Bioentrepreneurship

Introduction

traditional therapies for Breast cancer requires accurate signatures that correspond withthe dynamic state of the disease and its stage, as well as they need to becontinuouslyoptimized and modulated for adjusting tolerated dose and selecting the proper drug foreach patient, which is both time and money consuming, compared with Immunotherapeuticapproaches. In addition to their adverse effects which are more money consuming for boththe patients and the company. DNA vaccination as a promising approach yetremains achallenge for an improved delivery system, it was remarkable how Immunotherapy showedoutstanding results based on our mathematical modeling and simulation regarding , itseffect on enhancing body's own immune system with least side effects and with affordablefinancial funds required for its development. DREP-based Vaccine is cost-effective as it is aself-replicating system with switches which avoids the need of multiple doses that costsmore. In addition to decreasing the patients’ compliance too. So, the usage of DREP-basedvaccines would elicit a higher efficacy (as illustrated in our mathematical modelling andsimulation) with lower cost (as avoiding multiple doses in DREP) that results in increasingpatients’compliance

What is unique about our solution?

Integration with custommune

Our integration with custommune's hostpot neoantigen identification platform eliminates the need for extensive sequencing approaches and allows for selection of multi-epitopes.

Usage of DREP platform

Delivery of our neoepitopes is cheaper and more efficient due to the natural abilities of self-amplifying RNA replicons.

Safety

Our product is anticipated to be highly safe due to our design which incorporates DREP advantages (no genome integration, little replication) and a safety switch

Local Cancer Therapeutics Market

Local TAM estimation

$190 Mn

(Including Chemotherapeutics)

Global Cancer Vaccine Market

Global TAM

$4Bn

CAGR of 12.6% from 2020 to 2027.

Stakeholder mapping

Onion model

Product: Multi-epitope DREP-based vaccine for TNBC
System: Patients
Containing system: Hospitals and physicians
Wider Environment: Ministries and governing bodies

Milestones	Description	Anticipated challenges	Potential Solutions	Steps taken toachieve it
In vitro proof of concept	The first milestone in our project is to get our vaccine into the lab and assemble it to be able to experimentally test it and its efficacy invitro	During the time that we live in, our main challenges would beto get into a lab during Covid-19 pandemic to test thisexperimentally followed by the problem of getting the funds needed forour project	This could be solved by applying for internal & external grants as well as finding a safe lab to be able towork in it.	We applied for internal grants As well as Deliberating potential partnerships to grant us both the funds we need and access to freely open labs.
Animal model studies	The second milestone is to test our vaccine on animal models to see its effect and how effective it would be in a live setting.	We see that here in egypt we have a lack of animal studies facilities which would pose a problem in how we could do this	We think that we could propose a potential collaboration with research centers to experiment withanimal models	We discussed a partnership with the Egyptian Center for Research and Regenerative Medicine
Clinical trials phases I, II& III	Our final milestone is to get to clinical trials and test our vaccine on phases to allow us at the end to measure its efficacy and safety and get approval for its use.	The main challenge would be strict regulatory systems in egypt that restricts research & clinical trials	Recently a new law has just been approved that governs clinical trials so we might benefit from it	We familiarized ourselves with the current laws & systems of Egypt as well as trying to find solutions in order to bypass the hurdles the might comein our way

Team:AFCM-Egypt/Entrepreneurship