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Humanigen Inc (HGEN)

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Last Post: 8/13/2020 11:21:13 PM - Followers: 183 - Board type: Free - Posts Today: 0

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: Statement of Changes in Beneficial Ownership (4) 08/12/2020 05:15:32 PM
HGEN News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 08/10/2020 09:15:50 AM
HGEN News: Current Report Filing (8-k) 08/10/2020 09:09:13 AM
HGEN News: Notice of Effectiveness (effect) 08/06/2020 06:06:34 AM
HGEN News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 08/05/2020 05:08:12 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
#14445   Welcome to the party! You'll find plenty of Knuckle Sandwich 08/13/20 11:21:13 PM
#14444   Here’s another story in the AZ paper a Curecovid 08/13/20 11:18:39 PM
#14443   Lol ES I came to the same conclusion jb128 08/13/20 11:09:17 PM
#14442   Yep we have plenty of liquidity. Now bring MWM 08/13/20 11:02:01 PM
#14441   So the float increased by about 50m? Liquidity jb128 08/13/20 10:57:49 PM
#14440   Interesting to see that the Authorized is 250M, cowtown jay 08/13/20 10:48:42 PM
#14439   Isn't that a good write up! My wife MWM 08/13/20 10:32:15 PM
#14438   Just noticed everything was updated this week on MWM 08/13/20 10:30:22 PM
#14437   “Could one of these drugs be the next Fezziwig2008 08/13/20 10:28:55 PM
#14436   Not to split hairs, but I really don't cowtown jay 08/13/20 10:25:53 PM
#14435   I like to ride them all the way MWM 08/13/20 10:15:26 PM
#14434   haha we don't know! And it's a split decision. Engineering_Simple 08/13/20 08:46:58 PM
#14433   Thanks jay, I will read through it later tonight. jb128 08/13/20 08:34:56 PM
#14432   You’re only a pumper if you actually sell Neophius 08/13/20 07:33:46 PM
#14431   No, I’m on your side. I think it’s Annex 08/13/20 07:17:11 PM
#14430   I too have famliy money at risk here roygbiv 08/13/20 06:34:53 PM
#14429   I assume this was directed at me. Thanks MWM 08/13/20 06:32:55 PM
#14428   I didn't see any language in terms of cowtown jay 08/13/20 06:32:15 PM
#14427   I’m thrilled to have the size that I MWM 08/13/20 06:27:37 PM
#14426   Very gracious of you to say, PIT. Thank you! cowtown jay 08/13/20 06:08:40 PM
#14425   Thanks roy, there have been a lot more jb128 08/13/20 06:01:22 PM
#14424   jb128, Cowtown Jay is spot on with his post roygbiv 08/13/20 05:52:39 PM
#14423   I feel like this was an under-appreciated discovery/thought PITrader87 08/13/20 05:41:48 PM
#14422   Jay, ES, or actually anyone who knows can jb128 08/13/20 05:26:54 PM
#14421   Apparently you’re a pumper, so I guess we Annex 08/13/20 04:46:07 PM
#14420   In a way, I feel blessed to buy Annex 08/13/20 04:44:59 PM
#14419   Thanks. I have no worries HGEN will be drifter 08/13/20 04:42:19 PM
#14418   I don't think you're going to be very cowtown jay 08/13/20 04:33:36 PM
#14417   Disappointed in myself the last few days drifter 08/13/20 04:30:10 PM
#14416   Fantastic catch! I'm jealous. Really good cowtown jay 08/13/20 04:22:37 PM
#14415   Good Luck this time! Knuckle Sandwich 08/13/20 04:17:25 PM
#14413   Back in $2.50 :D Annex 08/13/20 04:14:12 PM
#14408   Every once in awhile, you gotta love the cowtown jay 08/13/20 04:02:43 PM
#14407   I’m not much of a “chartist” but If/when PITrader87 08/13/20 03:59:30 PM
#14406   No worries you are so correct . I just dloggold 08/13/20 03:39:43 PM
#14405   I completely agree with you. No way CEO Knuckle Sandwich 08/13/20 03:38:34 PM
#14404   I got the same response from Richard also abaj 08/13/20 03:36:22 PM
#14403   Not too far off but more like 7, MWM 08/13/20 03:30:34 PM
#14402   Thank you for taking this on! Engineering_Simple 08/13/20 03:30:24 PM
#14401   Lol was lazy to count figured about 4 abaj 08/13/20 03:28:56 PM
#14400   Yes my buddy got a similar response yesterday also... MWM 08/13/20 03:28:20 PM
#14399   We are in good hands here people we dloggold 08/13/20 03:25:40 PM
#14398   8-9 million his week? Counting is hard? MWM 08/13/20 03:25:10 PM
#14397   Durrant has made all the difference. cowtown jay 08/13/20 03:20:18 PM
#14396   I don't know if there's been a delay. cowtown jay 08/13/20 03:14:18 PM
#14395   It’s boilerplate so I can save everyone the dloggold 08/13/20 03:10:44 PM
#14394   None of what happened this week is random. abaj 08/13/20 03:09:22 PM
#14393   Goldy, don't tease us!! What did papaphilip 08/13/20 03:08:03 PM
#14392   "Thank you for your interest in our position Engineering_Simple 08/13/20 03:01:40 PM
#14391   We are literally reliving June 22nd again today.. PITrader87 08/13/20 03:00:31 PM
PostSubject