News & Events

21 02, 2023

Weill Cornell study demonstrates safety of intravenous administration of an AAV8 gene therapy

2025-10-06T21:50:14+00:00

Researchers report on the safety of a gene therapy to treat the common autosomal recessive hereditary disorder alpha 1-antitrypsin (AAT) deficiency in a new article in the peer-reviewed journal Human Gene Therapy. In ATT deficiency, neutrophil proteases destroy the lung parenchyma, the portion of the lungs...

Weill Cornell study demonstrates safety of intravenous administration of an AAV8 gene therapy2025-10-06T21:50:14+00:00
14 02, 2023

mRNA Analytical Development Summit – 2023

2025-06-24T14:26:29+00:00

With several years of experience supporting a world-renowned mRNA COVID-19 vaccine company with raw material and drug substance release, Avance Biosciences™ is well-positioned to provide industry-leading assay design, validation, and sample testing services that advance our clients’ mRNA therapeutic...

mRNA Analytical Development Summit – 20232025-06-24T14:26:29+00:00
7 02, 2023

FDA clears Sana Biotechnology’s CAR T Therapy IND application for patients with B-cell malignancies

2025-10-06T21:48:29+00:00

The goal of the hypoimmune platform is to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune platform includes disruption of major...

FDA clears Sana Biotechnology’s CAR T Therapy IND application for patients with B-cell malignancies2025-10-06T21:48:29+00:00
17 01, 2023

Scientists develop novel mRNA delivery method using extracellular vesicles

2025-06-24T13:58:50+00:00

In the study, published in Nature Biomedical Engineering, researchers from MD Anderson Cancer Center use EV-encapsulated mRNA to initiate and sustain collagen production for several months in the cells of photoaged skin in laboratory models. It is the first therapy to demonstrate this ability and represents a proof-of-concept for deploying the EV mRNA therapy...

Scientists develop novel mRNA delivery method using extracellular vesicles2025-06-24T13:58:50+00:00
1 01, 2023

Randomized, Double-Blind, Placebo-Controlled, Phase I, Dose- Escalation Study to Evaluate the Tolerance, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PEGylated Urate Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers: Study Protocol

2023-01-01T00:00:00+00:00

INTRODUCTION: Hyperuricemia is a disease with abnormal purine metabolism, which leads to the increase of urate concentration. It is an independent risk factor for the occurrence and development of metabolic syndrome, type 2 diabetes, hypertension, cardiovascular disease, chronic kidney disease, and gout. The enzyme urate oxidase can metabolize urate to allantoin, resulting in decreased urate [...]

Randomized, Double-Blind, Placebo-Controlled, Phase I, Dose- Escalation Study to Evaluate the Tolerance, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PEGylated Urate Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers: Study Protocol2023-01-01T00:00:00+00:00
1 01, 2023

Understanding preclinical and clinical immunogenicity risks in novel biotherapeutics development

2023-01-01T00:00:00+00:00

Immunogenicity continues to pose a challenge in the development of biotherapeutics like conventional therapeutic-proteins and monoclonal antibodies as well as emerging modalities such as gene-therapy components, gene editing, and CAR T cells. The approval of any therapeutic is based on a benefit-risk evaluation. Most biotherapeutics address serious medical conditions where the standard of care has [...]

Understanding preclinical and clinical immunogenicity risks in novel biotherapeutics development2023-01-01T00:00:00+00:00
1 01, 2023

Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy

2023-01-01T00:00:00+00:00

INTRODUCTION: In oncology, anti-drug antibody (ADA) development that significantly curtails response durability has not historically risen to a level of concern. The relevance and attention ascribed to ADAs in oncology clinical studies have therefore been limited, and the extant literature on this subject scarce. In recent years, T cell engagers have gained preeminence within the [...]

Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy2023-01-01T00:00:00+00:00
1 01, 2023

Tumor cell cytoplasmic metallothionein expression associates with differential tumor immunogenicity and prognostic outcome in high-grade serous ovarian carcinoma

2023-01-01T00:00:00+00:00

BACKGROUND: The underlying mechanism of high T-cell presence as a favorable prognostic factor in high-grade serous ovarian carcinoma (HGSOC) is not yet understood. In addition to immune cells, various cofactors are essential for immune processes. One of those are metallothioneins (MTs), metal-binding proteins comprising various isoforms. MTs play a role in tumor development and drug [...]

Tumor cell cytoplasmic metallothionein expression associates with differential tumor immunogenicity and prognostic outcome in high-grade serous ovarian carcinoma2023-01-01T00:00:00+00:00
1 01, 2023

Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study

2023-01-01T00:00:00+00:00

Objective: The pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) still protracts worldwide. HFB30132A is an anti- SARS-CoV-2 monoclonal antibody purposely engineered for an extended half-life with neutralizing activity against majority of the virus variants identified so far. The aim of this study was to evaluate the safety, tolerability, [...]

Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study2023-01-01T00:00:00+00:00
1 01, 2023

Development of a semi-automated MHC-associated peptide proteomics (MAPPs) method using streptavidin bead-based immunoaffinity capture and nano LC-MS/MS to support immunogenicity risk assessment in drug development

2023-01-01T00:00:00+00:00

Major histocompatibility complex (MHC)-Associated Peptide Proteomics (MAPPs) is an ex vivo method used to assess the immunogenicity risk of biotherapeutics. MAPPs can identify potential T-cell epitopes within the biotherapeutic molecule. Using adalimumab treated human monocyte derived dendritic cells (DCs) and a pan anti-HLA-DR antibody (Ab), we systematically automated and optimized biotin/streptavidin (SA)-capture antibody coupling, lysate [...]

Development of a semi-automated MHC-associated peptide proteomics (MAPPs) method using streptavidin bead-based immunoaffinity capture and nano LC-MS/MS to support immunogenicity risk assessment in drug development2023-01-01T00:00:00+00:00
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