- GM-CSF from the donor T cells initiates a cascade that drives lethal GvHD
- Without GM-CSF signaling, there was a significant reduction in acute GvHD
- Provide a logical rationale to administer lenzilumab (to neutralize GM-CSF) early after allogeneic transplant to prevent or treat high risk acute GvHD
- Humanigen, in conjunction with the Impact Partnership, planning a multi-center, randomized, phase II trial with lenzilumab in high risk GvHD patients
BURLINGAME, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) — Humanigen, Inc. (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on the development of next generation cell and gene therapies using its proprietary granulocyte-macrophage colony stimulating factor (GM-CSF) neutralization and gene knockout platforms to simultaneously improve the efficacy and safety of chimeric antigen receptor T (CAR-T) and other cell therapies, today commented on an article and associated visual abstract published October 8, 2019 in ‘blood advances’, the official journal of the American Society of Hematology, entitled “Donor T-cell derived GM-CSF drives alloantigen presentation by dendritic cells in the gastrointestinal tract”. A link to the article and associated visual abstract can be found at: http://www.bloodadvances.org/content/3/19/2859
The study utilized a fate-reporting system to track the role and lineage of GM-CSF secreting donor T cells during development of graft versus host disease (GvHD) in a mouse model. The study demonstrated that GM-CSF signaling was required to initiate the cascade that drives lethal GvHD. In the absence of GM-CSF signaling, there ws a significant reduction in acute GvHD. This work builds on earlier work published in Science Translational Medicine entitled, “Graft-versus-host disease, but not graft-versus-leukemia immunity, is mediated by GM-CSF-licensed myeloid cells1” and helps validate the key role of GM-CSF in the pathophysiology of GvHD. Collectively, the data provide a logical rationale to administer lenzilumab, a proprietary Humaneered® anti-GM-CSF immunotherapy, to prevent or treat acute GvHD.
On July 22, 2019 Humanigen secured an exclusive worldwide license from the University of Zurich for technologies to prevent and treat GvHD through GM-CSF neutralization. Humanigen is currently planning a multi-center, randomized, double blind, phase II trial in conjunction with the Impact Partnership in the UK in patients at high risk of acute GvHD.
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. The company is focused on breaking the efficacy/toxicity linkage with T-cell therapies, making T-cell therapies potentially safer, more effective and more efficiently administered for patients and providers thereby improving healthcare resource utilization for payers. The company’s immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, was recently announced to evaluate the sequential use of lenzilumab with Yescarta®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using GM-CSF gene knockout technologies and developing its own portfolio of proprietary first-in-class CAR-Ts leveraging ifabotuzumab (anti-EphA3 immunotherapy) for various hematologic and solid cancers and HGEN005 (anti-EMR1 immunotherapy) for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T and immunotherapy treatments to break the efficacy/toxicity linkage and prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline. For more information, visit www.humanigen.com
1 Tugues et al., Sci.Transl.Med. 28 November 2018: Vol. 10, Issue 469, eaat8410