Month: November 2021

Astria Therapeutics Presents New Preclinical Data Showing the Differentiated Profile of STAR-0215, in Development to Treat Hereditary Angioedema

11/11/2021

— STAR-0215 Demonstrates High Potency to Inhibit Plasma Kallikrein Preclinically — — Preclinical Data Show STAR-0215’s Extended Plasma Half-Life, Predicting Long Duration of Action — Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE), today presented new preclinical data that included demonstration of…

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MAGENTA THERAPEUTICS ANNOUNCES DATA PRESENTATIONS RELATED TO ITS MOBILIZATION AND CONDITIONING PROGRAMS AT THE 2021 AMERICAN SOCIETY OF HEMATOLOGY (ASH) ANNUAL MEETING

11/11/2021

— Positive topline clinical data from MGTA-145 investigator-initiated Phase 2 clinical trial in multiple myeloma — — Successful conditioning with monotherapy CD117 antibody drug conjugate in a primate model of transplant for gene therapy of sickle cell disease — — Successful conditioning with CD117 antibody drug conjugate in combination with lymphodepleting antibodies leading to effective…

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AC Immune Extends Research Collaboration with University of Pennsylvania Focusing on the Pathogenic Protein TDP-43, a Major Driver of Neurodegenerative Diseases

11/10/2021

Excerpt from the Press Release: LAUSANNE, Switzerland, Nov. 04, 2021 (GLOBE NEWSWIRE) — AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced it is extending its research partnership with leading scientists at the Center for Neurodegenerative Disease Research at the Perelman School of Medicine…

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Spirovant Presents Preclinical Data Showing SP-101 Restores CF Transmembrane Conductance Regulator Function at the 2021 North American Cystic Fibrosis Conference

11/10/2021

Excerpt from the Press Release: Philadelphia, PA, November 4, 2021 – Spirovant Sciences, a gene therapy company developing treatments and cures for inherited respiratory diseases including cystic fibrosis (CF), today presented SP-101, an investigational novel recombinant adeno-associated virus (AAV) gene therapy selected for its tropism to human airway epithelia, at the 2021 North American Cystic Fibrosis Conference (NACFC 2021).…

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Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years

11/10/2021

COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines,…

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Codexis and Nestlé Health Science Initiate a Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency

11/09/2021

Excerpt from the Press Release: REDWOOD CITY, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) — Codexis, Inc. (NASDAQ: CDXS), a leading protein engineering company and developer of novel biotherapeutics, and Nestlé Health Science, a globally recognized leader in the field of nutritional science, announced today the dosing of the first subject in a Phase 1 study…

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Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with Chemotherapy as First-Line Treatment for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

11/09/2021

Excerpt from the Press Release: SAN FRANCISCO and SUZHOU, China, Nov. 4, 2021 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application…

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Neurona Therapeutics Receives IND Clearance to Initiate Phase 1/2 Clinical Trial of Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients

11/09/2021

Excerpt from the Press Release: SAN FRANCISCO, Nov. 04, 2021 (GLOBE NEWSWIRE) — Neurona Therapeutics, a biotherapeutics company advancing restorative neural cell therapies for the treatment of chronic neurological disorders, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a first-in-human…

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ReCode Therapeutics Presents Preclinical Data from mRNA-based Cystic Fibrosis Program at 2021 North American Cystic Fibrosis Conference

11/08/2021

– Data show ability to rescue cystic fibrosis transmembrane conductance regulator (CFTR) function using proprietary lipid nanoparticle (LNP) platform to deliver optimized CFTR mRNA as an aerosol to patient-derived human bronchial epithelial cells – Optimized LNP formulation delivered mRNA to therapeutically relevant lung secretory and basal cells Excerpt from the Press Release: MENLO PARK, Calif. & DALLAS–(BUSINESS…

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Ambrx Biopharma Inc. Announces First Patient Dosed in its Global Phase 2 ACE-Breast-03 Clinical Study of ARX788 for the Treatment of HER2-Positive Metastatic Breast Cancer

11/08/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the first patient has been dosed in its global ACE-Breast-03 Phase 2 clinical study of ARX788 in patients with HER2-positive metastatic breast…

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