Anti-COVID-19 immunoglobulin - Kamada
Alternative Names: Anti-corona (COVID-19) hyperimmune polyclonal immunoglobulin - Kamada; Anti-Corona (COVID-19) IgG - Kamada; Anti-Corona (COVID-19) polyclonal immunoglobulin - Kamada; Kamada Anti-SARS-CoV-2; Plasma-derived Anti-SARS-CoV-2 IgG - KamadaLatest Information Update: 19 May 2023
At a glance
- Originator Kamada
- Class Antivirals; Immunoglobulins; Polyclonal antibodies
- Mechanism of Action Immunomodulators
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Discontinued COVID 2019 infections; COVID-19 pneumonia
Most Recent Events
- 31 Dec 2022 Discontinued - Phase-I/II for COVID-19 pneumonia in Israel (IV) as of December 2022
- 31 Dec 2022 Discontinued for COVID-2019 infections in USA (unspecified route) as of December 2022
- 31 Mar 2021 Topline therapeutic efficacy, adverse events, pharmacodynamics data from a phase I/II trial in COVID-2019 pneumonia released by Kamada
Development Overview
Introduction
Plasma-derived polyclonal immunoglobulin (IgG) against SARS-CoV-2 virus was being developed by Kamada, for the treatment of COVID-2019 infections and COVID-19 pneumonia. The hyperimmune IgG was to be produced from plasma derived from donors recovered from the virus, anticipating to include antibodies to the novel Corona virus (COVID-19). The IgG was produced using the company's proprietary plasma derived IgG platform technology. Clinical development was ongoing in Israel for COVID-19 pneumonia and early stage research was underway in the US for COVID-2019 infections.
As of December 2022, due to the increased vaccination rate of the population as well as approvals of monoclonal antibodies for COVID-19, the company decided to discontinue the development program for plasma-derived polyclonal immunoglobulin [1] .
Company Agreements
In October 2020, Kamada signed supply agreement with the Israeli Ministry of Health (MoH) to supply its anti-COVID-19 immunoglobulin for COVID-2019 infections in Israel. The use of anti-COVID-19 immunoglobulin will be regulated by the MoH. Under the terms of agreement, Kamada will manufacture the product, to be supplied to the MoH, from convalescent plasma collected and supplied by the Israeli National Blood Services, a division of Magen David Adom (MADA), and additional Israeli medical institutions. The initial order, planned to be supplied during the beginning of 2021, is sufficient to treat approximately 500 hospitalised patients. This initial supply is expected to generate approximately $US3.4 million in revenue for Kamada during the first quarter of 2021. [2]
In July 2020, Kedrion Biopharma entered into a research partnership with Columbia University Irving Medical Center to develop and test a new IgG therapy for COVID-19 infections which is being developed by Kedrion and Kamada Ltd. Under the terms of the agreement, Kedrion will supply Columbia University with convalescent plasma from patients who have recovered from COVID-19 to be used for the manufacturing of IgG therapy. Columbia University will test the convalescent plasma against viral proteins to check the neutralizing power of the hyperimmune immunoglobins. Financial terms of the agreement were not disclosed. [3]
In April 2020, Kamada and Kedrion Biopharma, entered into a global collaboration for the development, manufacturing and distribution of a human plasma-COVID-19 polyclonal immunoglobulin (IgG) product for treatment of coronavirus. The initial primary focus of the collaboration is to provide the product as treatment to patients in Italy, Israel and the U.S. through various clinical programs, while subsequently expanding development and commercialization efforts to additional markets. As per the agreement terms, Kedrion will provide plasma, collected at its KEDPLASMA centers, from donors who have recovered from the virus and, upon receipt of regulatory approvals, will be responsible for commercialisation of the product in the US., Europe, Australia, and South Korea. Kamada will responsible for product development, manufacturing, clinical development, with Kedrion’s support, and regulatory submissions. Kamada will also assume distribution responsibility in all territories outside of those Kedrion is responsible for. Marketing rights for the product in China will be shared by the parties. In June 2020, Kamada announced completion of manufacturing and released of the first batch of the product and continuation of additional production. [4] [5]
Key Development Milestones
As of December 2022, due to the increased vaccination rate of the population as well as approvals of monoclonal antibodies for COVID-19, the company decided to discontinue the development program for plasma-derived polyclonal immunoglobulin [1] .
In October 2020, Kamada reported submission of a Investigational New Drug (IND) application with the US FDA, for the evaluation of plasma-derived immunoglobulins for the treatment of COVID-2019 infections [6] .
In September 2020, Kamada reported submission of a pre-Investigational New Drug (IND) information package to the US FDA, which also include proposed clinical development plan for the evaluation of plasma-derived immunoglobulins for the treatment of COVID-2019 infections [7] .
In March 2021, Kamada announced topline from the phase I/II trial that was completed in November 2020 to evaluate the safety, pharmacokinetics, and pharmacodynamics of anti-corona (COVID-19) polyclonal immunoglobulin in hospitalized, non-ventilated COVID-19 patients with pneumonia (NCT04550325; Kamada Anti-SARS-CoV-2-001) [8] . The open label trial was initiated in August 2020, and had recruited 12 patients in Israel. Earlier, the Ministry of Health in Israel had approved the clinical trial application for this study. Earlier, Kamada submitted proposed clinical protocol for a phase I/II clinical trial to the Ministry of Health, Israel. In September 2020, Kamada released positive interim results from the trial [7] [9] [5] [10] .
In August 2020, Kamada reported that it intends to investigate potential of anti-corona (COVID-19) polyclonal immunoglobulin for prevention of COVID-2019 infections in a separate study in healthy volunteers [9] .
Anti-COVID-19 immunoglobulin was available for compassionate use for the treatment of COVID-19 infections in Israel [5] [11] .
As of March 2020, early research of the anti-corona (COVID-19) polyclonal immunoglobulin is underway in Israel [12] .
Kamada has emphasised that the development plan and manufacturing of the product are highly dependent on the availability of hyperimmune plasma and on the regulatory path to be defined with the health authorities [12] .
Drug Properties & Chemical Synopsis
- Route of administration IV
- Formulation Infusion, unspecified
- Class Antivirals, Immunoglobulins, Polyclonal antibodies
- Mechanism of Action Immunomodulators
-
WHO ATC code
J06B-C (Antibacterial monoclonal antibodies)
-
EPhMRA code
J6H (Specific Immunoglobulins - Antiviral)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Discontinued (Research) | USA | unspecified / unspecified | Kamada | 31 Dec 2022 |
| COVID-19 pneumonia | in hospitalised, non-ventilated patients with pneumonia | - | Discontinued (I/II) | Israel | IV / Infusion | Kamada | 31 Dec 2022 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Kamada | Originator | Israel |
| Kamada | Owner | Israel |
| Kedrion Biopharma | Collaborator | USA, USA, USA, USA |
| Columbia University Medical Center | Collaborator | USA |
Scientific Summary
Adverse Events
Topline data from the phase I/II trial in hospitalised, non-ventilated COVID-19 patients with pneumonia showed no infusion-related reactions or adverse events considered related to anti-COVID-19 immunoglobulin were observed. Earlier interim results from the phase I/II trial showed that the plasma-derived immunoglobulins demonstrated favourable safety profile in 12 hospitalised, non-ventilated COVID-19 patients with pneumonia. One patient treated with immunoglobulins developed a serious adverse event four days after treatment, which was unrelated to the immunoglobulins treatment. The data were reported from 12 patients [8] [7] [10] .
Pharmacodynamics
Topline data from the phase I/II trial in hospitalised, non-ventilated COVID-19 patients with pneumonia showed that upon plasma-derived immunoglobulins infusion, anti-SARS CoV-2 IgG levels in all patients had increased. The observed increase in IgG is anticipated to be associated with enhanced neutralization activity [8] [10] .
Therapeutic Trials
Phase I/II
Topline results from the phase I/II trial in hospitalised, non-ventilated COVID-19 patients with pneumonia showed that 11 of the 12 patients recovered following treatment. Seven patients were discharged at or before day 5 post-treatment; remaining four patients were discharged by day 9. Earlier interim results from a phase I/II trial showed that plasma-derived immunoglobulins demonstrated improvement in clinical symptoms within 24 to 48 hrs of treatment in 11 of the 12 hospitalised, non-ventilated COVID-19 patients with pneumonia. Subsequently, all 11 patients were discharged from hospital within a median of 4.5 days from treatment. As at September 2020, five of the 12 patients have completed 21-day post-treatment follow-up, two patients have completed 14-day post-treatment follow-up and the additional five patients have completed 7-day post-treatment follow-up. The single arm trial enrolled 12 patients. Clinical symptoms were deteriorated in one patients who completed the 14-day post-treatment follow-up who was later shifted on mechanical ventilation [8] [7] [10] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 01 Jan 2021 | Trial Update | Kamada plans clinical trials in COVID-2019 infections in USA in early 2021 (700326594) [9] | 14 Aug 2020 |
| 31 Dec 2020 | Trial Update | Kamada plans a phase I/II trial for COVID-2019 infections in Israel in third quarter of 2020 (700323562) [5] | 14 Aug 2020 |
| 31 Dec 2020 | Regulatory Status | Kamada intends to conduct a pre-IND meeting for clinical development of anti-COVID-19 immunoglobulin with the US FDA in the third quarter of 2020 [5] | 26 Oct 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 31 Dec 2022 | Phase Change - Discontinued(I/II) | Discontinued - Phase-I/II for COVID-19 pneumonia in Israel (IV) as of December 2022 [1] Updated 19 May 2023 |
| 31 Dec 2022 | Phase Change - Discontinued | Discontinued for COVID-2019 infections in USA (unspecified route) as of December 2022 [1] Updated 19 May 2023 |
| 31 Mar 2021 | Scientific Update | Topline therapeutic efficacy, adverse events, pharmacodynamics data from a phase I/II trial in COVID-2019 pneumonia released by Kamada [8] Updated 07 Apr 2021 |
| 26 Nov 2020 | Trial Update | Kamada completes a Phase-I/II clinical trials in COVID-19 pneumonia in Israel (IV) (NCT04550325) Updated 11 Jan 2021 |
| 22 Oct 2020 | Regulatory Status | Kamada files an IND application with the US FDA for COVID-2019 infections before October 2020 [6] Updated 26 Oct 2020 |
| 08 Sep 2020 | Scientific Update | Interim efficacy and adverse events data from a phase I/II trial in COVID-2019 infections released by Kamada [7] Updated 10 Sep 2020 |
| 10 Aug 2020 | Regulatory Status | Ministry of Health in Israel approves clinical trial application for anti-COVID-19 immunoglobulin in COVID-2019 infections (in patients with pneumonia) before August 2020 [9] Updated 21 Aug 2020 |
| 10 Aug 2020 | Phase Change - I/II | Phase-I/II clinical trials in COVID-19 pneumonia in Israel (IV) [9] (NCT04550325) Updated 14 Aug 2020 |
| 10 Aug 2020 | Trial Update | Kamada plans a clinical trial in COVID-2019 infections (Prevention) [9] Updated 14 Aug 2020 |
| 10 Aug 2020 | Trial Update | Kamada plans clinical trials in COVID-2019 infections in USA in early 2021 [9] Updated 14 Aug 2020 |
| 20 Jul 2020 | Licensing Status | Kedrion Biopharma enters into a research partnership with Columbia University Irving Medical Center to develop and test an anti-COVID-19 immunoglobulin [3] Updated 22 Jul 2020 |
| 22 Jun 2020 | Regulatory Status | Kamada intends to conduct a pre-IND meeting for clinical development of anti-COVID-19 immunoglobulin with the US FDA in the third quarter of 2020 [5] Updated 26 Oct 2020 |
| 22 Jun 2020 | Regulatory Status | Anti-COVID-19 immunoglobulin is available for compassionate use for the treatment of COVID-19 infections in Israel [5] Updated 28 Sep 2020 |
| 22 Jun 2020 | Trial Update | Kamada plans a phase I/II trial for COVID-2019 infections in Israel in third quarter of 2020 [5] Updated 14 Aug 2020 |
| 22 Jun 2020 | Phase Change | Early research in COVID-2019 infections in USA (Parenteral) [5] Updated 29 Jun 2020 |
| 22 Jun 2020 | Regulatory Status | Kamada submits clinical protocol for a phase I/II clinical trial to the Ministry of Health, Israel for COVID-19 infections, before June 2020 [5] Updated 29 Jun 2020 |
| 27 Apr 2020 | Licensing Status | Kamada and Kedrion Biopharma collaborate to develop, manufacture and distribute plasma-derived anti-SARS-CoV-2 polyclonal immunoglobulin [4] Updated 30 Apr 2020 |
| 11 Mar 2020 | Phase Change | Early research in COVID-2019 infections in Israel (Parenteral) [12] Updated 19 Mar 2020 |
References
-
Kamada - Form 20F - 2023. Internet-Doc 2023;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1567529/000121390023020114/f20f2022_kamadaltd.htm -
Kamada Announces Supply Agreement with Israeli Ministry of Health for its Investigational IgG Product for COVID-19; Initial Order Expected to Generate $3.4 Million in Revenue in First Quarter of 2021.
Media Release -
Kedrion Biopharma forms research partnership with Columbia University Irving Medical Center to support development of new IgG therapy for COVID-19.
Media Release -
Kamada and Kedrion Biopharma Announce Global Collaboration for the Development, Manufacturing and Distribution of a Plasma-Derived Anti-SARS-CoV-2 (COVID-19) Polyclonal Immunoglobulin Product.
Media Release -
KEDRION-KAMADA COLLABORATION, FIRST BATCH OF COVID-19 IG RELEASED IN ISRAEL.
Media Release -
Kedrion's Partner, Kamada Ltd, Signs a Supply Agreement with the Israeli Health Authorities for the Investigational Anti-COVID-19 Plasma-Derived Therapy.
Media Release -
Kamada Announces Completion of Enrollment and Initial Interim Results from its Phase 1/2 Clinical Trial in Israel of its Plasma-Derived Hyperimmune Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19).
Media Release -
Kamada Announces Top-line Results from its Phase 1/2 Clinical Trial of its Plasma-Derived Hyperimmune Globulin (IgG) Treatment for Coronavirus Disease (COVID-19).
Media Release -
Kamada Announces Enrollment of First Patient in its Phase 1/2 Clinical Trial of its Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19) in Israel.
Media Release -
A Phase 1/2 Open Label, Multicenter, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients With Pneumonia
ctiprofile -
Nanoform and Aprecia collaborate to advance 3D printed Nanomedicines.
Media Release -
Kamada Provides Update on Progress Related to its Proprietary Hyper-Immunoglobulin (IgGs) Platform Technology including its Commercial Anti-Rabies IgG and its Pipeline Products Anti-Corona (COVID-19) and Anti-Zika IgGs.
Media Release
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