Humanigen is the Rodney Dangerfield of the Biotech world. The company just cannot get any respect. A big part is that many institutional investors won’t touch the stock because it’s the former Martin Shkreli play KaloBios Pharmaceuticals. Many got burned in KaloBios and once burned, twice shy.
However, Humanigen remains a promising biotech with its Lenzilumab drug. In this article, Insider Financial takes a look at Humanigen and why this overlooked biotech belongs in one’s portfolio.
First up, here’s a little background info for anyone not familiar with the company. Humanigen, Inc., a biopharmaceutical company, develops proprietary monoclonal antibodies for immunotherapy and oncology treatments. The company’s lead product candidate is Lenzilumab, a monoclonal antibody that targets and neutralizes granulocyte-macrophage colony-stimulating factor, which is in Phase I/II clinical trial in patients with chronic myelomonocytic leukemia, and for the treatment of juvenile myelomonocytic leukemia.
It also develops Ifabotuzumab, a monoclonal antibody that targets EphA3 receptor, which has completed the Phase I dose escalation portion of a Phase I/II clinical trial in multiple hematologic malignancies; and HGEN005 an anti-EMR1 monoclonal antibody, which is in pre-clinical stage for the treatment of eosinophilic diseases.
The company has a clinical collaboration agreement with Kite Pharma, Inc. to conduct a multi-center Phase I/II study of Lenzilumab in patients with relapsed or refractory diffuse large B-cell lymphoma; and a partnership with Catalent Biologics to manufacture investigational covid-19 therapeutic candidate Lenzilumab.
The company was formerly known as KaloBios Pharmaceuticals, Inc. and changed its name to Humanigen, Inc. in August 2017. Humanigen, Inc. was founded in 2000 and is based in Burlingame, California.
National Institutes of Health (NIH)
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) has launched ACTIV-5 Big Effect trial, to compare different investigational therapies to a common control arm to determine which experimental treatments have relatively large effects.
The Phase 2 trial will enroll hospitalized COVID-19 volunteers at as many as 40 U.S sites; ~100 subjects will be assigned to each study arm with each of the study sites testing no more than three investigational treatments at once.
The trial will test Boehringer Ingelheim’s monoclonal antibody risankizumab, in conjunction with the antiviral drug Gilead’s remdesivir, compared to a placebo plus remdesivir. The trial will also test the investigational monoclonal antibody Humanigen’s lenzilumab, with remdesivir, compared to placebo and remdesivir. Cameron Durrant, MD, MBA, chief executive officer of Humanigen, said:
“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.”
The primary purpose of the ACTIV-5/BET study is to evaluate the clinical efficacy of the different investigational therapeutics relative to the control arm on the volunteers’ clinical status at day 8. Secondary point of evaluation is clinical efficacy of the different investigational therapeutics as assessed by the amount of time it takes for each volunteer to recover from COVID-19.
Humanigen and Lenzilumab
Lensilumab has been showing very positive results when it comes to the treatment of COVID-19. A recently published case describes a 77-year-old Caucasian male patient with a past medical history of type II diabetes, coronary artery disease with coronary artery bypass graft, systolic heart failure, severe chronic obstructive pulmonary disease (COPD) with emphysema, and obstructive sleep apnea.
The patient tested positive for SARS-CoV-2 and was admitted to the ICU in March 2020 for COVID-19 and put on respiratory isolation. The patient was treated with steroids, broad-spectrum antibiotics for community-acquired pneumonia and bronchodilators for possible COPD exacerbation, and hydroxychloroquine with zinc.
The patient continued to deteriorate for the next 12 weeks with an increase in oxygen demand from continuous low-flow oxygen to high-flow and eventually intermittent bilevel positive airway pressure (BIPAP) and developed acute respiratory distress syndrome (ARDS) during that time.
At week 13 of hospitalization and multiple unsuccessful attempts at oxygen weaning, an emergency single-use IND for lenzilumab, Humanigen’s Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, was approved by the FDA and administered to the patient.
Seven days following the administration of lenzilumab, the patient’s oxygen decreased from high-flow to low-flow nasal cannula and the patient was able to walk outside of his hospital room with physical therapy.
Sixteen days post-treatment with lenzilumab, the patient was discharged from the hospital on home oxygen.
A separate case-control study of lenzilumab in severe and critical COVID-19 published in Mayo Clinic Proceedings demonstrated 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 is being evaluated in an ongoing Phase 3 trial and trial site locations can be found here: https://www.humanigen.com/covid-19-sites.
Type B Meeting For Lenzilumab
According to the FDA, Humanigen’s planned submission is sufficient to support EUA requests subject to the Phase 3 trial results. Equally, the company has announced more updates in Phase 3 lenzilumab registration study, which is enrolling subjects in Brazil, the U.S. and has been approved for expansion to Mexico.
The double-blind, placebo-controlled, randomized phase 3 study has 29 approved study sites with 24 of those actively enrolling hospitalized patients with COVID-19 who are at risk of disease progression or who need supplemental oxygen.
Humanigen CEO Cameron Durrant said that the FDA has helped the company and has offered clear guidance on the EUA submission plan. He added that they are encouraged by the Type B meeting with the FDA, and they are upbeat in their program and preparedness plans in advancing the EUA.
Chief Scientific Officer Dale Chappell said that lenzilumab is among the few third phase treatment alternatives currently in development for the treatment of COVID-19. Dale added that lenzilumab has the potential of being a first-line treatment that can improve recovery time and also mitigate potentially fatal and serious outcomes in hospitalized COVID-19 patients.
We believe Humanigen is on the verge of a major breakthrough with lenzilumab. With a market cap of just $700 million and the potential for lenzilumab being in the billions, Humanigen is one small-cap biotech that belongs in an investor’s portfolio. The current risk/reward setup is too great to ignore. We don’t think Humanigen will remain under the radar for much longer.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in NASDAQ:HGEN or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.