Israeli plasma-derived biopharmaceutical company Kamada Ltd. (TASE: KMDA) has completed manufacturing of the first batch of its plasma-derived (immunoglobulin) IgG product for Covid-19. The treatment utilizes the company’s approved proprietary IgG platform technology. Additional production is underway and the initial vials are available for compassionate use in Israel.
The source of the immunoglobin, which is meant to isolate Covid-19 from within blood plasma, will be blood from healthy donors who have recovered from the disease. This immunoglobin will be used to treat severe cases in which patients have not developed immunity to the disease. The plan to develop the product is dependent on enough people who have recovered from disease being willing to donate their blood, and on a regulatory track specified by the health authorities.
Kamada has proposed a clinical protocol for a Phase 1/2 clinical trial, which has been submitted to Israel’s Ministry of Health, and the company expects to initiate the study during the third quarter of 2020.
Kamada, with the support of Kedrion Biopharma, plans expanding its clinical development program to the US, and 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.
As part of the company’s global collaboration agreement with Kedrion for the development, manufacturing and distribution of the plasma-derived IgG product for Covid-19, Kedrion is 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 US.
Kamada CEO Amir London said, “We are extremely pleased with the rapid and important progress achieved to date in advancing our plasma-derived IgG product for Covid-19. 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.
He added, “This achievement validates our advanced IgG development and manufacturing capabilities and our ability to rapidly focus our efforts on providing potential solutions to emerging pandemic situations. We anticipate the initiation of a Phase 1/2 clinical trial in Israel during the third quarter and are concurrently expanding our development program to the US. with our partner, Kedrion. 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.”
Header: The plasma of a patient who has recovered from COVID-19. Photo credit: Carlo Cozzoli for Fotogramma via REUTERS
Original: Globes, Israel business news – June 17, 2020