Results of the LIVE-AIR trial, evaluating Humanigen Inc.'s (HGEN:NASDAQ) lead asset lenzilumab in hospitalized patients with COVID-19 pneumonia, completed earlier this year, were published in a recent issue of the British medical journal Lancet Respiratory Medicine, reported ROTH Capital Partners analyst Tony Butler in a Dec. 2 research note. Lenzilumab is an antibody that neutralizes the cytokine GM-CSF.
Butler reiterated LIVE-AIR's results, writing that "the conclusion of the study demonstrated that lenzilumab treatment of hospitalized patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile similar to that of placebo."
In other news, Humanigen has a type B meeting with the U.S. Food and Drug Administration (FDA) this month to discuss additional LIVE-AIR data. Three months ago, the FDA denied Humanigen emergency use authorization of lenzilumab in the same patient population.
Also in the U.S., the biopharma is working to submit a biologic license application for lenzilumab with the FDA while the ACTIV-5/Big Effects trial of lenzilumab is underway, Butler indicated. The population of the study, sponsored by the National Institutes of Health and in the enrollment stage, will be hospitalized, hypoxic COVID-19 patients but only those with a C-reactive protein of less than 150 milligrams per liter.
"It is possible this type B meeting may serve as a prelude to an advisory panel for lenzilumab and/or that the FDA may wait until a readout from the ACTIV-5/BET-B trial before taking further action concerning the use of lenzilumab in COVID-19 in the U.S.," Butler explained.
Outside the United States, Humanigen continues to pursue approval of lenzilumab. In the United Kingdom (U.K.), for instance, the biopharma has a meeting this month with the Medicines and Healthcare products Regulatory Agency concerning further information it requested in conjunction with Humanigen's conditional marketing authorization application. The company plans to respond to the request formally in Q1/22.
Also, Humanigen's marketing authorization application filed with the European Medicines Agency is still under review.
Butler pointed out Humanigen is testing lenzilumab in indications other than COVID-19, and has three such multisite trials on tap. One, the PREACH-M study, for which patient recruitment is underway at five Australian sites, will evaluate the efficacy of combination treatment, lenzilumab plus azacitidine, in patients with chronic myelomonocytic leukemia.
The other two trials, SHIELD and RATinG, are slated to commence in H1/22. SHIELD will evaluate the use of a combination therapy of lenzilumab plus commercially available chimeric antigen receptor T-cell therapies in patients with non-Hodgkin's lymphoma. About 250 patients will be enrolled from 30 sites.
RATinG will evaluate lenzilumab in patients who have undergone allogeneic hematopoietic stem cell therapy and have an intermediate to high risk of developing acute graft versus host disease. The trial will span 22 sites in the U.K.
ROTH has a Buy rating and a $19 per share price target on Humanigen. Its current share price is about $5.57.
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Important Disclaimers for ROTH Capital Partners LLC, Humanigen Inc., Dec. 2, 2021
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has received compensation for investment banking services from Humanigen, Inc.
ROTH makes a market in shares of Humanigen, Inc. and as such, buys and sells from customers on a principal basis.
Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has managed or co-managed a public offering for Humanigen, Inc.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH. Copyright 2021. Member: FINRA/SIPC.