Takeda, CSL to end alliance as plasma-based COVID-19 drug fails key test

 

• An experimental, concentrated antibody solution from Takeda and CSL Behring failed to reduce the risk of disease progression in hospitalized COVID-19 patients in a large study funded by the U.S. government.
• The medicine was developed by Takeda and CSL through an alliance that included several other drug manufacturers and a clinical trial network set up for drugs to test HIV. On Friday, Takeda reported the so-called hyperimmune globulin treatment, when added to standard care including Gilead's Veklury, didn't meet any of the study's efficacy goals.
• The companies will now end their partnership, which was called the CoVIg-19 Plasma Alliance and formed last April to quickly test the blood-based treatment. The agreement, however, could provide a "framework for future collaborative opportunities," Takeda said.

In the early days of the coronavirus pandemic, drugmakers, governments and regulators partnered in creative and unusual ways to quickly respond to the global health threat.

The National Institutes of Health, for instance, teamed with a big group of drugmakers to form what's known in shorthand as "ACTIV" and has been testing a variety of different potential treatments and vaccines for COVID-19. Sanofi and GlaxoSmithKline, two rival vaccine developers, teamed up to make a coronavirus shot. Other philanthropies, biotechs and venture firms joined forces with ambitions to conduct targeted and speedy research.

Taked and CSL were among them. Both have considerable experience with plasma-derived therapies, with approved products for hepatitis, certain immune deficiencies and other diseases. And both decided to forego their own drugs and work together on a treatment for coronavirus infections, claiming that with a group of manufacturers — Biotest, BioPharma Plasma, GC Pharma, LFB, National Bioproducts Institute, Octopharma and Sanquin — they could accelerate the development of a treatment and, if successful, widely supply it.

The alliance was formed at a different stage of the pandemic. Coronavirus vaccines from Moderna, Pfizer and others were just beginning clinical testing, and much of the focus was on testing and advancing repurposed or existing drugs.

One that received plenty of attention, for instance, was convalescent plasma, which is an antibody-rich blood sample from a recovered COVID-19 patient. The approach has been used for a century to treat certain infectious diseases and respiratory infections, and was thought of as a potential COVID-19 therapy as well.

Takeda and CSL aimed to take the idea a step further. Because convalescent plasma is taken from individuals, its therapeutic punch can be highly variable and depend on the levels of antibodies in each sample. Takeda and CSL extracted antibodies from a much wider pool of donated plasma, hoping to develop a more concentrated and standardized medicine — hyperimmune globulin — that could provide a reliable benefit. If potent, it could have served as an alternative to the synthetic antibody drugs developed by Regeneron, Eli Lilly and others.

Yet both strategies for plasma-derived therapies didn't pan out as hoped. The Food and Drug Administration controversially granted emergency clearance to convalescent plasma last year based on results from an expanded access program from the Mayo Clinic. But the decision, which reportedly came amid political pressure from the Trump administration and opposition from the National Institutes of Health, hurt the credibility of the agency. The FDA later narrowed its authorization as multiple controlled trials have since found limited benefit to treatment, if any.

Takeda and CSL's drug fell short in a study of roughly 600 patients hospitalized with COVID-19 and at high risk of serious complications from the disease. The companies didn't provide specifics, but treatment didn't succeed on any of the efficacy measures, like a positive change on a 7-point scale that evaluates the condition of COVID-19 patients. Results will be published in a peer-reviewed journal.

The companies will end their partnership, but said the experience could provide a model for similar, future collaborations should another public health crisis arise.

https://www.biopharmadive.com/news/takeda-csl-behring-covid-plasma-alliance-results/597781/