Before the coronavirus pandemic, Humanigen (OTCMKTS: HGEN) was heavily focused on the prevention and treatment of cytokine storm, which occurs in certain cancer therapies and bone marrow transplants, through the use of their lead product. However, with the COVID-19 pandemic reshaping life as we know it, the company’s approach to therapeutic options may prove effective for those infected with the virus.
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Providing Shelter From Cytokine Storm
The subheading above was taken directly from the home page of Humanigen’s website, and there’s simply no better way to say it. Humanagen’s claim to fame in the coronavirus space is known as lenzilumab (or ‘lenz’).
The drug is a monoclonal antibody that neutralizes GM-CSF (a cytokine) which is a key trigger in COVID-19 patients’ deterioration. GM-CSF is up-regulated in patients who have a harmful immune response and can end up on a ventilator and on the ICU. In fact, clinical evidence suggests that this response contributes to a cytokine storm caused by SARS-CoV-2 in COVID-19 patients with, or at risk of, developing acute respiratory distress syndrome. So, what is a cytokine storm?
A cytokine storm is an overproduction of immune cells and their activating compounds, known as cytokines. In the COVID-19 infection, like in flu infections, cytokine storms are often associated with a surge of activated immune cells into the lungs.
When a cytokine storm takes place in COVID-19 patients, the action results in excessive fluids in the lungs. Not only does this lead to respiratory distress in patients, these fluids are often contaminated with the virus and sometimes bacteria causing pneumonia and leading to acute respiratory distress syndrome.
Given the fact that HGEN has already shown efficacy in the prevention of cytokine storm in preclinical and is in an ongoing clinical oncology study in collaboration with Kite Pharma (a division of the huge biotech company, Gilead Sciences) to prevent cytokine storm in a cancer therapy, lenzilumab has tremendous potential to be an effective treatment for the current coronavirus patients.
HGEN Has A Phase 3 Study On The Horizon
In a recent press release, Humanigen announced that it plans to quickly move forward with a Phase 3 clinical trial of lenzilumab in COVID-19 patients. In the announcement, the company not only said that clinical trials will begin as soon as it receives relevant regulatory approvals, it is working on making the treatment available on a compassionate use basis.
In a statement. Dr. Cameron Durrant, CEO at HGEN, had the following to offer:
Humanigen has pioneered in the field of GM-CSF neutralization and, unlike others, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results
While other anti-GM-CSF antibodies have been primarily focused on arthritic and other inflammatory conditions, we have been working on prevention of cytokine storm for nearly three years and consider lenzilumab, which has been developed over more than a decade, with its published data in prevention of cytokine storm in animal models and the ongoing ZUMA-19 clinical study in collaboration with Kite, to be the leading anti-GM-CSF monoclonal antibody. Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events, including in patients who are immunosuppressed or with severe asthma.
Further, we have filed extensive IP in GM-CSF neutralization across a wide range of areas, including COVID-19, over the course of many years.
We have been conducting work on targeting GM-CSF to prevent or treat cytokine storm in a number of conditions. It now appears that this is a key trigger in ARDS associated with COVID-19 and we look forward to continuing to lead in the area of GM-CSF neutralization in this setting.
While there has been use of, and investigational studies planned, which are focused on IL-6 neutralization, unfortunately these compounds are associated with increased rates of infection in pulmonary conditions, which in some cases is reflected in a Black Box Warning for these products.
We look forward to studying whether, with its excellent and proven safety and tolerability profile, lenzilumab may offer an alternative potential therapeutic solution in COVID-19 for already fragile, high-risk patients.
The Opportunity Here Is An Incredible One
COVID-19 is changing life as we know it. When was the last time that you remember schools being closed across the United States due to a medical pandemic? It hasn’t happened in my lifetime.
In my small community, we rarely have traffic, but the lack of any sign of life on our roads has ceased to exist. The local stores are closing their doors, and the few that are open have little on the shelves. Sadly, this story is repeating itself around the world.
Lately, we’ve seen several biotechnology companies announce that they are working in some way to fight the novel coronavirus. Most of these announcements have surrounded increases in production of face masks, the development and launch of diagnostic tests, and work toward the development of a vaccine.
What we haven’t seen a lot of yet is companies like Humanigen that have announced that they are working on a late-stage therapy for those that have already become sick. Of the few that have announced that they are working on a treatment, even fewer have anything tangible that’s even ready for animal studies. The number gets even smaller when we’re talking about a treatment that is already ready for potentially approvable human trials. That’s where HGEN sits.
Not only is the company one of less than a handful that have a potential treatment option ready for clinical trials, IT IS THE ONLY COMPANY that has already proven efficacy in the reduction of risk in cytokine storms. IT IS ALSO THE ONLY COMPANY that has a treatment ready for human trials that ALREADY HAS A favorable safety and tolerability profile.
The bottom line is that when it comes to the development of a treatment for COVID-19, HGEN is a frontrunner in the race, if not the leader!
At the moment, there are no clear estimates as to how large the COVID-19 treatment market might be, but considering the strain the condition is putting on health care systems around the world, demand for a treatment is expected to be incredibly high. For a company with a market cap of just over $135 million, tapping into a market opportunity this big is a huge move.
Humanigen Beyond COVID-19
Importantly, Humanigen is no one-trick pony. The company has been working hard for years to develop effective, yet safe, gene and cell therapies. As mentioned above, lenzilumab is currently being studied as a potential option in the field of oncology.
In fact, the treatment is the subject of four clinical programs, ranging in stages from Phase I to Phase 3 in the field of oncology and transplantation. The company also completed a 160 patient Phase II clinical trial in severe asthma with lenzilumab, another worry-some respiratory condition.
Under collaborations with names like Kite, a Gilead Company (GILD), MD Anderson Cancer Institute, University of Zurich, Mayo Clinic, Moffitt Cancer Center, and others, HGEN has amassed an incredible roster of world-leading partners, and is paving several potential pathways to market approval.
A Management Team That’s Hard To Ignore
We all know that having a great candidate means nothing if a management team can’t bring that candidate through development and to successful commercialization. As such, management should play a key role when making investment decisions. In the case of HGEN, the company has a management team that’s hard to ignore.
First and foremost, we have Cameron Durrant, MD, MBA, Chairman and CEO at Humanigen. As a former practicing physician and now a serial biotechnology executive, Dr. Durrant has held several Executive Chairman, CEO, and CFO positions at small companies, but also executive positions at companies like Pharmacia (now part of Pfizer), Johnson & Johnson (JNJ), GlaxoSmithKline (GSK), and Merck (MRK). He helped to cement deals with Gilead (GILD) while at Johnson & Johnson and did the deal with Kite (a Gilead company) last year. He also launched multiple blockbuster drugs in his career, including 3 anti-virals, which is very relevant in the context of COVID-19, bringing with him the experience it takes to bring a drug from development to successful commercialization.
Next on the roster, we have Dale Chappell, MD, MBA, acting Chief Scientific Officer at HGEN. Dr. Chappell was the founder of Black Horse Capital Advisors. He has decades of biotechnology investment experience and has multiple publications in T-cell therapy, GM-CSF and immunology pathways.
Finally, we have Omar Ahmed, PharmD, Vice President at HGEN. Ahmed has 20 years of pharmaceutical executive experience, with roles at Roche (RHHBY), Novartis (NVS) and Johnson and Johnson. He has deep expertise in I/O and biologics development and has led successful collaborations with GlaxoSmithKline, Merck, Astellas (ALPMY), Vertex Pharmaceuticals (VRTX), Idenix Pharmaceuticals, and others.
Then we should look at the Board of Directors. That includes Bob Savage, the former Worldwide Chairman of Pharmaceuticals at J+J. Another impressive senior industry executive is Dr. Rainer Boehm. He has been the interim CEO for Novartis Pharma and was also their Chief Commercial Officer Officer and Chief Medical Affairs Officer. He is also on the board of Cellectis, a leading CAR-T company and Incyte, a leading immuno-oncology company. Both are very significant size companies. Then there is Tim Morris, the CFO of Iovance, another very successful and large immuno-oncology company. Their most recent Board hire is Cheryl Buxton, who is the Vice Chair for Pharmaceuticals for KornFerry, the world’s leading recruitment firm. And finally there’s Ron Barliant, who is the ‘legal guy’ and a former high court circuit judge. That is a stellar board and, frankly, way more impressive than you would expect of companies of this stage and size. They are clearly equipped to help steer this to become a much larger company and to do more deals.
The Bottom Line
The bottom line here is simple. HGEN is a stock that investors should be paying close attention to. As the world braces for the full brunt of COVID-19 to hit, demand for a viable prevention or treatment for pneumonia and ARDS caused by the virus will only rise. HGEN is on the cutting edge of innovation in this space, and far beyond the vast majority of its competitors who are much earlier in the development process.
At the same time, the company has a management team and board that is impressive to say the least. Made of highly experienced biotechnology executives, the team has what it takes to rapidly advance lenzilumab and successfully bring the drug to market.
Beyond the COVID-19 pandemic, HGEN has plenty more opportunities for tremendous growth ahead. With several clinical programs in various stages, there are likely multiple catalysts in the near future. All in all, if you’re interested in investing in the biotech space, and you’re not paying attention to HGEN, now is the time to start.
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