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COVID-19 Vaccine Developed by Clover Biopharmaceuticals Using Dynavax’s CpG 1018 Adjuvant Meets Primary and Secondary Efficacy Endpoints in Global Phase 2/3 Trial

10/01/2021

– Global Phase 2/3 SPECTRA Trial enrolled over 30,000 adult and elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants– 100% efficacy against severe COVID-19 and hospitalizations, and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2– Favorable safety profile; no significant differences in systemic adverse events…

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Interim Results From Phase 1/2 Clinical Trial in Solid Tumor Cancers Demonstrate Aulos Bioscience’s AU-007 is Well Tolerated and Uniquely Reduces Regulatory T Cells

05/31/2023

New data in ASCO 2023 abstract show continued trend in decreasing Tregs and eosinophils, bolstering novel mechanism of action of AU-007, Aulos’ computationally designed antibody in the IL-2 class Initial anti-tumor activity has been observed since the ASCO data cutoff date, with additional data anticipated by year-end as the Phase 1/2 trial continues to enroll…

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Scipher Medicine Acquires CrossBridge and its SaaS Platform to Collect and Map Patient Molecular, Outcomes and Claims Data in Real Time

01/26/2023

First-of-its-kind technology stack in autoimmune diseases. Provides unprecedented insights into optimal patient treatment pathway. Excerpt from the Press Release: WALTHAM, Mass. (January 10, 2023) – ScipherMedicine, a precision immunology company matching each patient with their most effective therapy, has acquired Philadelphia-based data, analytics, and software company CrossBridge to bolster its data and analytics capabilities. The…

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VBI Vaccines Announces New Preclinical Data and Initiation of VBI-2905 Clinical Study Targeting Broadened Immunity Against COVID-19 and Variants of Concern

10/04/2021

New preclinical data demonstrate VBI-2905 induced robust neutralizing and antibody binding activity, as a 2-dose course and as a single booster dose, against COVID-19 and variants of concern including Beta and Delta– Data also demonstrate trivalent VBI-2901 induced robust and consistent levels of immunity against the ancestral COVID-19 strain and a panel of variants including…

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Q32 Bio Presents New Preclinical Data at the International Society of Nephrology Frontiers Meeting Demonstrating the Therapeutic Potential of ADX-097

07/01/2022

Data show that C3d-mediated tissue targeting of factor H results in potent, durable and efficacious local complement blockade without systemic complement inhibition Excerpt from the Press Release: WALTHAM, Mass., June 23, 2022 /PRNewswire/ — Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, today announced that the Company presented new preclinical data…

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Selva to Present Preclinical Data at ASV 2021 Demonstrating Prophylactic and Therapeutic Oral Dosing of SLV213 for COVID-19 Protected Lungs from SARS-CoV-2-Induced Damage

07/28/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Selva Therapeutics, Inc. (“Selva”) announced new preclinical data demonstrating SLV213, when given as a prophylactic or a treatment for SARS-CoV-2 infection, protects against SARS-CoV-2-induced diffuse alveolar damage (DAD), which is associated with the early stages of acute respiratory distress syndrome (ARDS). Additional in vitro data show that SLV213 greatly enhances the…

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Anokion Announces Presentation of Data from Phase 1 ACeD Clinical Trial Evaluating KAN-101 as a Treatment for Celiac Disease at the 19th International Celiac Disease Symposium

10/28/2022

Positive Phase 1 Data Support Near-term Initiation of Global Phase 2 Trial Excerpt from the Press Release: CAMBRIDGE, Mass. & LAUSANNE, Switzerland–(BUSINESS WIRE)–Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today announced that data from the Phase 1 ACeD (Assessment of KAN-101 in Celiac Disease) clinical trial…

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Aileron Therapeutics Announces Positive Data from Cohort 1 of the Phase 1b Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis (IPF)

05/08/2024

Low-dose LTI-03 (2.5 mg BID), a Caveolin-1 related peptide, reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts and increased the expression of a biomarker indicative of epithelial health, suggesting potential therapeutic effect Positive trend was observed in seven of eight IPF biomarkers evaluated Low-dose LTI-03 was well-tolerated, with no safety…

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Arcturus Reports Durability Data Against Omicron Variants, Including BA.5, at Six-Month Timepoint Following Booster with ARCT-154 COVID-19 Vaccine

08/25/2022

New clinical data demonstrate high and sustained geometric mean fold rises (GMFR) in neutralizing antibodies against all evaluated Omicron variants Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, “Arcturus Therapeutics”, Nasdaq: ARCT), a global, late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and…

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Ask Us Anything In Clinical Trials – Data Management Tools We Love and Hate To Use

09/20/2020

Our third episode in the Ask Us Anything In Clinical Trials virtual networking series. Heather and Christopher along with their guests dive into a discussion around the Data Management tools we love and hate to use, as well as how data management is changing under the evolving conditions brought on by the pandemic. If you…

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