Month: April 2021

Isoray To Announce Third Quarter Fiscal 2021 Financial Results on May 13, 2021

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

Viewpoint Molecular Targeting™ Presents Positive Preclinical Results of VMT01 at the 10th World Congress of Melanoma

– Results demonstrated that the combination of [212Pb] VMT01 and immune checkpoint inhibitors induced synergistic anti-tumor effect and 43% complete tumor responses –
– Company is launching Phase 1 imaging study of VMT01 imminently with provisional results expected in Q4 2021, followed
by Phase 1/2a therapy study for the treatment of metastatic melanoma –


Coralville, IA, April 19, 2021 – Viewpoint Molecular Targeting, Inc. (“Viewpoint” or the “Company”), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, today announced additional positive preclinical results from its [212Pb] VMT01 program currently in development for the treatment of metastatic melanoma. These results were presented at the virtual 10th World Congress of Melanoma held April 15 – 17, 2021.

VMT01 is a specialized peptide designed to target the melanocortin 1 receptor (MC1R) on tumor cells. The results from this preclinical study indicate that MC1R-targeted therapies, such as peptide receptor radionuclide therapies (PRRT), are a promising alternative to current therapies for metastatic melanoma. VMT01 is currently being evaluated in a Phase 1 imaging study being conducted at the Mayo Clinic. Provisional results for the VMT01 imaging study are targeted for Q4 2021. Following the results of the imaging trial, the Company plans to initiate a Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.

​The abstract titled, Validation of melanocortin 1 receptor (MC1R) expression in human metastatic melanoma biopsy samples and preclinical evaluation of combination of MC1R-targeted α-particle radiotherapy with immunotherapies, was presented by Viewpoint Biomedical Engineer, Brenna Marks.

Key Findings:

The data from the study demonstrated high expression of MC1R in human melanoma biopsy samples as well as in melanoma cancer cell lines. The expression of MC1R in normal tissues is largely absent.

125I-NDP-α-MSH binding assay results revealed positive staining in all melanoma cell lines, with the density ranging from 100 to 28,430 receptors/cell in melanoma cell lines.

The IHC staining demonstrated positive immunoreactivity against MC1R in stage III and IV human melanoma biopsy samples. Heterogenous expression of MC1R was also found within the biopsy samples as well as among tumor biopsy samples but was absent in normal tissues.

The staining intensity fell within the range of the melanoma cancer cell line xenografts.

In the preclinical combination therapy study, a single administration of [212Pb] VMT01 significantly arrested tumor growth of B16 melanoma and extended survival.

Combination of [212Pb] VMT01 and immune checkpoint inhibitors induced a synergistic anti-tumor effect and 43% (3/7) complete tumor response. Animals with complete tumor responses also developed anti-tumor immunity to reject further tumor cell challenge (i.e., subcutaneous naïve cancer cell implants).

​About the 10th World Congress of Melanoma

The 10th World Congress of Melanoma is being held in conjunction with the 17th EADO Congress which will be held under the auspices of the Melanoma World Society (MWS) and European Association of Dermato-Oncology (EADO).

The scientific programme will provide rich educational opportunities for all delegates. The field of melanoma will be covered as well as Squamous Cell Carcinoma (SCC), Merkel Cell Carcinoma (MCC), Basal Cell Carcinoma (BCC), Actinic Keratosis, Cutaneous Sarcoma and Cutaneous T- and B-Cell Lymphoma.

The congress offers a great opportunity for young doctors and researchers to familiarize themselves with melanoma and non-melanoma skin cancers. The entire spectrum of questions related to melanoma and non-melanoma skin cancers will be covered. Epidemiology, prevention and early detection, diagnostics and staging, surgical and radiotherapy and systemic and intralesional therapies are core themes of the meeting.

About Viewpoint

Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s proprietary technology utilizes 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. This “theranostic” approach enables 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.


Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
viewpoint@jtcir.com

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Viewpoint Molecular Targeting™ Presents Positive Preclinical Results of VMT01 at the 2021 American Association for Cancer (AACR) Annual Meeting

– Preclinical study evaluated melanocortin 1 receptor (MC1R) as a potential target for MC1R-targeted
therapies for metastatic melanoma, the lead target of VMT01 –
 
– Results indicate that MC1R-targeted therapies, such as VMT01, are a promising alternative to current therapies for metastatic melanoma –
 
– Company is launching Phase 1 imaging study of VMT01 imminently with provisional results expected in Q4 2021, followed by Phase 1/2a therapy study for the treatment of metastatic melanoma –
 

Coralville, IA, April 13, 2021 – Viewpoint Molecular Targeting, Inc. (“Viewpoint” or the “Company”), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, today announced positive preclinical results from a study investigating the potential of the melanocortin 1 receptor (MC1R) for targeted drug delivery for the treatment of metastatic melanoma. Results were presented at the American Association for Cancer Research (AACR) Annual Meeting, being held virtually from April 10 – 15, 2021.

MC1R, a G protein-coupled receptor, has been investigated as a potential target for drug delivery (e.g., peptide receptor radionuclide therapies, peptide-drug conjugates, etc.) to metastatic melanoma cells, as it is overexpressed in melanomas but largely absent in normal tissues. The results from this study indicate that MC1R-targeted therapies, such as peptide receptor radionuclide therapies (PRRT), are a promising alternative to current therapies for metastatic melanoma.

Michael K. Schultz, PhD, Chief Science Officer of Viewpoint commented, “We are very pleased with the results of this preclinical study which demonstrated the viability of leveraging MC1R to specifically target metastatic melanoma, the target for our VMT01 program. Its overexpression on metastatic melanoma cells and absence from normal cells may provide a unique opportunity to deliver radioactive payloads to the tumor while reducing off-target toxicity. Additionally, these results give us confidence in our specialized MC1R targeting peptide as we prepare to launch our Phase 1 imaging study of VMT01. The upcoming study being conducted at the Mayo Clinic will evaluate the ability of VMT01 to identify MC1R positive metastatic melanoma tumors and prepare us for a Phase 1 therapy study for the treatment of metastatic melanoma.”

The abstract titled, Assessing Melanocortin 1 receptor as a target for metastatic melanoma drug delivery, was presented by Viewpoint Biomedical Engineer, Brenna Marks in the Experimental and Molecular Therapeutics session on Saturday, April 10.

Bmax and MC1Rs per cell in five human melanoma cell lines (TXM13, TXM40, Sk-Mel-28, A375, and A2058) were calculated from saturation binding assays using synthetic MC1R ligand [125I]Nle-D-Phe-α-MSH (125I-NDP-α-MSH). An immunohistochemistry (IHC) staining protocol was developed using paraffin-embedded xenografts of TXM13, TXM40, Sk-Mel-28, A375, and A2058 human melanoma cells. IHC staining of MC1R was performed using human melanoma biopsy samples of stage III and IV metastatic melanoma. MC1R-IHC was also performed on Caucasian North American normal tissue specimens including skin, muscle, pituitary gland, adrenal gland, cerebellum, and testis.

125I-NDP-α-MSH binding assay results revealed positive staining in all melanoma cell lines, with the densities up to approximately 3000 receptors/cell in TXM13. The IHC staining also demonstrated positive immunoreactivity against MC1R in stage III and IV human metastatic melanoma biopsy samples. Heterogenous expression of MC1R was found within the biopsy samples and among tumor biopsy samples, and the staining intensity fell within the range of the melanoma cancer cell line xenografts. Conversely, negative IHC staining of MC1R was found in normal tissue specimens, indicating that the expression of MC1R in normal tissues is largely absent. This study establishes an MC1R-IHC staining protocol optimized for clinical applications, and these data demonstrate high expression of MC1R in human melanoma biopsy samples as well as in melanoma cancer cell lines.

​VMT01 is specialized peptide designed to target the melanocortin 1 receptor (MC1R) on tumor cells. VMT01 is currently being evaluated in a Phase 1 imaging study being conducted at the Mayo Clinic. Provisional results for the VMT01 imaging study are targeted for Q4 2021. Following the results of the imaging trial, the Company plans to initiate a Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.

About the American Association for Cancer Research (AACR) Annual Meeting
The AACR Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world.

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 imaging diagnostics that utilize the same targeting peptide which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enables 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.br />

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.

Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
viewpoint@jtcir.com

Isoray Announces the Appointment of Donna Fort as Vice President Sales and Marketing

CEO Lori Woods said Fort’s appointment adds key expertise. “I am very excited to welcome Donna to the Isoray team.

Viewpoint Molecular Targeting™ Announces Strategic Partnership with Eichrom Technologies to Accelerate Isotope Production Process Development

– Automation of manufacturing is critical to scaling Viewpoint’s isotope production technologies in a way that is safe for personnel and cost effective –


​Coralville, IA, April 6, 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 established a strategic partnership with Eichrom Technologies, LLC (“Eichrom”) to accelerate the automation and scale up of Viewpoint’s isotope production process.

Eichrom is a world leader in radiometal separations and chromatography technologies that play a central role in radiopharmaceutical development and production. The company operates a subsidiary called Nuclear Power Outfitters (“NPO”) that specializes in custom radiation shielding for the nuclear industry. Eichrom and NPO represent an ideal supplier of Pb-212 generator pre-assemblies for manufacturing as well as a world-class organization with vast knowledge of radiometal purifications and radiation safety components for Viewpoint applications.

By working with the team at Eichrom, we gain decades of experience in optimizing the key aspects of radiometal chromatography for our isotope production technologies. In addition, NPO is a nimble-custom radiation shielding partner with deep experience and knowledge that can be implemented as our production process is scaled up. We have had a long-standing supplier relationship with both of these great teams, and we are excited to further strengthen our relationship as a means to accelerate our manufacturing roll out,” commented Michael Schultz, PhD, Chief Science Officer of Viewpoint.

​Michael Fern, President of Eichrom, added, “We believe the combination of Eichrom’s expertise in the fields of radiochemistry and radiation protection with Viewpoint’s cutting edge theranostic technology will have significant impact in the future of cancer diagnosis and treatment. It is an exciting time for both companies as we collaborate to bring the Pb-212 generator to market.”

Viewpoint’s proprietary VMT-𝛼-GEN is an elegantly-designed isotope generator that provides therapeutic doses of Pb-212 for the Company’s therapeutic and diagnostic (“Theranostic”) programs for the treatment of cancers, including metastatic melanoma and neuroendocrine tumors.

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.

​About Eichrom Technologies, LLC

Eichrom Technologies and subsidiaries are world leaders in radiochemistry and radiation protection. Founded in 1990, Eichrom has been at the forefront of new product development and commercialization in the areas of environmental radiochemistry, nuclear medicine, and geochemistry. With more than 30 years of developing chromatography products and methods of separation and purification in the field of radiochemistry which have become the global standard for laboratory analysis of actinides and beta-emitting fission products for environmental monitoring and internal dosimetry programs at nuclear facilities in over 150 countries and on all 7 continents.

As experts in chromatography, column packing, and radiochemistry, we have long addressed the chemical separation and purification needs of organizations involved in radiopharmaceutical R&D and production. We apply our experience base to solve customer problems with both proprietary and commercially available separation media.

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 imaging diagnostics that utilize the same targeting peptide which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enables 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.

​Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
viewpoint@jtcir.com

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