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Experimental malaria monoclonal antibody prevents infection

Drug Discovery World

A single injection of an experimental monoclonal antibody called L9LS was 77% effective at preventing malaria infection in children in Mali, according to the results of a mid-stage clinical trial. The antibody was modified with a mutation that prolonged its durability in the bloodstream following administration.

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Astellas' gastric cancer candidate rejected by FDA because of manufacturing issues

Fierce Pharma

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

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Phase I clinical trial for first-in-class bispecific antibody for cancer treatment 

Drug Discovery World

Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress. manufacture, preclinical pharmacology and toxicology studies, as well as clinical development and regulatory application of OT-A201 rapidly and efficiently.

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Machine learning: A useful tool in the development of next generation antibody therapeutics

Drug Discovery World

Ben Holland , CTO and Co-Founder of Antiverse discusses how artificial intelligence and machine learning are benefitting antibody discovery and design. Modern experimental procedures, such as immunisation, B-cell screening, and synthetic library generation, have been pivotal in developing approximately 80 FDA-approved antibody therapeutics.

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Manufacturing challenges set back development progress of cell therapies in oncology

Pharmaceutical Technology

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. DELTA-1 is a Phase II single-arm trial in metastatic melanoma, evaluating the efficacy of ITIL-168 in patients who have progressed on previous therapy.

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Cancer Research UK and UCB advance oncology antibody candidates

Drug Discovery World

Cancer Research UK and UCB have agreed a clinical development collaboration to advance two of UCB’s investigational oncology antibody candidates through clinical trials. If successful in clinical trials the investigational candidates may have the potential to offer cancer patients access to new targeted treatment options.

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). SK Biotek is contracted to manufacture the small molecule API.