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Created: 01/31/2013 01:42:42 PM - Followers: 324 - Board type: Free - Posts Today: 3

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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#37408
It is called a placebo. HGEN has a shajandr 09/06/2022 01:05:21 AM
#24524
There's a prevailing belief from a growing number Engineering_Simple 01/21/2021 08:30:04 PM
#37559
Most of our trading activity continues to be cowtown jay 10/01/2022 02:16:49 PM
#37558
$HGEN Watching close to see if Friday move TommyBoyTrader9460 10/01/2022 11:53:14 AM
#37557
"Management did mislead investors and now they are cowtown jay 10/01/2022 08:23:32 AM
#37556
anyone can sue anyone ..... some make it eb0783 09/30/2022 10:16:21 PM
#37555
Management sucks and destroyed shareholders with there inability Yooo 09/30/2022 07:50:12 PM
#37554
Dale SOLD shortly before the EUA DENIAL. Yooo 09/30/2022 07:49:12 PM
#37553
LMAO!!! Yooo 09/30/2022 07:48:44 PM
#37552
What is the Price Change Parity with BLUE now? shajandr 09/30/2022 06:22:36 PM
#37551
Management did mislead investors and now they are Djia 09/30/2022 05:59:09 PM
#37550
You’re so full of it. I want this Mr. C 09/30/2022 04:56:16 PM
#37549
Same as before, nothing really new there Mr. C 09/30/2022 04:53:43 PM
#37548
https://seekingalpha.com/article/4544095-humanigen-hgen-investor-presentation-sl Preciouslife1 09/30/2022 03:21:50 PM
#37547
You want to give management crap for doing cowtown jay 09/30/2022 01:22:00 PM
#37546
Two massive failures and near bankruptcy. No one Mr. C 09/30/2022 11:04:27 AM
#37545
This company is prepared for trouble. They cowtown jay 09/30/2022 10:23:23 AM
#37544
You know darn well that he bailed and Mr. C 09/30/2022 10:17:05 AM
#37543
There's no way out for NIAID, should their cowtown jay 09/30/2022 10:16:12 AM
#37542
Morris' 30 day notice was a decent gesture. cowtown jay 09/30/2022 07:53:10 AM
#37541
LOL! @ this pennyturd still trading. shajandr 09/26/2022 08:42:51 PM
#37540
Just need a certified letter to STEVE MNUNCHIN shajandr 09/26/2022 08:37:18 PM
#37539
"So many questions that need answering. . . ." cowtown jay 09/26/2022 02:12:44 PM
#37538
I had not heard of NAC before, although oakhill3 09/26/2022 01:24:40 PM
#37537
Regarding "things such as my smoking, and my oakhill3 09/26/2022 12:42:19 PM
#37536
What is the Price Change Parity with BLUE now? shajandr 09/26/2022 10:47:44 AM
#37535
I now have 22 times the number of TheGreatSwami 09/26/2022 10:41:53 AM
#37534
You got called out on Twitter for manipulation Mr. C 09/25/2022 10:23:41 PM
#37533
A real linchpin at this point is the cowtown jay 09/25/2022 12:09:16 PM
#37532
$HGEN Hello beautiful! Looks like a near perfect TommyBoyTrader9460 09/25/2022 07:39:48 AM
#37531
It’s a con. No reason in the world herbied47 09/25/2022 02:15:57 AM
#37530
It’s a con. No reason in the world herbied47 09/25/2022 02:15:56 AM
#37529
Im in a similar postion. Averaged down with Skiluc 09/23/2022 05:23:00 PM
#37528
Someone posted on Stocktwits that they got a Mr. C 09/23/2022 04:08:17 PM
#37527
We got some price movement in the up TheGreatSwami 09/23/2022 03:43:38 PM
#37526
Sorry this didn't work out here my friend. DTGoody 09/23/2022 11:36:22 AM
#37525
Lawsuit, Reverse Split, or Delisting? Whats next? Skiluc 09/23/2022 09:18:00 AM
#37524
5 amputations due to Covid huh? You spend Mr. C 09/23/2022 12:20:25 AM
#37523
Covid-associated brain injury and blood clotting. The cowtown jay 09/23/2022 12:09:04 AM
#37522
What is the Price Change Parity with BLUE now? shajandr 09/23/2022 12:01:48 AM
#37521
Well, that post is some babbling nonsense right there. shajandr 09/22/2022 11:04:41 PM
#37520
LOL@ this pennyscam turd still being traded. shajandr 09/22/2022 11:03:09 PM
#37519
maybe he did cash i dont know. lenzilu gelTabs dloggold 09/22/2022 10:35:34 PM
#37518
Hahaha think he was feeling really good after Mr. C 09/22/2022 10:32:13 PM
#37517
Hahaha think he was feeling really good after Mr. C 09/22/2022 10:32:12 PM
#37516
and the lord knows its time to bypass dloggold 09/22/2022 10:30:56 PM
#37515
well he bragged about how many shares he dloggold 09/22/2022 10:28:20 PM
#37514
“Trap shut”? In what regard? Or do you Mr. C 09/22/2022 10:19:10 PM
#37513
institutional investors need to finish raping and pillaging dloggold 09/22/2022 10:10:38 PM
#37512
You’re talking about executing a stock play by Mr. C 09/22/2022 09:49:00 PM
#37511
HGEN stock - Where money comes to die..... Djia 09/22/2022 08:00:06 PM
#37510
i think its safe to say no one dloggold 09/22/2022 07:56:25 PM
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