PIPELINE

Dr. James Burke is a University of California, San Francisco trained hematologist and oncologist who has led clinical development of gene therapy and oncolytic viruses for cancer for over 15 years including first in human through Phase 3 studies. Most recently, Dr Burke served as Chief Medical Officer of Sillajen (previously Jennerex) leading Phase 1-3 global development of a vaccinia virus platform for multiple cancers including HCC, RCC, and CRC.

The global Phase 3 registration trial targeting advanced HCC represents one of the largest oncolytic studies conducted to date spanning four continents including North America, Europe, Australia, and Asia. This Phase 3 study was the first oncolytic virus study conducted by a foreign biotech in China and one of only a few OV trials to ever be conducted in mainland China. Aside from Sillajen, Dr Burke led initial Phase 1-2 clinical development of Turnstone’s maraba virus prime-boost oncolytic virus program as CMO through initial studies and fund raising.

Dr Burke started his career at Cell Genesys spearheading early gene and immunotherapy studies including oncolytic adenovirus, lentivirus, AAV, and tumor vaccine programs. In addition to his biotechnology experience, Dr Burke directed studies as a clinical scientist including first in human studies in oncolytic viruses, tumor vaccines, as well as other cancer therapeutics in Phase 1-3 development.

Throughout his career he has had extensive interaction with global regulatory authorities and key academicians, led clinical development of numerous agents, built expert research teams, presented his research findings in key scientific journals and symposia, and led medical discussions and negotiations with external financing entities including venture capital and pharma.

Ms. Pelusio has more than 20 years of experience in drug development. Before joining KaliVir, she served as Senior Vice President of Clinical Operations at Turnstone Biologics, where she oversaw the advancement of candidate oncolytic viruses, cancer vaccines and adoptive cell therapies into clinical trials. Prior, Ms. Pelusio spent 10 years at SillaJen, Inc. (formerly Jennerex Biotherapeutics) where she led the introduction of oncolytic viruses into 17 countries across Phase I-III clinical trials. She holds an M.S. from the University of Florida and is pursuing an M.P.H. from Harvard University T.H. Chan School of Public Health.

Stephen Thorne co-founded Kalivir in 2019 and currently serves as Chief Scientific Officer. He is a leader in the field of oncolytic viral immunotherapy and previously co-founded Western Oncolytics, BioEclipse and Jennerex, which is currently advancing Pexa-Vec through late-stage clinical trials.

Stephen was a Professor of Cell Biology and Immunology at the University of Pittsburgh and received his B.A. from Oxford University, UK and Ph.D. from Imperial College of London. Stephen has served in post doctorate roles at Surrey University, Cancer Research UK, and Stanford University and has authored more than 100 scientific publications in the field.

Helena has over 23 years of experience in the biotechnology industry having held leadership positions in operations, corporate affairs, business development and IP management primarily in oncolytic virotherapy development. Most recently, Helena served as Chief Business Officer at SillaJen Biotherapeutics, Inc. where she managed all operations including corporate and business development strategies, R&D strategy and intellectual property. Prior to joining SillaJen, Helena held the positions of VP of Corporate Affairs & IP at Jennerex Biotherapeutics and the Director of Business Development at MediGene. Helena received her B.S. in Biochemistry and her Ph.D. in Genetics from the University of British Columbia and her J.D. from Dalhousie University.