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Dale bought more calls on Tuesday, Wednesday, and Thursday this week. Here is the Form 4.
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001293310/fce1234c-bded-4518-9583-e280dc42231a.pdf
HGEN is $2.99 in After-Hours
Here are some lenzilumab science-related articles for those wanting to do some due diligence. Lenzilumab is a GM-CSF inhibitor. The "M" in GM-CSF is macrophage.
Covid
https://www.bbc.com/news/health-56352128
https://immunology.sciencemag.org/content/6/57/eabg9873
https://directorsblog.nih.gov/2021/04/13/mapping-severe-covid-19-in-the-lungs-at-single-cell-resolution/
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30267-8/fulltext
https://www.nature.com/articles/s41586-021-03569-1
https://www.pharmaceutical-technology.com/news/humanigen-lenzilumab-improves-survival/
CAR-T
https://www.nature.com/articles/s41408-021-00459-7
https://www.nature.com/articles/s41421-021-00255-4
https://www.targetedonc.com/view/lenzilumab-plus-axi-cel-achieves-responses-in-100-of-patients-with-dlbcl-with-limited-toxicity-in-small-study
https://www.healio.com/news/hematology-oncology/20210422/lenzilumab-before-cart-induces-high-response-rates-without-severe-toxicities
Sentiment is strong. We will go green today.
New Slides from the Roth Presentation
https://s28.q4cdn.com/539885110/files/doc_presentations/2022/HGEN-Roth-Conference-03-13-22.pdf
In Hérouville-Saint-Clair, the Cenexi laboratory will produce a treatment against Covid
https://eng-premium.paris-normandie.fr/id285219/article/2022-03-07/herouville-saint-clair-le-laboratoire-cenexi-produira-un-traitement-contre-le
Cenexi, a pharmaceutical laboratory in Hérouville-Saint-Clair (Calvados), will produce a drug against Covid-19 developed by an American company. The latter came on site to visit the site.
His name is not a seller but his future is full of hope! Lenzilumab, as it is called, is one of the ten most promising molecules against severe forms of Covid-19. It was developed in the United States, at Humanigen , a biopharmaceutical company based in San Fransisco and it is in the Cenexi laboratory , located in Hérouville-Saint-Clair, near Caen, that it will be manufactured for the next five years, both for France but also for Europe. The good news of the partnership between the two actors has just been announced during the visit of American leaders to Normandy a few days ago.
Launch early 2023
A subcontractor for the pharmaceutical industry (CDMO for Contract Development Manufacturing Organizations), Cenexi, a French player in pharmaceutical manufacturing specializing in the formulation, development and manufacture of innovative sterile products, now designated as exclusive supplier, has prepared for this impressive order. "We were looking for a laboratory in Europe with sterile lines, high capacity, quality and obviously at a good price" , smiles Timothy Morris, financial and operations director of Humanigen, in the premises of Cenexi. The American start-up had been working on an anti-inflammatory product for more than five years. The Covid-19 health crisis has accelerated his research.
Of course, the amounts of the transactions between the two players remain secret. In Hérouville, the lines, specializing in the manufacture and filling of sterile liquid vials, are ready. Humanigen has already submitted to the High Authority for Health (HAS), in February 2022, a request for early access for lenzilumab in France in order to allow patients in therapeutic impasse to benefit, on an exceptional and temporary basis, from the molecule, effective against hyper-inflammation of the bronchi. Until all authorizations, French and European, are granted, the launch of large-scale production should not take place before the beginning of 2023.
One million bottles per year
"We will be able to supply 1 million bottles per year, but we could go up to 2 million per year if necessary", emphasizes Alexis Paul, development director of the French laboratory. Created in 2004, Cenexi, in addition to Hérouville (280 employees for €41 million in turnover), also has laboratories in Fontenay-sous-Bois and Osny, as well as Braine-l'Alleud, in Belgium. At the head of 1,500 employees and nearly €200 million in turnover in 2021, Cenexi is experiencing steady growth. This last transaction should help it position itself on the very active international market for drugs with major therapeutic indications. "Hérouville could even become the second production site for the USA", hopes Alexis Paul.
(Translation by Google)
Afterhours up to $2.65. I think next week will be bountiful.
Dale just filed a Form 4 announcing his buying of a bunch of calls. You have 65 minutes to buy some shares before afterhours closes.
In the last 5 years, the 10-k has been released between March 9th and March 27th. Today's release means the 10-k is likely coming much sooner this year, maybe as soon as later today. Dale and the other insiders have to wait 2 days after the release of the 10-k before they are allowed to buy stock. Dale sold approximately $50 million of stock last summer. He could send the share price parabolic if he decides to buy back in big. With data from the ACTIV-5 coming very soon, he might buy a lot of shares very quickly to get in before data unblinds.
We subsequently discover that PD-L1+TANs induced by LSCC-derived GM-CSF potently impair CD8+ T-cells proliferation and cytokines production function, which are partially blocked by a PD-L1-neutralizing antibody. Clinical data further support GM-CSF as an unfavorable prognostic biomarker and reveal a potential association with inflammatory immune cell infiltration, in particular neutrophils.
Conclusion: Tumor-infiltrating PD-L1+ neutrophils induced by LSCC-derived GM-CSF suppress T cell proliferation and activation in the inflammatory microenvironment of LSCC and predict unfavorable prognosis. These TANs cripple antitumor T cell immunity and promote tumor progression. Our findings provide a basis for targeting PD-L1+TANs or GM-CSF as a new immunotherapeutic strategy for LSCC.
https://www.dovepress.com/tumor-infiltrating-pd-l1-neutrophils-induced-by-gm-csf-suppress-t-cell-peer-reviewed-fulltext-article-JIR
Humanigen and Mayo patent application for CRISPR CAR-T with GM-CSF knockout.
T cells at the inflammatory site produce several cytokines including granulocyte macrophage-colony stimulating factor (GM-CSF), which is strikingly elevated in fatal cases of COVID-19 [1] and capable of triggering a hyperinflammatory storm
https://www.nature.com/articles/s41419-022-04589-z#:~:text=T%20cells%20at%20the%20inflammatory,storm%20%5B2%2C%203%5D
(From Jerry)
Humanigen Launches Managed Access Program for Lenzilumab
https://ir.humanigen.com/English/news/news-details/2022/Humanigen-Launches-Managed-Access-Program-for-Lenzilumab/default.aspx
Lenzilumab is available via LenzMAP in the following 17 countries:
Austria
Bulgaria
Croatia
Cyprus
Denmark
Estonia
France
Greece
Ireland
Lithuania
Luxembourg
Netherlands
Portugal
Spain
Sweden
Switzerland
United Kingdom
LenzMAP will enable access to lenzilumab on a case-by-case basis for hospitalized patients with COVID-19 for whom the treating physician deems there are no suitable alternatives and where regulations allow.
“We are pleased to be working with Clinigen to provide access to lenzilumab on a patient-by-patient basis in the United Kingdom and certain other European countries,” said Timothy E. Morris, COO and CFO of Humanigen. “While we continue to pursue our development program for lenzilumab and seek to attain appropriate authorizations or approvals for its potential commercial use in the United States, European Union and United Kingdom, LenzMAP will enable Humanigen to respond to requests from healthcare professionals for access to lenzilumab to treat certain hospitalized patients where allowed by local regulations.”
Clinigen will manage key elements of LenzMAP, including regulatory oversight, reimbursement, logistics, and access management.
“We are proud to partner with Humanigen in offering this potential treatment option for certain hospitalized patients with COVID-19 in the UK and across Europe. LenzMAP underscores Clinigen’s strength in partnering with biotechnology companies to provide services that enable quicker and broader access to critical medicines,” commented Pete Belden, Executive Vice President Services Division, Clinigen.
Clinigen currently oversees more than 161 similar managed access programs for other companies and has access to over 20,000 healthcare providers in 5,000 hospitals across more than 120 countries.
“As we move from the pandemic stage to the endemic stage of COVID-19, healthcare professionals continue to see vaccinated and unvaccinated patients alike presenting with elevated inflammatory markers,” stated Andrea Aroldi, MD, San Gerardo Hospital (Monza, Italy). “Now that lenzilumab is available on a compassionate-use/named-patient basis in certain European countries, physicians have available an additional treatment option, an immunomodulator, in their armamentarium of therapies in the fight against COVID-19.”
Healthcare professionals may obtain details about LenzMAP™ by calling the Clinigen customer service team at +44 (0) 1932 824100, e-mailing MedicineAccess@clinigengroup.com, or going online at www.clinigendirect.com.
Patients seeking medical information should contact their physician.
Humanigen and Cenexi Announce Collaboration to Manufacture Lenzilumab in France
https://ir.humanigen.com/English/news/news-details/2022/Humanigen-and-Cenexi-Announce-Collaboration-to-Manufacture-Lenzilumab-in-France/default.aspx
Cenexi to Become Preferred Drug Product Supplier for France and the European Union
BURLINGAME, Calif. & FONTENAY-SOUS-BOIS, France--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ and Cenexi, a French CDMO specializing in the formulation, analytical development, and manufacture of complex molecule drugs, announced a collaboration aimed at making Cenexi a preferred supplier of lenzilumab in France and the European Union. The initial step of the collaboration includes the execution of a Master Supply Agreement (“MSA”) providing for Cenexi to provide aseptic fill and finish services for lenzilumab for the next five years.
Under the terms of the agreement, Humanigen will transfer the technology and knowledge to Cenexi to allow them to establish drug product processes utilizing their state-of-the-art high speed filling line at their Herouville-Saint-Clair facility in Normandy. Humanigen and Cenexi will enter into discussions to potentially expand the agreement to other services Cenexi offers. These include labeling and packaging, importation of bulk drug substance and quality release of materials in France and throughout Europe. Humanigen plans to include the Cenexi Normandy site in certain of its future regulatory filings for lenzilumab for COVID-19 and other indications. The companies will collaborate to secure potential funding and investment in capital equipment from AD Normandie, the regional authority and the Government of France, the national authority. In addition, Cenexi will assist Humanigen as it seeks an advanced purchase agreement for lenzilumab in France.
“The goal of the collaboration with Cenexi is to further our efforts to establish a supply of lenzilumab made in Europe,” commented Cameron Durrant, chief executive officer of Humanigen. “Cenexi is an ideal partner for sterile filling and with their strong base of resources and aggressive growth plan, we may expand our collaboration beyond the typical customer/vendor relationship. We may work with Cenexi to become our preferred partner for multiple services and to establish a stable and secure supply chain for lenzilumab in France and Europe longer-term.”
In 2021, French authorities modified existing regulations to provide for early access to unauthorized medicinal products. The early access authorization (autorisation d’acces precoce of “AAP”) allows for a manufacturer to supply product to a cohort of individuals for a specific use, for example, lenzilumab for COVID-19. Humanigen plans to file a request for AAP with the Haute Authorite de Sante in February 2022.
“Cenexi desires a leadership position in France to assist in establishing a strong supply chain for COVID-19 and for future pandemics. Since 2004, Cenexi has been at the forefront of bringing critical medicines to patients and we continue to build on our strong reputation for value, high quality, flexibility and timeliness,” commented Christophe Durand, chief executive officer of Cenexi. “Our partnership with Humanigen will use our core competencies of sterile filling and to potentially expand into to an end-to-end solution for lenzilumab in France and other countries in Europe.”
Pending positive results from the NIH-sponsored ACTIV-5/BET-B study, Humanigen plans to amend the Emergency Use Authorization application in the United States. For the European Union, Humanigen anticipates submission of a Conditional Marketing Authorization with a request for Accelerated Approval in the third quarter of 2022.
Lenzilumab is an investigational product and is not approved or authorized in any country.
BlackRock just filed a 13g stating that they now own 3,343,800 shares of HGEN which constitutes more than 5% of total shares.
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001293310/a8107b95-823f-4bf0-ada3-24eacc0a1ec5.pdf
https://www.biorxiv.org/content/10.1101/2022.01.31.478497v1
I tried to post some images from this study but they won't post. If you click on "view pdf", there is a graphic towards the bottom that shows a crazy increase of GM-CSF. Much more than any other cytokine. But I guess we already knew that from the Thwaites trial.
https://www.nature.com/articles/s41590-021-01117-7
During inflammation, Ly6Chi monocytes are rapidly mobilized from the bone marrow (BM) and are recruited into inflamed tissues, where they undergo monocyte-to-phagocyte transition (MTPT). The in vivo developmental trajectories of the MTPT and the contribution of individual cytokines to this process remain unclear. Here, we used a murine model of neuroinflammation to investigate how granulocyte–macrophage colony-stimulating factor (GM-CSF) and interferon-? (IFN?), two type 1 cytokines, controlled MTPT. Using genetic fate mapping, gene targeting and high-dimensional single-cell multiomics analyses, we found that IFN? was essential for the gradual acquisition of a mature inflammatory phagocyte phenotype in Ly6Chi monocytes, while GM-CSF was required to license interleukin-1ß (IL-1ß) production, phagocytosis and oxidative burst. These results suggest that the proinflammatory cytokine environment guided MTPT trajectories in the inflamed central nervous system (CNS) and indicated that GM-CSF was the most prominent target for the disarming of monocyte progenies during neuroinflammation.
We need ACTIV-5 data badly. Hitting stat sig on primary endpoint again will solve everything. Hitting stat sig on mortality will send us parabolic. GM-CSF is the key to Covid so I think lenz will hit stat sig on both.
https://www.bbc.com/news/health-56352128
Clinical and economic benefits of lenzilumab plus standard of care compared with standard of care alone for the treatment of hospitalized patients with COVID-19 in the United States from the hospital perspective
https://www.tandfonline.com/doi/full/10.1080/13696998.2022.2030148?src=&