Regeneron and Vyriad to develop oncolytic virus therapies

Pharmaceutical Technology | November 07, 2019

Regeneron Pharmaceuticals has formed a five-year alliance with Vyriad for the development of oncolytic virus-based treatments for cancer. Under the research collaboration and option licensing agreement, a clinical trial is set to be initiated next year to assess Regeneron’s Libtayo (cemiplimab-rwlc) in combination with Vyriad’s Voyager-V1. The trial will enrol patients with various cancer types including lung, liver and endometrial cancers, as well as melanoma. Libtayo is a PD-1 inhibitor, while Voyager-V1 is an oncolytic virus. Regeneron invented Libtayo using its VelocImmune technology, which involves the use of a genetically-humanised mouse to generate fully-human antibodies. The drug is being developed in alliance with Sanofi. Vyriad programmed Voyager-V1 to selectively attack cancer cells and also stimulate the immune system to destroy local and distant cancer cells. The oncolytic virus also boosts inflammatory and antitumor immune system responses for turning ‘cold’ tumours ‘hot’, which is believed to improve anti-PD-1 activity.

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Vivera Partners with NINDS of NIH to Identify Potential Stuttering Treatments

Vivera Pharmaceuticals, Inc. | May 18, 2022

Vivera Biosciences, a division of Vivera Pharmaceuticals dedicated to the research and development of innovative medical technologies and pharmaceutical therapies, is pleased to announce its collaborative progress on a Cooperative Research and Development Agreement with the National Institute of Neurological Disorders and Stroke an Institute within the National Institutes of Health that aims to foster and advance cutting-edge neuroscience research to reduce the burden of neurological disease. The collaboration aims to identify therapeutic agents for the potential treatment of stuttering disorders, estimated to affect approximately 70 million people worldwide. Stuttering, also referred to as childhood-onset fluency disorder, is a neurological condition characterized by speech disfluencies, which can be disabling to patients affected. While there are currently no FDA-approved therapies for stuttering, in recent years, much has been discovered to understand the underlying neurological basis for the disorder. Scientists at Vivera and NINDS have discovered differences in the structure and function of the areas of the brain that regulate the timing and initiation of speech related to stuttering. These neurological revelations and the potential to develop related therapeutics inspired the partnership between Vivera and NINDS. The initiative is unique because of the individuals it will be led by: Vivera Biosciences' Investigator, Gerald A. Maguire, M.D., D.F.A.P.A., and NINDS' Principal Investigator, Shahriar SheikhBahaei, Ph.D. Both are persons who stutter and doctors who have dedicated their careers to understanding the disorder they share with millions of others and one they are working to develop novel treatments for. "I am grateful to the NIH, NINDS, and Vivera Biosciences for supporting this translational collaborative research with my friend and colleague, Dr. SheikhBahaei, as we potentially develop therapeutics to assist our stuttering community," said Dr. Maguire. Dr. Maguire is a world-renowned clinical researcher. He has over three decades of experience as an academic psychiatrist and has served as principal investigator for numerous studies involving investigational medications for various neuropsychiatric disorders, specializing in stuttering. "This collaboration may be an initial step toward developing novel and personalized therapeutic approaches for changing the course of the disorder for people who stutter," Dr. SheikhBahaei. Dr. SheikhBahaei's graduate studies focused on how astrocytic networks control activities of respiratory motor circuits within the brainstem. He currently leads the Neuron-Glia Signaling and Circuits Unit at NINDS, whose goal is to understand how different glial and neural cell types in the brain contribute to the neural circuits controlling voluntary speech production to enhance the ability to intervene in motor control disorders like stuttering. "Vivera is confident in our choice in partnership with NIH," said Vivera's Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A. "Since day one, Vivera has been dedicated to the research and development of patient-centric treatments," said Paul Edalat, CEO of Vivera. "This partnership with NIH and NINDS is about bettering the lives of people who stutter, further solidifying the Company's commitment to our mission." About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled electronic medical device. The Company has also received a Notice of Allowance for its portable telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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Orbit Discovery and WuXi AppTec Sign Agreement to Access Peptide Discovery and Optimisation Technologies

Orbit Discovery | March 08, 2022

Orbit Discovery a ground-breaking peptide discovery company is pleased to announce the commencement of a partnership with WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry. Orbit will combine its leading peptide discovery platform and experience with WuXi AppTec’s downstream capabilities. Specifically, Orbit gains access to WuXi AppTec’s expertise in peptide optimisation, peptide production and manufacturing to help its Partners obtain clinically relevant data packs and materials in a rapid timeframe. Orbit will also utilise other capabilities within WuXi AppTec, in particular their expertise in cell line and assay development and biophysical analysis. Incorporating these capabilities into the Orbit platform will enable functional assays to be developed against a wider range of targets, facilitating direct functional screens using novel bead-based technologies and microfluidics. This is the first strategic technology link Orbit has penned since its formation in 2016. The partnership underlines the commitment of the new management team to deliver ground-breaking technology and broader capabilities to the Partners engaged in applying the Company’s technology for the discovery of peptide therapeutic leads. “We aim to move Orbit to the forefront of peptide discovery, and relationships such as this help us leverage expertise that would take far longer to grow organically. We see the partnership with WuXi AppTec as being a key relationship and a great asset to our current Partners, and Partners of the future.” He added: “We see particular value in the development and manufacturing platform of WuXi AppTec, that will enable us to generate peptides at small or large scale that incorporate chemical modifications to facilitate peptide optimisations and the journey towards a therapeutic candidate.” Dr Neil Butt, Chief Executive Officer of Orbit Discovery

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TIKOMED and IQVIA announce a strategic collaboration for the development of TIKOMED's lead drug platform candidate ILB®

Tikomed | May 09, 2022

Swedish biopharmaceutical company TikoMed AB and IQVIA announce a key strategic collaboration with the aim to accelerate the development of TikoMed's lead drug platform candidate ILB®, a broad-spectrum small molecule drug candidate with curative potential in a wide range of diseases driven by acute and chronic inflammation. The collaboration will support TikoMed's clinical development, regulatory and commercial strategies. IQVIA brings together deep therapeutic expertise, unparalleled data, and technology alongside flexible operating models to enable biopharma organisations such as TikoMed to accelerate the clinical development and commercialisation of innovative products that improve patient lives. "We are thrilled to have IQVIA involved supporting TikoMed with the next steps in our journey to improve human life by enhancing the body's natural ability to self-repair and regenerate. With our highly scalable proprietary drug platform we aim to provide safe, effective and affordable therapies to as many patients as possible across the globe", CEO Anders Kristensson Fiona Stewart, Head of Strategic Alliance Management Europe from IQVIA said "We are delighted TikoMed has selected IQVIA to strategically collaborate in the development of ILB®. We look forward to leveraging our depth of experience to help accelerate the availability of these medicines to the patients who need them the most." TikoMed was advised by The Connecting Architects on this strategic collaboration. TikoMed AB TikoMed is committed to improve human life by exploring and harnessing the medical potential of the body's ability to self-repair and regenerate. With an adaptive, multi modal mechanism of action, TikoMed's drug platform rebalances the body's inflammatory, immune and fibrotic responses to acute and chronic inflammation in order to enhance self-repair and regeneration. Currently applied as a therapy in neurodegeneration and an enabling technology for advanced therapies, the initial development programs include ALS, TBI and islet cell transplantation. Broader use of the drug platform will be considered for a wider range of diseases using a creative business and financing model. TikoMed's highly scalable proprietary technology aims to provide safe, qualitative and affordable medicine to as many patients as possible across the globe. TikoMed is privately-owned and based in Viken, Sweden. IQVIA IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility - enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 79,000 employees, IQVIA conducts operations in more than 100 countries.

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PhaseBio Pharmaceuticals to Participate in the Cowen 42nd Annual Health Care Conference

PhaseBio Pharmaceuticals, Inc. | February 25, 2022

PhaseBio Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular diseases, today announced that Chief Executive Officer Jonathan P. Mow will participate in a panel discussion during Cowen’s 42nd Annual Health Care Conference taking place virtually on Tuesday, March 8, 2022 from 12:50 pm – 1:50 pm ET. Interested parties can access the live and archived webcasts of the virtual session on the “Events and Presentations” page of the “Investors” section of the company’s website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation. About PhaseBio PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. PhaseBio’s pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio’s proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacok

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It's clear that healthcare prices weigh heavily on the minds of Americans, and the time has come for the pharmaceutical industry to take the reins of the prescription drug pricing dialogue with consumers.

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