Contract Pharma Staff12.03.20
Inovio, a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, has executed an agreement with Kaneka Eurogentec S.A., an affiliate of Kaneka Corporation, for Eurogentec to manufacture Inovio's Covid-19 vaccine candidate INO-4800 at their industry-leading GMP plasmid production scales. Terms of the agreement were not disclosed.
Kaneka Eurogentec joins existing partners Thermo Fisher Scientific, Richter-Helm BioLogics and Ology Biosciences in Inovio's global manufacturing consortium. Each contract development and manufacturing organization that has been selected to join the consortium is compliant with commercial GMP standards and capable of supporting Inovio's future large-scale global manufacturing needs across its portfolio of DNA medicines and vaccines.
Inovio's president & CEO, Dr. J. Joseph Kim, said, "Our partnership with Kaneka Eurogentec, one of the world's largest and most experienced plasmid manufacturers, provides additional scale to our growing global manufacturing coalition. Kaneka Eurogentec will be a crucial member of Inovio's global manufacturing consortium, supporting our plans to produce, manufacture and scale our Covid-19 vaccine candidate, INO-4800."
Dr. Lieven Janssens, Kaneka Eurogentec's President and CEO, added, "We are excited to join Inovio's growing global manufacturing consortium and look forward to supporting the manufacturing needs of DNA medicines and vaccines across Inovio's platform. We are pleased that our large-scale manufacturing technologies are well-recognized by Inovio, a leading player in the DNA plasmid field."
Inovio recognizes the importance of having a robust coalition to support its broader development platform for DNA medicines as well as its Covid-19 vaccine candidate, INO-4800. As a result, the company continues to build the coalition to ensure timely, cost-effective and scalable production of DNA medicines and vaccines.
Manufacturing INO-4800
Inovio's third-party manufacturers will produce the patent-protected formulation for INO-4800, developed to enhance stability of the vaccine with a favorable tolerability profile. Importantly, INO-4800 has shown an excellent thermo-stability profile. Inovio's other platform DNA vaccine candidates have also demonstrated a shelf life of greater than 5 years when refrigerated and stability for more than 30 days at 37 degrees Celsius, and more than one year at room temperature.
Inovio's candidates also do not need to be frozen during transport or storage, a vital factor when implementing immunizations on a global scale. INO-4800 is administered via Inovio's proprietary Cellectra smart delivery device, which delivers the vaccine locally into the patient's skin, a process that takes only a few seconds.
Clinical Trials
Inovio is conducting a Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its Covid-19 vaccine candidate. The planned Phase 2/3 clinical trial, called INNOVATE (INovio INO-4800 Vaccine Trial for Efficacy), is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 to be conducted in adults in the U.S. The INNOVATE trial will be funded by the U.S. Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA).
The DoD has agreed to provide funding for both the Phase 2 and Phase 3 segments of the INNOVATE clinical trial, in addition to the $71 million of funding previously announced in June for the large-scale manufacture of the company's proprietary smart device Cellectra 3PSP and the procurement of Cellectra 2000 devices.
Kaneka Eurogentec joins existing partners Thermo Fisher Scientific, Richter-Helm BioLogics and Ology Biosciences in Inovio's global manufacturing consortium. Each contract development and manufacturing organization that has been selected to join the consortium is compliant with commercial GMP standards and capable of supporting Inovio's future large-scale global manufacturing needs across its portfolio of DNA medicines and vaccines.
Inovio's president & CEO, Dr. J. Joseph Kim, said, "Our partnership with Kaneka Eurogentec, one of the world's largest and most experienced plasmid manufacturers, provides additional scale to our growing global manufacturing coalition. Kaneka Eurogentec will be a crucial member of Inovio's global manufacturing consortium, supporting our plans to produce, manufacture and scale our Covid-19 vaccine candidate, INO-4800."
Dr. Lieven Janssens, Kaneka Eurogentec's President and CEO, added, "We are excited to join Inovio's growing global manufacturing consortium and look forward to supporting the manufacturing needs of DNA medicines and vaccines across Inovio's platform. We are pleased that our large-scale manufacturing technologies are well-recognized by Inovio, a leading player in the DNA plasmid field."
Inovio recognizes the importance of having a robust coalition to support its broader development platform for DNA medicines as well as its Covid-19 vaccine candidate, INO-4800. As a result, the company continues to build the coalition to ensure timely, cost-effective and scalable production of DNA medicines and vaccines.
Manufacturing INO-4800
Inovio's third-party manufacturers will produce the patent-protected formulation for INO-4800, developed to enhance stability of the vaccine with a favorable tolerability profile. Importantly, INO-4800 has shown an excellent thermo-stability profile. Inovio's other platform DNA vaccine candidates have also demonstrated a shelf life of greater than 5 years when refrigerated and stability for more than 30 days at 37 degrees Celsius, and more than one year at room temperature.
Inovio's candidates also do not need to be frozen during transport or storage, a vital factor when implementing immunizations on a global scale. INO-4800 is administered via Inovio's proprietary Cellectra smart delivery device, which delivers the vaccine locally into the patient's skin, a process that takes only a few seconds.
Clinical Trials
Inovio is conducting a Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its Covid-19 vaccine candidate. The planned Phase 2/3 clinical trial, called INNOVATE (INovio INO-4800 Vaccine Trial for Efficacy), is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 to be conducted in adults in the U.S. The INNOVATE trial will be funded by the U.S. Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA).
The DoD has agreed to provide funding for both the Phase 2 and Phase 3 segments of the INNOVATE clinical trial, in addition to the $71 million of funding previously announced in June for the large-scale manufacture of the company's proprietary smart device Cellectra 3PSP and the procurement of Cellectra 2000 devices.
