Team:CGU Taiwan/Entrepreneurship
Entrepreneurship
Motivation and Goal
One reason that some severe diseases do not have efficient vaccine is the lack of T cell pathway activation. Due to this finding, leijuvant purpose to directly activate CD4 T cell pathway, and further induced better antibody production. Leijuvant prevent people from infectious diseases that do not have proper drugs, including tuberculosis, malaria and hepatitis C. With leijuvant, hundreds and thousands of people will be saved. Leijuvant has several advantages as a vaccine adjuvant, providing us with a new perspective of protecting ourselves.
Business model
Marketing
The number of vaccination per person is increasing while the number of vaccine-preventable diseases is also increasing. This situation accelerates virus recombination and evolution, thus, new approach is necessary for vaccine industry. Furthermore, therapeutic vaccines that target specific antigens develop rapidly in oncology and immune diseases, heralding a new vaccine market.
In our own survey, we made a questionnaire for public to figure out the demands of indirectly customers. For integrated marketing, we also interviewed with several experts of both basic research, industries and the hospital system (read more). In the future, we will collect information from our main customers in a large scale and further analyze the data to solid our business model.
In our own survey, we made a questionnaire for public to figure out the demands of indirectly customers. For integrated marketing, we also interviewed with several experts of both basic research, industries and the hospital system (read more). In the future, we will collect information from our main customers in a large scale and further analyze the data to solid our business model.
Law and regulation
FDA is the main administrative organ managing pharmaceutical products in Taiwan, following the acts of GMP and ISO. The environmental impact, safety, and production issues are also under our concern. Detail information is written in our integrated HP wiki page.
Progress
We have proven that Leishmania could activate CD4 T cell pathway inducing efficient humoral immune response. In Further study, we will change the well-established OVA protein into our target protein from hepatitis C virus, plasmodium and tuberculosis. Since Leishmania can also be used as treatment drugs toward cytotoxic pathway, it is possible that generate both therapeutic and prophylactic drugs toward Leishmania system. Leijuvant targets diseases that are under rare medical conditions which correspond to the applicant qualifications of orphan drug. In order to benefit patients suffering from diseases without efficient drugs, FDA fastens the process of orphan drug development clinical trial phase 3, accelerating the procedure of leijuvant launched on the market and reducing the cost. The orphan drug application will be summited after preclinical trial is completed. Patent application will also be submitted before clinical trial start. In our blue plan, we will finish preclinical trial and clinical trial in 7 and 4 years respectively and launch leijuvant in 2029.
Leijuvant production (mimic real-world conditions)
Suppose our target antigen is an unknown virus. First, enter the antigen sequence into the MHC peptide prediction system, McHug, to analysis the MHC binding affinity and other basic features. And get the antigen sequence of your interest. Construct the sequence into shuttle vector to maximize the production of the antigen. Transfect the vectors into Leishmania through electroporation. Through drug selection we can select the successfully transfected Leishmania and mass culture it. Then we will use double-photo inactivation system to completely remove its infectiousness. Repeat the same process and we can design and produce different antigen specific leijuvant.
Sponsor
We will solicit cooperation with pharmaceutical companies that produce vaccines and adjuvants, such as GSK, Merck, Novartis, Pfizer and Sanofi. Project could be improved and process more smoothly toward discussion that combine both scientific and business perception.
