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Human Clinical Trial Articles & Analysis

97 news found

SOPHiA Genetics Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024

SOPHiA Genetics Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024

Together, SOPHiA GENETICS and Boundless Bio pioneered the ecDNA Solution (ECS) algorithm to detect the presence of ecDNA using routine clinical next-generation sequencing (NGS) data. ECS is the first ecDNA clinical trial assay and was designed by SOPHiA GENETICS in alignment with FDA guidelines as an Investigational Use Only ...

BySOPHiA Genetics


First-Ever Computationally Designed Antibody, Created by Biolojic Design, Entering Human Clinical Trial In Cancer Patients

First-Ever Computationally Designed Antibody, Created by Biolojic Design, Entering Human Clinical Trial In Cancer Patients

Biolojic uses its proprietary AI platform to design antibodies with new capabilities to cure disease, ushering in a new era of smart therapeutics Biolojic Tel Aviv to focus on computational design of antibodies; Boston location will focus on drug development Biolojic Design, a unique technology company pioneering computational design of human antibodies to develop smart ...

ByBiolojic Design, Ltd.


Viral Vector Manufacturing

Viral Vector Manufacturing

Viral vectors can be used for the treatment of various diseases such as: muscular, metabolic, hematologic, ophthalmologic, and infectious diseases as well as different types of cancer. An increasing number of clinical trials in the field of viral vector therapy and viral vector manufacturing, confirms the value of this new medicinal technology, and ...

ByNuvonis


Oligomerix Announces Issuance of Key U.S. Patent for Lead Tau-Targeting Candidate OLX-07010 to Treat Neurodegenerative Diseases

Oligomerix Announces Issuance of Key U.S. Patent for Lead Tau-Targeting Candidate OLX-07010 to Treat Neurodegenerative Diseases

” The ‘776 patent further strengthens the company’s intellectual property position and coverage for their tau oligomer formation inhibitors and provides product protection for Oligomerix’s lead clinical candidate, OLX-07010, including composition of matter and methods of use until October 2037. ...

ByOligomerix, Inc.


Cartherics granted first patent in China for multiple development candidates

Cartherics granted first patent in China for multiple development candidates

CTH-001 for the treatment of CTCL is the first product candidate progressing into human clinical trials. A second candidate, CTH-004, is being developed for the treatment of ovarian cancer. ...

ByCartherics Pty ltd


Eikonoklastes Therapeutics and Forge Biologics Announce Viral Vector Contract Development and AAV Manufacturing Partnership

Eikonoklastes Therapeutics and Forge Biologics Announce Viral Vector Contract Development and AAV Manufacturing Partnership

Eikonoklastes Therapeutics, a preclinical biotech company developing treatments for today’s most challenging diseases, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership that will advance Eikonoklastes’ AAV-based gene therapy, ET-101, into clinical trials for the ...

ByForge Biologics, Inc.


Peter MacCallum Cancer Centre and Cartherics Announce Collaboration to Develop Autologous CAR-T Cell Therapy for Cutaneous T-Cell Lymphoma

Peter MacCallum Cancer Centre and Cartherics Announce Collaboration to Develop Autologous CAR-T Cell Therapy for Cutaneous T-Cell Lymphoma

Professor Alan Trounson, CEO of Cartherics, said “We are excited to be working with a premier global cancer centre to advance CTH-001 into human clinical trials. We are very pleased to partner with Peter Mac’s Centre of Excellence in Cellular Immunotherapy, which was established in 2019 with backing from the Australian Federal ...

ByCartherics Pty ltd


Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update

Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update

Immune-Onc also announced successful completion of dose escalation in the first-in-human clinical trial (NCT05054348) of IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4), for the treatment of solid tumors. ...

ByImmune-Onc Therapeutics, Inc.


Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients with Krabbe Disease

Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients with Krabbe Disease

PT, in Carlsbad, CA Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Chief Medical Officer Maria Escolar, M.D, MS., will present updated clinical data from the RESKUE Phase 1/2 clinical trial for FBX-101—the Company’s novel gene therapy for the treatment of patients ...

ByForge Biologics, Inc.


Lumen Bioscience Announces Publication in NPJ Vaccines of Preclinical Data Demonstrating Needle Free, Spirulina-produced Vaccination Offering Protection Against Malaria

Lumen Bioscience Announces Publication in NPJ Vaccines of Preclinical Data Demonstrating Needle Free, Spirulina-produced Vaccination Offering Protection Against Malaria

Lumen Bioscience, a clinical-stage biotechnology company developing biologic drugs for highly prevalent diseases, today announced the publication of data demonstrating a needle-free, spirulina-produced recombinant vaccine that protects against malaria. ...

ByLumen Bioscience, Inc.


MediPrint™ Ophthalmics Announces Acceptance and Presentation of Poster at the Upcoming GSLS in Las Vegas

MediPrint™ Ophthalmics Announces Acceptance and Presentation of Poster at the Upcoming GSLS in Las Vegas

SAN DIEGO–(BUSINESS WIRE)–Today, MediPrint™ Ophthalmics, an emerging San Diego-based clinical stage eye care pharmaceutical company focused on helping protect sight, announces the acceptance and presentation of a poster highlighting its latest clinical results at the upcoming Global Specialty Lens Symposium (GSLS), a leading eye care conference. ...

ByMediprint Ophthalmics


Forge Reports Positive Clinical Data on Brain Development and Motor Function from the RESKUE Novel Phase 1/2 Gene Therapy Trial in Patients with Krabbe Disease at the SSIEM Annual Symposium

Forge Reports Positive Clinical Data on Brain Development and Motor Function from the RESKUE Novel Phase 1/2 Gene Therapy Trial in Patients with Krabbe Disease at the SSIEM Annual Symposium

The data will be presented on August 31, 2022, at the annual symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) in Freiburg, Germany. RESKUE is the first-in-human clinical trial where subjects are administered FBX-101, an Adeno-Associated Virus (AAV) systemic gene replacement strategy, after full myeloablation and ...

ByForge Biologics, Inc.


Eagle Pharmaceuticals Takes Equity Stake in, with Option to Acquire, Enalare Therapeutics to Advance Global Development of ENA-001, a Novel Agnostic Respiratory Stimulant

Eagle Pharmaceuticals Takes Equity Stake in, with Option to Acquire, Enalare Therapeutics to Advance Global Development of ENA-001, a Novel Agnostic Respiratory Stimulant

The investment consists of an upfront investment of $25 million, $12.5 million now and $12.5 to be paid in six months, and two potential follow-on equity investments of $15 million each contingent upon (i) the commencement of the ENA-001 Phase 2 clinical trial, and (ii) the ENA-001 Phase 2 clinical trial reaching 50% enrollment. ...

ByEnalare Therapeutics Inc.


N8 Medical Announces First-in-Human Use of its CeraShield™ Endotracheal Tube

N8 Medical Announces First-in-Human Use of its CeraShield™ Endotracheal Tube

N8 Medical, LLC (N8 Medical) today announced its first-in-human clinical trials of its flagship CeraShield™ endotracheal tube (CeraShield™ ETT) for intensive care unit patients expected to require mechanical ventilation for more than 48 hours. ...

ByN8 Medical, LLC


Procyrion Selects Former Abbott/St. Jude Medical Group President Dr. Eric S. Fain as CEO

Procyrion Selects Former Abbott/St. Jude Medical Group President Dr. Eric S. Fain as CEO

Fain to build upon the foundation of innovative technology established over recent years and accelerate the progression of product development leading to human clinical trials and commercialization of the company’s novel and proprietary heart pump. ...

ByProcyrion, Inc.


New Agreement Set to Scale Up Production of Hem A Gene Therapy

New Agreement Set to Scale Up Production of Hem A Gene Therapy

Food and Drug Administration (FDA) to launch the first-in-human clinical trial of ASC618. The study (NCT04676048) is expected to assess the one-time gene therapy’s safety and preliminary effectiveness in up to 12 adults with moderate to severe hemophilia A. ...

ByASC Therapeutics


Altimmune Announces Oral Presentation of Pemvidutide Clinical Data at Upcoming EASL International Liver Congress on June 25, 2022

Altimmune Announces Oral Presentation of Pemvidutide Clinical Data at Upcoming EASL International Liver Congress on June 25, 2022

Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that Dr. Stephen A. Harrison, Medical Director, Pinnacle Clinical Research, will present the results of Altimmune’s recently completed Phase 1, first-in-human clinical trial of pemvidutide in an oral presentation at ...

ByAltimmune Inc.


Titan Medical Appoints Bill Fahey as Vice President, Manufacturing and Operations

Titan Medical Appoints Bill Fahey as Vice President, Manufacturing and Operations

He will also be working closely with Titan’s product development and the quality and regulatory affairs teams as the company completes its Investigational Device Exemption (IDE) application and, following IDE approval, proceed to human clinical trials. “Bill brings the necessary skills, experience and energy to our Chapel Hill ...

ByConavi Medical Inc.


3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute Conduct Human Ear Reconstruction Using 3D-Bioprinted Living Tissue Implant in a First-in-Human Clinical Trial

3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute Conduct Human Ear Reconstruction Using 3D-Bioprinted Living Tissue Implant in a First-in-Human Clinical Trial

3DBio Therapeutics (3DBio), a clinical-stage regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute announced they have conducted a human ear reconstruction using the AuriNovo™ implant, an investigational, patient-matched, 3D-bioprinted living tissue ear implant. The groundbreaking reconstructive procedure in the ...

By3DBio Therapeutics


Carina Biotech appoints Cell Therapies to undertake manufacture of LGR5 CAR-T cells for clinical trial

Carina Biotech appoints Cell Therapies to undertake manufacture of LGR5 CAR-T cells for clinical trial

Highlights Melbourne-based contract development and manufacturing organisation Cell Therapies will manufacture Carina Biotech’s LGR5 CAR-T cells for a first-in-human clinical trial for patients with advanced colorectal (bowel) cancer. ...

ByCarina Biotech

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