-

FDA Approves Investigational New Drug (IND) for Neuroendocrine Tumors from Molecular Targeting Technologies, Inc.

WEST CHESTER, Pa.--(BUSINESS WIRE)--Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, announced today 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: “The 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).”

Molecular Targeting Technologies, Inc. is a privately held, clinical stage biotech company, developing targeted radiotherapeutics and diagnostics for rare cancers. MTTI has received an exclusive worldwide license from the National Institutes of Health to commercialize selected targeted radiopharmaceuticals covered by their Evans blue (EB) platform technology patents. This transformative technology has potential applications for other types of cancer patients overexpressing somatostatin receptor type 2 (SSTR2), such as Hürthle Cell Thyroid Carcinoma. The company is committed to building value by acquiring and translating innovative imaging, radiopharmaceutical therapy assets to improve human health, reduce healthcare costs and reward stakeholders. It contracts with ClinSmart as a Clinical Research Organization (Newtown, PA). MTTI expects to orchestrate multiple clinical trials in 2021. For more information: www.mtarget.com

Contacts

Chris Pak, Email: cpak@mtarget.com; Tel: 610-738-7938

Molecular Targeting Technologies, Inc.


Release Summary
FDA approves Investigational New Drug (IND) for Neuroendocrine Tumors from Molecular Targeting Technologies, Inc.
Release Versions

Contacts

Chris Pak, Email: cpak@mtarget.com; Tel: 610-738-7938

More News From Molecular Targeting Technologies, Inc.

Molecular Targeting Technologies Presents First Clinical Validation of the Evans Blue Platform, Demonstrating Up to 15-Day Tumor Retention Using Approximately 12.5% of the Radioactivity Required for Conventional PRRT

WEST CHESTER, Pa.--(BUSINESS WIRE)--Molecular Targeting Technologies, Inc. (MTTI), a clinical-stage biotechnology company developing next-generation radiopharmaceutical platform technologies, today announced that clinical data from 81 patients—the largest reported clinical dataset for an albumin-binding radiotherapeutic—will be presented at the 5th Targeted Radiopharmaceuticals Summit. The dataset provides what the Company believes is the first clinical validation of its proprietary Evans Blue...

MTTI Highlights Clinical Experience in 81 GEP-NETs Patients and Differentiated Profile of Next-Generation PRRT Candidate EBTATE Following Presentation at SNMMI 2026

WEST CHESTER, Pa.--(BUSINESS WIRE)--Molecular Targeting Technologies, Inc. (MTTI), a clinical-stage radiopharmaceutical company developing next-generation albumin-binding targeted radiotherapeutics, today announced updated clinical findings from patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treated with its lead investigational product candidate, ¹⁷⁷Lu-DOTA-EB-TATE (EBTATE), following presentation at the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annu...

Molecular Targeting Technologies Reports Clinical Data Supporting Two-Cycle EBTATE and Enhanced Tumor Targeting in GEP-NET Patients at SNMMI 2026

WEST CHESTER, Pa.--(BUSINESS WIRE)--Molecular Targeting Technologies, Inc. (MTTI) announced the clinical findings of the Next-Generation PRRT, ¹⁷⁷Lu-DOTA-EB-TATE to treat GEP-NET Patients. The Phase 1 dose-escalation and dosimetry study will be presented at the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place May 29–June 3, 2026, in Los Angeles, California. Neuroendocrine tumors (NETs) are often detected late, limiting curative treatments and requiring...
Back to Newsroom