given lenzilumab the moment they are admitted into the hospital. The US FDA didn't have the CRP data when they decided on lenz's EUA. They have that data now. Good things are going to come from this month's type B meeting with the US FDA.
https://journal.chestnet.org/article/S0012-3692(21)03654-0/fulltext
Dr. David Lyness
Could we look at GM-CSF as a target? It's associated with endothelial injury and thrombosis. High GM-CSF levels were not found in fatal FLU, but were found in fatal COVID. #SOA21 pic.twitter.com/ut0iD6bBcw
— Dr. David Lyness (@Gas_Craic) December 6, 2021