On September 23, media got the information about Humanigen and Thermo Fisher deal to scale up manufacturing of monoclonal antibody for COVID-19.
To date Humanigen inc., clinical-stage biopharmaceutical company developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, GM-CSF neutralization and gene-knockout platforms, moved to phase 3 trials of Lenzilumab, potential COVID-19 treatment.
Lenzilumab, which is recently come to phase 3 of researches, is potential treatment for patients with severe or critical COVID-19 pneumonia. Drug should be addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and reduce the time to recovery.
Company announced main research objectives, “In COVID-19, high levels of granulocyte macrophage-colony stimulating factor (GM-CSF) and inflammatory myeloid cells correlate with disease severity, cytokine storm, and respiratory failure. This phase 3 randomized, double-blind, multicenter, placebo-controlled clinical trial will evaluate the impact of lenzilumab (anti-human GM-CSF monoclonal antibody) on time to recovery in hospitalized patients with severe or critical COVID-19 pneumonia.”
Treatment show itself as a monoclonal antibody that targets the granulocyte macrophage colony-stimulating factor cytokine. It stops the immune system overreaction that leads to acute respiratory distress syndrome (ARDS) in COVID-19 patients, according to Humanigen.
300 Patient Took Part In Testing
For effective testing’s in researches take part about 300 volunteers. A pre-specified interim futility analysis is planned for the DSMB (Data and Safety Monitoring Board). After the deal with Thermo Fisher Scientific, Humanigen will receive capability to expand the manufacturing capacity for lenzilumab.
Thermo Fisher Scientific is famous provisionary of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry (including in the biotechnology and pharmaceutical sectors).
“Manufacturing preparation, precision and expertise are critical as we execute on an aggressive strategy, pending a potential EUA from the FDA, to deliver a COVID-19 therapeutic this winter that has the potential to reduce the risk of ventilation or death and send patients home from the hospital earlier,” said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “Thermo Fisher provides biologics manufacturing expertise and scalable capacity to further support our production and growth trajectory.”
“Effective therapeutics are an important part of the overall approach to curb the arc of the current pandemic, and we are committed to enabling leading therapeutic innovations forward for patients through comprehensive supply chain capabilities and expertise,” said Leon Wyszkowski, president, commercial operations for Thermo Fisher’s pharma services business.
Thermo Fisher start their transfers for the lenzilumab platform as soon as possible. Humanigen counts to begin commercial production not later than this winter. In a release, Humanigen said the pact would allow it to pursue an “aggressive” commercial strategy if the drug receives the FDA’s emergency use authorization.
Thermo Fisher Contract With Government
Need to be said that in May 2020, Thermo Fisher won a contract with the U.S. government to produce viral transport media tubes to carry COVID-19 test samples to laboratories.
“Our production ramp-up in Lenexa has been impressive and our employees deserve recognition for their ingenuity and dedication to making this happen,” said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. “We have a proven blueprint for high-quality VTM production in Lenexa and look forward to bringing significant new capacity online as quickly as possible to continue the necessary testing ramp-up in the U.S.”
This deal was expanded its manufacturing capacity to 1 million media-filled tubes per week to meet increased demand for COVID-19 testing, including its U.S. contract.