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News & Events

1 09, 2023

Impact of methotrexate treatment on vaccines immunogenicity in adult rheumatological patients – Lessons learned from the COVID-19 pandemic

2023-09-01T00:00:00+00:00

Despite the development of new biological and synthetic targeted therapies, methotrexate remains one of the most commonly used immunomodulatory drugs in rheumatology. However, its effect on the immunogenicity of vaccines has been studied only to a limited extent until recently, resulting in the lack of clear guidelines on the use of methotrexate during vaccination. Significant [...]

Impact of methotrexate treatment on vaccines immunogenicity in adult rheumatological patients – Lessons learned from the COVID-19 pandemic2023-09-01T00:00:00+00:00
29 08, 2023

Gene Therapy Potency Assay Summit – 2023

2025-10-06T21:50:11+00:00

We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated Gene Therapy Potency Assay Summit, and we cordially invite you to join us! As a leader in advanced therapies, we understand the importance of staying at the forefront of gene therapy innovation...

Gene Therapy Potency Assay Summit – 20232025-10-06T21:50:11+00:00
29 08, 2023

FDA issues new draft guidelines on cell and gene therapy manufacturing changes

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

Specifically, the guidance recommends conducting analytical comparability studies to provide scientific evidence of the impact that manufacturing changes may have on the safety, potency, and purity of human cellular and gene therapy products...

FDA issues new draft guidelines on cell and gene therapy manufacturing changes2025-10-06T21:50:12+00:00
23 08, 2023

First IND clearance for an allogeneic, off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease

2025-10-06T21:48:22+00:00

Artiva Biotherapeutics announced today that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application for AlloNK®, in combination with rituximab for treatment of systemic lupus erythematosus in patients with active lupus nephritis...

First IND clearance for an allogeneic, off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease2025-10-06T21:48:22+00:00
15 08, 2023

Study shows promise of gene therapy for alcohol use disorder

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

A form of gene therapy currently used to treat Parkinson’s disease may dramatically reduce alcohol use among chronic heavy drinkers, researchers at Oregon Health & Science University and institutions across the country have found...

Study shows promise of gene therapy for alcohol use disorder2025-10-06T21:50:12+00:00
8 08, 2023

Study reveals new way to reduce friendly fire in cell therapy

2025-10-06T21:48:22+00:00

In a promising form of immunotherapy known as CAR T-cell (chimeric antigen receptor) therapy, the patient’s T cells are engineered to better recognize and attack antigens on the surface of cancer cells. In treatments currently approved for use in battling lymphoma and leukemia...

Study reveals new way to reduce friendly fire in cell therapy2025-10-06T21:48:22+00:00
18 07, 2023

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

2025-10-06T21:48:28+00:00

The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current...

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes2025-10-06T21:48:28+00:00
11 07, 2023

Enhancing Safety and Efficacy – Biodistribution Services for Advanced Cell and Gene Therapies

2025-06-24T14:33:19+00:00

As the field of advanced cell and gene therapies continues to grow exponentially, ensuring their safety and efficacy becomes paramount. Biodistribution studies, which evaluate the distribution of viral vectors and transgenes in the body, play a crucial role in pre-clinical pharmacokinetics and toxicity assessments...

Enhancing Safety and Efficacy – Biodistribution Services for Advanced Cell and Gene Therapies2025-06-24T14:33:19+00:00
1 07, 2023

Immunogenicity, safety, and efficacy of rurioctocog alfa pegol in previously untreated patients with severe hemophilia A: interim results from a phase 3, prospective, multicenter, open-label study

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

AIM: To determine the immunogenicity, safety, and efficacy of rurioctocog alfa pegol in previously untreated patients (PUPs) with severe hemophilia A (HA). METHODS: This prospective, phase 3 study (NCT02615691) was conducted in PUPs, or patients with /=1 dose of rurioctocog alfa pegol; 54 received prophylaxis, and 35 on-demand treatment. Incidence of inhibitor development was 0.19 [...]

Immunogenicity, safety, and efficacy of rurioctocog alfa pegol in previously untreated patients with severe hemophilia A: interim results from a phase 3, prospective, multicenter, open-label study2023-07-01T00:00:00+00:00
1 07, 2023

ALK peptide vaccination restores the immunogenicity of ALK-rearranged non-small cell lung cancer

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

Anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) is treated with ALK tyrosine kinase inhibitors (TKIs), but the lack of activity of immune checkpoint inhibitors (ICIs) is poorly understood. Here, we identified immunogenic ALK peptides to show that ICIs induced rejection of ALK(+) tumors in the flank but not in the lung. A single-peptide [...]

ALK peptide vaccination restores the immunogenicity of ALK-rearranged non-small cell lung cancer2023-07-01T00:00:00+00:00
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