Clinical stage biopharmaceutical company Humanigen Inc. (HGEN:NASDAQ), which is focused on developing therapies for treating cancer and infectious diseases, today announced that "it is completing enrollment in its Phase 1 bioimaging study of ifabotuzumab in patients with recurrent glioblastoma multiforme (GBM)."
The firm explained that its proprietary ifabotuzumab is an anti-EphA3 monoclonal antibody. Humanigan noted that it has received funding for the study from the Cure Brain Cancer Foundation and that the trial is being conducted at the Olivia Newton-John Cancer Research Institute in Heidelberg, Victoria, Australia. The company stated that it expects to receive the results from the study in H1/21.
Professor Andrew Scott, head of the Tumor Targeting Laboratory at Olivia Newton-John Cancer Research Institute, professor in the School of Cancer Medicine of La Trobe University and a member of the Australian Brain Cancer Mission Strategic Advisory Group, commented, "GBM represents an extremely aggressive form of cancer that has historically eluded effective treatment, and we remain committed to investigating ifabotuzumab as a potential new approach to treat this devastating disease as well as other solid tumors."
The company explained that "GBM is the most frequent and lethal type of primary brain cancer, with only 10% of patients surviving five years." The firm described ifabotuzumab as a non-fucosylated IgG1K antibody that is designed to bind to EphA3, which is expressed in about 40% of GBM cases and 100% of the tumor vasculature and additionally is widely expressed in tumor stroma and tumor vasculature of other solid tumors.
Humanigen indicated that the primary objective of the Phase 1 study is to determine the safety and optimum dosage levels for ifabotuzumab in a future Phase 2 trial either as a monotherapy or in combination with an antibody drug conjugate (ADC).
The firm reported that the study is designed to use "radiolabelled ifabotuzumab followed by sequential positron emission tomography (PET) imaging to determine biodistribution, frequency of in situ EphA3 expression and quantitative tumor uptake of ifabotuzumab." Patients have been split into three groups where they are scheduled to receive various levels of weekly escalating doses of ifabotuzumab and will be monitored for receptor occupancy, response rate and overall survival.
"The study has now completed recruitment and we are very excited at having shown that ifabotuzumab is able to target the brain tumor in all the patients tested without binding to healthy tissue...We saw some signs that ifabotuzumab was affecting the blood vessels that feed the tumors and may halt their ability to grow in some patients," stated Professor Hui Gan, clinical research lead at the Olivia Newton-John Cancer Research Institute and director of Cancer Clinical Trials Center, Austin Health.
The company's CEO Cameron Durrant, M.D., M.B.A., remarked, "There is a tremendous need to advance new therapies for solid tumors and we look forward to progressing the clinical development of ifabotuzumab...Ifabotuzumab represents an important part of our immuno-oncology arsenal as we advance our pipeline to target a wide-range of cancers."
Humanigen, Inc. is based in Burlingame, Calif., and concentrates its efforts on developing clinical and pre-clinical therapies to treat cancers and infectious diseases. The firm also stated that its novel, cutting-edge GM-CSF neutralization and gene-knockout platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company stated that "its immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection."
The company mentioned that the Olivia Newton-John Cancer Research Institute is a leading center for creating experimental and breakthrough cancer treatments. The institute's researchers are presently engaged in conducting over 200 clinical trials in investigating potential treatments for bowel, brain, breast, gastrointestinal tract, liver, lung, melanoma and prostate cancers. The center endeavors to offer patients personalized medicine and provide access to potential new treatments including immunotherapies.
Humanigen has a market capitalization of around $585.3 million with approximately 51.6 million shares outstanding and a short interest of about 2.3%. HGEN shares opened relatively unchanged today at $11.31 (-$0.03, -0.26%) compared to yesterday's $11.34 closing price. The stock has traded today between $11.31 and $14.36 per share and is currently trading at $14.06 (+$2.72, +23.99%).
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