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Viewpoint Molecular Targeting™ Receives FDA Clearance of Investigational New Drug Application for Phase 1 Imaging Study ...
09/09/2021

Viewpoint Molecular Targeting™ Receives FDA Clearance of Investigational New Drug Application for Phase 1 Imaging Study for VMT-a-NET for Neuroendocrine Tumors

September 9, 2021
Coralville, IA, September 9, 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 that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence a Phase 1 imaging study of VMT-a-NET for imaging of neuroendocrine tumors (NETs). The Phase 1 imaging study is an investigator-initiated study that will be conducted at the University of Iowa Hospitals and Clinics.

The Phase 1 imaging study will evaluate [ 203Pb]VMT-a-NET as an agent for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors. The images obtained will inform future therapeutic trials of [212Pb]VMT-a-NET alpha-particle therapy for this tumor type. In parallel to this investigator initiated imaging trial, the Company plans to move forward with a Phase 1/2a therapy study of VMT-a-NET for the treatment of neuroendocrine tumors.

“We are incredibly pleased that our second product has received IND clearance from the FDA, allowing our collaborators at the University of Iowa to proceed with another first-in-human Phase 1 imaging study. We continue to be encouraged by the preclinical results demonstrated to date, that show the promise of treating this disease with targeted alpha-particle therapy. With this milestone now achieved, Viewpoint together with the team at the University of Iowa is excited to progress toward enrollment and provisional results in our imaging study over the remainder of this year,” commented Frances L. Johnson, MD, Chief Executive Officer and Co-Founder of Viewpoint Molecular Targeting.

Preclinical data seen to-date provides strong evidence that the VMT-a-NET image-guided approach can be an effective therapy with a promising toxicity profile. Supported by over $4 million in the form of Small Business Innovation Research grants and R01 academic research grants from the NCI to advance this treatment, VMT-a-NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, re**um, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.

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-a-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. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. 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

[email protected]

Viewpoint Molecular Targeting™ Receives FDA Clearance of Investigational New Drug Application for Phase 1 Imaging Study for VMT-a-NET for Neuroendocrine Tumors

September 9, 2021
Coralville, IA, September 9, 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 that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence a Phase 1 imaging study of VMT-a-NET for imaging of neuroendocrine tumors (NETs). The Phase 1 imaging study is an investigator-initiated study that will be conducted at the University of Iowa Hospitals and Clinics.

The Phase 1 imaging study will evaluate [ 203Pb]VMT-a-NET as an agent for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors. The images obtained will inform future therapeutic trials of [212Pb]VMT-a-NET alpha-particle therapy for this tumor type. In parallel to this investigator initiated imaging trial, the Company plans to move forward with a Phase 1/2a therapy study of VMT-a-NET for the treatment of neuroendocrine tumors.

“We are incredibly pleased that our second product has received IND clearance from the FDA, allowing our collaborators at the University of Iowa to proceed with another first-in-human Phase 1 imaging study. We continue to be encouraged by the preclinical results demonstrated to date, that show the promise of treating this disease with targeted alpha-particle therapy. With this milestone now achieved, Viewpoint together with the team at the University of Iowa is excited to progress toward enrollment and provisional results in our imaging study over the remainder of this year,” commented Frances L. Johnson, MD, Chief Executive Officer and Co-Founder of Viewpoint Molecular Targeting.

Preclinical data seen to-date provides strong evidence that the VMT-a-NET image-guided approach can be an effective therapy with a promising toxicity profile. Supported by over $4 million in the form of Small Business Innovation Research grants and R01 academic research grants from the NCI to advance this treatment, VMT-a-NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, re**um, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.

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-a-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. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. 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

[email protected]

08/17/2021

Congratulations to CET!

ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement

License allows Cellular Engineering Technologies to develop, manufacture and commercialize next generation stem cell lines using CRISPR/Cas9 technology

DUBLIN, Ireland and Coralville, Iowa, 17 August 2021: ERS Genomics Limited, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by Dr. Emmanuelle Charpentier, and Cellular Engineering Technologies (CET), a biotechnology company specializing in cell manufacturing and contract research services, today announced a non-exclusive license agreement granting CET access to ERS Genomics’ CRISPR/Cas9 patent portfolio.

With its expertise in cell and tissue engineering, CET supports research organizations at the interface of stem cell research and preclinical drug discovery. CET’s portfolio includes its proprietary induced pluripotent stem cell technology, which is both virus- and oncogene-free to improve cell line genetic stability, safety, and reproducibility in drug discovery workflows for cell and gene therapies. The license from ERS Genomics will allow CET to develop, manufacture and commercialize next generation stem cell lines using CRISPR/Cas9 technology.

ERS Genomics holds an exclusive worldwide license from co-founder and recent Nobel prize winner Dr. Emmanuelle Charpentier to the foundational intellectual property covering CRISPR/Cas9 for use as a research platform.

Eric Rhodes, CEO of ERS Genomics, said: “CRISPR/Cas9 is a powerful genome engineering tool that has revolutionized many research areas. At ERS Genomics, we are committed to making this technology broadly available and we are very pleased to support CET, a dynamic and innovative company at the forefront of cell engineering.”

Alan Moy, MD, CEO and Co-Founder of CET, commented: “We are excited to secure this essential license agreement with ERS Genomics, which will allow us to integrate our stem cell technology with CRISPR/Cas9 to create next generation stem cells that better serve the life science market. This will offer greatly improved cells to produce therapeutic biologics, viral vectors for cell and gene therapy, and vaccines for both the human and animal health sectors.”

Financial details of the agreement are not disclosed.

Viewpoint Molecular Targeting® Partners with Industry Leader Pepscan to Accelerate Peptide Discovery Program– Companies ...
07/07/2021

Viewpoint Molecular Targeting® Partners with Industry Leader Pepscan to Accelerate Peptide Discovery Program

– Companies forge relationship to accelerate peptide drug discovery for next-generation radiopharmaceuticals –

– Pepscan brings proprietary world-leading peptide drug discovery expertise and technologies –

– Viewpoint to apply expertise in radiopharmaceuticals, chelation technologies and bioconjugate chemistry to accelerate the pace of discovery to clinic-ready
radiopharmaceuticals –

Coralville, IA, July 7, 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 it has entered into a collaborative partnership with Netherlands-based Pepscan Therapeutics B.V. (“Pepscan”), the all-in-one peptide service provider with proprietary peptide constraining technologies.

“Pepscan is clearly a world leader in peptide discovery and lead optimization, and we are delighted to have taken the first step on this journey,” commented Michael K. Schultz, PhD, Chief Science Officer and Co-Founder of Viewpoint. “In our diligence, the Pepscan team is technically and professionally the strongest we’ve had the pleasure to work with. We are particularly excited to see how their CLIPS™ innovative scaffold technology results in superior synthetic peptide candidates for us to develop.”

Peptide-based radiopharmaceuticals have recently emerged as an exciting therapeutic and diagnostic platform in the areas of neuroendocrine tumors, prostate cancer, and other solid tumors. Pepscan’s world-leading libraries of CLIPS™ (Chemical Linkage of Peptides onto Scaffolds) constrained peptides combined with its screening technologies and deep knowledge of the discovery process will result in optimal ligands which bind cancer-specific cellular targets with high affinity and selectivity. In post-discovery the candidates can be modified with Viewpoint’s proprietary linker and chelator technology which is specific for the lead-212 therapeutic isotope and lead-203 imaging isotope. This allows Viewpoint’s in-house scientists to optimize the pharmacokinetic “tuning” of the peptides to ensure high tumor uptake and reduced healthy organ uptake.

“We are excited to join Viewpoint’s journey and enable them to develop life-improving breakthroughs. Ultimately, the success of our peptide discovery and optimization for radiopharmaceuticals lies in the technical strength, expertise, and understanding of the team that transitions our candidates into clinically relevant radiopharmaceutical drugs,” added

Pepscan’s Director of Peptide Discovery, Michael Goldflam. “Given Viewpoint’s track-record in translating its two lead products through development to clinic-ready status, we have great confidence that the Viewpoint team will achieve success based on our discovery results.”

This collaborative partnership agreement provides an avenue for both Viewpoint and Pepscan to focus on their world-leading expertise and technologies in order to accelerate the process from discovery phase to clinic-ready radiopharmaceuticals. The terms of the agreement are to remain confidential.

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. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. For more information, please visit the Company’s website viewpointmt.com.

About Pepscan Therapeutics B.V.

Pepscan is an all-in-one partner in peptides, building on 25 years of experience in advancing and applying peptide expertise to facilitate customers in the development and production of peptides. At its end-to-end facility in Lelystad, the Netherlands, Pepscan offers a range of patented technologies, phage display capabilities, a lead-optimization array platform, and production facilities for R&D- to GMP-grade peptides, including libraries and neoantigen vaccines. Among its patents is the CLIPS™ technology, which locks peptides into active conformations.

Pepscan has a proven track record in the field of radiopharmaceuticals and synthesized precursors for radiolabeled peptides suitable for a wider range of applications. Its unique CLIPS™ phage display platform enables the discovery of highly constrained de novo peptides with enhanced affinities, selectivities and proteolytic stabilities. Next to the peptides emerging from the discovery platform, Pepscan has successfully produced radiopharmaceutical peptides as developed by customers themselves.


Investor Inquiries:
Jenene Thomas
Chief Executive Officer JTC Team, LLC
T: 833.475.8247
[email protected]

Viewpoint Molecular Targeting® Partners with Industry Leader Pepscan to Accelerate Peptide Discovery Program

– Companies forge relationship to accelerate peptide drug discovery for next-generation radiopharmaceuticals –

– Pepscan brings proprietary world-leading peptide drug discovery expertise and technologies –

– Viewpoint to apply expertise in radiopharmaceuticals, chelation technologies and bioconjugate chemistry to accelerate the pace of discovery to clinic-ready
radiopharmaceuticals –

Coralville, IA, July 7, 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 it has entered into a collaborative partnership with Netherlands-based Pepscan Therapeutics B.V. (“Pepscan”), the all-in-one peptide service provider with proprietary peptide constraining technologies.

“Pepscan is clearly a world leader in peptide discovery and lead optimization, and we are delighted to have taken the first step on this journey,” commented Michael K. Schultz, PhD, Chief Science Officer and Co-Founder of Viewpoint. “In our diligence, the Pepscan team is technically and professionally the strongest we’ve had the pleasure to work with. We are particularly excited to see how their CLIPS™ innovative scaffold technology results in superior synthetic peptide candidates for us to develop.”

Peptide-based radiopharmaceuticals have recently emerged as an exciting therapeutic and diagnostic platform in the areas of neuroendocrine tumors, prostate cancer, and other solid tumors. Pepscan’s world-leading libraries of CLIPS™ (Chemical Linkage of Peptides onto Scaffolds) constrained peptides combined with its screening technologies and deep knowledge of the discovery process will result in optimal ligands which bind cancer-specific cellular targets with high affinity and selectivity. In post-discovery the candidates can be modified with Viewpoint’s proprietary linker and chelator technology which is specific for the lead-212 therapeutic isotope and lead-203 imaging isotope. This allows Viewpoint’s in-house scientists to optimize the pharmacokinetic “tuning” of the peptides to ensure high tumor uptake and reduced healthy organ uptake.

“We are excited to join Viewpoint’s journey and enable them to develop life-improving breakthroughs. Ultimately, the success of our peptide discovery and optimization for radiopharmaceuticals lies in the technical strength, expertise, and understanding of the team that transitions our candidates into clinically relevant radiopharmaceutical drugs,” added

Pepscan’s Director of Peptide Discovery, Michael Goldflam. “Given Viewpoint’s track-record in translating its two lead products through development to clinic-ready status, we have great confidence that the Viewpoint team will achieve success based on our discovery results.”

This collaborative partnership agreement provides an avenue for both Viewpoint and Pepscan to focus on their world-leading expertise and technologies in order to accelerate the process from discovery phase to clinic-ready radiopharmaceuticals. The terms of the agreement are to remain confidential.

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. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. For more information, please visit the Company’s website viewpointmt.com.

About Pepscan Therapeutics B.V.

Pepscan is an all-in-one partner in peptides, building on 25 years of experience in advancing and applying peptide expertise to facilitate customers in the development and production of peptides. At its end-to-end facility in Lelystad, the Netherlands, Pepscan offers a range of patented technologies, phage display capabilities, a lead-optimization array platform, and production facilities for R&D- to GMP-grade peptides, including libraries and neoantigen vaccines. Among its patents is the CLIPS™ technology, which locks peptides into active conformations.

Pepscan has a proven track record in the field of radiopharmaceuticals and synthesized precursors for radiolabeled peptides suitable for a wider range of applications. Its unique CLIPS™ phage display platform enables the discovery of highly constrained de novo peptides with enhanced affinities, selectivities and proteolytic stabilities. Next to the peptides emerging from the discovery platform, Pepscan has successfully produced radiopharmaceutical peptides as developed by customers themselves.


Investor Inquiries:
Jenene Thomas
Chief Executive Officer JTC Team, LLC
T: 833.475.8247
[email protected]

Address

2500 Crosspark Rd
Coralville, IA
52241

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