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Monoclonal Antibody To Be A Candidate In Treating ARDS in COVID-19.

The use of a human monoclonal antibody, Narsoplimab, to treat acute respiratory distress syndrome (ARDS) associated with COVID-19 resulted in the recovery and survival of the affected patients.

Narsoplimab is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2. Narsoplimab also has been investigated in hematopoietic stem cell transplant-associated thrombotic microangiopathy that also causes endothelial damage and blocks microvascular injury-associated thrombus formation and MASP-2-mediated activation of thrombin, kallikrein and, factor XII may be therapeutic in both HSCT-TMA and COVID-19.

Alessandro Rambaldi, Professor and lead investigator in the trial of narsoplimab in HSCT-TMA, requested compassionate use of the drug considering the clinical and pathologic similarities between COVID-19 and HSCT-TMA, for patients in Bergamo, the location of which the pandemic originated.

Six COVID-19 patients with ARDS required continuous positive airway pressure or intubation and were treated with narsoplimab. The results obtained from the six patients can provide further evidence of the potential role of narsoplimab in treating diseases caused by endothelial damage.

(Source: Opthalmology Times, 2020)

A Biotechnology Company Granted Patent For The Use Of An Anti CD3 Monoclonal Antibody for Treatment of Crohn’s Disease.

Tiziana Life Sciences recently announced that the United States Patent and Trademark Office (USPTO) has granted a patent on the use and methods of treatment of Crohn’s disease with Foralumab, using its proprietary fully human monoclonal antibody and all other anti-CD3 monoclonal antibodies. The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is vital for the regulation of the immune system.

Tiziana also previously reported the successful completion of a Phase 1 trial utilizing oral administration of Foralumab back in January, which was designed to evaluate its efficacy. They plan to move forward with a phase 2 trial in the last quarter of 2020 with orally administered Foralumab for the evaluation of moderate-to-severe patients with Crohn’s Disease.

Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Lifesciences, said that they are excited about the continued development of the oral administration of Foralumab for the treatment of Crohn’s disease.

(Source: Biospace, 2020)

New Monoclonal Antibodies For Yellow Fever Can Be Expected In A Few Months.

Yellow fever, a mosquito-borne hemorrhagic disease annually infects about 200,000 people and causes an estimated 30,000 deaths. Currently, there are no approved treatments for the disease.

However, an international team of researchers led by Professor Ram Sasisekharan has been developing a treatment using an engineered monoclonal antibody, and have shown success in early-stage clinical trials in Singapore.

It was demonstrated that the team of researchers could design, produce, and start clinical trials of their antibody drug within nine months, which is faster than the usually expected timeline. 

They were able to shorten the antibody development timeline by performing many of the necessary steps in parallel, using analytical techniques to address regulatory risks associated with drug safety, manufacturing, and clinical study design, which could also potentially be used to develop treatments for COVID-19. 

The researchers were able to conduct a clinical trial using the available vaccine. Volunteers were vaccinated and were then given either the experimental antibody drug or a placebo. Two days after that, they measured whether the drug cleared the weakened viruses that make up the vaccine. After treatment, the virus was undetectable in blood samples from people who received the antibodies.

(Source: Technology Review, 2020)