VIPR

WEDNESDAY, Sept. 4, 2024 -- The humanized monoclonal antibody directed against the pituitary adenylate cyclase-activating polypeptide (PACAP) ligand, Lu AG09222, is better than placebo for reducing migraine frequency over four weeks, according to a study published in the Sept. 5 issue of the New England Journal of Medicine . Messoud Ashina, M.D., from Copenhagen University Hospital in Denmark, and colleagues conducted a phase 2, double-blind trial involving adults with migraine for whom two to four previous preventive treatments had failed to provide a benefit. The trial included a four-week treatment period and eight-week follow-up period. Participants were randomly assigned to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo (97, 46, and 94 individuals, respectively). The researchers found that in the overall population, the mean number of migraine days per month was 16.7, and the mean change from baseline over weeks 1 through 4 was −6.2 and −4.2 days in the Lu AG09222 750-mg group and placebo group, respectively (difference, −2.0 days). During the 12-week observation period, adverse events with a higher incidence in the Lu AG09222 750-mg group versus the placebo group included COVID-19 (7 versus 3 percent), nasopharyngitis (7 versus 4 percent), and fatigue (5 versus 1 percent). "This finding establishes proof of concept, supporting the notion that inhibition of PACAP signaling by Lu AG09222 represents a potentially effective mechanism for migraine prevention," the authors write. The study was partially funded by H. Lundbeck, which is developing Lu AG09222.

Schizophrenia is a serious mental health disorder linked to the imbalance of chemical neurotransmitters that affect cognitive capabilities. Current therapies against schizophrenia have numerous limitations, largely due to the selective permeability of blood-brain barrier, which necessitates the development of novel strategies. Schizophrenia is a complicated mental health disorder accompanied by wide range of symptoms such as hallucinations, impaired cognitive ability, and disorganized speech or behavior. It has been associated with anomalies in neurotransmission due to the imbalance of chemical neurotransmitters. Current treatment strategies against schizophrenia involve the administration of antipsychotic drugs, which can cause adverse effects and are associated with a high risk of cardiovascular disease. Moreover, in patients, response to therapeutic drugs is often inadequate as the blood-brain barrier (BBB), a protective barrier of cells, strictly regulates the movement of ions and molecules into the brain. To overcome the hurdle of BBB and facilitate the transport of therapeutic drugs into brain tissue to treat schizophrenia, researchers have explored the applicability of receptor-mediated transcytosis (RMT) using low-density lipoprotein receptor-related protein 1 (LRP1). This research was conducted by team led by Associate Professor Eijiro Miyako from Japan Advanced Institute of Science and Technology (JAIST), included Prof. Yukio Ago from Hiroshima University, Prof. Shinsaku Nakagawa from Osaka University, Prof. Takatsugu Hirokawa from Tsukuba University, and Dr. Kotaro Sakamoto, Senior Principal Scientist at Ichimaru Pharcos Co., Ltd. Their study was published in JACS Au journal on June 20, 2024. The researchers were inspired by previous findings which showed the interactions of vasoactive intestinal peptide receptor 2 (VIPR2) gene duplication in schizophrenia and their own discovery of a novel peptide, KS-133. The novel peptide, KS-133, has selective antagonist activity to VIPR2, leading to its downregulation. However, the major limitation associated with KS-133 was its poor permeability across BBB. To facilitate the effective transport of KS-133 into the brain, they developed a brain-targeting peptide, KS-487, that could specifically bind to LRP1 and influence RMT. Finally, the researchers developed a novel nanoparticle-based drug delivery system (DDS) where KS-133 peptide was encapsulated with KS-487 targeting peptide and studied its efficacy in treating schizophrenia. The administration of peptide formulations via the DDS resulted in the effective distribution of the drug in the brains of mice. Drug release profiles assessed by pharmacokinetic analysis confirmed the role of the brain-targeting peptide in transporting KS-133 into the brain. Furthermore, the efficacy of DDS was evaluated in mice with induced schizophrenia by elevated activation of VIPR2. Mice treated with KS-133/KS-487 nanoparticles showed significant improvement in cognitive functions during novel object recognition tests, which could be attributed to the inhibition of VIPR2. Explaining the real-life applications and potential of their study, Dr. Miyako shares, "Existing drugs only have mechanisms involving neurotransmitter modulation, and their therapeutic effects are limited, especially for cognitive dysfunction. Thus, our peptide formulation could be used as a novel drug to restore cognitive dysfunction in schizophrenia." In summary, this study by Dr. Miyako and co-researchers provides preclinical evidence of a novel therapeutic strategy for targeting VIPR2 that could improve cognitive impairment in schizophrenia. "Going ahead, we will extend our study to involve cells and animal models, as well as human clinical trials, to confirm the efficacy and safety of this peptide formulation and promote its development as a new treatment for schizophrenia within 5 years," concludes Dr. Miyako, optimistic about the long-term implications of their study.

Two Additional Board Appointments Expected in 2024 as NuView Advances Pipeline of Theranostic Radiopharmaceuticals for Various Cancers PARK CITY, Utah, Jan. 3, 2024 /PRNewswire/ -- NuView Life Sciences, Inc. ("NuView", the "company"), a radiopharmaceutical company seeking to enhance the global oncology market with its novel platform (NV-VPAC1™) capable of detecting and precisely targeting G protein-coupled receptors for cancer, announced the appointments of Dr. Stanley J. Pappelbaum and A.J. Boechler to its board of directors. Their combined experience and expertise developing, commercializing, and scaling therapeutics that span the product lifecycle adds further depth to NuView's leadership team as the Company advances its NV-VPAC1™ theranostic technology towards key clinical and commercialization milestones in 2024. NuView is leveraging its NV-VPAC1™ platform to advance a pipeline of precision in vitro laboratory diagnostics tests and in vivo cancer diagnostics and therapy delivery systems targeting multiple high-need, large-market indications, including prostate and bladder cancer. "On behalf of the Board, I am pleased to welcome Stan and A.J. and look forward to benefitting from their knowledge and expertise," said Paul Crowe, Chairman and Chief Executive Officer of NuView. "They join our board of directors at a pivotal time for NuView as we plan to initiate clinical trials in early 2024 of NV-VPAC1™ Liquid Biopsy Diagnostic Test, our precision in vitro laboratory diagnostics test for detecting tumor cells in biological fluid. Additionally, their strategic planning and insight will be invaluable as we advance our NV-VPAC1™ Theranostics Platform that combines the diagnostic acuity of Copper-64 (Cu-64) with the precision therapeutic intervention of Copper-67 (Cu-67)." Stanley J. Pappelbaum, MD, SM, FAAP, FACC, is a La Jolla, California-based strategic healthcare consultant who advises hospitals, medical groups, and biomedical research entities across the United States. Dr. Pappelbaum began his career as a pediatric cardiologist at the University of California, San Diego School of Medicine and San Diego Rady Children's Hospital, where he led the establishment of a comprehensive children's cardiac center throughout an area serving 5 million Southern Californians. His role as CEO of Scripps Health system leading five hospitals in San Diego County and the subsequent launch of Pappelbaum Turner Healthcare Consulting highlight his expertise guiding complex healthcare organizations. In addition to his medical credentials, Dr. Pappelbaum earned a master's degree in management with a health focus at the Sloan School of Management at Massachusetts Institute of Technology. A.J. Boechler joins the NuView board offering more than 30 years of executive leadership experience at the General Electric Company. His expertise spans multiple business models, global operations, sales and marketing, and P&L leadership. A.J. spent 10 years in GE Healthcare where he expanded the business footprint in the U.S. with the launch of functional imaging (PET), radiopharmacy (cyclotron), and 3T MRI product lines. A.J. applied his leadership skills in additional global business roles at GE Plastics, GE Lighting, GE Fanuc Automation, and GE Oil and Gas. His global tenure in sales, marketing, consulting, manufacturing, and digital transformation showcases his ability to steward complex teams and successfully execute business strategies to deliver results on a global scale. Mr. Boechler holds a Bachelor of Arts in Business Administration from California State University, Long Beach. NuView's NV-VPAC1™ Liquid Biopsy Diagnostic Test clinical trial is planned to commence in early 2024 in Guadalajara and Mexico City with approval from Mexico's Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) anticipated in early 2025. Following approval from COFEPRIS, NuView plans to immediately request U.S. Food and Drug Administration (FDA) reciprocal recognition of NV-VPAC1™ Liquid Biopsy Diagnostic Test for commercial use in the United States. About NV-VPAC1™ NuView's technology, branded NV-VPAC1™, consists of a small molecule peptide construct that targets the vasoactive intestinal peptide receptor type 1 (VPAC1), a part of the G protein-coupled receptor family. The VPAC1 receptor becomes highly overexpressed on the cell surface of a variety of cancers including brain, breast, lung, bladder, prostate, cervical, and colon. Attaching a molecular imaging or therapeutic passenger to NV-VPAC1 enables NuView to develop a precisely targeted approach that has been used in clinical studies for the diagnosis and treatment of cancer. About NuView Life Sciences, Inc NuView Life Sciences, Inc. ("NuView") is a Park City, Utah-based, precision radiopharmaceutical company seeking to revolutionize the global oncology market with its novel targeted technology, NV-VPAC1™, a first-of-its-kind, binary diagnostic platform engineered to bind with over-expressed VPAC1 receptors on the surface of a variety of cancer cells at the onset of oncogenesis. NuView is leveraging its NV-VPAC1™ platform to advance a pipeline of precision in vitro laboratory diagnostics tests and in vivo cancer diagnostics and therapy delivery systems targeting multiple high-need, large-market indications, including prostate and bladder cancer. To learn more, visit . Forward Looking Statements This press release includes forward-looking statements including, but not limited to, statements related to the development of our technology, our operations and business strategy, our expected financial results, and corporate updates. The forward-looking statements contained in this press release are based on management's current expectations and are subject to substantial risks, uncertainty, and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to review or update any forward-looking statement except as may be required by applicable law. Contact Tiberend Strategic Advisors, Inc. Investors Daniel Kontoh-Boateng +1 862-213-1398 [email protected] Media Casey McDonald +1 646-577-8520 [email protected] Eric Reiss +1-802-249-1136 [email protected] SOURCE NuView Life Sciences