Biotechnology

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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Biophytis Reports Positive Post-hoc Analysis of The Phase 2-3 COVA Clinical Study Strongly Supporting Therapeutic Potential of Sarconeos (BIO101) In COVID-19

11/14/2022

A reduction in the risk of early death or respiratory failure at day 28 of 45% in the Intent-To-Treat (ITT) population and 53% in the Per Protocol (PP) population A reduction in the risk of death at day 90 of 43% in the ITT population and 70% in the PP population The start of regulatory…

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Adicet Bio Reports ASH Abstract Data from Ongoing ADI-001 Phase 1 Trial in Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL)

11/10/2022

As of the July 15, 2022 ASH abstract data-cut date, ADI-001 demonstrated a 78% overall and complete response rate and sustained durability in patients, including those previously exposed to CAR T therapy 100% ORR and CR rate in four anti-CD19 CAR T relapsed patients ADI-001 continued to demonstrate a favorable safety and tolerability profile Clinical…

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Rain Therapeutics Provides Interim Analysis of Phase 2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors (MANTRA-2)

11/07/2022

– Two patients exhibited an unconfirmed partial response at their first scan, and two additional patients saw promising tumor regression activity out of ten efficacy evaluable patients, demonstrating monotherapy activity of milademetan in MDM2-amplified patients – – Drug safety profile of milademetan preliminarily consistent with prior Phase 1 trial – – Protocol amendment planned to…

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