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Created: 01/31/2013 01:42:42 PM - Followers: 335 - 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. 
 

Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19

May 28, 2021 09:00 AM Eastern Daylight Time

https://www.businesswire.com/news/home/20210528005244/en/Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19 
 


Humanigen Announces Publication of Results From Phase 3 Randomized Double-Blind Placebo-Controlled Study Demonstrating the Efficacy and Safety of Lenzilumab™ in Hospitalized COVID-19 Patients

https://finance.yahoo.com/news/humanigen-announces-publication-results-phase-155300197.html

Humanigen's Lenzilumab With CAR T-Cell Therapy Improves Response in Lymphoma

https://www.precisiononcologynews.com/cancer/humanigens-lenzilumab-car-t-cell-therapy-improves-response-lymphoma#.YKFqsahKhcU
 


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 

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







 
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#24524
There's a prevailing belief from a growing number Engineering_Simple 01/21/2021 08:30:04 PM
#37310
so how much did active f us ? dloggold 08/18/2022 11:45:44 PM
#37309
LENZ does NOTHING for this problem. If so Yooo 08/18/2022 11:11:03 PM
#37308
Well said, Jay. You are thorough. I would eb0783 08/18/2022 10:36:38 PM
#37307
Edit. "Hire" a lawyer. cowtown jay 08/18/2022 10:01:06 PM
#37306
Sorry, I forgot to link the article. But cowtown jay 08/18/2022 09:39:10 PM
#37305
I'm always glad to hear from you, eb. cowtown jay 08/18/2022 09:26:49 PM
#37304
If true, LENZ cannot change this anyway Yooo 08/18/2022 09:12:31 PM
#37303
"Silent crisis of soaring excess deaths gripping Britain cowtown jay 08/18/2022 07:12:59 PM
#37302
Meanwhile, the White House COVID response coordinator Ashish Preciouslife1 08/18/2022 01:37:14 PM
#37301
they must all be on summer vacation. i dloggold 08/18/2022 12:26:15 PM
#37300
well dale is definitely not buying anything for dloggold 08/18/2022 12:13:37 PM
#37299
hgen if this gap fills. wow seventhcircle 08/18/2022 11:02:53 AM
#37298
https://rumble.com/v1a7gwj-dr.-david-martin-calls-for-prosecutions-fauci-knew-re Preciouslife1 08/18/2022 10:49:01 AM
#37297
I appreciate your opinion and how you laid eb0783 08/18/2022 10:13:23 AM
#37296
I am not holding my breath for the cowtown jay 08/18/2022 09:17:52 AM
#37295
https://www.foxnews.com/health/cdc-director-orders-reorganization-saying-covid19 Preciouslife1 08/18/2022 08:36:52 AM
#37294
CDC says, "... the country's public health infrastructure cowtown jay 08/18/2022 08:17:14 AM
#37293
No, EUA was declined, one trial has been cowtown jay 08/17/2022 09:39:17 PM
#37292
Top 10 Prescription Drugs That Cost Medicare Preciouslife1 08/17/2022 07:43:52 PM
#37291
Management sucks if they can’t relay this information Yooo 08/17/2022 07:23:21 PM
#37290
He would buy the shares straight from the shajandr 08/17/2022 05:32:14 PM
#37289
How has hospital standard of care changed since cowtown jay 08/17/2022 04:10:50 PM
#37288
U Often posted that HGEN traded in parity Yooo 08/17/2022 02:59:24 PM
#37287
hgen major gap. seventhcircle 08/17/2022 02:51:40 PM
#37286
that would be another smart dale move , dloggold 08/17/2022 02:30:29 PM
#37285
The PPS should reflect that type of buying DonDonDonDon 08/17/2022 01:35:21 PM
#37284
If Annoying is pointing out facts then you Yooo 08/17/2022 01:27:13 PM
#37283
The PPS should reflect that type of buying Yooo 08/17/2022 01:24:18 PM
#37282
If Dale buys straight from the ATM, we DonDonDonDon 08/17/2022 01:21:07 PM
#37280
‘shut up’ it’s now 34 cents LOL Yooo 08/17/2022 12:06:29 PM
#37279
pulling trigger meant buy dale not sell geez dloggold 08/17/2022 11:31:17 AM
#37278
dale please pull trigger its high time dloggold 08/17/2022 10:17:20 AM
#37277
yahoo finance says 1upandaway 08/17/2022 10:16:39 AM
#37276
Bagholding sucks Yooo 08/17/2022 09:36:44 AM
#37274
It’s .37 cents PPS and a worthless drug Yooo 08/17/2022 12:50:41 AM
#37273
So, according to your analogy, if GM-CSF starts DonDonDonDon 08/16/2022 11:17:47 PM
#37272
.37 cents is what they feel it’s worth. Yooo 08/16/2022 10:39:18 PM
#37271
Cede shares, owned by insiders, held in nominee cowtown jay 08/16/2022 08:59:31 PM
#37270
So, according to your analogy, if GM-CSF starts shajandr 08/16/2022 08:57:50 PM
#37269
I've been buying more every couple of days....just eb0783 08/16/2022 04:07:08 PM
#37268
i love his analogies including “ instead of DonDonDonDon 08/16/2022 03:04:31 PM
#37267
The PPS is reflecting the level of BS Yooo 08/16/2022 02:29:24 PM
#37266
i love his analogies including “ instead dloggold 08/16/2022 02:05:25 PM
#37265
Keep Durant away from a microphone and Camera.. Yooo 08/16/2022 01:57:12 PM
#37264
Keep Asurea t away from a microphone and Yooo 08/16/2022 01:56:48 PM
#37263
"Our OS should not have exceeded the 62,376,876 cowtown jay 08/16/2022 01:55:50 PM
#37262
too many shares out. dont think dale will dloggold 08/16/2022 01:25:58 PM
#37261
Regretful mistake Yooo 08/16/2022 01:01:56 PM
#37260
But he can sell days before the EUA denial? DonDonDonDon 08/16/2022 12:57:44 PM
#37259
But he can sell days before the EUA denial? Yooo 08/16/2022 12:50:13 PM
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