Companies Archives - Page 3 of 67

AASLD 2024: Tune Therapeutics Shows Near-Complete HepB Virus Repression with Tune-401 Epigenetic Silencer

DURHAM, N.C. & SEATTLE--November 19, 2024--Leading epigenome editing company Tune Therapeutics showcased new data yesterday at the American Association for the Study of Liver Diseases (AASLD) conference, in support of its drive to develop a lasting, functional cure for chronic Hepatitis B Virus (HBV).

Tune unveiled its lead HBV program at the 2023 AASLD event with preclinical data showing strong and durable effect in targeted human hepatocytes. This year, Tune Therapeutics Principal Scientist Brian Cosgrove shared new in vitro and in vivo data, showcasing Tune’s clinically optimized liver-targeting LNP-RNA epi-silencing drug (Tune-401) – which enabled the near-complete repression of HBV RNA in human cells, and in a ‘true infection’ FRG mouse model.

Tune Therapeutics Moves into Clinical Spotlight with TUNE-401: A First-in-Class Epigenetic Silencer for Hepatitis B

DURHAM, N.C. & SEATTLE--November 14, 2024--Leading epigenome editing company Tune Therapeutics announced today that it has received clinical trial application (CTA) approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) to initiate a Phase 1b clinical trial for TUNE-401 – an investigational epigenetic silencing therapy designed to treat chronic Hepatitis B (HBV). With this approval, TUNE-401 is expected to be the first epigenetic therapy to enter the clinic for the treatment of a common and infectious disease.

Tune Therapeutics - 11/14/2024

Aura Biosciences Reports Multiple Clinical Complete Responses Demonstrated in Ongoing Phase 1 Trial

BOSTON, Oct. 17, 2024 -- Aura Biosciences, Inc. (NASDAQ: AURA), today announced positive early data from an ongoing Phase 1 clinical trial of bel-sar (AU-011) in patients with NMIBC. To date, the trial includes 13 patients, with the primary endpoints of evaluating the safety and feasibility of local administration of bel-sar alone (n=5) and bel-sar with light activation (n=8). The secondary endpoints are to evaluate biological activity and immune mediated changes in the tumor microenvironment (TME). 10 of 13 study participants had low grade disease, approximating the 70% incidence of this patient population among all NMIBC patients. The other 3 study participants had high grade disease. In patients receiving bel-sar with light activation (n=8), 4 out of 5 patients with low grade disease demonstrated a clinical complete response with no tumor cells remaining on histopathological evaluation. 2 out of 3 patients with high grade disease demonstrated visual tumor shrinkage observed on cystoscopy.

Aura - 10/18/2024

BioAtla and Context Therapeutics Announce Exclusive Worldwide License Agreement to Develop and Commercialize BA3362

SAN DIEGO and PHILADELPHIA, Sept. 23, 2024 -- BioAtla, Inc. (“BioAtla”) (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (“CAB”) antibody therapeutics for the treatment of solid tumors, and Context Therapeutics Inc. (“Context”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today announced that the companies have entered into an agreement under which Context has obtained from BioAtla an exclusive, worldwide license to develop, manufacture and commercialize BA3362, BioAtla’s Nectin-4 x CD3 TCE. Context will assume and fund all development and commercialization activities.

BioAtla - 09/23/2024

Glycomine Receives FDA Fast Track Designation for GLM101 for the Treatment of PMM2-CDG

SAN CARLOS, Calif.--September 18, 2024--Glycomine, Inc., a biotechnology company focused on developing new therapies for orphan diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLM101, a mannose-1-phosphate replacement therapy in development for the treatment of patients with phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG).

Glycomine - 09/18/2024

Aura Biosciences Reports Positive Phase 2 End of Study Results Evaluating Bel-sar as a First-Line Treatment for Early-Stage Choroidal Melanoma

BOSTON, Sept. 12, 2024 -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced positive Phase 2 end of study results evaluating bel-sar (AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a vision and life-threatening ocular cancer. The results were presented at The Retina Society Annual Meeting, on Thursday, September 12, 2024, in Lisbon, Portugal.

Aura - 09/12/2024

Sorriso Pharmaceuticals Completes Enrollment in Phase 1b Clinical Trial of Patients with Ulcerative Colitis

SALT LAKE CITY, UT, UNITED STATES, September 3, 2024 -- Sorriso Pharmaceuticals, a biopharmaceutical company developing novel oral antibodies for immune-mediated disease, today announced the completion of patient enrollment in its Phase 1b clinical trial evaluating the safety, tolerability, and preliminary efficacy of SOR102, a bispecific oral dual-acting biologic for the treatment of ulcerative colitis.

Sorriso Pharmaceuticals - 09/03/2024

EarthOptics, Pattern Ag Merge to Digitize Soil Health for Climate and Agriculture

ARLINGTON, VA and EMERYVILLE, CA – August 28, 2024 – EarthOptics and Pattern Ag have merged, creating a category leader in soil digitization to power advanced crop management and climate sustainability. The newly combined soil intelligence company will operate under the name EarthOptics and be the authoritative source of soil insights and the leader in Predictive Agronomy. Its comprehensive data will enable farmers and advisors to know their soil's exact physical, chemical, and biological properties, helping them plan their most impactful input and management decisions to maximize profitability and sustainability goals. The combination pairs Pattern Ag’s cutting-edge lab-based analysis with proprietary field-based sensing technologies from EarthOptics to create a high-resolution digital twin of the soil, giving farmers insights into pests and pathogens, biofertility, nutrients, soil compaction, carbon levels, moisture, and more.

EarthOptics - 08/28/2024

Veralox Therapeutics Announces EMA Orphan Drug Designation for VLX-1005

Frederick, MD., Aug. 14, 2024 -- Veralox Therapeutics, a clinical-stage biotechnology company developing first-in-class therapies targeting the 12-lipoxygenase (12-LOX) pathway, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to VLX-1005, a small molecule 12-LOX inhibitor for the treatment of platelet-activating anti-platelet factor 4 (PF4) disorders. VLX-1005 previously secured ODD from the U.S. Food and Drug Administration for prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia (HIT) as well as FDA Fast Track Designation. This latest decision in Europe represents another regulatory achievement and builds on the successful development of VLX-1005 that has progressed through completed Phase 1 clinical studies, and into the ongoing Phase 2 trial ALATHEA (“A study of VLX-1005 to evaluate thrombocyte change in HEpArin-induced thrombocytopenia”).

Veralox Therapeutics - 08/14/2024

Leriglitazone halts disease progression in adult patients with early cerebral adrenoleukodystrophy in compassionate-use study published in Brain

Mataró, Barcelona, Spain, 11 June, 2024 - Minoryx Therapeutics today announced that results from a compassionate use study of leriglitazone for treatment of progressive cerebral adrenoleukodystrophy (cALD) in adult male patients, published¹ in the peer-reviewed journal Brain.

Minoryx - 06/11/2024