Cbio’s unique and proprietary REVITA technology platform enables development of clearly differentiated T-cell therapy products with transformative potential – products designed to revitalize resting immune cells and to expand them to the billions faster, securing a highly potent multitargeted T-cell product that effectively track down and kill cancer cells
Cancer cells only survive, if they somehow can avoid being recognized and killed by the immune system. When tumors grow out of control and metastasize, it is evident that cancer have had the upper hand in this battle. Popularly speaking, the cancer is somehow making the immune cells fall asleep.
The core principle of T-cell therapy is basically to revert this imbalance and secure that enough tumor reactive T-cells are reinfused back into the patient to overcome the hostile tumor environment, thereby securing that the immune cells can track down and kill cancer cells all over the body.
Cbio’s unique REVITA technology is based on novel discoveries and in-depth understanding about the immune cells and the tumor micro-environment. The key question we are addressing is, how we can secure that all lymphocytes residing in the tumor are reinvigorated and expanded in the fastest possible way to benefit the patient.
Through structured discovery work, we have tested the effect of numerous molecules known to stimulate T-cells, downregulate negative signals and in general to minimize the hostility of the tumor micro-environment. In this way, we have been able to generate a novel T-cell product optimized for growth, viability, functionality, and T-cell fitness.
T-cell therapy utilizes the patient’s own immune defense to combat cancer. In T-cell therapy, a piece of the tumor is resected from the patient and transported to the laboratory, where immune cells are extracted, stimulated with IL-2 and expanded to the billions. Following lymphodepleting therapy, the immune cells (primarily T-cells) are reinfused in the patient, where the TILs track down and eradicate the cancer.
Through structured discovery work, Cbio has developed a novel T-cell therapy product by adding a proprietary cocktail of stimulators in addition to IL-2 to the first step of the expansion phase thereby reinvigorating and growing the immune cells much faster and to higher numbers than the standard T-cell therapy approaches.
With the improved T-cell product, novoleucel provides a differentiated product with transformative potential. It enables for minimally invasive therapy, as fine needle biopsies can be used instead of surgery to get the required starting material. This is vital for late-stage cancer patients who have inoperable tumors or are too ill to undergo surgery. Also, novoleucel has a much broader T-cell repertoire than standard IL-2 only products leaving less opportunities for the cancer to escape - and potentially leading to an improved clinical outcome.
In addition, the high-dose novoleucel T-cell product can be produced in just 22 days without compromising yield (~1011 TILs), generating a favorable CD8+ T-cell population known to be associated with improved clinical outcome.
Cbio has perfected the T-cell manufacturing process with its proprietary Fast Lymphocyte Expansion (FLeX) protocol providing novoleucel with a number of differentiated benefits versus standard IL-2 only expanded T-cell therapies:
LESS STARTING MATERIAL
1-2 cm3
→
1-3 MM3
Allows for fine needle biopsy – 2-3 times more patients can be treated as no surgery is required
REDUCED PRODUCTION TIME
49 Days
→
22 Days
Time matters – the health of late-stage cancer patients can quickly deteriorate
HIGHER POTENCY
3X TUMOR REACTIVE
More tumor reactive T-cells in T-cell product – linked to improved clinical outcome
IMPROVED SUCCESS RATE
68%
→
98%
50% more patients can be offered novoleucel therapy – also in less immunogenic cancers
SCALABLE, LESS MANUAL STEPS
2,437
→
378
Manufacturability and scalability are critical parameters for a commercially viable T-cell product
CRYOPRESERVED FINAL PRODUCT
20°C
→
-180°C PRODUCT
With a cryopreserved final product formulation, novoleucel can be distributed globally
Based on proprietary, leading technology pushing the boundaries of where T-cell therapy can be applied
Intellectual property is of great importance and Cbio constantly seeks to protect and enhance proprietary technology, inventions, and improvements that are commercially important to the development of its business.
Cbio’s T-cell technology is a further development of early discoveries made by Steve Rosenberg and his team at NIH in Bethesda US, where they already back in the 1980ies discovered that T-cell therapy could have a remarkable effect on late-stage cancer patients.
All innovations to the REVITA technology platfrom and novoleucel T-cell product including the proprietary ex-vivo checkpoint inhibition and stimulation belong to Cbio and are protected (patent pending) until 2040. Furthermore, Cbio has filed several patent applications covering further developments to the basic T-cell therapy technology.