MediciNova, Inc. (MNOV)

[Raffis]

BC-PIV, an innovative non-transmissible viral vector co-developed by BioComo and Mie University, is derived from the recombinant human parainfluenza virus type 2 (hPIV2). BC-PIV is highly efficient to transfer multiple foreign proteins to recipients with a strong safety profile, without secondary protein infections.  BC-PIV displays the gene and foreign protein inside and outside of the viral membrane. BC-PIV can carry large membrane proteins of viruses and signal transduction receptors/ligand proteins on the viral surface.  BC-PIV can carry proteins that require a proper three-dimensional structure or multimeric structure while maintaining the structure.  BC-PIV elicits good immunogenicity against antigen proteins without adjuvants.  The SARS-CoV-2 vaccine prototype has been developed to include the specific SARS-CoV-2 antigen protein in order to express maximum antigenicity.  To date, BioComo has succeeded in producing a recombinant Ebola virus vaccine (https://www.nature.com/articles/s41598-019-49579-y) and a Respiratory Syncytial virus prefusion F vaccine (unpublished data) using this BC-PIV platform technology.

Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc., commented, "Given the current global pandemic of COVID-19, we appreciate this very important opportunity to jointly develop a vaccine against SARS-CoV-2 with BC-PIV in collaboration with BioComo and Mie University.

Previously, BioComo has also successfully developed vaccines against Ebola and RS viruses with BC-PIV technology and assured a successful vaccine for SARS-CoV-2.  

We feel a great sense of mission to initiate this SARS-CoV-2 vaccine project in addition to our MN-166 project targeting ARDS, which is a very serious and potentially fatal disease that can be caused by COVID-19."

Masayuki Fukumura, President of BioComo, commented, “We are very pleased to proceed with the co-development of a SARS-CoV-2 vaccine with MediciNova which has a proven track record of international clinical development for unmet medical needs.  We initiated the development of a novel BC-PIV SARS-CoV-2 vaccine with Dr. Tetsuya Nosaka in March of this year (http://www.biocomo.jp/20200319.pdf).

Multiple stabilized Spike protein mutants of SARS-CoV-2 were devised and the respective genes and proteins were loaded onto BC-PIV.  

We already completed core characterization studies with mice models.  

BC-PIV is characterized by its ability to load a large antigenic protein retaining the three-dimensional structure of the vector envelope and its high affinity for the nasal mucosa and upper respiratory tract mucosa and induces local mucosal immunity.  

BC-PIV can be an intra-nasal vaccine in addition to an intra-muscular injection because of its high affinity to nasal and upper respiratory tract mucosa, which is the same route of the natural infection of SARS-CoV-2.  An intra-nasal vaccine is expected to induce local mucosal immunity.  

GMP manufacturing has been one of the barriers for us until now, but through our joint development with MediciNova, we will proceed with further non-clinical and clinical trial development as quickly as possible globally and not only in Japan.  

We are thrilled with the challenge to develop a vaccine that has potential clinical application to limit the spread of SARS-CoV-2.”

Tetsuya Nosaka, Professor at Mie University Graduate School of Medicine, commented, “I am very excited about the outcome of the long-standing development of the vector and genetically modified vaccines with BioComo that can be applied to prevent COVID-19, a major global health threat.  We believe BC-PIV is effective, safe, convenient, and cost efficient as a vaccine vector, and have been seeking an opportunity for the clinical application for long time.  

However, the academic research environment has been less encouraging lately.  Therefore, it is a great encouragement for us as member of the academic community to achieve this international joint development with MediciNova, which has an abundant track record of manufacturing and clinical development.  

We are confident that the BC-PIV SARS-CoV-2 vaccine will be successful and hope that this vaccine will be available in a clinical setting as soon as possible and will be the “gospel” for the people in the world.”