IPSIRIUS is looking for funds to produce a large scale batches of mutagenized and unmutagenized IPS cells that will be used to produce IPVAC and IPVAC-Mut for future phase I/II clinical studies. SNBTS/Edinburgh will bring support as CDMO for the development of iPSC manufacturing in cGMP conditions. IPSIRIUS will secure this industrialization phase by gathering all the expertise required (quality, regulatory and technical skills) thanks to the CDMO and the Miltenyi Biotech (Prodigy) technology.

IPSIRIUS has reached TRL4 and demonstrated the technology in an,d R&D environment.

IPSIRIUS now ambitions, with the support of a CDMO (Contract Development Manufacturing Organisation) to achieve TRL5 by translating the solution into a pre-GMP environement and then TRL6 with the GMP manufacturing environment and development of a first Phase I/II clinical trial with an escalating dose of IPVAC, with support of a CRO (Contract ResearchOrganisation) who will be in charge along with IPSIRIUS to conduct clinical trials (medical writing,monitoring, data management, and statistical analysis).

IPSIRIUS is committed to developing a portfolio of engineered immune cell products using our proprietary induced Pluripotent Stem Cells (iPSCs) biotechnology platform. Our objectives are to:

1. Generate the first proprietary line of mutagenized and unmutagenized iPSCs in compliance with GMP standards.
2. Create value by advancing projects to Phase I/IIb clinical trials for NSCLC patients.
3. Establish partnerships and licensing agreements with pharmaceutical companies, potentially engaging in co-development during Phase II.

IPSIRIUS has developed a robust and replicable technology to produce standardized, off-the-shelf, pan-cancer vaccines (IPVAC and IPVACmut) targeting epithelial cancers with high metastatic risk. Our product leverages Nobel Prize-winning induced Pluripotent Stem (iPS) cells, modified through proprietary pharmacological treatments to share multiple neo-antigens with metastatic tumor cells. When lethally irradiated iPS cells are administered to mice with aggressive tumors, these neo-antigens elicit a cytotoxic and memory immune response against a wide array of neo-antigens common to many agressive cancers. This response has consistently and significantly inhibited tumor growth, prevented metastatic spread, and increased survival rates in various cancer models (breast, lung, pancreas). The application of these vaccines will be guided by the genomic profile and genetic classification of the targeted cancers.

IPSIRIUS is developing two cancer vaccines based on iPSCs biotechnology:

1. IPVAC: Utilizing iPSCs, this vaccine is intended for a multi-cancer (pan-cancer) indication, with an initial clinical focus on non-small cell lung cancer (NSCLC).
2. IPVAC Mut: This next-generation immunotherapy product uses mutagenized iPSCs and is designed for specific, highly mutated cancers, including NSCLC.

Additionally, IPSIRIUS will design and manufacture its own iPS cells (autologous, allogenic, or universal) for customers. These cells will be available for partnership or licensing agreements with pharmaceutical companies, which will oversee further development and commercialization.