Takeda, CSL Behring fold big plasma alliance after PhIII flop — joining a slew of antibodies that failed to help hospitalized patients
The big plasma alliance spearheaded by Takeda and CSL Behring has a big Phase III verdict: Adding their hyperimmune intravenous immunoglobulin product to Gilead’s remdesivir does not stall disease progression.
Dubbed H-Ig, the treatment was supposed to be a higher grade version of convalescent plasma, which former President Donald Trump once hailed as a “historic breakthrough.” But it seems to be following plasma down the same path toward obsolescence.
Coming a year after the companies announced the partnership — which they called a bold move to find answers amid uncertainty — the failure would mark an end to their work, which had included manufacturing the product at-risk.
“We are especially proud that we pooled resources, brought our plasma expertise and infrastructure together at our own cost to benefit public health and added to our understanding of a complex field,” said Julie Kim, president of Takeda’s plasma-derived therapies business unit. She co-led the initiative with Bill Mezzanotte, head of R&D at CSL Behring.
Funded by the NIH, the ITAC trial had enrolled 600 adult patients hospitalized for Covid-19 across 11 countries and offered them investigational H-Ig plasma treatments. In addition to Takeda and CSL Behring, Emergent BioSolutions and Grifols also supplied some of the clinical material, which was processed and purified in a way that resulted in more concentrated neutralizing antibody activity while minimizing safety issues.
“IgG concentration and IgG specific to SARS-CoV-2 were increased over 10-fold from convalescent plasma to the final product,” a group from Grifols described in a recent paper. “Normalized enzyme-linked immunosorbent assay activity (per mg/ml IgG) was maintained throughout the process. Protein content in these final product batches was 100% IgG, consisting of 98% monomer and dimer forms. Potentially hazardous proteins (IgM, IgA, and anti-A, anti-B, and anti-D) were reduced to minimal levels.”
Investigators compared the clinical status of patients in each group on day 7 of followup, measuring a spectrum of outcomes from limiting symptoms to death. The companies didn’t say much beyond the fact that H-Ig didn’t meet the primary endpoint, saying they will publish the results later.
Plasma from healthy donors who have recovered from Covid-19, meanwhile, has also had trouble living up to early expectations.
The UK’s RECOVERY trial stopped recruiting patients for its convalescent plasma arm after an independent data monitoring committee found no significant improvement in mortality.
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