Cbio’s unique and proprietary technology forms the basis for a clearly differentiated TIL product with transformative potential – a product designed to reinvigorate resting immune cells and to expand them to the billions faster, securing a highly potent multitargeted TIL 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 TIL therapy is basically to revert this imbalance and secure that enough tumor reactive immune 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 technology is based on the clinically proven TIL therapy and is centered around an 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.
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 TIL product optimized for TIL growth, viability, functionality, and T-cell fitness.
TIL therapy utilizes the patient’s own immune defense to combat cancer. In TIL 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 TIL therapy product by adding a proprietary cocktail of TIL 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 TIL therapy approaches.
With the improved TIL product, novoleucel provides a differentiated TIL product with transformative potential. It enables for minimally invasive TIL 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 TIL products leaving less opportunities for the cancer to escape - and potentially leading to an improved clinical outcome.
In addition, the high-dose novoleucel TIL product can be produced in just 20 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 TIL manufacturing process with its proprietary technology providing novoleucel with a number of differentiated benefits versus standard IL-2 only expanded TILs:
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
→
20 Days
Time matters – the health of late-stage cancer patients can quickly deteriorate
HIGHER POTENCY
3X TUMOR REACTIVE
More tumor reactive T-cells in TIL product – potential improved clinical outcome
IMPROVED SUCCESS RATE
68%
→
98%
50% more patients can be offered novoleucel TIL therapy – also in less immunogenic cancers
SCALABLE, LESS MANUAL STEPS
2,437
→
378
Manufacturability and scalability are critical parameters for a commercially viable TIL 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 TIL 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 underlying TIL technology is based on the discoveries made by Steve Rosenberg and his team at NIH in Bethesda US, where they already back in the 1980ies discovered that TIL therapy could have a remarkable effect on late-stage cancer patients.
All innovations to the novoleucel process including the proprietary TIL stimulator cocktail belong to Cbio and are protected (patent pending) until 2040. Furthermore, Cbio has filed several patent applications covering further developments to the TIL technology.