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Humanigen Inc. (HGEN)

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Last Post: 9/25/2020 12:15:39 AM - Followers: 202 - Board type: Free - Posts Today: 1

https://www.humanigen.com/
 

COMPANY OVERVIEW

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. 




Mayo Clinic Study of Humanigen’s Lenzilumab Shows Rapid Recovery and Discharge in Severe and Critical COVID-19 Patients

June 15, 2020

https://www.businesswire.com/news/home/20200615005324/en/Mayo-Clinic-Study-Humanigen%E2%80%99s-Lenzilumab-Shows-Rapid


Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia 

https://clinicaltrials.gov/ct2/show/NCT04351152 
 

Coronavirus (COVID-19) Therapeutic Treatment: The Potential Lenzilumab | Cytokine Storm

Disintegrating coronavirus

Anti-GM-CSF antibodies expected to show better effect in Covid-19 than cytokine-specific targets

https://www.clinicaltrialsarena.com/comment/anti-gm-csf-antibodies-covid-19/ 
 
National Institutes of Health Selects Humanigen’s Lenzilumab for its COVID-19 Big Effect Trial

July 27, 2020

https://www.humanigen.com/press/National-Institutes-of-Health-Selects-Humanigen%E2%80%99s-Lenzilumab-for-its-COVID-19-Big-Effect-Trial







 
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HGEN News: Humanigen Announces Thermo Fisher Partnership to Expand Manufacturing for COVID-19 Therapeutic Candidate Lenzilumab 09/23/2020 07:00:00 AM
HGEN News: Statement of Changes in Beneficial Ownership (4) 09/22/2020 06:03:02 PM
HGEN News: Statement of Changes in Beneficial Ownership (4) 09/22/2020 05:38:41 PM
HGEN News: Statement of Changes in Beneficial Ownership (4) 09/22/2020 05:38:16 PM
HGEN News: Statement of Changes in Beneficial Ownership (4) 09/22/2020 05:37:51 PM
PostSubject
#11863  Sticky Note National Institutes of Health Selects Humanigen’s Lenzilumab for kairos 07/27/20 04:07:41 PM
#10590  Sticky Note They will unblind the trial for an interim Millstone 07/07/20 11:21:58 PM
#8210  Sticky Note Humanigen Announces $71,800,000 Equity Financing MWM 06/02/20 01:37:48 PM
#7749  Sticky Note $hgen $10 with news Taurus69 09/18/19 01:29:04 AM
#18551   "...the million dollar hospital bills I’m seeing for cowtown jay 09/25/20 12:15:39 AM
#18550   Gilead has their hands full. Tort lawyers cowtown jay 09/24/20 11:53:50 PM
#18549   Three reasons tscott4 09/24/20 11:25:02 PM
#18548   Yes we are not directly tasked with making dloggold 09/24/20 10:48:14 PM
#18547   I’m pretty confident it will save lives. But tscott4 09/24/20 10:16:21 PM
#18546   Drop to what ? Below 8.50? I suppose dloggold 09/24/20 10:07:04 PM
#18545   Not true I’m a shareholder here just feel Itchy palm 09/24/20 09:47:06 PM
#18544   Very good I have a PT degree been dloggold 09/24/20 09:43:08 PM
#18543   Gilead almost hit their 7 year low today. tscott4 09/24/20 09:37:51 PM
#18542   DPT,OCS. tscott4 09/24/20 09:22:28 PM
#18541   T are you the medical field ? I’m dloggold 09/24/20 09:14:40 PM
#18540   Seems the smart money is buying in AH nelskof 09/24/20 07:49:10 PM
#18539   NITE* had their ask @ 1000 the other Engineering_Simple 09/24/20 07:28:40 PM
#18538   1mm to 90.00! lol rstar 09/24/20 07:02:55 PM
#18537   CYDY on board!!!! JustAguy and itchy tscott4 09/24/20 06:05:23 PM
#18536   Completely wrong. EUA can come as early as tscott4 09/24/20 06:00:34 PM
#18535   This isnt correct. Management said on the last jdc1 09/24/20 05:52:50 PM
#18534   Apparently the catalysts won’t be happening for awhile Itchy palm 09/24/20 05:46:55 PM
#18533   The data cannot be used to request an JustAguy22 09/24/20 05:22:59 PM
#18532   Not a chance. JustAguy22 09/24/20 05:18:14 PM
#18531   It’s all or nothing at all without dloggold 09/24/20 04:29:31 PM
#18530   Market has fallen asleep on HGEN. Only reason tmoney2555 09/24/20 04:25:09 PM
#18529   Seems like short covering is happening Trying to dloggold 09/24/20 04:12:05 PM
#18528   Very well could be! I'd like to see MWM 09/24/20 04:02:02 PM
#18527   We got massive buying at the end of Neophius 09/24/20 04:00:47 PM
#18526   Looks like we will close right on the MWM 09/24/20 03:54:42 PM
#18525   Well I am not a millionaire but I MWM 09/24/20 03:46:35 PM
#18524   Everything is in place for one announcement of tscott4 09/24/20 03:45:26 PM
#18523   Yep it will be nice to hold $9. MWM 09/24/20 03:35:01 PM
#18522   LOLOL @ holding this TURD pennyscam stock. shajandr 09/24/20 03:34:43 PM
#18521   That’s risk-taking in a nutshell. Neophius 09/24/20 03:30:39 PM
#18520   One day we wake up to a beast. MWM 09/24/20 03:30:10 PM
#18519   Looks like the same again. Profit-taking, shorting, and Neophius 09/24/20 03:23:41 PM
#18518   We saw this kind of battle at yesterday's cowtown jay 09/24/20 02:57:51 PM
#18517   chart looks terrible - target 7.5 1upandaway 09/24/20 02:51:32 PM
#18516   Europe being bombarded again. Now is the Time MWM 09/24/20 02:40:42 PM
#18515   If we fail this re-test of our LOD, cowtown jay 09/24/20 02:37:18 PM
#18514   1e9 eom7 09/24/20 02:37:02 PM
#18513   I predict crash to 9 at close or tscott4 09/24/20 02:32:25 PM
#18512   $9.21....... Legacy holders milking the cow.......... lthomp52 09/24/20 02:27:06 PM
#18511   Something Fez said here awhile back was that cowtown jay 09/24/20 02:21:17 PM
#18510   I’m going to have to live with one RobinX 09/24/20 02:19:31 PM
#18509   General Question about options and volume jdc1 09/24/20 01:30:06 PM
#18508   I suppose they will have to be very dloggold 09/24/20 01:27:59 PM
#18507   I added here on the crazy Ivan move haha dloggold 09/24/20 01:24:03 PM
#18506   The chart in yesterdays Oppenheimer presentation showed Complete lthomp52 09/24/20 01:22:21 PM
#18505   Well said Dlo. Big Pharma is too papaphilip 09/24/20 01:19:45 PM
#18504   I don't understand enough about the DSMB's interim cowtown jay 09/24/20 01:13:17 PM
#18503   I see the combination with Remdesivir as the Knuckle Sandwich 09/24/20 01:08:22 PM
#18502   That's funny! I definitely agree he's not the Knuckle Sandwich 09/24/20 01:05:30 PM
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