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News & Events

1 07, 2023

Assessing the Interchangeability of AVT02 and Humira((R)) in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study

2023-07-01T00:00:00+00:00

BACKGROUND: The US Food and Drug Administration (FDA) interchangeability guidelines state that the primary endpoint in a switching study should assess the impact of switching between the proposed interchangeable product and the reference product on clinical pharmacokinetics (PK) and pharmacodynamics (if available), as these assessments are generally sensitive to changes in immunogenicity and/or exposure that [...]

Assessing the Interchangeability of AVT02 and Humira((R)) in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study2023-07-01T00:00:00+00:00
29 06, 2023

Immunogenicity, efficacy, and safety of CoronaVac and Pfizer/BioNTech mRNA vaccines in patients with psoriasis receiving systemic therapies: A prospective cohort study

2023-06-29T00:00:00+00:00

BACKGROUND AND OBJECTIVES: Evidence of immune response to COVID-19 vaccine in psoriasis patients on biological agents is lacking. This study aimed to evaluate SARS-CoV-2 antibody levels following vaccination with CoronaVac or Pfizer/BioNTech mRNA in patients using biological agents or methotrexate, high-titer antibody levels achievement rate, and impact of medications on immunogenicity. METHODS: This noninterventional, prospective [...]

Immunogenicity, efficacy, and safety of CoronaVac and Pfizer/BioNTech mRNA vaccines in patients with psoriasis receiving systemic therapies: A prospective cohort study2023-06-29T00:00:00+00:00
27 06, 2023

A historic first for gene therapy

2025-10-06T21:50:12+00:00

Sarepta Therapeutics announces FDA approval of ELEVIDYS, the first gene therapy to treat Duchenne Muscular Dystrophy. ELEVIDYS addresses the root genetic cause of Duchenne – mutations in the dystrophin gene that result in the lack of dystrophin protein – by delivering a gene that codes for a shortened form of dystrophin to muscle cells known as ELEVIDYS micro-dystrophin...

A historic first for gene therapy2025-10-06T21:50:12+00:00
13 06, 2023

2seventy bio presents broad range of new data highlighting novel approaches across its cell therapies portfolio

2025-06-24T13:49:48+00:00

2seventy bio announced new data featuring novel approaches combining the company’s platform CAR T cell and T cell receptor technology and unique cell therapy engineering capabilities to potentially enhance treatment potency in a range of cancers...

2seventy bio presents broad range of new data highlighting novel approaches across its cell therapies portfolio2025-06-24T13:49:48+00:00
2 06, 2023

Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development

2023-06-02T00:00:00+00:00

A survey conducted by the Therapeutic Product Immunogenicity (TPI) community within the American Association of Pharmaceutical Scientists (AAPS) posed questions to the participants on their immunogenicity risk assessment strategies prior to clinical development. The survey was conducted in 2 phases spanning 5 years, and queried information about in silico algorithms and in vitro assay formats [...]

Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development2023-06-02T00:00:00+00:00
1 06, 2023

Synthesis of plant-based, self-adjuvanted, dual antigen specific to Mycobacterium tuberculosis as a novel tuberculosis subunit vaccine that elicits immunogenicity in rabbit

2023-06-01T00:00:00+00:00

OBJECTIVES: The only approved vaccine, Bacillus Calmette Guerin (BCG) used in global tuberculosis (TB) immunization programmes has been very effective in childhood TB but not in adult pulmonary and latent TB. Moreover, the emergence of multi-drug resistance-TB cases demands either to increase efficiency of BCG or replace it with the one with improved efficacy. RESULTS: [...]

Synthesis of plant-based, self-adjuvanted, dual antigen specific to Mycobacterium tuberculosis as a novel tuberculosis subunit vaccine that elicits immunogenicity in rabbit2023-06-01T00:00:00+00:00
31 05, 2023

Cell Therapy Potency Assay Summit – 2023

2025-10-06T21:48:23+00:00

Ensure the Success of Your Cell Therapy Drug Development - Avance Provides Assays to Support your Biopharmaceutical Development & Manufacturing - Avance Biosciences™ is a world-leading CRO specializing in GLP & GMP compliant biological assay development, assay validation, and [...]

Cell Therapy Potency Assay Summit – 20232025-10-06T21:48:23+00:00
16 05, 2023

New preclinical data from Sana Biotechnology highlights the potential of CAR T cell therapy

2025-10-06T21:48:23+00:00

Preclinical data demonstrates that hypoimmune-modified allogeneic iPSCs evade immune response and rejection without immunosuppression in a non-human primate model and long-term survival and immune evasion was at least equivalent to the survival of autologous iPSCs...

New preclinical data from Sana Biotechnology highlights the potential of CAR T cell therapy2025-10-06T21:48:23+00:00
9 05, 2023

NGS for ID and characterization of AAV genomes

2025-06-24T14:00:41+00:00

Adeno-associated virus (AAV) is a small, non-pathogenic, and non-enveloped virus that has become an important tool for gene therapy research and applications. AAV is a type of virus that requires a helper virus (such as adenovirus) to replicate, and it has a high degree of stability and safety, as it does not...

NGS for ID and characterization of AAV genomes2025-06-24T14:00:41+00:00
1 05, 2023

Safety, Pharmacokinetics, Serum Neutralizing Titers, and Immunogenicity of Adintrevimab, a Monoclonal Antibody Targeting SARS-CoV-2: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Dose-escalation Study in Healthy Adults

2023-05-01T00:00:00+00:00

INTRODUCTION: Adintrevimab is a fully human immunoglobulin G1 extended half-life monoclonal antibody that was developed to have broad neutralization against SARS-CoV, SARS-CoV-2, and other SARS-like CoVs with pandemic potential. Here we report the safety, pharmacokinetics (PK), serum viral neutralizing antibody (sVNA) titers, and immunogenicity results of the first three cohorts evaluated in the first-in-human study [...]

Safety, Pharmacokinetics, Serum Neutralizing Titers, and Immunogenicity of Adintrevimab, a Monoclonal Antibody Targeting SARS-CoV-2: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Dose-escalation Study in Healthy Adults2023-05-01T00:00:00+00:00
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