Category: Evathera News

FOR IMMEDIATE RELEASE

West Chester, PA, and Singapore, September 12, 2023 — Molecular Targeting Technologies, Inc. (MTTI), a clinical-stage company accelerating the development and global access of life-changing radiopharmaceuticals, announced the appointment of Dr. Jerry Huang, M.D., Ph.D. as the Senior Vice President of Clinical Development. 

Dr. Huang has over twenty years of global clinical development experience and has had expanding leadership responsibilities in the US, Europe, and Asia Pacific at Taiho Oncology, Novartis, BeiGene and Covance. 

She guided organizations and teams on clinical strategy, clinical operational practices and process improvement in clinical research and development. Dr. Huang has led multiple oncology clinical studies in advanced solid tumors and orphan oncology indications; completed First-in-Human, Proof-of-Concept, pivotal registration studies, and has experience with multiple health authority interactions (FDA [CDER, CDRH] and EMA). 

She received her M.D. from Sun Yat-Sen University of Medical Sciences in China, Ph.D. in Biophysics, and an M.S. in Clinical Research Methods from Albert Einstein College of Medicine in the US. 

Chris Pak, President and CEO of MTTI said “MTTI is delighted to welcome Jerry, an experienced biotech executive. Her perspective and track record in oncology and precision medicine development are key complements to our team as we expedite our theranostic pipeline development.” 

Molecular Targeting Technologies, Inc. (MTTI). MTTI is a privately held, clinical-stage biotech company developing next-generation targeted radiotherapeutics for rare cancers with high unmet medical needs. MTTI is committed to building value by translating innovative radiopharmaceutical assets to improve human health and reduce healthcare costs. MTTI is committing multiple clinical trials to meet that goal in the coming months and years. For more information: www.evathera.com 

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

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.

FOR IMMEDIATE RELEASE

West Chester, PA December 8, 2022, 6:01 am Eastern Standard Time (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 nonresponsive 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: www.evathera.com

Contact : NIDDK, Email : niddkmedia@niddk.nih.gov
MTTI, Chris Pak, Email: cpak@mtarget.com

See* below:
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.

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.

FOR IMMEDIATE RELEASE

West Chester, Pennsylvania, December 6, 2022 — Molecular Targeting Technologies, Inc. (MTTI) announces the issuance of Chinese Patent CN109153641B covering MTTI’s lead radiotherapeutic product, EBTATE™ and others in its EvaThera™ platform. Approval of “Chemical conjugates of Evans blue derivatives and their use as radiotherapeutic and imaging agents” follows issued patents in the US, Europe, Singapore, and Japan this past year.

EBTATE is a new generation of peptide receptor radiotherapeutic drug that has demonstrated potential clinical superiority over standard of care. It selectively targets and binds to somatostatin receptor 2 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.

Our recent 3-year follow-up report on a 30-patient, ex-US, EBTATE study showed stable
disease with progression-free survival of 43 months after three cycles of EBTATE. EBTATE
treatment is effective and less toxic for neuroendocrine tumor patients.

Chris Pak, MTTI’s President & CEO, commented, “This complements our IP portfolio, further
protecting our EvaThera platform.” He added, “We’re continuing to bolster our position in
radiotheranostics with planned clinical trials of our two platform products in multiple indications.”

About Molecular Targeting Technologies, Inc. (MTTI)

Molecular Targeting Technologies, Inc., is a privately held, rapidly growing, well financed, clinicalstage biotech company developing next-generation targeted radiotherapeutics and diagnostics for rare cancers. We are 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: www.evathera.com

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

See* below:
https://www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=36701

Molecular Targeting Technologies, Inc. (MTTI), announced that the first patient has been dosed in a clinical trial of EBTATE

West Chester, PA, June 29, 2022 — Molecular Targeting Technologies, Inc. (MTTI),
announced that the first patient has been dosed in a clinical trial of EBTATE (177Lu-DOTA-EB-
TATE) for the treatment of patients with advanced, well differentiated neuroendocrine tumors. This US based, Phase I clinical trial will evaluate the safety and dosimetry of EBTATE.

EBTATE is a patented peptide targeting radiotherapeutic drug. It selectively targets and binds
to somatostatin receptor 2 on neuroendocrine tumors, which are then killed by the radionuclide. EBTATE was designed to bind to serum albumin, extending in vivo residence time, enabling lower, less frequent dosing of the radiopharmaceutical vs. the current standard of care. Early, ex.-US, clinical results in 60 patients showed EBTATE is more effective and safer for neuroendocrine tumor patients*.

Chris Pak, President & CEO of MTTI comments “This is a substantive milestone for MTTI. It
marks the advent of safer, more effective, economical targeted radiotherapy drugs for
neuroendocrine tumors. Recent clinical data presented at the 2022 SNMMI meeting also
suggests that EBTATE treatment without the conventional amino acids infusion is safe and does no harm to kidney function, potentially, significantly improving patient comfort vs current treatments.”

About Molecular Targeting Technologies, Inc. (MTTI)

Molecular Targeting Technologies, Inc. is a privately held, rapidly growing, well financed, clinical stage biotech developing next-generation 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: www.evathera.com

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

See* below:
https://www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=36701

West Chester, PA, June 9, 2022 — Molecular Targeting Technologies, Inc. (MTTI), a clinical stage oncology company, will highlight advances on its EvaThera^TM 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  EBTATE^TM (¹⁷⁷Lu-DOTA-EB-TATE) for Neuroendocrine Neoplasms (NENs), Hürthle cell thyroid and nasopharyngeal cancers and EBRGD^TM (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:

• 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.
  
• 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: www.mtarget.com; www.evathera.com 

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

Molecular Targeting Technologies, Inc. Announces a new PET imaging agent for Rapid Monitoring Tumor Response to Therapy.

The Zhu Zhaohui/Chen Xiaoyuan team develops more effective, safer and more economical new radiotherapy drugs for neuroendocrine tumors