Biotechnology

NeuroPace Feasibility Study of Its RNS System for Lennox-Gastaut Syndrome Now Underway

12/09/2022

First patient receives brain-responsive neuromodulation for LGS, a severe and disabling childhood-onset epilepsy Excerpt from the Press Release: MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced that the first patient with Lennox-Gastaut Syndrome (LGS) was treated in its feasibility…

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Alector Presents Results from First-in-Human Phase 1 Study of AL101 for the Treatment of Neurodegenerative Diseases

12/09/2022

AL101 is being developed to elevate progranulin (PGRN) levels with dosing regimens to be optimized for larger indications such as Alzheimer’s disease Study results in healthy volunteers demonstrated that AL101 increased the level of PGRN, a key regulator of immune activity and lysosomal function in the brain Excerpt from the Press Release: SOUTH SAN FRANCISCO,…

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UroGen Announces New Data from the OLYMPUS Trial that Shows Median Durability of Response of 28.9 Months for JELMYTO®, the Only Non-Surgical, Chemoablative Treatment for Adults with Low-Grade Upper Tract Urothelial Cancer

12/06/2022

–Results from this ongoing, non-interventional, rollover study were presented at the 23rd Annual Society of Urologic Oncology (SUO) Meeting in San Diego Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today announced new data from the OLYMPUS…

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U.S. Food and Drug Administration approves CSL’s HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

12/01/2022

KING OF PRUSSIA, PA, USA This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion. Excerpt from the Press Release: This historic approval provides a new treatment option…

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Lineage Announces Launch of Phase 2a Study by Genentech of RG6501 (OpRegen®) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

11/29/2022

Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that its partner Genentech, a member of the Roche Group, has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), a…

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LianBio Doses First Patient in Phase 1 Trial of BBP-398 in Chinese Patients with Advanced Solid Tumors

11/21/2022

Excerpt from the Press Release: SHANGHAI, China and PRINCETON, N.J., Nov. 09, 2022 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, a SHP2 inhibitor,…

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ROME Therapeutics Demonstrates Efficacy of its Novel LINE-1 Reverse Transcriptase Inhibitor in Translational Models of Autoimmune Disease

11/18/2022

Company to share preclinical data from lead program in autoimmune disease at American College of Rheumatology (ACR) Convergence 2022 Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–ROME Therapeutics, a biotechnology company harnessing the power of the dark genome to develop breakthrough medicines for cancer and autoimmune diseases, today announced it will share preclinical data from its…

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Aura Announces Global Phase 3 Trial Design with Suprachoroidal Route of Administration Based on Positive Phase 2 Interim Data of Belzupacap Sarotalocan in Early-Stage Choroidal Melanoma

11/17/2022

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that it has initiated startup activities for the global Phase 3 trial. After presenting positive interim data at the American Academy of Ophthalmology from…

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Asher Bio Presents New Preclinical Data at SITC 2022 Further Supporting Advancement of AB248 and AB821 as Highly Differentiated Cis-targeted Cancer Immunotherapies

11/14/2022

— AB248 demonstrates non-clinical activity and safety profile suggesting its potential as a best-in-class IL-2 — — AB821 shows differentiated anti-tumor activity and enhanced bioavailability over wild type IL-21 — — On track to initiate Phase 1 trial of AB248 in 4Q 2022; Plan to file investigational new drug (IND) application for AB821 in 2H…

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Allogene Therapeutics Unveils Novel Approach to Generate Engineered AlloCAR T™ Cells to Control Immune Rejection at the Annual Meeting of the Society for Immunotherapy of Cancer

11/14/2022

Promising Preclinical Data Highlights a Simple One-Step Gene Editing Strategy to Prevent the Rejection of AlloCAR T™ Cells by Host T Cells and NK Cells Cloaking Approach Demonstrates Superiority to B2M Knock Out in a Syngeneic In Vivo Model Proprietary Approach Is One of Several Next Generation Technologies Being Pioneered at Allogene to Control Rejection Excerpt…

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