INO-4500 DNA Vaccine Description
INO-4500 is a DNA vaccine candidate.
INOVIO is leveraging its optimized plasmid design and delivery technology to develop DNA medicines to treat and prevent infectious diseases.
INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using one of INOVIO’s proprietary hand-held CELLECTRA smart devices.
INOVIO’s DNA medicines are made using a process called SynCon®. SynCon uses a proprietary computer algorithm that has been designed to identify and optimize the DNA sequence of the target antigen, whether it is a virus or a tumor. Once this sequence has been determined, the DNA is synthesized or reorganized, and manufacturing can begin, says the company.
DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. INO-4500 is the first vaccine candidate for Lassa fever to enter human trials, says the company.
On February 23, 2021, INOVIO announced the first participant was dosed in a Phase 1B clinical trial for INO-4500 in Ghana, Africa. The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, is the first vaccine clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic.
Plymouth Meeting, Pennsylvania-based INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations and the U.S. Department of Defense.
INO-4500 DNA Vaccine Indication
INO-4500 is being clinically tested for the prevention of Lassa Fever.
The U.S. CDC says Lassa fever is an animal-borne, or zoonotic, acute viral illness. It is endemic in West Africa, including Sierra Leone, Liberia, Guinea, and Nigeria. Neighboring countries are also at risk, as the animal vector for the Lassa virus, the “multimammate rat” (Mastomys natalensis), is distributed throughout the region.
The illness was discovered in 1969 and is named after the town in Nigeria where the first cases occurred.
An estimated 100,000 to 300,000 infections of Lassa fever occur annually, with approximately 5,000 deaths, says the CDC. Surveillance for Lassa fever is not standardized; therefore, these estimates are crude. In some areas of Sierra Leone and Liberia, it is known that 10-16% of people admitted to hospitals annually have Lassa fever, demonstrating the serious impact the disease has on the region.
INO-4500 DNA Vaccine Dosage
This vaccine is injected into the muscle or skin with Inovio's proprietary Cellectra electroporation device. Injection of the DNA plasmid into a patient generates robust in vivo monoclonal antibody production. This approach has the potential to generate in vivo production of therapeutic antibodies.
INOVIO's Phase 1B clinical trial, LSV-002, dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels. In addition to providing valuable insights on the INO-4500 safety and immunogenicity profile, this trial will inform dose selection for subsequent Phase 2 studies in West Africa.
INO-4500 DNA Vaccine News
February 23, 2021 - INOVIO announced the first participant was dosed in a Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, in Ghana. The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, is the first vaccine clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic.
October 11, 2018 - According to new research published in Nature Communications, a novel vaccine designed to protect people from both Lassa fever and rabies showed promise in preclinical testing. The investigational vaccine, called LASSARAB, was developed and tested by scientists at Thomas Jefferson University in Philadelphia; the University of Minho in Braga, Portugal; the University of California, San Diego; and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
April 11, 2018 - Inovio Pharmaceuticals, Inc. (NASDAQ: INO) and the Coalition for Epidemic Preparedness Innovations announced a partnership under which Inovio will develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome.
INO-4500 DNA Vaccine Clinical Trials
Clinical Trial NCT04093076: INOVIO's Phase 1B clinical trial, LSV-002, will enroll approximately 220 adult participants 18-50 years old, with the primary endpoints of evaluating safety and immunogenicity in an African population. The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 or 2.0 mg dosing levels. In addition to providing valuable insights on the INO-4500 safety and immunogenicity profile, this trial will inform dose selection for subsequent Phase 2 studies in West Africa. Last Update Posted: February 25, 2021. Estimated study completion date: September 2022.
Clinical Trial NCT03805984: Safety, Tolerability, and Immunogenicity of INO-4500 in Healthy Volunteers. This Phase 1 trial is a randomized and double-blinded study group, placebo-controlled trial to evaluate the safety, tolerability, and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Last Update Posted: November 23, 2020. Actual completion date: October 21, 2020.