Humanigen Inc. (NASDAQ: HGEN) has announced the strategic realignment of its resources and pipeline in a bid to achieve its main clinical milestone. The clinical-stage pharmaceutical firm is planning to expedite the development of lenzilumab, its first in a class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF) for chronic myelomonocytic leukemia (CMML) treatment for the ongoing PREACH-M study.
RATinG study to recruit participants in Q3 2022
The RATinG study, which is anticipated to recruit its first participant in Q3 2022, will focus on lenzilumab in treating acute graft versus host disease (“aGvHD”) that develops in patients receiving bone marrow transplants. Humanigen will also pursue its plan to investigate this condition. The majority of this research funding comes from our clinical partners.
The termination of current lenzilumab production, a considerable decrease in other R&D expenses, and a small decrease in SG&A costs via personnel reduction are just a few of the activities Humanigen anticipates to result from this realignment.
Core elements of the strategic alignment include the expansion and advancement of the current PREACH-M trial of lenzilumab for CMML treatment in KRAS, NRAS, and CBL genetic mutations to quickly reach clinical assessment in the open-label trial after enough subjects have received three lenzilumab treatment cycles in addition to azacitidine. Already three participants are enrolled in the trial and monitored for multiple cycles with promising findings.
According to the International Working Group Criteria, hypomethylating drugs such as decitabine and azacitidine represent the current gold standard of therapy for CMML.
Study to be expanded to New Zealand
The trial may be expanded to include New Zealand facilities and other locations in Australia, according to the Australian clinical partners. Humanigen has gained permission from the Principal Investigator to publish the protocol and offer to monitor to such additional locations, and it intends to facilitate the study’s extension to US sites.
Humanigen CEO Cameron Durrant said, “We remain committed to advancing the scientific effort to prove the clinical benefits of neutralizing GM-CSF in life-threatening conditions for patients and have had to take difficult though necessary measures to do so.”