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Sunday, November 27, 2022

The Fascinating Story of Lenzilumab; Humanigen Inc (OTCMKTS: HGEN)

Humanigen Inc (OTCMKTS: HGEN) recently spiked to highs of $6.79 after the Company announced the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the United States Government Department of Health and Human Services (HHS) and Humanigen have executed a clinical trial agreement for Lenzilumab as an agent to be evaluated in the NIAID-sponsored Big Effect Trial (BET) in hospitalized patients with COVID-19.

This is big news for Lenzilumab which is proving to be effective against cytokine storms, according to a study from scientists at the Mayo Clinic. The Phase 3 trial is ongoing. 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. HGEN is quickly attracting legions of shareholders. The Company recently applied to have its common stock approved for listing on the Nasdaq Capital Market.

Humanigen Inc (OTCMKTS: HGEN) is a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.

HGEN started moving up in March after the Company begain actively exploring clinical stage strategies and partnerships to evaluate whether Lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF monoclonal antibody, may reduce or prevent cytokine storm resulting from COVID-19 (or coronavirus, also referred to as SARS-CoV-2) infection. Lenzilumab has come a long way as a treatment for coronavirus since than; on June 15 HGEN announced data on the first clinical use of lenzilumab in 12 COVID-19 patients. The manuscript, titled ‘First Clinical Use of Lenzilumab to Neutralize GM-CSF in Patients with Severe and Critical COVID-19 Pneumonia’ was published online at medRxiv.org (www.medrxiv.org/content/10.1101/2020.06.08.20125369v1). 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. Patients also demonstrated rapid improvement in oxygenation, temperature, inflammatory cytokines and key hematological parameters consistent with improved clinical outcomes.

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HGEN

On July 27 HGEN announced is has executed a clinical trial agreement for Lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, as an agent to be evaluated in the NIAID-sponsored Big Effect Trial (BET) in hospitalized patients with COVID-19. BET will help advance NIAID’s strategic plan for COVID-19 research, which includes conducting studies to advance high-priority therapeutic candidates.1 Identification of agents with novel mechanisms of action for therapy is a strategic priority.

This trial builds on initial data from NIAID’s Adaptive COVID-19 Treatment Trial (ACTT) that demonstrated Gilead’s investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19. BET will evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial is expected to enroll 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients have been enrolled in each arm.

Cameron Durrant, MD, MBA, chief executive officer of Humanigen stated: “We have been encouraged by the lenzilumab efficacy and safety data demonstrated in the compassionate use series in COVID-19 patients and are thrilled that NIH selected lenzilumab to be part of its Big Effect Trial. With data from the BET and our ongoing Phase III study, we will have data from approximately 500 hospitalized COVID-19 patients.”

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Microcapdaily reported on HGEN as it ran from $0.30 to $6.9. The Company already has the look and feel of a big board stock already since applying to have its common stock approved for listing on the Nasdaq Capital Market. It’s easy to get excited about HGEN; lenzilumab is proving to be effective against cytokine storms, according to a study from scientists at the Mayo Clinic. The Phase 3 trial is ongoing. 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. The lenzilumab story is starting to get picked up by main stream press with a recent mention in CNN and FOX. Eerlier this month the Company completed a $71,800,000 equity financing with J.P. Morgan Securities LLC iacting as the placement agent with a group of healthcare investors including Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), HealthCor, Valiant Capital Partners, First Light Asset Management and Ghost Tree Capital. 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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