Author: evathera

Largest Reported Clinical Dataset for an Albumin-Binding Radiotherapeutic Supports the Evans Blue Platform as a Foundational Technology for Next-Generation Targeted Radiopharmaceuticals 

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 (EB) platform, a reversible albumin-binding technology designed to enhance the pharmacokinetics and therapeutic performance of targeted radiopharmaceuticals. 

The presentation supports an emerging paradigm in radiopharmaceutical oncology: optimizing pharmacokinetics may become as important as discovering new molecular targets. The Evans Blue platform is designed to enhance the therapeutic performance of existing and next-generation targeted radiopharmaceuticals across multiple validated molecular targets. 

Clinical imaging and dosimetry demonstrated tumor retention for up to 15 days, approximately eight-fold greater tumor uptake, and efficient therapeutic radiation delivery while requiring only approximately 12.5% of the cumulative administered radioactivity used in conventional peptide receptor radionuclide therapy (PRRT). These findings suggest that improving pharmacokinetics through reversible albumin binding may substantially improve therapeutic efficiency while reducing the administered radioactivity required to achieve comparable tumor radiation delivery. 

Key clinical and preclinical findings include:

• Largest reported clinical dataset evaluating an albumin-binding PRRT in 81 patients with GEP-NETs.
• Tumor retention sustained for up to 15 days after a single administration.
• Approximately eight-fold greater tumor uptake and retention than conventional ¹⁷⁷Lu-DOTA-TATE, based on clinical dosimetry evaluations.
• Comparable tumor radiation dose delivery achieved using approximately 12.5% of the cumulative administered radioactivity required for conventional PRRT.
• Across multiple Evans Blue–enabled radiopharmaceuticals, preclinical studies demonstrated up to 35-fold greater tumor retention, than conventional ¹⁷⁷Lu-DOTA-TATE supporting the broad applicability of the Evans Blue platform across validated molecular targets, including SSTR2 and integrin αvβ3.
• In preclinical studies, ²²⁵Ac-EBTATE demonstrated antitumor activity comparable to that observed with RayzeBio’s RYZ101 while using approximately 40% of the administered radioactivity under the study conditions evaluated.
• ¹⁷⁷Lu-EBTATE demonstrated superior, dose-dependent, and durable antitumor efficacy compared with ¹⁷⁷Lu-DOTA-TATE in human lung adenocarcinoma and pancreatic xenograft models. 
• ¹⁷⁷Lu-EBRGD combined with anti-PD-1 immunotherapy produced complete long-term survival and substantially outperformed monotherapy and sequential treatment in preclinical colorectal cancer models. 
• Modular platform compatible with diverse radionuclides, targeting ligands, peptide classes, and both beta- and alpha-emitting therapeutic payloads, supporting broad applicability across multiple radiopharmaceutical programs. 

Because the Evans Blue platform functions independently of the targeting ligand, it has the potential to enhance a broad range of approved and investigational targeted radiopharmaceuticals across multiple molecular targets. Its modular design enables integration with diverse targeting ligands, radionuclides, and therapeutic payloads, providing a versatile platform for extending the lifecycle of established radiopharmaceuticals while enabling development of next-generation targeted radiotherapeutics. 

“Radiopharmaceutical oncology is entering a new era in which optimizing pharmacokinetics may become as important as discovering new molecular targets. Our clinical dataset from 81 patients provides what we believe is the first clinical validation of reversible albumin binding. We believe the Evans Blue platform has the potential to provide a broadly applicable pharmacokinetic enhancement platform for existing approved radiopharmaceuticals as well as next-generation therapeutic candidates across multiple validated molecular targets,” said Norman LaFrance, M.D., Chief Strategy Officer. 

“We believe the Evans Blue platform has the potential to redefine the development of targeted radiopharmaceuticals. Rather than replacing established radiopharmaceuticals, our strategy is to enhance the therapeutic performance of established and next-generation radiopharmaceuticals through reversible albumin binding. The Evans Blue platform is designed to increase tumor exposure, improve therapeutic efficiency, and enhance the clinical and commercial potential of both proprietary and partner radiopharmaceutical programs. Our vision is to establish Evans Blue as the foundational enabling technology powering the next generation of targeted radiopharmaceuticals through internal innovation, strategic collaborations, and licensing partnerships,” said Chris Pak, Ph.D., Chairman and Chief Executive Officer. 

MTTI is actively seeking strategic collaborations with pharmaceutical and biotechnology companies interested in applying the Evans Blue platform to enhance approved and investigational radiopharmaceuticals through research collaborations, co-development, licensing, or other strategic partnerships. The Company welcomes discussions with partners seeking to improve the therapeutic performance of existing and next-generation targeted radiopharmaceuticals through the Evans Blue platform. 

About Molecular Targeting Technologies, Inc. 

Molecular Targeting Technologies (MTTI) is a clinical-stage biotechnology company developing the proprietary Evans Blue (EB) platform, a reversible albumin-binding technology designed to enhance pharmacokinetics, improve tumor targeting, and optimize the therapeutic performance of targeted radiopharmaceuticals. The Company’s pipeline includes EB-TATE, EB-RGD, EB-FAPI, and EB-GRPR, reflecting the broad applicability of the Evans Blue platform across multiple molecular targets. For more information, visit www.mtarget.com. 

Forward-Looking Statements

This press release contains forward-looking statements regarding the development, potential applications, and future evaluation of MTTI’s Evans Blue platform and related product candidates. These statements involve risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Preclinical and clinical observations may not be predictive of future clinical outcomes or regulatory decisions. MTTI undertakes no obligation to update these statements except as required by applicable law. 

Contacts

Media Contact

Chris Pak, Ph.D., Chairman and Chief Executive Officer; Email: cpak@mtarget.com

FOR IMMEDIATE RELEASE

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) Annual Meeting.

The 81-patient experience represents one of the largest clinical datasets reported to date for an albumin-binding peptide receptor radionuclide therapy (PRRT) and provides growing evidence that EBTATE may offer a differentiated and potentially best-in-class profile compared with conventional PRRT approaches.

Key Clinical Highlights from 81 Treated GEP-NET Patients

• Approximately 8-fold higher tumor uptake compared with conventional PRRT
• 50% objective response rate (ORR)
• 100% disease control rate (DCR)
• 36-month median progression-free survival (PFS)
• No observed kidney toxicity through one year of follow-up
• Equivalent renal absorbed dose with or without amino acid infusion
• Potential two-cycle treatment regimen versus the conventional four-cycle PRRT
• Clinical activity achieved using only approximately 12.5% of the cumulative radioactivity administered in current standard-of-care PRRT

The findings further validate MTTI’s proprietary Evans Blue (EB) technology platform, which utilizes reversible albumin binding to extend circulation time, enhance tumor uptake, and increase tumor retention. Preclinical studies have demonstrated up to 26-fold higher tumor retention compared with conventional radiopharmaceutical approaches, supporting broad applicability across multiple radionuclides, targeting vectors, and tumor types.

“The clinical experience in 81 patients validates both EBTATE and the broader Evans Blue platform,” said Chris Pak, Chairman and Chief Executive Officer of MTTI. “By improving tumor delivery and retention while requiring only approximately 12.5% of the cumulative radioactivity administered in current standard-of-care PRRT, the platform has the potential to enhance the therapeutic index of radiopharmaceuticals across multiple cancers and with both beta- and alpha-emitting radionuclides. The combination of enhanced tumor uptake, prolonged tumor retention, favorable clinical responses, and robust safety observations supports the continued development of EBTATE and highlights the broader potential of the Evans Blue platform to improve targeted radiotherapeutics across a wide range of solid tumors.”

“EBTATE achieved markedly higher tumor uptake and longer tumor retention than conventional ¹⁷⁷Lu-DOTATATE while maintaining a favorable safety profile,” said Lisa Bodei, MD, PhD, a nuclear medicine physician at Memorial Sloan Kettering Cancer Center and recipient of the 2026 Castle Connolly America’s Top Doctor Award. “The ability to deliver higher radiation doses to tumors with significantly lower administered radioactivity highlights the potential of this albumin-binding approach to improve the therapeutic index of PRRT. This data from NET patients supports continued clinical development and further evaluation of a streamlined treatment regimen.”

About Molecular Targeting Technologies, Inc.

Molecular Targeting Technologies, Inc. (MTTI) is a clinical-stage radiopharmaceutical company developing next-generation albumin-binding targeted radiotherapeutics for cancer. Powered by its proprietary Evans Blue (EB) technology platform, MTTI is advancing a pipeline of beta- and alpha-emitting radiopharmaceuticals designed to improve tumor targeting, increase therapeutic index, and enhance treatment efficiency. In addition to EBTATE, MTTI is developing ²²⁵Ac-EBTATE for small cell lung cancer, where preclinical studies have demonstrated comparable efficacy to ²²⁵Ac-DOTATATE at approximately 40% of the administered dose.

For more information, visit www.mtarget.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the potential safety, efficacy, clinical benefits, development plans, and commercial opportunities of EBTATE and MTTI’s Evans Blue technology platform. Actual results may differ materially from those indicated by such forward-looking statements. EBTATE is an investigational product candidate that has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.

Contacts
Chris Pak
Chairman and Chief Executive Officer
Molecular Targeting Technologies, Inc.
cpak@mtarget.com

FOR IMMEDIATE RELEASE

West Chester, PA (Business Wire) – May 28, 2026 – 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 systemic therapies like Peptide Receptor Radionuclide Therapy (PRRT).  While ¹⁷⁷Lu-DOTATATE has demonstrated efficacy, its rapid clearance limits tumor radiation delivery and may increase renal toxicity risk. 

“Our Clinical findings suggest that EBTATE may achieve meaningful clinical responses after only two treatment cycles while delivering approximately 12.5% of the cumulative radioactivity required for standard PRRT,” said Chris Pak, Chairman and Chief Executive Officer of MTTI. “If validated in larger studies, EBTATE could represent a transformative advance in radiopharmaceutical therapy, shortening treatment duration, reducing radiation exposure, and enabling physicians to evaluate efficacy much earlier than is possible today.”

“EBTATE achieved substantially higher tumor uptake and prolonged retention than conventional ¹⁷⁷Lu-DOTATATE while maintaining a favorable safety profile, with no kidney toxicity observed for one year follow-up,” said Lisa Bodei, MD, PhD, a nuclear medicine physician at Memorial Sloan Kettering Cancer Center. “The ability to deliver greater tumor radiation with significantly less administered radioactivity positions EBTATE as a potentially transformative PRRT. These data also support the possibility of a streamlined two-cycle regimen, enabling earlier evaluation of treatment efficacy.”

The presentation entitled, “Next-Generation PRRT” by Dr. Bodei (poster # 261874). The poster has also been selected for a 10-minute oral presentation during the 2026 Patient Education Day NETS Program Schedule (https://snmmi.org/Web/Education-and-Meetings/Patient_Education_Day_2026_NET.aspx), on 5/31/26 during the SNMMI meeting.

MTTI will present its proprietary Evans Blue (EB) albumin-binding technology platform at Booth #1758 during the SNMMI Annual Meeting, featuring clinical data from 81 GEP-NET patients and compelling preclinical results.

MTTI’s EB technology enhances tumor targeting through reversible albumin binding, delivering up to 26-fold greater tumor retention in preclinical models and approximately eight-fold higher tumor uptake in patients compared with conventional DOTA-TATE. These findings position the platform as a potentially transformative approach for next-generation radiopharmaceuticals, with the potential to improve efficacy, expand therapeutic opportunities, and create significant strategic value.

About Molecular Targeting Technologies, Inc.

Molecular Targeting Technologies, Inc. (MTTI) is a clinical-stage radiopharmaceutical company developing next-generation albumin-binding targeted radiotherapeutics for cancer. Powered by its proprietary Evans Blue (EB) technology platform, MTTI is advancing Ac-225 and Lu-177–based PRRT agents designed to enhance tumor targeting and retention, potentially enabling improved efficacy, lower radiation exposure, and earlier therapeutic responses.

For more information, please visit www.mtarget.com.

Media Contact: Chris Pak; Email: cpak@mtarget.com 

FOR IMMEDIATE RELEASE

WEST CHESTER, Pa. (BUSINESS WIRE) — Molecular Targeting Technologies, Inc. (MTTI) today announced the appointment of Danielle Meyrick, PhD, MD, as Chief Medical Officer. Dr. Meyrick brings more than 20 years of medical research, targeted radiotherapeutic (TRT) development and leadership to MTTI. She has held Chief Medical Officer roles across radiopharmaceutical organizations including Telix Pharmaceuticals and ITM Radiopharm. Dr. Meyrick will lead MTTI’s medical team to advance clinical development of lead assets, EVA101 and EVA 102 and further progress the company’s radiopharmaceutical pipeline. 

“My career goal in the TRT area has always been to improve care and outcomes for cancer patients. I believe MTTI is an exciting company with technology that is able to deliver on this goal. Our unique EvaThera platform has demonstrated the ability to enhance delivery of radiation to tumors, minimize off-target activity and reduce dosing requirements —collectively offering a potentially safer, more effective approach to TRT. I am thrilled to be supporting the team in leading EVA101 and EVA102 through the critical final stages of development,” said Danielle Meyrick, CMO of MTTI. 

Dr. Chris Pak, President & CEO commented “MTTI is delighted to welcome Dr. Danielle Meyrick, an experienced clinician and executive. Her perspective and track record in TRT development are key complements to our team as we expedite advancement of our targeted radiotherapeutic pipeline.” 

Molecular Targeting Technologies, Inc. (MTTI). MTTI is a private, clinical stage biotech developing targeted radiotherapeutics (TRT). MTTI is committed to building value by translating innovative TRT to improve human healthcare. For more information: www.mtarget.com. 

Contacts 

Chris Pak, Email: cpak@mtarget.com 

FOR IMMEDIATE RELEASE

West Chester, PA, September 12, 2024, 6:01 am Eastern Standard Time (Business Wire) —Molecular Targeting Technologies, Inc. (MTTI) will update findings on its proprietary topical near-infrared fluorescent dye, CypH-11 (Cmetglo), at the World Molecular Imaging Conference (WMIC) meeting in Montreal from September 9-13 and at the Peritoneal Surface Oncology Group International (PSOGI) meeting in Lyon from September 26-28, 2024.

This convenient fast-acting technology* shows promise as an effective real-time tool for oncologists in fluorescence-guided surgery (FGS). This will allow clinicians to see small tumor residue and achieve a more complete resection of cancer in the abdominal cavity. We expect that Cmetglo may improve patient outcomes by avoiding unnecessary damage to normal tissue and increase progression-free survival of patients with peritoneal surface malignancies (PM).

Dr. Johnny Ong, MD, Associate Professor, Department of Sarcoma, Peritoneal and Rare Tumors, National Cancer Centre Singapore** commented: “One of the limitations of cytoreductive surgery (CRS) is the difficulty in distinguishing tumors from normal and scar tissues. Here, we performed ex vivo validation of patient tissues to evaluate the clinical utility of Cmetglo in detecting PM via topical administration. Preliminary analysis suggests that the best clinical utility of Cmetglo could be in patients with colorectal malignancy, with the possibility of expanding its use to other histological subtypes.”

Dr. Brian D Gray, SVP Research and Development noted: “MTTI’s Cmetglo makes the invisible visible. Tumor margins and metastases glow under near-infrared light. It can be a valuable addition to the surgeon’s’ armamentarium to achieve maximal cytoreduction during FGS.”

Dr. Seung Koo Lee, Assistant Professor of Cell Biology Research, in Radiology at Weill Cornell Medicine***, commented: “CypH-11 is a sprayable pH-responsive fluorogenic probe that exhibits minimal fluorescence at neutral pH; however, it fluoresces brightly in an acidic environment which is a universal signature of cancer cell proliferation. Its capability of detecting small-sized ovarian tumors was further demonstrated by the spray of CypH-11 in a disseminated high-grade serous ovarian cancer (HGSOC) model.”

Chris Pak, President & CEO of MTTI commented: This groundbreaking molecule builds on MTTI’s innovative legacy in targeted diagnostics and therapeutics. We’re pursuing its use in colorectal, ovarian, and brain cancers, adding value to patients, surgeons, and other stakeholders.”

Molecular Targeting Technologies, Inc. (MTTI). MTTI is a private, clinical stage biotech developing targeted radiotherapeutics for rare cancers. MTTI is committed to building value by translating innovative radiopharmaceuticals to improve human health. For more information: www.mtarget.com.

Contact: Chris Pak, Email: cpak@mtarget.com

*This research is supported by the National Cancer Institute (NCI) for a SBIR phase II grant # R44CA275434 to MTTI.

** This research is also supported by the Singapore Ministry of Health through the National Medical Research Council (NMRC) Office, MOH Holdings Pte Ltd and administered by National Health Innovation Centre (NHIC) under its Innovation to Industry (I2I) grant (NHIC Ref No.: NHIC-I2I-2306016) to National Cancer Centre Singapore. Any opinions, findings and conclusions or recommendations expressed in this material are those of the authors and do not reflect the views of NHIC

***Weill Cornell Medicine and MTTI hold intellectual property and financial interests in Cmetglo technology under development by MTTI. 

FOR IMMEDIATE RELEASE

September 11, 2024, 6:01 am Eastern Standard Time, West Chester, PA (Business Wire)

Molecular Targeting Technologies, Inc. (MTTI), is delighted to be working with Brookline Capital Markets at the 2nd Targeted Radionuclide Pharmaceuticals (TRPs) Supply Chain & Manufacturing Summit. They will present a special workshop “Evaluating the Commercial & Pharmaceutical Viability of Radioisotopes to Benchmark Potential” on September 24-26, 2024, in Boston, MA.

TRP industry experts will address commercial and pharmaceutical challenges and strategies as we bring actinium-225, lutetium-177, lead-212 and copper-67 isotopes to market, discussing: (i) Assessing Market Demand and Commercial Viability, (ii) Navigating Radiopharmaceutical Development Challenges, and (iii) Strategic Partnerships and Investment Opportunities.

Kemp Dolliver of Brookline Capital Markets stated: “The radiopharmaceutical sector is at the start of a long upcycle. We will explore market opportunities and the capital markets’ view of them.”

Chris Pak, founder and CEO of MTTI noted: “MTTI’s EB technology overcomes many challenges in TRPs today. Our long-acting patented platform provides 8 to 30-fold more uptake at the target compared to the standard TRPs. Both preclinical and clinical studies show better efficacy and medical economics with only 40% of the radiation dose. We’re excited to expose the broad TRP audience to our high value, long-acting EB platform.”

ABOUT The 2nd Targeted Radiopharmaceuticals Supply Chain & Manufacturing Summit. This summit focuses on enhancing radiopharmaceutical production to keep pace with rapid innovation driven by substantial investments from pharmaceutical giants. Leading senior decision-makers from the radiopharmaceutical field will discuss critical topics such as isotope production, radiolabeling, quality control, regulatory considerations, and supply chain logistics. Amid challenges like key material scarcity, this forum offers valuable insights from leading companies to optimize manufacturing processes, ensure reliable supply, and accelerate clinical trials. For more information: https://ter.li/eigjvk

ABOUT Molecular Targeting Technologies, Inc. MTTI is a clinical-stage company developing innovative targeted radiotherapeutics for rare cancers with high unmet needs. MTTI’s pipeline includes: EBTATE® (ongoing studies in neuroendocrine [NET]; Hürthle cell thyroid [HTC], Nasopharyngeal [NPC] and small cell lung cancers) and EBRGDTM for non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM). For more information: https://mtarget.com

Contact:
Chris Pak, Email: cpak@mtarget.com;
Iwan Cleave, Email: info@hansonwade.com 

FOR IMMEDIATE RELEASE

West Chester, PA, May 21, 2024, 6:01 am Eastern Standard Time (Business Wire)–Molecular Targeting Technologies, Inc. (MTTI), will update findings on both ¹⁷⁷Lu-EBTATE clinical and ²²⁵Ac-EBTATE preclinical work during the 2024 SNMMI meeting in Toronto June 8-11 (exhibition booth #1819).

¹⁷⁷Lu-EBTATE^® an EvaThera drug, is the first patented long-acting peptide targeted radiotherapeutic drugs. It selectively targets and binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide payload. Evans blue in EBTATE binds to serum albumin, extending in vivo circulatory half-life and tumor residence time, enabling effective use of significantly lower radiopharmaceutical activity and fewer dosing cycles vs. the current standard of care (SOC). These benefits are also evident in recent studies of the ²²⁵Ac-EBTATE homolog.

Professor Zhaohui Zhu, MD, Peking Union Medical College Hospital, reflected “In our 3-year follow up on 30 patients* with metastatic neuroendocrine tumors (mNETs), ¹⁷⁷Lu-EBTATE demonstrated good safety, with no nephro- or hepatoxicity and 86% disease control rate using 60% less radioactivity than ¹⁷⁷Lu-DOTATATE. We observed low incidence of grade 3 hematoxicity (3.4% vs 15% of reported SOC) and no long-term nephrotoxicity of any grade.”

The study “Long acting ²²⁵Ac-EBTATE is highly efficacious against somatostatin receptor-2-positive small-cell lung cancer (SCLC)**” has been accepted for presentation at 2024 SNMMI. Professor Humphrey Fonge of the University of Saskatchewan commented, “²²⁵Ac-EBTATE (2x 30 kBq administered 10 days apart) was effective against SCLC with 80% complete remissions and 100% survival. Treatment yielded a 2-fold greater tumor growth inhibition when compared with ²²⁵Ac-DOTATATE, at 60% less administered radioactivity. Toxicity, as measured by body weight, blood counts, and chemistry showed that ²²⁵Ac-EBTATE was well tolerated at a highly effective dose. ²²⁵Ac-EBTATE shows great promise against SCLC.” Chris Pak, President & CEO of MTTI commented: “We are pleased to learn that ¹⁷⁷Lu-EBTATE exhibited no safety concerns and was effective at a lower dose than SOC in mNET patients. We are also encouraged that ²²⁵Ac-EBTATE out-performed ²²⁵Ac-DOTATATE, providing a 2-fold greater tumor growth inhibition in preclinical findings using a much lower dose of radioactivity.  We look forward to advancing our clinical trials with these radiotherapeutic drugs in small-cell lung and other cancers.”

Molecular Targeting Technologies, Inc. (MTTI). MTTI is a private, clinical stage biotech developing targeted radiotherapeutics for rare cancers. MTTI is committed to building value by translating innovative radiopharmaceuticals to improve human health. For more information: www.mtarget.com.

Contact: Chris Pak, Email: cpak@mtarget.com

*Safety and efficacy of peptide receptor radionuclide therapy with ¹⁷⁷Lu-DOTA-EB-TATE in patients with metastatic neuroendocrine tumors. Theranostics 2022; 12: 6437-6445 

**The data will be presented in 2024 SNMMI.  Fabrice Njotu, Humphrey Fonge et al. of the University of Saskatchewan, and Molecular Targeting Technologies, Inc. 

FOR IMMEDIATE RELEASE

West Chester, PA, and Singapore, August 2, 2023 — 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). 

Contact : Chris Pak, Email: cpak@mtarget.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

FOR IMMEDIATE RELEASE

West Chester, PA June 21, 2023 — Molecular Targeting Technologies, Inc. (MTTI) announced promising results from a 1-year follow-up on EBTATE (2 cycles, 3.7 GBq/cycle) treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) without amino acid pretreatment. EBTATE’s safety, biodistribution, and dosimetry in a crossover randomized protocol in patients (N=10) with and without amino acids were published in Clinical Nuclear Medicine.¹

The kidney is sensitive to radiation. Peptide receptor radionuclide therapy (PRRT) dosing is constrained by potential kidney toxicity. A 4-hour long amino acid cocktail infusion reduces renal absorbed radiation dose, with significant side effects like nausea, vomiting and hyperkalemia. The Evans blue moiety in EBTATE binds to serum albumin, extending in vivo circulatory half-life and residence time, reducing renal uptake and hence making amino acid infusion unnecessary.

Professor Zhaohui Zhu, MD, principal investigator, commented, “Our results showed that administration of EBTATE without amino acid infusion had acceptable kidney radiation absorbed dose and residence time. One month after EBTATE, there were no significant changes in creatinine, blood urea nitrogen (BUN), and glomerular filtration rate (GFR). None of the patients had nephrotoxicity of any grade. Furthermore, a recent one-year follow-up showed creatine and BUN of all patients stayed within normal limits. EBTATE administration appears to be safe without amino acid infusion.”

Chris Pak, President & CEO of MTTI commented, “Amino acid infusion impacts quality of life, access to care, patient compliance to treatment and overall treatment costs. The benefits of EBTATE treatment without amino acids are clear. We expect EBTATE trials in small cell lung cancer, NET, nasopharyngeal cancers to show the same benefit.”

About Molecular Targeting Technologies, Inc. (MTTI)

Molecular Targeting Technologies, Inc. (MTTI). MTTI is a privately held, venture-backed, clinical-stage biotech company developing next-generation targeted radiotherapeutics for rare cancers with high unmet needs. MTTI is committed to building value by translating innovative radiopharmaceuticals to improve human health and reduce healthcare costs. MTTI is orchestrating multiple clinical trials. For more information: www.evathera.com

Contact : Chris Pak, Email: cpak@mtarget.com

1 Jiang Y, Liu Q, Wang G, et al. . Evaluation of Safety, Biodistribution and Dosimetry of a Long-Acting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE (EBTATE) with and without Amino Acid Infusion. Clin Nucl Med 18 Apr 2023, 48(6):e289-e293.

FOR IMMEDIATE RELEASE

West Chester, PA June 19, 2023 — Molecular Targeting Technologies, Inc. (MTTI) announced favorable findings of a 3-year follow- up of EBTATE (3 cycles, 3.7 GBq/cycle) against metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Results from this study were published in Theranostics.¹

EBTATE is the first patented long-acting peptide targeting radiotherapeutic drug. It selectively targets somatostatin receptor 2 (SSTR2) on GEP-NETs, which are then killed by the radionuclide payload. The Evans blue moiety in EBTATE binds to serum albumin, extending in vivo circulatory half-life and residence time, enabling effective but lower radioactivity and fewer dosing cycles vs. the current standard of care (SOC). These findings confirm the safety and efficacy of the previous EBTATE results in 62 NET patients.

Professor Zhaohui Zhu, MD, principal investigator, said “Low occurrence of short and long-term toxicity proved EBTATE is safe (N=29). None of the patients developed leukemia or bone marrow disease during the 3-year follow-up. We observed low incidence of grade 3 hematoxicity (3.4% vs 15% of reported SOC) and no nephrotoxicity of any grade in long-term safety evaluation. Using EBTATE at lower radioactivity (37%) was as effective as SOC in disease control and achieved higher objective response based on RECIST criteria.”

Chris Pak, President & CEO of MTTI commented: “It is rewarding to see how EBTATE helped these patients. We look forward to the same benefits from EBTATE trials in small cell lung cancer, nasopharyngeal cancers, Hürthle cell thyroid and others.”

About Molecular Targeting Technologies, Inc. (MTTI)

MTTI is a privately held, venture-backed, clinical-stage biotech company developing next-generation targeted radiotherapeutics for rare cancers with high unmet needs. MTTI is committed to building value by translating innovative radiopharmaceutical assets to improve human health and reduce healthcare costs. MTTI is orchestrating multiple clinical trials. For more information: www.evathera.com

Contact : Chris Pak, Email: cpak@mtarget.com

1 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.