First IRB approval for APTN-101’s Ph 1 trial in GBM granted, enabling patient recruitment to begin
“Following the successful preclinical development and acceptance of our Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA), we are extremely pleased to receive our first IRB approval for APTN-101’s Phase I clinical trial,” said Michael J. Roberts, Ph.D., Chief Executive Officer of Adaptin Bio. “This represents a major inflection point for our lead program and validates the translation readiness of our targeted bispecific antibody platform. In collaboration with Duke University investigators, the inventors of our BRiTE platform, APTN-101 demonstrated compelling anti-tumor activity and a favorable safety profile in multiple preclinical models. With clinical, manufacturing, and regulatory foundations now in place, we are positioned to advance APTN-101 into the clinic and work toward delivering a meaningful new therapeutic option for patients facing a devastating disease.”
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