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Bulls Take Charge of Humanigen Inc (OTCMKTS: HGEN)

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Humanigen Inc (OTCMKTS: HGEN) continues to rocket up in recent days emerging as one of the top most traded stocks in small caps regularly topping $5 million in dollar volume. The stock was trading for as low as $0.30 before coronavirus came along

its easy to get excited about HGEN here; Humanigen’s 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. On June 15 the Company announced data on the first clinical use of lenzilumab. 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.

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.

The Company 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. The Company believes its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection as well as the 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. The company’s immediate focus is to prevent or minimize the cytokine storm that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection and also in 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, to evaluate the sequential use of lenzilumab with Yescarta®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma is currently enrolling. 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).

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HGEN

HGEN took off from its $0.30 lows back in March when the Company announced it was 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.

Dr. Zelalem Temesgen, Professor of Medicine at Mayo Clinic and one of the key authors of the study, said, “Lenzilumab use was associated with improved clinical outcomes and oxygen requirement, with no reported mortality. We did not observe any treatment-emergent adverse events attributable to lenzilumab and it was well-tolerated. Based on the pathophysiology of cytokine storm following SARS-CoV-2 infection, along with work conducted at Mayo Clinic on GM-CSF depletion in CAR-T therapy, lenzilumab may offer a rational approach to ameliorate the consequences of cytokine storm in COVID-19.”

On June 30 HGEN announced the first patient has been infused in the ZUMA-19 study, which is being conducted in collaboration with Kite, A Gilead Company. Details of the ZUMA-19 study can be found at www.clinicaltrials.gov/ct2/show/NCT04314843.

Humanigen CEO Cameron Durrant, MD, stated: “We are excited to see this clinical collaboration move forward as we seek to understand the potential benefit of lenzilumab being administered with CAR T therapy in patients with relapsed or refractory large B-cell lymphoma.”

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Currently trading at a $900 million market valuation HGEN has the look and feel of a big board stock already. It’s easy to get excited about HGEN here; Humanigen’s 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. On June 15 the Company announced data on the first clinical use of lenzilumab. 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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