Within the global collaboration agreement established in April with Kedrion for the development, manufacturing and distribution of the plasma-derived Anti-SARs-COV-2 IgG, the Israeli biopharmaceutical company Kamada announced that it has completed manufacturing and released the first batch of the product utilizing its approved proprietary IgG platform technology, and additional production is ongoing. The initial vials are already available for compassionate use in Israel, where Kamada’s proposed clinical protocol for a Phase 1/2 clinical trial was submitted to the Ministry of Health, and the Company expects to initiate the study during the third quarter of this year.
In order to expand its clinical development program to the US, Kamada, with the support of Kedrion, intends to conduct a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) early in the third quarter in order to obtain FDA’s acceptance of the proposed clinical development program.
Kedrion is currently collecting COVID-19 convalescent plasma from US recovered patients that will be used by Kamada to manufacture additional batches of the product. Kedrion is collecting the plasma, through its plasma business unit, KEDPLASMA, at 23 FDA-approved centers across the United States.
“We are extremely pleased with the rapid and important progress achieved to date in advancing our plasma-derived Anti-SARs-COV-2 IgG product,” 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. We believe that Kamada and Kedrion, two leaders in plasma-derived protein therapeutics, are uniquely positioned to make a positive impact in the treatment of COVID-19 patients.”
“We are very excited about the progress that Kamada has been making and we look forward to supporting their work in all of our joint efforts,” said Paolo Marcucci, Kedrion’s Chief Executive Officer.