On May 2, 2018 Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments, reported that preclinical findings on lenzilumab’s potential as a new strategy to increase the safety and efficacy of chimeric antigen receptor T-cell (CAR-T) therapy were presented at The Essential Protein Engineering Summit (PEGS) by Dr. Saad Kenderian, director, T cell engineering program at Mayo Clinic (Press release, Humanigen, MAY 2, 2018, View Source [SID1234525967]).

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Lenzilumab is a first-in-class Humaneered recombinant monoclonal antibody that targets and is an antagonist of soluble granulocyte-macrophage colony-stimulating factor (GM-CSF). Neutralization of circulating GM-CSF has the potential to blunt or prevent an inflammatory cascade that can result in serious and life-threatening CAR-T-induced side effects – neurotoxicity and Cytokine Release Syndrome – and possibly boost efficacy of CAR-T therapy. Improved treatment response could come through increased expansion of CAR-T, as seen in the ZUMA-1 pivotal trial.

The PEGS presentation on May 1 highlighted findings from preclinical studies using validated animal models. The key findings included:

Lenzilumab effectively neutralizes GM-CSF.
Lenzilumab does not inhibit CAR-T efficacy in vivo, as CAR-T plus lenzilumab exhibited an improved rate of survival compared to a control in the same mouse xenograft model.
GM-CSF depletion by lenzilumab may increase CAR-T expansion in vivo, as a more robust proliferation was observed after adding lenzilumab.
"There’s significant need for new science to find therapeutic combinations to improve the safety and efficacy of CAR-T therapy. These encouraging findings reinforce our belief that lenzilumab has the potential to make CAR-T safer, better and more routine in the treatment of cancer," said Cameron Durrant, M.D., chairman and chief executive officer of Humanigen. "We look forward to starting clinical work soon with the goal of improving this groundbreaking treatment for patients."

The company anticipates commencing a potentially pivotal phase I/II trial of lenzilumab as a prophylactic therapy prior to CAR-T infusion to optimize treatment and minimize or prevent neurotoxicity associated with CAR-T cancer therapy in the summer of 2018.

About Lenzilumab

Lenzilumab is a first-in-class, novel Humaneered recombinant monoclonal antibody designed to target and neutralize circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), the myeloid inflammation factor involved in the recruitment of myeloid cells to a tumor and a central actor in leukocyte differentiation, autoimmunity and inflammation. There is also extensive evidence linking GM-CSF expression to serious and potentially life-threatening side effects in chimeric antigen receptor T-cell (CAR-T) therapy, such as neurotoxicity and Cytokine Release Syndrome (CRS). Humanigen is working with leading CAR-T experts to develop lenzilumab as a potential prophylactic therapy to optimize treatment and minimize or prevent neurotoxicity associated with CAR-T cancer therapy. In addition, lenzilumab is currently being evaluated as a potential treatment for rare leukemias in a phase I trial (NCT02546284) in patients with chronic myelomonocytic leukemia (CMML), with additional potential in juvenile myelomonocytic leukemia (JMML), a rare pediatric cancer. In previous clinical trials, lenzilumab has shown to be safe and well tolerated in more than 100 patients, including those with rheumatoid arthritis, asthma and healthy volunteers. It is a potent inhibitor of GM-CSF in vivo