HA22 is licensed to Medimmune and been given the name Moxetumomab pasudotox (Moxe). It has been tested in patients with advanced chemo-resistant hairy cell leukemia (HCL) in adults and in acute lymphoblastic leukemia in children. The HCL phase 3 trial has met its FDA mandated efficacy endpoint and the agent may be approved by the FDA this year. New trials with Moxe are planned in patients with less advanced Hairy Cell Leukemia in combination with an immune suppressing agent. LMB-100 is an immunotoxin targeting mesothelin expressing cancers. In collaboration with Drs Hassan and Alewine, it is being tested in patients with mesothelioma and pancreatic cancer as a single agent and in combination with Abraxane. Finally, because the development of anti-drug antibodies to agents like LMB-100, interferes with the activity of immunotoxins in humans, we have collaborated with Selecta Biosciences and shown that ADA formation vs immunotoxins is prevented and immune tolerance induced by co-administration nanoparticles containing rapamycin. A clinical trial combining these 2 agents has recently opened.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIABC010020-23
Application #
9779596
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
23
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Basic Sciences
Department
Type
DUNS #
City
State
Country
Zip Code
Chandramohan, Vidyalakshmi; Pegram, Charles N; Piao, Hailan et al. (2017) Production and quality control assessment of a GLP-grade immunotoxin, D2C7-(scdsFv)-PE38KDEL, for a phase I/II clinical trial. Appl Microbiol Biotechnol 101:2747-2766
Hassan, Raffit; Alewine, Christine; Pastan, Ira (2016) New Life for Immunotoxin Cancer Therapy. Clin Cancer Res 22:1055-8
Hassan, Raffit; Thomas, Anish; Alewine, Christine et al. (2016) Mesothelin Immunotherapy for Cancer: Ready for Prime Time? J Clin Oncol 34:4171-4179
Bao, Xuhui; Pastan, Ira; Bigner, Darell D et al. (2016) EGFR/EGFRvIII-targeted immunotoxin therapy for the treatment of glioblastomas via convection-enhanced delivery. Receptors Clin Investig 3:
Pastan, Ira; Hassan, Raffit (2014) Discovery of mesothelin and exploiting it as a target for immunotherapy. Cancer Res 74:2907-12
Sharon, Elad; Zhang, Jingli; Hollevoet, Kevin et al. (2012) Serum mesothelin and megakaryocyte potentiating factor in pancreatic and biliary cancers. Clin Chem Lab Med 50:721-5
Kelly, Ronan J; Sharon, Elad; Pastan, Ira et al. (2012) Mesothelin-targeted agents in clinical trials and in preclinical development. Mol Cancer Ther 11:517-25
Kreitman, Robert J; Tallman, Martin S; Robak, Tadeusz et al. (2012) Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia. J Clin Oncol 30:1822-8
Mehta, Ankit I; Choi, Bryan D; Ajay, Divya et al. (2012) Convection enhanced delivery of macromolecules for brain tumors. Curr Drug Discov Technol 9:305-10
Mehta, Ankit I; Choi, Bryan D; Raghavan, Raghu et al. (2011) Imaging of convection enhanced delivery of toxins in humans. Toxins (Basel) 3:201-6

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