Alnylam’s lumasiran results; AZ’s oncology drug; Astellas Roxadustat; Evotec’s partnership with ABL

Alnylam Pharmaceuticals has released the Phase III results of the clinical trial ILLUMINATE-A evaluating lumasiran for Primary Hyperoxaluria Type 1

Primary Hyperoxaluria Type 1 (PH1) is a rare disorder that affects kidneys due to an excess buildup of oxalate, which in normal cases is filtered through the kidneys and excreted in the urine.  

Alnylam’s Lumasiran is an experimental RNA interference (RNAi) therapy that targets hydroxy acid oxidase 1 (HAO1) responsible for the production of the glycolate oxidase (GO), thus blocking the production of oxalate. The drug was able to hit all the primary endpoints and secondary endpoints with no reported serious side effects besides mild injection site reactions. 

Results of the clinical trial were presented at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) International Congress. 

AstraZeneca’s Calquence (acalabrutinib) – an oncology drug was found to be effective in treating COVID-19

Researchers at The U.S. Oncology Network found AstraZeneca’s oncology drug, Calquence (acalabrutinib) beneficial in treating a smaller section of patients suffering from novel coronavirus infections. 

The preliminary research showed that the drug – Calquence, a Bruton Tyrosine Kinase (BTK) Inhibitor – was able to improve oxygenation of the patients with acute respiratory distress syndrome (ARDS) due to COVID-19, with no observed toxicities attributable to acalabrutinib, including those listed on the product’s important safety information, such as cardiac arrhythmia, bleeding, diarrhea or opportunistic infection.

Calquence is available in the market as an approved therapy for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), relapsed or refractory mantle cell lymphoma (MCL). 

Astellas Pharma has released the results of its Phase III DOLOMITES trial comparing its roxadustat with Amgen’s Aranesp (darbepoetin alfa) for anemia in non-dialysis dependent (NDD) due to stage 3-5 chronic kidney disease (CKD)

The results demonstrated Roxadustat was belt meet the primary endpoint and was proved non-inferior to Aranesp in hemoglobin levels during the first 24 weeks of treatment. Furthermore, the drug successfully hit several secondary endpoints with overall safety comparable to that of Aranesp.

Roxadustat is a first-in-class oral inhibitor of hypoxia-inductible factor (HIF) prolyl hydroxylase (PH). It increases the hemoglobin level by stimulating the body’s natural protective response to decreased blood oxygen levels. 

The results were presented the data at an oral presentation of the 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress. 

Evotec SE has announced a partnership between its subsidiary Just – Evotec Biologics with Advanced BioScience Laboratories (ABL) for designing broadly neutralizing antibody against HIV

The whole project has been funded with Federal funds under a USD 318.5 M contract from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services. 

Under the terms of the agreement, Just – Evotec Biologics will be responsible for developing a highly efficient manufacturing process required for the production of Phase I cGMP clinical supply of a broadly neutralizing antibody (“bnAb”) against HIV. Moreover, the company will also produce a suitably scaled production run under cGMP conditions acceptable for human clinical trials, a product formulation suitable for clinical infusion and provide assay development and release and stability testing services.