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Ronny Allan
Viewpoint Molecular Targeting Announces First Neuroendocrine Tumor Patients Dosed with Therapeutic Intent
In early December, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumors was administered to patients in India on a compassionate use basis, independent of a planned US trial
No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition
CORALVILLE, Iowa –
Viewpoint Molecular Targeting®, Inc., a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents, today announced the first dosing of two neuroendocrine tumor patients with therapeutic intent. VMT-α-NET, which is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, was administered to the patients in early December. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing neuroendocrine tumors (NETs).
The administration of VMT-α-NET was under the supervision of the patients’ doctor, Dr. Ishida Sen MBBS, Director and Head of Nuclear Medicine at Fortis Hospital, New Delhi, in partnership with BJ Madan, a diagnostic & therapeutic radiopharmaceutical company in New Delhi. No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition.
“Preclinical and clinical data associated with this new radiopharmaceutical demonstrates significant potential to help our NET patients,” noted Dr. Sen. “We are pleased that the patients are doing well, and we have appreciated the professionalism and scientific strength of the Viewpoint team.”
Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Viewpoint supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET.
“We are highly committed to the rapid development of alpha-particle radionuclide therapy for cancer,” said Viewpoint CEO Thijs Spoor. “We are pleased to support Dr Sen’s team in making this product available for her patients.”
The progress of these patients will be followed by Dr. Sen and her team over the coming months. The safety and effectiveness of the treatments will be evaluated by Dr. Sen’s team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.
In the U.S., VMT-α-NET will imminently enter a Phase 1 imaging and therapy study, to be conducted at various hospitals and clinics. VMT-α-NET, is categorized as an investigational new drug by the U.S. Food and Drug Association and the administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company’s Phase 1 trial.
About Viewpoint Molecular Targeting
Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s proprietary technology utilizes the isotope lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Viewpoint is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes.
Update 3rd October 2022
An announcement from Viewpoint Molecular Targeting indicates the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of [212Pb]VMT-α-NET for treatment of patients with SSTR2-positive unresectable or metastatic neuroendocrine tumors (NETs) (including GEP-NETs or bronchial NETs and pheochromocytomas and paragangliomas).
This does not mean the drug is approved for routine use, it just means the drug development has been given special treatment based on closer collaboration with FDA to ensure a smoother path when required. Clearly the drug still needs to meet FDA criteria along the way. Read the announcement here.
Update 10 September 2021
Edit: This is now delayed. The Phase 0 imaging trial precedes the therapy trialSome years ago I wrote about an emerging type of peptide receptor radionuclide therapy (PRRT) suggesting it could be next generation. That work continues. It was being labelled with the term “Targeted Alpha-emitter Therapy (TAT)” using “alpha particles”. The current approved types of PRRT use beta particles so is a totally different method. You might be thinking what the differences are and how does it affect me? You can read more in my article PRRT – The Sequel? – Targeted Alpha-emitter Therapy (TAT).
I also wrote about the term THERANOSTICS, a combo term for THERAPY and DIAGNOSTICS. In the same way that you have a theranostic pair in Ga68 PET and Lu177 DOTATATE/DOTATOC, alpha particle therapy will eventually need the same approach in order that specialists know the output from the diagnostic imaging, will have a therapeutic effect using alpha therapy.
So, it is good to see trials emerging along these lines. VMT-𝛼-NET is entering a Phase 0 imaging study followed by a Phase 1 therapy study for neuroendocrine tumours at the University of Iowa.
VMT = Viewpoint Molecular Targeting
Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s proprietary technology utilizes lead-212 (i.e. 212Pb mentioned in the TAT article above) to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Viewpoint is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This ‘theranostic’ approach enables the ability to see the specific tumour and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.
VMT-𝛼-NET is designed to deliver powerful alpha particle radiation specifically to the NET, while minimizing risk to normal organs and tissues. In 2019, the University of Iowa was awarded an R01 research grant from the National Cancer Institute (NCI) to prepare for and conduct an image-guided alpha-particle therapy trial of VMT-𝛼-NET for NETs. The first-in-human imaging trial was anticipated to commence in early 2021 but in April 2022, I don’t believe the trial linked below was commenced (to be confirmed). Viewpoint has further been awarded over $4M in the form of Small Business Innovation Research grants from the NCI to advance this cutting-edge treatment to clinical development. Thus, the VMT-𝛼-NET receptor-targeted alpha-particle radiotherapy is positioned to advance a new transformative treatment paradigm for NET patients.
A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent is a stepping stone to therapy trials.
This is the first-in-human study to determine if [203Pb]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing [212Pb]-based alpha radiation therapy in neuroendocrine therapy. Details of this clinical trial can be found here.
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors (212-Pb-VMT)
The Company’s melanoma (VMT01) and neuroendocrine tumour (VMT-𝛼-NET) programs will then commence Phase 1/2a therapy trials for the treatment of metastatic melanoma and neuroendocrine tumours at two leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trials and commercial operations. For more information, please visit the Company’s website viewpointmt.com.
The Phase 1/2a is not yet recruiting but I will alert you when that happens. Criteria includes GEPNETs, Lung NETs and Pheo/Para. Locations listed to date include Iowa and Minnesota.
Clinical Trial Document can be viewed by clicking here
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
Finally
Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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