Industry News

Omega Therapeutics Announces FDA Clearance of IND Application for OTX-2002, First Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma

07/21/2022

Represents First Ever Epigenomic Controller, a New Class of Programmable mRNA Therapeutics, to Receive IND Clearance Phase 1/2 Clinical Trial Expected to Launch in 2H’22 and Will Evaluate the Safety and Preliminary Antitumor Activity of OTX-2002 Excerpt from the Press Release: CAMBRIDGE, Mass., July 14, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), today announced that it has received…

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Health Canada Authorizes Moderna’s COVID-19 Vaccine in Young Children (6 Months-5 Years)

07/21/2022

Two-dose series takes one month to complete, with similar vaccine efficacy estimates against Omicron to those seen in adults Excerpt from the Press Release: CAMBRIDGE, MA / ACCESSWIRE / July 14, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has approved the use of…

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LG Chem Announces First Subject Enrolled in Phase 1 Clinical Trial of NASH New Drug

07/20/2022

CAMBRIDGE, Mass.–(BUSINESS WIRE)–LG Chem recently announced the enrollment of first subject in Phase 1 clinical trial of LG203003, LG Chem’s second NASH (non-alcoholic steatohepatitis) drug in development. Excerpt from the Press Release: LG203003 received clearance from the U.S. Food and Drug Administration (FDA) in March 2022 for the Company’s Investigational New Drug (IND) application to…

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Oncternal Therapeutics Announces Clinical Trial Collaboration to Advance Zilovertamab Phase 3 Study in combination with Ibrutinib for Patients with MCL

07/20/2022

Clinical trial collaboration supports global registrational Phase 3 study ZILO-301, to treat patients with relapsed or refractory MCL with zilovertamab plus ibrutinib Agreement is supportive of the planned initiation of ZILO-301 in Q3 2022 and will also supply ibrutinib for the open-label companion study ZILO-302 Excerpt from the Press Release: SAN DIEGO, July 14, 2022…

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Adverum Biotechnologies Presents Best-Corrected Visual Acuity and Central Subfield Thickness Analyses After a Single IVT Injection of ADVM-022 (Ixo-vec) in the OPTIC Study in Wet AMD

07/20/2022

– Study participants had an 81%-98% reduction in annualized anti-VEGF injections and demonstrated continuous aflibercept expression levels through three years – Mean best-corrected visual acuity and central subfield thickness were maintained or improved in subjects treated with ADVM-022 -The Phase 2 LUNA trial is expected to dose the first subject in the third quarter of…

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Annovis Bio Announces Positive FDA Notice For Buntanetap Phase 3 Clinical Trial In Parkinson’s Disease

07/19/2022

FDA indicates the Company may proceed with the Phase 3 clinical study of buntanetap for the treatment of Parkinson’s disease Excerpt from the Press Release: BERWYN, Pa., July 7, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the Company…

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Newly Released Clinical Data Demonstrates Substantial Improvement in Overall Health-Related Quality of Life in Patients with Painful Diabetic Neuropathy Treated with Nevro HFX Spinal Cord Stimulation Therapy

07/19/2022

High-Frequency 10 kHz Therapy Provided Substantial and Durable Pain Relief, Improved Health-Related Quality of Life, Better Sleep Quality and Neurologic Improvements Over 12 Months Excerpt from the Press Release: REDWOOD CITY, Calif., July 5, 2022 /PRNewswire/ — Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of…

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Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007

07/18/2022

Excerpt from the Press Release: SAN DIEGO and HONG KONG and SYDNEY, July 6, 2022 /PRNewswire/ — Inmagene Biopharmaceuticals (“Inmagene“) and HUTCHMED (China) Limited (“HUTCHMED“) (Nasdaq/AIM:HCM; HKEX:13) announces today that the first participant, based in Australia, was dosed in a global Phase I trial of IMG-007, an investigational OX40 antagonistic monoclonal antibody. The Phase I study…

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Elicio Therapeutics Presents Preclinical Data on its Lymph Node-Targeted SARS-CoV-2 Amphiphile Vaccine, ELI-005, at the 2022 Keystone Symposia on Viral Immunity: Basic Mechanisms and Therapeutic Applications

07/18/2022

The presented data show ELI-005 elicits strong and long-lasting cellular and humoral immune responses that were maintained at significantly higher levels than comparator vaccines over 32 weeks in mice. ELI-005, containing the lymph node-targeted Amphiphile vaccine adjuvant AMP-CpG, induced potent, comprehensive and persistent innate immune responses in draining lymph nodes in mice. Animals treated with…

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Homology Medicines Announces Peer-Reviewed Publication on Novel Discovery of AAVHSC with Robust Distribution to the Central Nervous System and Peripheral Organs with Low Affinity for the Liver

07/15/2022

AAVHSC16 Biodistribution Properties in Preclinical Models Demonstrated Potential for Systemic Delivery of Genetic Medicines to Brain, Heart and Muscle Excerpt from the Press Release: BEDFORD, Mass., July 05, 2022 (GLOBE NEWSWIRE) — Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today the peer-reviewed publication of data showing that AAVHSC16, one of the capsids…

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