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Samsung Biologics and AstraZeneca Enter Into A $331 Million Supply Deal.

AstraZeneca has recently signed a $331 million supply agreement with Samsung Biologics. Under the agreement, Samsung is to produce bulk drug substances at its CMO Plant 3 facility in Incheon, South Korea. 

The deal can be expanded to $546 million and is expected to last for several years. No other details were presented. 

This new agreement aligns with Samsung’s expansion plans. Just in August, Samsung laid out plans for the ambitious facility, which would encompass 256 million square feet of floor space and 256,000 liters of capacity. The plant is expected to be operable by 2022.

(Source: Fierce Pharma, 2020)

Celltrion begins Phase II/III clinical trials of anti-COVID-19 mAb treatment candidate

Celltrion has recently announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved its Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody (mAb) treatment candidate.

The clinical trial will evaluate the efficacy and safety of CT-P59 in patients with mild-to-moderate symptoms of SARS-CoV-2 infection. Celltrion is expected to receive a summary of the primary results for Phase II of the study by the end of the year.

Celltrion has also submitted the IND application in 5 different countries including and plans to enroll more than 1,000 patients from up to 12 countries. The company expects to be able to apply for emergency use authorization (EUA), based on the results of the clinical trials.

Celltrion has begun manufacturing the process validation batch of CT-P59 and plans to increase manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate.

(Source: BioSpectrum Asia, 2020)

Lupus mAb Targeting Plasma Cells Treatment Shows Hopeful Results in Patients.

A team of scientists from Charité-Universitätsmedizin Berlin and the Deutsches Rheuma-Forschungszentrum (DRFZ) Berlin, reports that they have successfully treated two patients with the autoimmune disease systemic lupus erythematosus (SLE).

They use daratumumab, a monoclonal antibody (mAb) targeting specific immune cells known as plasma cells. They were able to modulate the abnormal immunological memory processes found in these patients. Treatment-induced sustainable clinical responses and resulted in a reduction in systemic inflammation.

The treated patients were two females diagnosed with life-threatening lupus, whose symptoms included inflammation of the heart and kidneys and antibody-induced anemia. Weekly administrations of daratumumab over four weeks resulted in a rapid and significant improvement in symptoms, which remained stable for several months. The patients also showed a marked decline in serum autoantibody levels.

They hope to test the efficacy and safety of the treatment in a larger group of lupus patients as they advance the treatment’s clinical study.

(Source: GEN ENG News, 2020)