Molecular Targeting Technologies, Inc. and Molecular Theranostics Center of Singapore Receive HSA Approval for Clinical Trial Authorization for EBTATE® in Nasopharyngeal Cancer

WEST CHESTER, Pa. & SINGAPORE--(BUSINESS WIRE)--Molecular Targeting Technologies, Inc. (MTTI), and its wholly owned subsidiary, Molecular Theranostic Center of Singapore (MTCS), announced the approval of a Clinical Trial Authorization (CTA) application by the Health Sciences Authority (HSA) of Singapore. The CTA enables a Phase IB/II, open-label study of the safety and efficacy of a 3-dose regimen of ¹⁷⁷Lu-DOTA-EB-TATE (EBTATE) in patients with nasopharyngeal cancer (NPC) to be conducted at the National University Cancer Institute Singapore (NCIS) and the National University of Singapore (NUS).

Somatostatin receptor 2 (SSTR2) is found in 81% of primary, recurrent, and metastatic NPC patients. EBTATE, the first patented and only long-acting peptide receptor radionuclide therapy (PRRT) targeting SSTR2 receptors, binds reversibly to serum albumin, resulting in prolonged circulation half-life, increased tumor uptake and retention, and improved therapeutic outcome by delivering an 8-fold greater dose to the tumor compared to ¹⁷⁷Lu-Dotatate. A recent three-year clinical trial follow-up* showed EBTATE was effective at controlling tumor and well tolerated without serious adverse events or nephrotoxicity.

NPC has a high prevalence with 133,354 new cases and 80,008 deaths in 2020**. While treatment options include surgery, chemotherapy and radiation therapy, there are no approved molecularly targeted therapies for NPC.

Professor Goh Boon Cher, MD, Deputy Director of NICS and NUS, stated “We are pleased to be collaborating with MTTI/MTCS to evaluate this novel treatment for SSTR2 expressing NPC. The study which will be conducted at our hospital will bring new hope for nasopharyngeal cancer patients.”

Dr. Chris Pak, President & CEO of MTTI and Chairman of MTCS, remarked: “The Evans Blue (EB)-albumin binding motif of EBTATE prolongs its circulation half-life and enhances tumor targeting. In preclinical and early clinical studies, EBTATE provided several advantages such as 8-fold uptake in tumor and lower administered radioactive dose versus first generation ¹⁷⁷Lu-Dotatate in many cancers. We hope this groundbreaking treatment will be beneficial for nasopharyngeal cancer patients.”

Molecular Targeting Technologies, Inc. (MTTI). MTTI is a clinical-stage company developing innovative targeted radiotherapeutics for rare cancers with high unmet needs. MTTI’s products include: EBTATE (neuroendocrine tumors (“NET”); Hürthle thyroid cancer (HTC), and nasopharyngeal cancer (NPC); EBRGD for non-small cell lung cancer (NSCLC) and glioblastoma (GBM). For more information: www.evathera.com

^* Jiang Y, Liu Q, Wang G, et al. Safety and efficacy of peptide receptor radionuclide therapy with ¹⁷⁷Lu-DOTA-EB-TATE (EBTATE) in patients with metastatic neuroendocrine tumors. Theranostics. 2022;12(15):6437-6445.

** https://www.cancer.net/cancer-types/nasopharyngeal-cancer/statistics