Candidate: Anti-Corona Immunoglobulin (IgG)
Type: Polyclonal immunoglobulin based on company’s proprietary plasma-derived IgG platform technology as a potential treatment for severely ill coronavirus patients. The treatment is expected to be produced from plasma derived from donors recovered from the virus, which is anticipated to include antibodies to COVID-19.
2021 Status: Kamada on March 31 announced topline results from its Phase I/II open-label, single-arm, multi-center trial (NCT04550325) in Israel of the company’s IgG. Eleven of 12 patients recovered following treatment, of which seven were discharged from the hospital at or before day 5 post-treatment, while the other four patients were discharged by day 9. Following infusion of the product, anti-SARS CoV-2 IgG levels in the plasma of all patients increased.
Preliminary results showed that the IgG level increase was associated with enhanced neutralization activity, though the effect of the treatment on neutralization activity is being further analyzed, Kamada said.
There were no infusion-related reactions or adverse events considered related to study drug. However, there were two serious adverse events, both found unrelated to the study drug. One patient died on day 37 post-treatment due to complications from COVID-19. Another patient was diagnosed post-discharge with pulmonary embolism on day 7. That patient was re-hospitalized, treated with anticoagulation therapy, recovered within two days, and later discharged from the hospital.
Also as of March 31, more than 100 patients were enrolled into a multi-center clinical study of Kamada’s COVID-19 IgG product being conducted by the Israeli Ministry of Health (IMOH). The study was launched in January 2021. The study is enrolling hospitalized patients with moderate to severe COVID-19 illness. Enrolled patients are randomized 1:1 to receive either 4 grams of Kamada’s IgG product or two units of convalescent plasma. Planned follow-up is 14 days.
2020 Status: Kamada said October 19 it will supply its IgG product for the treatment of coronavirus (COVID-19) patients in Israel, under an agreement with that country’s Ministry of Health. Kamada agreed to manufacture IgG from convalescent plasma collected and supplied by the Israeli National Blood Services, a division of Magen David Adom (MADA), and additional Israeli medical institutions, then supply it to the health ministry. The initial order of IgG, set to be supplied during the start of 2021, is sufficient to treat approximately 500 hospitalized patients, Kamada said.
The initial IgG supply is expected to generate approximately $3.4 million in revenue for Kamada during the first quarter of 2021, according to the company.
“The execution of this supply agreement with the MoH is an important milestone in our development program, and to our knowledge represents the first such contract globally for the supply of a plasma-derived IgG product for COVID-19,” Kamada CEO Amir London said. “We will continue to ramp up the production and supply of the product during the next few months.”
London cited positive interim results Kamada reported in its Phase I/II trial of IgG in Israel, saying that the product showed a favorable safety profile and showed symptoms improvement in hospitalized, non-ventilated COVID-19 patients with pneumonia. The trial is being conducted under Kamada’s global collaboration with Kedrion Biopharma, established in April 2020 to develop, manufacture, and distribute a plasma-derived IgG product as a potential treatment for COVID-19.
The companies’ U.S. clinical development of a plasma-derived IgG product as a potential COVID-19 treatment is expected to begin in early 2021 pending IND acceptance, Kamada added.
The first patient was recruited to its Phase I/II clinical trial of IgG on August 10. The open-label, single-arm multi-center study evaluated the safety, pharmacokinetics, and pharmacodynamics of the company’s plasma-derived IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia.
A total of 12 eligible patients will be enrolled and receive Kamada’s product at a single dose of 4g within 10 days of initial symptoms. Patients will be followed for 84 days, Kamada said. In parallel, Kamada added, it intends to further explore in a separate study the potential of its IgG product to prevent COVID-19 disease in healthy subjects at risk. According to the company, preliminary results suggest potential high neutralization titer.
In June 17, Kamada completed manufacturing of the first batch of its plasma-derived IgG for COVID-19 using the company’s proprietary IgG platform technology, with additional production ongoing. Kamada has also submitted a proposed clinical protocol for a Phase I/II clinical trial to the Israeli Ministry of Health, and expects to begin the study during the third quarter.
Intent on expanding its clinical development program to the U.S., Kamada said it partnered with Kedrion Biopharma to obtain FDA acceptance of their proposed clinical development program. Kamada said Kedrion is collecting COVID-19 convalescent plasma from U.S. 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 U.S.
In April, Kamada launched a global collaboration with Kedrion Biopharma to develop its human plasma-derived COVID-19 polyclonal immunoglobulin (IgG) product, to be developed and manufactured using Kamada’s proprietary IgG platform technology, through a collaboration whose value was not disclosed. The companies said their initial primary focus will be to provide the product as treatment to patients in Italy, Israel and the U.S. through clinical programs.
Kedrion is responsible for commercialization of the product in the U.S., Europe, Australia, and South Korea. Kamada is responsible for product development, manufacturing, clinical development, with Kedrion’s support, and regulatory submissions. Kamada will also assume distribution responsibility in all territories not covered by Kedrion. The companies agreed to share marketing rights for the product in China.
In March, Kamada announced plans to initiate development of an Anti-Corona IgG, emphasizing that its development and manufacturing plans were “highly” dependent on the availability of hyper-immune plasma and on the treatment’s to-be-determined regulatory path.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: