West Chester-based Biotech Company Receives FDA Approval for Investigational New Drug

WEST CHESTER, PA β€” Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, announced the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). It enables a Phase I clinical study of the Safety and Dosimetry of its lead product, EBTATE (177Lu-DOTA-EB-TATE), in patients with neuroendocrine tumors (NET).

EBTATE is used in Precision Medicine for Targeted Radionuclide Therapy. The key feature of this technology is the appendage of Evans blue (EB) to the targeting radiopharmaceutical. EB binds reversibly to serum albumin to enhance the radiotherapeutic time window with longer circulation half-life and increase tumor uptake/retention to improve therapeutic outcome.

Dr. Chris Pak, President & CEO of MTTI commented: β€œThe clearance of our IND is an important milestone for MTTI. Having solidified our clinical trial preparedness and manufacturing readiness, we are well-positioned to advance EBTATE. The upcoming trial is an open-label, dose-escalation study planned for patients with neuroendocrine tumors (NET).”

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Molecular Targeting Technologies, Inc. is a privately held, clinical stage biotech company, developing targeted radiotherapeutics and diagnostics for rare cancers.

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