Humanigen showing positive results for cancer drug lenzilumab, also used to treat patients hospitalized with coronavirus

Key drug candidate lenzilumab is a recombinant monoclonal antibody Designed to reduce sometimes dangerous side effects associated with cancer therapy Conducting Phase 3 clinical trial for lenzilumab to treat patients hospitalized with coronavirus Raised approximately $72.7 million via a Nasdaq public offering and uplisting in September 2020 What Humaningen does: Humanigen Inc (NASDAQ:HGEN) is in the early stages of work on a drug designed to reduce the sometimes dangerous side effects associated with a cancer therapy involving altered T-cells. A goal is to improve the safety of so-called CAR-T therapies, used in the treatment of children with acute lymphoblastic leukemia and adults with advanced lymphomas. A frequent side-effect is cytokine release syndrome, which can include fever, nausea, headache, rash, rapid heartbeat, low blood pressure and trouble breathing. Reactions are often mild but occasionally life-threatening. The key drug candidate for the Burlingame, California, company is lenzilumab, a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells but is also tied to inflammations that can occur during CAR-T therapies and lead to side effects. Pre-clinical work involving mice shows lenzilumab is effective in preventing the side effects and may make the CAR-T therapies more effective, according to Humanigen. The company has completed a Phase 1 clinical trial of patients with a type of leukemia conducted to identify the recommended Phase 2 dose of lenzilumab and to assess its safety. The company is planning on starting pivotal studies this year involving CAR-T and hopes to complete them by the end of 2020. It has also initiated a Phase 3 clinical trial to evaluate lenzilumab combined with remdesivir vs. remdesivir alone as a treatment for severe coronavirus (COVID-19) patients.   Humanigen is also looking at two other drug candidates: ifabotuzumab and HGEN005. Ifabotuzumab, according to Humanigen, shows potential in attacking tumors by killing the stromal cells that protect them and the vasculature that feeds them without killing normal cells. The company says the first patients have been dosed in a Phase 1 trial at the Olivia Newton-John Cancer Research Institute in Australia to assess safety. The company’s other drug candidate, HGEN005, shows promise as a treatment for eosinophilia, a condition in which the number of eosinophil white blood cells is greatly increased. It can be a sign of a parasitic infection, an allergic reaction or cancer. Humanigen is talking with a leading US cancer center about pre-clinical testing in eosinophilic leukemia. However, under Cameron Durrant, a medical doctor and MBA who assumed the role of CEO in March 2016, the company has concentrated on realizing the promise of lenzilumab. Prior work for the turnaround specialist includes serving as CEO at three specialty pharma companies and senior executive roles at Pharmacia Corp, now part of Pfizer Inc (NYSE:PFE), as well Johnson & Johnson (NYSE:JNJ). How is it doing:   On November 6, Humanigen announced positive interim Phase 3 data on lenzilumab to treat patients hospitalized with COVID-19.  The company said this interim analysis for sizing and powering, suggests that lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37% more recoveries observed in the lenzilumab arm of the randomized, placebo-controlled, double-blinded study versus current standard of care (SOC).  Humanigen said the data safety monitoring board (DSMB) composed of independent subject matter experts conducted an interim analysis of the unblinded data for trial sizing and powering and recommended increasing the target number of events (recoveries) from 257 to 402 to maintain the power of the study at 90%.  At the recommendation of the DSMB, the company said it plans to increase enrollment to achieve 402 events (about 515 patients). This increase in enrollment ensures an even higher probability of success in meeting the primary endpoint and maintains the power of the study at 90%. The next interim analysis for efficacy is planned when the study reaches 75% events (302 events), which will require about 390 patients to be enrolled in the trial. Earlier in the month, Humanigen revealed it has also signed a licensing deal for lenzilumab in South Korea and the Philippines worth as much as $20 million, including $6 million in an upfront payment when the agreement is executed. On the financial front, the company ended the third quarter of 2020 with $91.4 million in cash and equivalents after raising approximately $72.7 million via a Nasdaq public offering and uplisting in September. For the remainder of 2020, Humanigen has said it is focused on enrolling more patients in its Phase 3 lenzilumab clincial trial and anticipates applying for an Emergency Use Application (EUA) in 1Q 2021. Elsewhere, the company launched Humanigen Australia Proprietary Limited on November 23 for the purpose of developing potential partnering opportunities and facilitating clinical development programs to increase its market access in the Asia-Pacific region. Inflection points: Next interim analysis for lenzilumab efficacy in its COVID-19 treatment trial  Filing for EUA in the first quarter of 2021 What the broker says: In a note to clients published on December 7, Roth Capital pointed to a study conducted by University Hospital Dijon in France, which compared clinical and biological characteristics, immune response, and outcomes between non-COVID-19 and COVID-19 patients with severe pneumonia. The significance of the study for Humanigen, according to Roth, is that the company’s anti-GM-CSF antibody lenzilumab is considered a promising therapy for hospitalized COVID-19 patients. It noted that Humanigen’s Phase III trial is ongoing with “very favorable” interim results. Complete results are expected to come out in early 2021. The brokerage firm reiterated its Buy rating on shares of Humanigen with a $25 price target, which it said is derived from a risk-adjusted net present value analysis of the utility of GM-CSF neutralizing antibody lenzilumab in suppressing cytokine release syndrome (CRS) in COVID-19 pneumonia, CAR-T therapy-induced CRS, and graft-versus-host disease (GvHD) after stem cell transplant.    “We consider revenues from (1) COVID-19 in the U.S. (2021 launch, $1.2 billion sales in 2021, 75% POS), (2) CAR-T in the U.S. and Europe (2022 Launch, $400 million peak sales, 45% POS), and (3) GvHD in the US and Europe (2023 Launch, $350 million peak sales, 45% POS),” the Roth Capital analysts wrote. What the boss says: Commenting on the company's 3Q 2020 operational results, Humanigen CEO Cameron Durrant said: “We’ve achieved many important milestones in the third quarter, including completing a public offering to begin trading on Nasdaq, being selected for the National Institutes of Health’s ACTIV-5/Big Effect Trial, strengthening our management team, adding clinical trial sites in Brazil for our Phase 3 clinical trial of lenzilumab in patients with COVID-19, and expanding our manufacturing capacity with new agreements with Catalent and Thermo Fisher.” He added: “For the last two months of 2020, we remain focused on enrollment of the Phase 3 trial of lenzilumab for patients hospitalized with COVID-19, in which we recently announced a positive analysis of interim Phase 3 data. As enrollment continues for this trial within the United States and in Brazil, we anticipate applying for an EUA in the first quarter of 2021. I’m pleased with how our team has remained dedicated to advancing promising therapeutics for cytokine storm and would like to thank the dedicated health care providers and essential workers who continue to expose themselves to risk during this pandemic.” Contact Sean at sean@proactiveinvestors.com