Immunotherapies have revolutionized cancer treatment and has given a new hope towards cancer cure. However, the average patient response rates to current immunotherapies are still low (25%), and the cure rate without relapse are even lower (10%). In addition, significant differences exist according to patients and tumor types. This gap represents a huge medical and market need.
HEPHAISTOS-Pharma develops ONCO-Boost, a platform of active and non-specific immuno-stimulants able to potentiate commercialized antibodies, by turning cold tumors hot, but also very effective as single agents against cancers with unmet medical needs. Our immunostimulants are based on natural Glycolipids extracted from the outer membrane of bacteria, and chemically detoxified using innovative proprietary process. By stimulating TLR4 receptors of the immune cells, our molecules have the potential to recruit, stimulate and potentiate the anti-tumor immune defenses, offering a great hope to potentiate the efficacy of cancer immunotherapies by turning hidden cold tumors into hot targets for our immune system. Compared to other immuno-stimulant molecules currently in development, including a handful of TLR4 agonists, our immunostimulants are both natural and significantly less toxic (Relevant structure, detoxification process) but also easier to formulate (Highly soluble molecules that can be formulated in Liposomes). This enable their systemic administration, which is unique in this competitive field, and leading to higher efficacy against metastatic cancers.
ONCO-Boost products have been produced and characterized, and their efficacy was validated in vitro on human cells but also in vivo in relevant animal models, first in combination with Rituximab for lymphoma (Raise of complete response rates from 17% to 67%), and then as monotherapy formulated in liposomes for rare and hard-to-treat cancers such as osteosarcoma (50% complete responses). We plan to finalize the pre-clinical development of our product within 2 years, to bring a lead product to the clinic.
The aims of the present project were to strengthen the relevance of our innovative technological and scientific approach and the technical and economic viability of the project by: 1/ Validating the manufacturing feasibility of our products in GMP conditions to demonstrate our capacity to produce GMP batches of our product for regulatory studies and clinical trials, 2/ Validating our regulatory validation plan toward clinical studies, and 3/ Completing economic viability of the project.
