Thyroid Cancer, Hurthle Cell

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). This press release features multimedia. View the full release here: 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: * 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. ** View source version on businesswire.com: Contacts Chris Pak, Email: cpak@mtarget.com Source: Molecular Targeting Technologies, Inc. View this news release online at:

CHESTER, Pa.--(BUSINESS WIRE)-- Molecular Targeting Technologies, Inc., (MTTI), a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, announced today the allowance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). It is now waiting for Institutional Review Board (IRB) approval. Once approved by IRB, it will enable a Phase I/II clinical study of the Safety, Dosimetry and Efficacy of EBTATE in adult patients with metastatic, radioactive iodine non-responsive Hürthle cell thyroid cancer.” EBTATE is a new generation of peptide receptor radiotherapeutic drug that has demonstrated potential clinical superiority over standard of care. It selectively binds to somatostatin receptor 2 (SSTR2) on neuroendocrine and other tumors, which are then killed by the radionuclide. EvaThera platform products were designed to bind to serum albumin, due to the Evans blue moiety, extending in vivo residence time, enabling lower, less frequent dosing of the radiopharmaceutical and reducing risk of renal injury vs. the current standard of care. Dr. Joanna Klubo-Gwiezdzinska, MD, Ph.D, MHSc, acting section chief of Thyroid Tumors and Functional Thyroid Disorders in the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH) and study author commented: “Hürthle cell thyroid cancer, which currently lacks effective treatment options, is characterized by a particularly high expression of SSTR2*. With this phase I/II clinical trial, we hope to implement individualized dosimetry-based dosing for each patient with Hürthle cell thyroid cancer that spread outside of the thyroid gland and analyze how much of an active agent is being accumulated in the tumor tissue to establish a threshold associated with the best efficacy and safety.” 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 to target Hürthle cell thyroid cancer.” About Molecular Targeting Technologies, Inc. (MTTI) Molecular Targeting Technologies, Inc., is a privately held, rapidly growing, well financed, clinical-stage biotech company developing next-generation targeted radiotherapeutics and diagnostics for rare cancers. Evathera platform technology product has shown application for glioblastoma multiforme (GBM) cancer patients overexpressing integrin. MTTI is committed to building value by acquiring and translating innovative imaging, radiopharmaceutical and theranostics assets to improve human health, reduce healthcare costs and reward stakeholders. MTTI expects to be orchestrating multiple clinical trials in 2023. For more information: See*: Thakur S and Klubo-Gwiezdzinska J et al. 177Lu-DOTA-EB-TATE, A Radiolabeled Analog of Somatostatin Receptor Type 2, for the Imaging and Treatment of Thyroid Cancer. Clin Cancer Res 2021; 27(5): 1399-1409 The content in this release is the sole responsibility of the authors and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.

June 9, 2022 11:01 UTC WEST CHESTER, Pa.--(BUSINESS WIRE)-- Molecular Targeting Technologies, Inc. (MTTI), a clinical stage oncology company, will highlight advances on its EvaTheraTM radiotheranostics platform at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting in Vancouver, BC, on June 11-15, 2022 (Exhibit booth #1715). The EvaThera platform includes EBTATETM (177Lu-DOTA-EB-TATE) for Neuroendocrine Neoplasms (NENs), Hürthle cell thyroid and nasopharyngeal cancers and EBRGDTM (177Lu-DOTA-EB-RGD) for glioblastoma multiforme and non-small cell lung cancer A video featuring the EBTATE story (see link below) will be released at the meeting. In addition, two abstracts highlighting MTTI’s EBTATE & our PET imaging agent,18F-glucarate, were selected for oral and poster presentations: (i) Evaluation of Safety, Biodistribution and Dosimetry of a long-Acting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE with and without Amino Acid Infusion by Qingxing Liu, Yuanyuan Jiang, Koon Pak, Guochang Wang, Jingjing Zhang, Xiaoyuan Chen and Zhaohui Zhu (oral presentation) EBTATE treatment without amino acid infusion, normally used in current treatments to block drug impact on non-target organs, has acceptable, minor effects on the kidneys and does no harm to kidney function. EBTATE may significantly improve patient comfort vs. current treatments. (ii) Assessment of 18F-glucarate as a potential PET tracer for cancer imaging by Junling Li, Huaiyu Zheng, Levi Beverly, Brian Gray, Koon Pak and Chin K. Ng (poster presentation) 18F-glucarate uptake in both in vitro and in vivo correlated well with the degree of cell death and shows early tumor response to chemotherapy, enabling faster assessment of treatment efficacy. About MTTI MTTI is a privately held, rapidly growing, well financed, clinical stage biotech developing targeted radiotherapeutics and diagnostics for rare cancers. We are committed to building value by acquiring and translating innovative imaging, radiopharmaceutical and theranostic assets to improve human health, reduce healthcare costs and reward stakeholders. MTTI expects to be orchestrating multiple clinical trials in 2022. For more information: ;