Israel's Kamada plasma-based COVID treatment shows potential in 1/2 trial
In 11 of 12 enrolled patients, symptoms were observed to have improved, and the patients were on average subsequently released in under five days.
By CELIA JEANBlood collection specialist Niilo Juntunen opens the apheresis machine to remove the kit used to collect convalescent plasma from a recovered coronavirus patient at the Central Seattle Donor Center of Bloodworks Northwest during the coronavirus disease (COVID-19) global outbreak, in Seattle, Washing(photo credit: REUTERS)
Kamada, an Israeli plasma-derived biopharmaceutical company, released the results of its 1/2 clinical trial for a new COVID-19 “passive vaccine” using virus antibodies – with potentially good news.The single-arm, multicenter clinical trial is designed to assess the safety and pharmacokinetics (the movement of drugs within the body), and pharmacodynamics (the drug’s effects and mechanism of action) of Kamada’s plasma-derived hyperimmune immunoglobulin (IgG) product in hospitalized, non-ventilated COVID-19 patients with pneumonia.In short, the treatment is developed by using antibodies (also known as IgG) from plasma that Hadassah Medical Center, Tel Hashomer, has been working on with Kamada for several months now, harvested from recovered corona patients – those who had the disease and now test negative for the virus – to make the “passive vaccine.” Passive immunization is when you are given antibodies developed by another patient who contracted the disease.Those who develop any virus, including the novel coronavirus, develop special antivirus proteins or antibodies in their plasma, which can help sick patients cope with the disease.Twelve patients were enrolled in the trial, 11 of whom showed improved symptoms and were subsequently discharged from the hospital. The condition of the 12th patient deteriorated.“The safety profile of our IgG product and symptoms improvement preliminary demonstrated by these results are favorable, and we plan to continue characterizing the virus neutralization activity of the product in order to calibrate the treatment dose,” said Dr. Naveh Tov, Kamada’s vice president of clinical development and medical director.Enrolled patients, aged 34-69, received the treatment as a single, 4-gram dose of IgG within five to 10 days of showing initial COVID-19 symptoms. To date, five of the 12 patients have completed a 21-day posttreatment follow-up, two patients have completed a 14-day posttreatment one, and the additional five patients have completed a seven-day posttreatment follow-up. The follow-ups for patients are set to last for 84 days.In 11 of the 12 patients, symptoms were observed to have improved within 24-48 hours of having received the treatment, and they were subsequently discharged from the hospital, having had a median stay of four-and-a-half days.However, amid the trial, the medical condition deteriorated for one patient who completed the 14-day posttreatment follow-up, resulting in the patient being intubated. In addition, one patient had a serious adverse event four days after treatment, which was categorized by an investigator as unrelated to Kamada’s IgG product.The first patient to be given the “passive vaccine” was treated in June at Hadassah-University Medical Center. In August, the first three patients treated with the vaccine were released from Hadassah, having shown rapid clinical benefits, just a week after the first patient in the 1/2 clinical trial was recruited.
ULTIMATELY, the results of both the current initial interim that was announced this week and the final trial are expected to be released by January 2021, according to Amir London, Kamada’s CEO.“As a reminder, the FDA recently issued an ‘Emergency Use Authorization’ for convalescent plasma as a potential treatment for COVID–19,” he said. “Convalescent plasma plays an important role in the immediate and intermediate response to the disease.”In an interview with The Jerusalem Post earlier this year, London said that he believes his company is the first one globally to complete manufacturing of a plasma-derived IgG product for the treatment of COVID-19.A “plasma-derived IgG product, as developed by Kamada, is considered to have multiple advantages over convalescent plasma transfusion, such as standardized antibody levels, higher potency, extensive viral inactivation processing, the absence of a blood-type matching requirement, smaller infusion volumes, the ability to be produced in large quantities, an expected longer shelf life and preferred storage conditions,” London said.The plasma used to treat the patients was initially collected with the help of the haredi (ultra-Orthodox) organization Yad Avraham along with the haredi community. Patients who tested negative for the novel coronavirus twice and showed high levels of antibodies in their blood were asked to donate.The plasma donations were collected by the blood bank at Hadassah and then transferred, together with doses collected by Magen David Adom, to Kamada’s facilities, where appropriate antibodies were produced for the experimental treatment.Kamada used the plasma to produce what it calls its “anti-SARS-CoV-2 plasma-derived immunoglobulin (IgG) product.”The Phase 1/2 trial in Israel is being conducted as part of Kamada’s global collaboration with Kedrion Biopharma, established in April 2020, for the development, manufacturing and distribution of a plasma-derived IgG product as a potential treatment for COVID-19.With Kedrion’s support, Kamada submitted a pre-Investigational New Drug information package to the FDA, with its proposed US clinical development plan. The FDA’s response is expected in October.Kamada already has two other FDA-approved drugs.Maayan-Jaffe Hoffman contributed to this report.
