On March 23, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that it has entered into a sponsored research agreement with the University of Minnesota to conduct a toxicity study of its TriKE cancer treatment (OXS-3550), a required step before researchers can apply for a Phase 1 clinical trial with the Food and Drug Administration (Press release, OXIS International, MAR 23, 2017, View Source [SID1234539507]).
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Under the agreement, Oxis will pay for the university to conduct a study that will determine the optimal dose for OXS-3550. The research will be led by Dr. Daniel Vallera, Director of the section on Molecular Cancer Therapeutics at the University of Minnesota Masonic Cancer Center. He is a member of the Scientific Advisory Board of Oxis’ wholly owned subsidiary, Oxis Biotech Inc.
Oxis and the University of Minnesota have reached a licensing agreement under which Oxis holds the worldwide rights to commercialize the TriKE therapy, once it receives regulatory approval.
"The agreement will support the TriKE toxicology studies that are needed for an FDA submission, which we expect to file soon," said Dr. Jeffrey Miller, Deputy Director of the University of Minnesota Masonic Cancer Center. "We are excited to see this drug development move forward."
Dr. Vallera and Dr. Miller were instrumental in developing Trispecific Killer Engager (TriKE) cancer therapy and Bispecific Killer Engager (BiKE). Both platforms have been licensed by Oxis. The BiKE therapy, OXS-1550, is currently in an FDA Phase 1/Phase 2 clinical trial in Minnesota.
Both treatments empower the body’s immune system to identify and selectively kill cancer cells, while leaving healthy cells alone.
Dr. Vallera has spent 35 years with the University of Minnesota’s cancer center, where he oversees a laboratory specializing in the development of biological recombinant drugs focusing on bispecific antibody therapies that directly deliver toxic signals to cancer cells.