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Breakthrough technology for cancer treatment

TIL therapy

novoleucel TIL

Benefits

IP

Technology

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 

Reverting the imbalance of cancer

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.

Overcoming the hostility of the tumor environment

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.

Unique technology, reinvigorating the immune cells

Cbio’s unique technology is based on years of TIL research experience and is centered around an in-depth understanding about the immune cells and the tumor microenvironment. 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.

New discoveries leading to groundbreaking improvements

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 — harnessing the power of the patient's own immune defence

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.

Novoleucel — a proprietary, commercially viable TIL product with transformative potential

Through structured discovery work, Cbio has developed an improved TIL manufacturing process 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 production process, novoleucel provides a differentiated TIL product with transformative potential. It enables a minimally invasive TIL therapy, as biopsy needles can be used instead of surgery to get the starting material for the treatment. This is vital for late-stage cancer patients who have inoperable tumors or are too ill to undergo surgery.

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.

Benefits

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

IP

Based on proprietary, leading technology pushing the boundaries of where TIL therapy can be applied

Intellectual Property (IP) — the cornerstone of Cbio's business

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. 

Unique knowhow based on 10+ years' leading academic research

Cbio’s underlying TIL technology is licensed from the National Center for Cancer Immune Therapy (CCIT-DK), Herlev Hospital – a globally recognized pioneer in TIL therapy. Herlev has especially been recognized for its ability to consistently produce high dose TIL products and for its strong contributions to the clinical evidence for TIL therapy in general. More than 100 patients have been treated with TILs in 9 different clinical studies at Herlev for more than a decade.

Strong IP filed protecting inventions to 2040

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 provisional patents covering further developments to the TIL technology.