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Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

XTalks

When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. A blood test can detect antibodies to gluten, but a definitive diagnosis requires a biopsy of the small intestine.

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Biologic CAR T cell engager approved for UK clinical trial

Drug Discovery World

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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The ABCs of Transitioning PK Assays from Preclinical to Clinical

Worldwide Clinical Trials

Preclinical assays designed to assess drug toxicity and safety must detect total drug. For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), anti-human IgG).

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AI-designed monoclonal antibody ‘redirects’ the immune system

Drug Discovery World

Immuno-oncology company Aulos Bioscience has revealed interim results from an ongoing Phase I/II trial of monoclonal antibody AU-007 in solid tumours. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumours. “In

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This week in drug discovery (21-25 August)  

Drug Discovery World

The headline news this week reflects the high level of interest and investment in neuroscience drug discovery, particularly neurodegenerative diseases like Alzheimer’s; including positive clinical trial results for new immunotherapy and biotherapeutic candidates, and hopes that existing medications could slow the progression of dementia.

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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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ASP-2138 by Xencor for Metastatic Adenocarcinoma of The Pancreas: Likelihood of Approval

Pharmaceutical Technology

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. According to GlobalData, Phase I drugs for Metastatic Adenocarcinoma of The Pancreas have an 88% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. Buy the report here.

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