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Lenzilumab; the Rise of Humanigen Inc (NASDAQ: HGEN)

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Humanigen Inc (NASDAQ: HGEN) is heating up and moving steadily northbound in recent weeks as the Company’s lead candidate Lenzilumab continues to gain serious traction. Lenzilumab is proving to be very effective against cytokine storms, according to a study from scientists at the Mayo Clinic and data from the first clinical use of Lenzilumab showed patients rapid clinical improvement with a median time to recovery of five days, median time to discharge of five days and 100% survival to the data cut-off date.

Lenzilumab is undergoing a phase 3 clinical trial that has enrolled patients both in the U.S. and abroad, and Humanigen expects to publish top-line data from this trial in the fourth quarter. Investors are rightfully enthusiastic that this study will produce positive results. Lensilumab was also just selected by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) for its ACTIV-5 “Big Effect Trial” (ACTIV-5/BET), designed to find drugs in late-stage clinical development that show promise against COVID-19. ACTIV-5/BET is enrolling at 40 US sites, and is evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with approximately 100 patients assigned to each study arm. Humanigen is backed by Venrock & Valiant and already has manufacturing agreements in place with Thermo Fisher & Lonza.

Humanigen Inc (NASDAQ: HGEN) operating out of Burlingame, California is a clinical stage biopharmaceutical company, developing its clinical stage COVID-19 immunology and immuno-oncology portfolio of monoclonal antibodies. The Company is focused on deveoping its lead product candidate, lenzilumab™, a proprietary Humaneered® anti-human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) immunotherapy. Humanigen’s proprietary and patented Humaneered technology platform is a method for converting existing antibodies such as murine into engineered, high-affinity human antibodies designed for therapeutic use, particularly for chronic conditions. Humanigen has developed or in-licensed targets or research (mouse) antibodies, typically from academic institutions, and then applied its Humaneered technology to them. Lenzilumab and its other two product candidates, ifabotuzumab and HGEN005, are Humaneered antibodies. The Company’s Humaneered antibodies are closer to human antibodies than chimeric or conventionally humanized antibodies and have a high affinity for their target but low immunogenicity. Humanigen believes its Humaneered antibodies offer additional advantages, such as lower likelihood to induce an inappropriate immune response when used chronically, high potency, and a slow off-rate.

Lenzilumab has been proven in animal models to neutralize GM-CSF, a cytokine that the Company believes is of critical importance in the inflammatory cascade, sometimes referred to as cytokine release syndrome (“CRS”) or cytokine storm, associated with COVID-19, chimeric antigen receptor T-cell (“CAR-T”) therapy and acute Graft versus Host Disease (“GvHD”) related side-effects. Lenzilumab binds to and neutralizes soluble, circulating GM-CSF. Humanigen believes its leadership position in GM-CSF pathway science and cytokine storm presents its with a diverse set of development opportunities; currently Humanigen is focused on developing lenzilumab for three primary indications: as a therapy targeting severe outcomes in hospitalized patients with confirmed COVID-19 pneumonia; as a sequenced therapy ahead of CAR-T administration in CD19 targeted CAR-T therapies; and as an early treatment or potential prophylaxis for acute GvHD in high and intermediate risk patients. Lenzilumab has shown to be safe in clinical settings following administration to 125 patients in multiple indications (including severe respiratory conditions and leukemia) with no serious adverse events

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Humanigen inks licensing agreement with the University of Zurich to strengthen its treatment of graft-versus-host disease in leukemia patientsHumanigen is led by CEO Dr. Cameron Durrant, a corporate executive with extensive experience as a pharma/biotech entrepreneur who has launched over 20 brands including two of the six fastest selling blockbusters in pharma history and 3 brands nominated for Prix Galien awards. Dr. Durrant earned his medical degree from the Welsh National School of Medicine, Cardiff, UK, his DRCOG from the Royal College of Obstetricians and Gynecologists, London, UK, his MRCGP from the Royal College of General Practitioners, London, UK, his DipCH from the Melbourne Academy, Australia and his MBA from Henley Management College, Oxford, UK.

Lenzilumab COVID-19 Case-Control Study Published in Mayo Clinic Proceedings Journal showed an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death for patients treated with lenzilumab compared to the matched control group. Lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, is being evaluated in an ongoing Phase III trial and was selected by the National Institutes of Health for its COVID-19 Big Effect Trial. Dale Chappell, chief scientific officer of Humanigen stated:  “We believe these to be some of the most compelling data published to date of an investigational therapeutic with potential to substantially fight the COVID-19 pandemic and we look forward to validating these data with the results of our ongoing Phase III study.”

On October 13 Humanigen reported the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), launched its ACTIV-5 “Big Effect Trial” (ACTIV-5/BET), designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and, therefore, merit advancement into larger clinical trials. ACTIV-5/BET, which will enroll at as many as 40 US sites, will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with approximately 100 patients assigned to each study arm. Humanigen is providing lenzilumab for the study, which is fully funded by NIH.

ACTIV-5/BET is being conducted in collaboration with the NIH’s public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program. The ACTIV partnership has evaluated approximately 400 therapeutic agents with a potential application for COVID-19 and developed a collaborative framework for prioritizing the most promising candidates, streamlining clinical trials, coordinating regulatory processes, and leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics. To date, ACTIV has designed five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.

Humanigen CEO Cameron Durrant stated: “Lenzilumab is one of the few Phase 3 treatment options in development for COVID-19, and we believe that its mechanism of action as an immunomodulator could work very nicely with remdesivir and potentially enhance first line standard of care therapy to prevent serious and potentially fatal outcomes. We are excited at NIH’s recognition of the potential of our drug candidate for this new ACTIV trial, reinforcing the importance of testing and funding for therapeutics to treat COVID-19, and we are eager to put lenzilumab through further rigorous testing to contribute to the battle against this pandemic.”

 

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Currently running northbound Humanigen is one exciting Company making waves in the fight of the world pandemic coronavirus. humanigen’s lenzilumab is proving to be very effective against cytokine storms, according to a study from scientists at the Mayo Clinic. According to the most recent date, patients showed rapid clinical improvement with a median time to recovery of five days, median time to discharge of five days and 100% survival to the data cut-off date.  Lenzilumab is undergoing a phase 3 clinical trial that has enrolled patients both in the U.S. and abroad, and Humanigen expects to publish top-line data from this trial in the fourth quarter. Investors are rightfully enthusiastic that this study will produce positive results. Lensilumab was also just selected by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) for its ACTIV-5 “Big Effect Trial” (ACTIV-5/BET), designed to find drugs in late-stage clinical development that show promise against COVID-19. ACTIV-5/BET is enrolling at 40 US sites, and is evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with approximately 100 patients assigned to each study arm. Humanigen is backed by Venrock & Valiant and already has manufacturing agreements in place with Thermo Fisher & Lonza. Microcapdaily has been covering Humanigen since the stock was $0.30 on the OTCQB. We will be updating on HGEN when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with HGEN.

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Disclosure: we hold no position in HGEN either long or short and we have not been compensated for this article.

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