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BARDA knows exactly what Lenz is capable of which is why the CRADA was updated on 1/21. I cannot wait for the day that we get news of Hospitals and Patients finally getting access, and for the news to start telling people there is an option that can help.
Yes, today's news is very positive. I am very happy to see the progress.
There is risk in any investing and as long as each individual determines what their risk tolerance is then it is okay to take a plunge. BIO Stocks carry allot of risk, but I enjoy the ride, and being invested with my own money forces me to learn more about a subject then I otherwise would.
I find being able to share ideas and information useful, educational, and entertaining. All that being said everyone should have proper expectations in place. With Lenzilumab I see a possible solution to a devastating pandemic, and the story of the Little Guy going big in front of our eyes with a Pipeline that is focused on some Big Targets that will make people's lives better. I'm invested to make money, but I am learning allot about this story along the way.
Great observation Jay. They have been laying out all of the groundwork to hit the market running. It is one thing for a company to Puff and tell us all the things thatv they are going to do. It is another for all of these important strategic partners to officially get involved. It is not a matter of if, but a matter of when, and we are very close.
No matter his intentions I do look back and validate things with Valiant, Venrock, Surveyor and other institutions making large investments knowing he is involved. They digested the risk of him being involved and still saw the value in making investments here.
Phase III Completion + NIH ACTIV-5 Completion + EUA + OWS/BARDA + Car-T w Kite/Gilead interim look (Phase III may not be required) + BLA for Lenzilumab + kickoffs for CMML (Phase II) & GVHD (Phase 2/3) & Ifab in Glioblastoma (Phase I at full enrollment already) Trial's = a very, very busy 2021 for HGEN
Yes, please get Lenzilumab into Hospitals as soon as possible. Many people in need, as we have seen here in US during most recent surge Hospitals were again running out of supplies and beds for treating ventalited Patients, and we know other Countries might not have the resources like we have here. In 2021 no one should have to die from Covid without the opportunity to gain access to Lenzilumab. I am excited as a shareholder, but even more so as a Human who want's everyone, everywhere to have another tool for survival. The investment money will come, many great future catalysts for HGEN, but the Virus will not wait and sadly we have seen that play out far too many times already.
EUA for Lenzilumab, Operation Warp Speed ahead!
Yes, the Eversana deal doesn't even happen without knowledge of what is possible now. I personally am very Bullish on the announcement of Ventilator Free Survival Endpoint. Focus of Trial was always placed on the most urgent need, and I think everyone can agree that Ventilator Free Survival is of the most urgent need for ICU'S and Patients alike. We have already had other therapies EUA'd before the most recent surge and those results have been terrible, it's obvious that this is exactly where Healthcare needs an immediate break to occur.
Let's finally get Lenzilumab to all of the Hospital's and Patients in need. It is time for Healthcare to take the wheel and get the job done with EUA and Operation Warp Speed.
Thanks for sharing this! Mayo Clinic has been getting it done right vs National Avg and their #'s show just that.
Phase 1 study of lenzilumab, a recombinant anti–human GM-CSF antibody, for chronic myelomonocytic leukemia
Yes, HGEN is getting ready for a great 2021 and they have the cash and Partnerships on hand to get it all done. A rare gem this one is going to be for sure.
Lenzilumab in Chronic Myelomonocytic Leukaemia (CMML)
University of Adelaide Newsroom June 29, 2020
Very interesting tweet stream from Dr. Matt McCarthy. I've combined them together to make it easier to read. Link is at bottom of page.
HGEN redesigned their website today. I like to new format.
https://www.humanigen.com/
Today's Conference Recording is now available online thru Company Website. Definitely a must watch if your learning about the company.
https://www.humanigen.com/events
It is time to Rip !
A session recording will be available soon. Per the website
That was a fantastic presentation. Looking good for HGEN & Lenzilumab
I hope there is a replay of today's conference. It is the best we have heard so far with updates and detailed information. A must listen for any new investor looking at HGEN.
30 minutes until ICR Conference. It is a Fireside chat format and I think it will be telling of what the next month has in store for the company. They tweeted out the link again, so they are definitely encouraging shareholders to listen in.
https://icrinc.touchcast.com/showtime/icr-conference/embed/19b8209f-86ae-93a7-6351-107304d2f9d0
Humanigen presentation today at 1 PM ET
2021 ICR Conference
Date: Thursday, January 14, 2021
Fireside Chat with Cosme Ordonez, National Securities: 1:00 PM ET
Event Link:
https://icrinc.touchcast.com/showtime/icr-conference/embed/19b8209f-86ae-93a7-6351-107304d2f9d0
https://www.humanigen.com/press/Humanigen-to-Present-at-Multiple-Upcoming-Investor-Conferences
Analysts Joe Pantginis & Tony Butler have reiterated their Buy Rating for HGEN in the last couple of days.
HC WAINWRIGHT Joe Pantginis
ROTH CAPITAL PARTNERS Tony Butler
NIH does have a Interim Analysis at 50%. They have to be at 50% of 200 Patients if enrollment started in late October with NIH backing.
LOL,no but they do have enough of my money invested that it feels like a lopsided marriage at times.
I am very interested in thier Pipeline, and view Covid treatment as a huge win for the little guy as an income stream to fuel growth in areas. Ultimately I expect the Company will be bought out, but if they resisted a buyout it would be very telling of the future.
It is very exciting to see a little company getting the opportunity to expand.
YES! This is really big news. We are watching every single step being completed. It's text book from start to finish. Here comes the Q&A!!
Cameron is bringing it today. I reccomend looking for a replay if anyone is unable to listen live. Looking forward to the Q&A coming up. Also Friday's wrap up will be a great finish to this week.
Link to today JPM2021 Presentation starting at 8:20 EST
J.P. Morgan Healthcare Conference
Date: Wednesday, January 13, 2021
Presentation Time: 8:20 AM ET
Event Link:
https://jpmorgan.metameetings.net/events/healthcare21/sessions/35565-humanigen/webcast?gpu_only=true&kiosk=true
https://www.humanigen.com/press/Humanigen-to-Present-at-Multiple-Upcoming-Investor-Conferences
HGEN Pipeline & Lenzilumab Development for anyone looking for info before tomorrow's JPM2021 Presentation.
https://www.humanigen.com/pipeline
https://www.humanigen.com/lenz-development
HGEN could definitely fit into the later part of his response as they are on the cusp of Major news. Not only will 2021 provide EUA & BLA for Lenzilumab, but they will see data in Car-T and Glioblastoma with Ifabotuzumab. They will also kick off Trials in GVHD and a Phase II in CMML following thier 2020 completion in Phase I. Future looks very bright here, and how they choose to navigate the next quarter will be very interesting to watch. I am excited for either possibility happening here. A buyout is great. A resistance to buyout is potentially explosive. I have always been of the mindset that Buyout is inevitable especially with the Gilead ties. Let's roll!
Excellent! Mayo Clinic continues to deliver on Lenzilumab.
Lol! We all gotta have some fun while we wait on the inevitable here.
So does that put you at $105? I think that is a very reasonable target with the news that could be coming here. Ohhh myyyy!
Shoot, I can't find my helmet !
They have allot of followers on LinkedIn
Could be an "all systems go" check before the big week ahead? We definitely shined during ASH 2020 Week, and I'm looking forward to the build up off that for JPM2021 Week as well.
Humanigen and EVERSANA Announce Partnership to Support the Launch and Commercialization of Lenzilumab for the Treatment of COVID-19
January 10, 2021
Burlingame, CA, and Chicago, IL – January 10, 2021 – Humanigen, Inc. (HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate lenzilumab™, and EVERSANA, a pioneer of next-generation services to the global life sciences industry, today announced that they are partnering to make lenzilumab available to hospitalized and hypoxic COVID-19 patients in the event that an Emergency Use Authorization is issued from the U.S. Food and Drug Administration (FDA) and subsequent BLA.
Humanigen’s investigational treatment, lenzilumab, a proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is designed to prevent and treat cytokine storm, a complication considered to be a leading cause of COVID-19 death. Data showed that up to 89 percent* of hospitalized patients with COVID-19 are hypoxic and at risk of this immune hyper-response, which can trigger acute respiratory distress syndrome in severe cases of COVID-19.
Under the terms of the agreement, and in anticipation of an EUA for the use of lenzilumab in hospitalized COVID-19 patients, Humanigen has immediate access to EVERSANA’s fully integrated services including, but not limited to, marketing, market access, medical education, health economics and outcomes research, medical information, compliance and medical science liaison teams, with each service optimized by data and predictive analytics. The agreement with EVERSANA builds on the commercial preparation and lenzilumab launch planning Humanigen has been conducting over the last several months.
“EVERSANA shares our tireless commitment to patients,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We’ve matched our dedication to research and development in COVID-19 with a proven commercialization partner to ensure lenzilumab will reach patients quickly and efficiently following a potential EUA.”
“We stand ready to immediately activate our services spanning all disciplines of the product journey to ensure lenzilumab delivers significant patient value,” said Jim Lang, chief executive officer of EVERSANA. “While EVERSANA’s model can be applied to any therapy or indication, we have a moral obligation to help COVID-19 patients in distress, knowing that even with the promise of vaccines there will be many patients who contract this virus and desperately need a treatment if hospitalized and hypoxic.”
*Source: National Institute of Allergy and Infectious Diseases’ Adaptive COVID-19 Treatment Trial (ACT-1)
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. 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. In addition, the company is 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, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.
About EVERSANA™
EVERSANA™ is the leading provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.
Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase 3 study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections, our estimated time to submit an application for, or to receive an Emergency Use Authorization from, FDA for such use, and statements regarding our beliefs relating to any of the other technologies in our current pipeline. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.
Contacts:
Humanigen
Media
Cammy Duong
Westwicke, an ICR company
Cammy.duong@westwicke.com
203-682-8380
EVERSANA
Sarah Zwicky
sarah.zwicky@eversana.com
414-434-4691
Source: Humanigen, Inc.
Released January 10, 2021
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https://www.humanigen.com/press/Humanigen-and-EVERSANA-Announce-Partnership-to-Support-the-Launch-and-Commercialization-of-Lenzilumab-for-the-Treatment-of-COVID-19
A very important week is on tap here. Looking forward to Monday's kickoff at 6 AM EST and then on to JPM2021 on Wednesday. Another day down is another day closer.
RATinG: Risk Adapted Therapy in Acute GvHD; investigating the use of Lenzilumab for treating high-risk acute graft versus host disease following allogenic stem cell transplantation.
Study design/summary: A multicentre, phase II/III, randomised (1:1) clinical trial of Lenzulimab compared to placebo in patients with acute GvHD following allogenic stem cell transplantation. Potentially eligible patients will be screened for expression of ST2 and REG3a using a validated assay and assigned a risk score. High-risk patients (interventional cohort) will be eligible for study entry and randomisation between Lenzulimab and placebo (1:1); low-risk patients will form an observational cohort and be treated as per standard of care.
Objectives:
Primary objective will be to study non-relapse mortality (NRM) at 6 months post-transplant.
Secondary objectives will be to determine biomarker risk score at D28 of treatment; response (complete remission + partial remission) at D28 of treatment; cumulative corticosteroid exposure at 6 months; time to treatment failure (increased dose of corticosteroids or starting additional systemic GvHD treatment); cumulative incidence and severity of chronic GvHD (cGvHD); overall survival (OS) at 1 year; GvHD- and relapse free survival at 1 year (GRFS); toxicity including adverse events of special interest; patient-reported outcomes; Lenzulimab immunogenicity, PK and PD. Samples will also be collected for translational research projects in a subset of patients.
Centres: 22 IMPACT centres & additional non-IMPACT centres
Target Number of patients: 220 patients will be randomised to receive either Lenzulimab or placebo (1:1); up to 370 patients will be recruited to the observational cohort.
Patient population: Adults with acute GvHD following allogenic stem cell transplantation will be recruited to this trial.
Sponsorship/Funding: RATinG is sponsored by the University of Birmingham. The trial will be delivered by IMPACT-funded Research Nurses at 9 IMPACT centres. The facilitatory hub, located at the CRCTU at the University of Birmingham, is funded by IMPACT.
Trial Status: In set-up
Trial contacts: RATING@trials.bham.ac.uk
Duration: Patients will be recruited over 3 years and will be followed up for 6 months. Long-term follow up will capture data regarding GvHD treatments as a surrogate for GvHD progression, relapse of underlying disease and survival.
If you are a patient and interested in taking part in a clinical trial, please speak with your consultant who will be able to offer you further information and discuss whether it is suitable for you. A referral from your medical team would be required in order to consider you for treatment on a clinical trial.
https://www.impactpartnership.org.uk/the-trials/rating/
And definitely searching Twitter under $HGEN there is some really good stuff popping up on there as well.