The Israeli biopharmaceutical company Kamada has completed manufacturing the first batch of its plasma-derived immunoglobulin (IgG) product for treating Covid-19. Israel has approved it for compassionate use.
The Rehovot-based company submitted a clinical protocol for a Phase 1/2 clinical trial to the Israeli Ministry of Health. Kamada expects to initiate the study during the third quarter of this year.
In order to expand its clinical development program to the United States, Kamada, with the support of Kedrion Biopharma, plans a pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration (FDA) early in the third quarter to obtain FDA approval of the proposed program.
In connection with Kamada’s global collaboration agreement with Kedrion for the development, manufacturing and distribution of the plasma-derived IgG product for the novel coronavirus, Kedrion is collecting Covid-19 convalescent plasma from recovered American patients at 23 FDA-approved centers in order to manufacture additional batches.
“We are extremely pleased with the rapid and important progress achieved to date in advancing our plasma-derived IgG product for Covid-19,” said Amir London, Kamada’s Chief Executive Officer.
“To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of Covid-19.”
Kamada develops plasma-derived biopharmaceuticals for orphan indications, with an existing marketed product portfolio and a late-stage product pipeline.