Month: November 2022

4D Molecular Therapeutics Announces Interim Clinical Data from Phase 1/2 Clinical Trial of 4D-710 for Cystic Fibrosis Lung Disease at NACFC 2022

11/10/2022

Cohort 1 lung bronchoscopy sample results demonstrate widespread delivery and expression of the 4D-710 CFTR∆R transgene in 100% of samples from all three patients Cohort 1 safety and tolerability of 4D-710 demonstrated to date, with no drug-related adverse events following aerosol delivery Cohort 1 enrollment completed; Cohort 2 enrollment on-going Conference call & webcast to…

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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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TRANSPLANT GENOMICS PRESENTS TRUGRAF® LIVER AT THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES

11/10/2022

TruGraf® Liver is a novel gene expression biomarker diagnostic test used to confirm immune quiescence and rule out organ rejection for liver transplant recipients. Excerpt from the Press Release: FRAMINGHAM, Mass., Nov. 3, 2022 /PRNewswire/ — Transplant Genomics (“TGI”), the transplant rejection diagnostics company committed to improving organ transplant outcomes worldwide, will be attending The…

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Kira Pharmaceuticals Presents Complete Data from Phase 1 SYNERGY-1 Trial of KP104 at American Society for Nephrology Kidney Week 2022

11/09/2022

Biomarker data demonstrates proof-of-concept for KP104’s dual-targeting mechanism via dose-dependent inhibition of alternative and terminal pathways and supports intravenous and subcutaneous administration of KP104 in phase 2 studies Excerpt from the Press Release: CAMBRIDGE, Mass., Nov. 3, 2022 /PRNewswire/ — Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, today presented…

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Ardelyx Presents New Data Analyses at Kidney Week 2022, Further Supporting the Clinical Relevance of XPHOZAH® (tenapanor), an Investigational, Phosphate Absorption Inhibitor to Control Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

11/09/2022

XPHOZAH monotherapy lowers serum phosphorus with early responders maintaining response with continued treatment XPHOZAH monotherapy meaningfully reduced serum phosphorus in patients with severe hyperphosphatemia XPHOZAH in combination with phosphate binders reduced patients’ interdialytic weight gain compared to binders alone Excerpt from the Press Release: WALTHAM, Mass., Nov. 3, 2022 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a…

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Ocelot Bio Presents Phase 1 Data Highlighting Activity and Safety of OCE-205 at AASLD The Liver Meeting®

11/09/2022

In healthy volunteers, OCE-205 administration led to increases in mean arterial pressure with promising safety profile Study findings support clinical program for OCE-205 in End-Stage Liver Disease focused on treating consequences associated with complications of portal hypertension, such as HRS-AKI and ascites Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Ocelot Bio, Inc., a clinical-stage biopharmaceutical…

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Inozyme Pharma Announces First Self-Administration of INZ-701 in Ongoing ENPP1 Deficiency Phase 1/2 Clinical Trial

11/08/2022

Excerpt from the Press Release: BOSTON, Nov. 03, 2022 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced the first self-administration of INZ-701 in the open-label Phase 2 extension portion of the ongoing Phase 1/2 clinical…

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Hologic’s 3Dimensions™ System for 3D Mammography Receives EUREF Type Test Certification

11/08/2022

3Dimensions System Earns Distinction for Meeting or Exceeding Rigorous European Image Quality and Dose Standards Excerpt from the Press Release: MARLBOROUGH, Mass.–(BUSINESS WIRE)–Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that its 3Dimensions™ mammography system was awarded EUREF Type Test certification by the European Reference Organisation for Quality Assured Breast Screening…

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Miraculous breast cancer vaccine passes first human trials that went on for 20 years

11/08/2022

Excerpt from the Press Release: A team of researchers at the University of Washington School of Medicine (UWSM) has been working on a breast cancer vaccine for over the last 20 years. In their recently published study, they finally revealed the results of the phase one human trials of their breast cancer vaccine. A WHO…

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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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