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Humanigen Inc. (HGEN)

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Last Post: 5/23/2022 9:56:33 AM - Followers: 324 - 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. 
 

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
 
Humanigen Appoints Dr. Adrian Kilcoyne to the role of Chief Medical Officer


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

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 
 

Experimental Treatment Pivots in Record Time

https://discoverysedge.mayo.edu/2021/06/22/cancer-to-covid-19/  
 

Therapeutic Drug Studied at DHMC Proven Effective at Treating COVID-19By NEWSROOM

 
https://www.dartmouth-hitchcock.org/stories/article/therapeutic-drug-studied-dhmc-proven-effective-treating-covid-19

 








 
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HGEN News: Statement of Changes in Beneficial Ownership (4) 05/20/2022 01:58:17 PM
HGEN News: Humanigen: A ‘Transformative Year’ Awaits, Says Analyst 05/11/2022 04:43:21 PM
HGEN News: Statement of Ownership (sc 13g) 05/09/2022 11:25:30 AM
HGEN News: Quarterly Report (10-q) 05/05/2022 12:27:52 PM
HGEN News: Current Report Filing (8-k) 05/05/2022 12:08:22 PM
PostSubject
#33543  Sticky Note Here are some lenzilumab science-related articles for those DonDonDonDon 09/21/21 04:36:05 PM
#24524  Sticky Note There's a prevailing belief from a growing number Engineering_Simple 01/21/21 03:30:04 PM
#36341   Enjoy the roller coaster ride! pandb5298 05/23/22 09:56:33 AM
#36340   100 million shares at what price? 2 dollars a share? dloggold 05/22/22 11:18:16 PM
#36339   now that is interesting , they are going 10nisman 05/22/22 10:39:10 PM
#36338   I'm excited about tomorrow and this week. DonDonDonDon 05/22/22 07:53:07 PM
#36334   @EricTopol Hard to get to a 2nd booster when DonDonDonDon 05/22/22 03:13:31 PM
#36333   @EricTopol The @CDCgov changes its 2nd booster tune from DonDonDonDon 05/22/22 03:11:07 PM
#36331   They heard you cowtown. https://www.catalent.com/catalent-news/catalent-to-invest-350-million-in- green maschine 05/22/22 01:20:51 PM
#36330   Room to run! Higher highs and higher lows. pandb5298 05/21/22 05:46:46 PM
#36329   I was pretty sure that Catalent was producing cowtown jay 05/21/22 03:07:56 PM
#36328   Well, since there is some insider buying, the DonDonDonDon 05/21/22 11:31:18 AM
#36327   Well, since there is some insider buying, the pandb5298 05/21/22 11:18:30 AM
#36326   So Don, this DC purchase pushes back the DonDonDonDon 05/21/22 10:59:55 AM
#36325   I finished listening to the full video and, cowtown jay 05/21/22 10:12:46 AM
#36324   So Don, this DC purchase pushes back the bristirpani 05/21/22 08:10:48 AM
#36323   That could be, dlog. After all, they cowtown jay 05/20/22 09:59:13 PM
#36322   Dale bought a million shares over the last DonDonDonDon 05/20/22 08:17:19 PM
#36321   Not a ton of volume in aftermarket, but pandb5298 05/20/22 07:55:53 PM
#36320   No. It sounds like a real mess. The Other Guy 05/20/22 12:55:11 PM
#36319   not good for either company dloggold 05/20/22 12:26:53 PM
#36318   We can probably assume Avid Biosciences is no The Other Guy 05/20/22 12:08:38 PM
#36317   gotcha i thought you had found the holy dloggold 05/20/22 10:43:07 AM
#36316   $2.28 S/R was triggered at 0935 Eastern. cowtown jay 05/20/22 09:43:28 AM
#36315   Thanks, dlog. I should have looked it cowtown jay 05/20/22 09:05:30 AM
#36314   its an oral medicine plant dloggold 05/19/22 11:35:23 PM
#36312   The plant that manufactured most of our bulk cowtown jay 05/19/22 04:12:42 PM
#36311   Thank you, 1upandaway. I've started listening to cowtown jay 05/19/22 04:05:54 PM
#36310   hard times ahead, looks like rest of 2022 1upandaway 05/19/22 03:14:36 PM
#36309   Possibly there may be some insider buying, or DonDonDonDon 05/19/22 01:38:22 PM
#36308   Decent volume out of the gate! Possibly there pandb5298 05/19/22 10:12:44 AM
#36307   Support & Resistance pandb5298 05/18/22 09:34:37 PM
#36306   Is isn't completely counterintuitive that HGEN could be DonDonDonDon 05/18/22 03:59:04 PM
#36305   Next week is the Wainwright presentation. It's their cowtown jay 05/18/22 02:37:22 PM
#36304   Pretty healthy move over the last two days. pandb5298 05/18/22 11:05:23 AM
#36303   We only tested adults 18+. We were cowtown jay 05/17/22 12:40:01 PM
#36302   fda just approved pfizer booster vaccine 5-11 year dloggold 05/17/22 12:14:13 PM
#36301   “A major misconception is that the vaccines are cowtown jay 05/17/22 10:12:39 AM
#36300   21,000 share block on the bid for $1.80. pandb5298 05/16/22 10:28:30 AM
#36297   sadly this stock is finished, its gonna be dloggold 05/14/22 06:53:41 PM
#36294   All I know of Alondra Nelson was what cowtown jay 05/14/22 05:12:18 PM
#36291   Where the hell is Alondra Nelson? cowtown jay 05/14/22 02:32:11 PM
#36289   Pre split prices here might have to take Itchy palm 05/14/22 09:02:05 AM
#36288  Restored Another strong day for HGEN. When will 10nisman 05/13/22 04:05:59 PM
#36287   I had many more shares and got crushed Djia 05/13/22 02:05:34 PM
#36286   Me too 1700 @$1.78 Blessings upon blessings to Preciouslife1 05/13/22 12:03:42 PM
#36285   my total position is 2,000 shares. good luck Djia 05/13/22 11:54:07 AM
#36284   added 2k @ 1.73 drifter 05/13/22 11:23:57 AM
#36282   Support & Resistance pandb5298 05/13/22 06:51:44 AM
#36279   The new May presentation is posted on Humanigen's DonDonDonDon 05/12/22 12:27:46 PM
#36278   I did see a 20,000 share block on pandb5298 05/12/22 11:31:11 AM
#36277   Humanigen: A ‘Transformative Year’ Awaits, Says Analyst DonDonDonDon 05/12/22 11:29:21 AM
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