Kamada seeks to begin phase 1/2 clinical trials for coronavirus vaccine

Its plasma-derived immunoglobulin (IgG) product for the coronavirus acts as a sort of passive vaccine, and functions by trying to using antibodies found in the blood plasma from recovered patients.

By AARON REICH
Plasma bags are pictured at the Interregional Transfusion CRS in Bern (photo credit: DENIS BALIBOUSE/REUTERS)
Plasma bags are pictured at the Interregional Transfusion CRS in Bern
(photo credit: DENIS BALIBOUSE/REUTERS)
Israeli plasma-derived biopharmaceutical firm Kamada gave an update on Wednesday on its plasma-derived immunoglobulin (IgG) product for the coronavirus, and said they are seeking to get approval for phase 1/2 clinical trials in Israel.
The product acts as a sort of passive vaccine, and functions by trying to using antibodies found in the blood plasma from recovered COVID-19 patients.
“The concept that we are developing is not new. People that are exposed to a virus develop antibodies for that virus,” Kamada CEO Amir London told The Jerusalem Post back in May. “If patients who have recovered from the disease and are in convalescence donate plasma, there is a very good likelihood that in that plasma there are going to be antibodies.
“A vaccine triggers the immune system of a person to develop antibodies; in this case, we are providing the antibodies themselves,” he explained. “Our treatment is a medicine: It targets the severely ill patients, whose situation is worsening and who need a booster to fight the virus.”
Kamada's proposed clinical protocol for phase 1/2 clinical trials was already submitted to the Health Ministry, and the firm expects to initiate its study in the third quarter of 2020.
The Rehovot-based company currently has a global collaboration agreement with Kedrion Biopharma over development, manufacturing and distribution of the IgG product. As part of this, Kedrion is collecting convalescent plasma from recovered COVID-19 patients in the US in order to manufacture the product. This is done at one of Kedrion's 23 centers throughout the US, all of which have been approved by the US Food and Drug Administration (FDA).
In order to facilitate clinical development in the US, Kamada and Kedrion will hold a pre-Investigational New Drug (pre-IND) meeting with the FDA at the start of Q3 in order to secure FDA approval.
“We are extremely pleased with the rapid and important progress achieved to date in advancing our plasma-derived IgG product for COVID-19,” London said in a statement. 
“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. 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.” 
Rossella Tercatin contributed to this report.