Month: February 2021

Viewpoint Molecular Targeting™ Enters into Long-Term Supply Agreement with the National Isotope Development Center of the U.S. Department of Energy Isotope Program

– Securing long-term supply advances development of Company’s proprietary VMT-𝛼-GEN isotope generator which enables a nimble supply of therapeutic radioisotopes with the power of alpha-particle therapy for cancer –

Coralville, IA, February 18, 2021 – Viewpoint Molecular Targeting, Inc. (“Viewpoint” or the “Company”), a radiopharmaceutical company developing precision α-particle oncology therapeutics and complementary diagnostic imaging agents, today announced it has entered into an agreement with the National Isotope Development Center (NIDC) for the long-term supply of parent feedstock radionuclide Th-228 for the manufacturing of the Company’s Ra-224/Pb-212 generator, VMT-𝛼-GEN. The long-term agreement provides deliveries from 2021 through 2030.

In order to build a fully integrated alpha-particle radiopharmaceutical business, Viewpoint is securing the supply of therapeutic Pb-212 radioisotope for medical centers and regional radiopharmacies. To achieve this distinction, Viewpoint is developing its own proprietary benchtop production device (VMT-𝛼-GEN) for delivering alpha-particle therapeutic isotope Pb-212. With a half-life of 10.6 hours, Pb-212 is ideally suited to deliver powerful alpha-particle therapy to cancerous tumors, while representing a lower risk for off-target unintended effects and the potential for treatment on an outpatient basis.

Michael Schultz, PhD, Chief Science Officer of Viewpoint commented, “This agreement is an important step that helps to de-risk our programs by providing a secure supplier of commercial levels of feedstock radionuclide Th-228, a raw material that is necessary for the production VMT-𝛼-GEN. It also secures our position in building a fully-integrated alpha-particle radiopharmaceutical business with cancer targeted ligands at preclinical and clinical stages of development.”

Radionuclide generators such as VMT-𝛼-GEN are used commonly in radiopharmacies and nuclear medicine facilities across the world. The devices share a common characteristic of enabling the production of a purified chemical form of the radionuclide needed that can be easily combined with ligands that seek out cancerous tumors. Because the shelf life of VMT-𝛼-GEN is based on a longer-lived radionuclide (Ra-224), a single shipment of VMT-𝛼-GEN can be used to produce radiopharmaceutical doses daily, for up to a week or more. The device can then be returned to the manufacturer in approved packaging to eliminate radioactive waste from the medical center or radiopharmacy.

Viewpoint is establishing centrally located manufacturing facilities in the United States with the goal of enabling overnight shipments of a nimble supply of both its Pb-203 radiopharmaceutical imaging agents and cancer-targeted Pb-212 alpha-particle therapeutics for personalized image-guided therapies anywhere in the continental United States.

About the National Isotope Development Center

The National Isotope Development Center (NIDC) is funded by the U.S. Department of Energy Isotope Program (DOE IP). It serves as an interface with the user community and manages the coordination of isotope production across the program facilities at Argonne, Brookhaven, Idaho, Los Alamos, Oak Ridge, and Pacific Northwest National Laboratories. These facilities produce stable and radioactive isotopes in short supply using reactors, accelerators, and other methods.

The DOE Isotope Program supports the production and the development of production techniques of radioactive and stable isotopes that are in short supply for research and applications. Isotopes are high-priority commodities of strategic importance for the nation and are essential for energy, medical, and national security applications and for basic research; a goal of the program is to make critical isotopes more readily available to meet domestic U.S. needs.

The program also coordinates and supports isotope production at numerous universities, national laboratories, and commercial accelerator and reactor facilities throughout the nation to promote a reliable supply of domestic isotopes. The NIDC coordinates isotope production across these facilities and manages the business operations of the sale and distribution of isotopes.

About Viewpoint

Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s leading alpha-particle radiotherapies are designed to deliver powerful alpha radiation specifically to cancer cells utilizing specialized targeting peptides. Viewpoint is also developing complementary diagnostics that utilize the same targeting peptide which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enabling the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

The Company’s melanoma (VMT01) and neuroendocrine tumor (VMT-𝛼-NET) programs are entering Phase 1 imaging studies, to be followed by Phase 1/2a therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at two leading academic institutions. For more information, please visit the Company’s website viewpointmt.com.

Isoray Announces the Appointment of Lisa Lauer As Vice President Business Development

CEO Lori Woods says Lauer’s appointment marks another important step forward for the Company, “Lisa Lauer brings deep industry experience and market knowledge to the Company.

Isoray Announces Second Quarter Fiscal 2021 Financial Results

Revenue for the second quarter of fiscal 2021 grew 7% to $2.36 million versus $2.21 million in the prior year comparable period.

Isoray To Announce Second Quarter Fiscal 2021 Financial Results on February 9, 2021

To listen to the conference call, please dial 877-407-8035. For callers outside the U.S., please dial 201-689-8035.

Isoray Announces Pricing of $45 Million Public Offering

The offering is expected to close on February 8, 2021, subject to the satisfaction of customary closing conditions.

Isoray Announces Proposed Underwritten Public Offering

Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering.

Viewpoint Molecular Targeting™ Presents Positive Preclinical Data from VMT01 Program at the 2021 SNMMI Mid-Winter Meeting

– Positive preclinical data demonstrating that a single dose of [212Pb]-VMT01 significantly enhanced response to immune checkpoint inhibitors relative to checkpoint inhibitor treatment alone with a 43% rate of complete response in a B16 melanoma tumor model in mice –

– Company plans to advance its VMT01 program into Phase 1 imaging study, to be followed by Phase 1/2a therapy study for the treatment of metastatic melanoma –

Coralville, IA, February 1, 2021 – Viewpoint Molecular Targeting, Inc. (“Viewpoint” or the “Company”), a radiopharmaceutical company developing precision α-particle oncology therapeutics and complementary diagnostic imaging agents, today announced the presentation of positive preclinical data from its VMT01 program at the 2021 SNMMI Mid-Winter Meeting, which was held virtually January 28-31, 2021.

Michael Schultz, PhD, Chief Science Officer of Viewpoint commented, “We continue to be encouraged by the data from our VMT01 program which highlights the potential of our proprietary alpha-particle radiotherapies and complementary diagnostic imaging agents. Our data suggest that our targeted alpha-particle therapies have the potential to significantly enhance responses to currently available immunotherapies for the treatment of metastatic melanoma. We look forward to exploring the potential of VMT01 further and entering the clinic with a Phase 1 imaging study in the near-term.”

The abstract titled, Pb-212 α-particle radiotherapy induces immunogenic cell death and synergistic anti-tumor effect in combination with immunotherapies, was presented by Viewpoint Research Scientist, Mengshi Li, PhD.

Key Findings:

Single dose of [212Pb]-VMT01 significantly arrested tumor growth of B16 melanoma and extended survival.

Immune checkpoint inhibitors did not significantly reduce tumor growth compared with control group, presumably due to the aggressiveness and non-responsive nature of B16 melanoma model.

Combination of [212Pb]-VMT01 and immune checkpoint inhibitors induced synergistic anti-tumor effect and 43% (3/7) complete tumor remission. Interestingly, animals with complete tumor clearance developed anti-tumor immunity to reject further tumor challenge.

Similar synergistic effect was not seen in RAG1 KO mice, indicating that adaptive immunity was necessary. FACS data demonstrated enhance TILs in animals dosed with [212Pb]

VMT01, including CD45+ leukocytes, CD3+, CD19+ lymphocytes. Specifically, increased CD8+ T cells were found after [212Pb] VMT01 dosing.

Viewpoint’s VMT01 program is intended to meet an unmet clinical need with the use of a new imaging agent to guide Viewpoint’s radiopharmaceutical therapy against metastatic melanoma. This image-guided approach is often referred to as “theranostics.” Using information guided by the low-risk medical imaging scan, a treatment plan utilizing the VMT01 ligand is designed to deliver the power of alpha-particle radiation specifically to melanoma tumors, while minimizing risk to unaffected organs and tissues. VMT01 represents a unique way to treat metastatic melanoma that has been vetted as scientifically sound by rigorous peer review and has the potential to be transformative for melanoma patients.

The Company plans to advance its VMT01 program into a Phase 1 imaging study followed by a Phase 1 therapy study for the treatment of metastatic melanoma at the Mayo Clinic.

About The 2021 SNMMI Mid-Winter Meeting

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to advancing nuclear medicine and molecular imaging—precision medicine that allows diagnosis and treatment to be tailored to individual patients in order to achieve the best possible outcomes. This year’s virtual meeting brings together leading molecular imaging and nuclear medicine physicians, radiologists, cardiologists, pharmacists, scientists, lab professionals, and technologists, representing the world's top medical and academic institutions and centers, and will feature three educational tracks highlighting the latest innovations and techniques in the field, including a dedicated track on therapy. For more information, visit www.snmmi.org

About Viewpoint

Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s leading alpha-particle radiotherapies are designed to deliver powerful alpha radiation specifically to cancer cells utilizing specialized targeting peptides. Viewpoint is also developing complementary diagnostics that utilize the same targeting peptide which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enabling the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

The Company’s melanoma (VMT01) and neuroendocrine tumor (VMT-𝛼-NET) programs are entering Phase 1 imaging studies, to be followed by Phase 1/2a therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at two leading academic institutions. For more information, please visit the Company’s website viewpointmt.com.

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