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Strong clinical evidence supporting TIL therapy

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Publications

Clinical

Strong Pipeline Targeting 4 Cancer Indications With High Unmet Medical Need (Ny tekst her)

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Cbio’s novoleucel TIL product licensed from Herlev Hospital has been tested clinically in more than 100 patients spanning 12 different solid tumor indications in 9 different clinical studies. Here, novoleucel has proven to be safe and tolerable with overall response rates up to 46% and complete remission in up to 13% in a late-stage cancer patient population.

It is currently being investigated in a phase III trial in metastatic melanoma in a large investigator-led clinical study. Cbio aims to initiate a company-sponsored pivotal clinical trial validating novoleucel in the following four cancer indications: cervical cancer, lung cancer, metastatic melanoma, and head & neck cancer with the goal to obtain a conditional marketing authorization. 

In addition, Cbio is collaborating with Odense University Hospital in Denmark, to evaluate the feasibility and develop novoleucel for an additional four cancer indications: colorectal, ovarian, kidney, and pancreatic cancer.

Novoleucel 1st generation manufacturing protocol (Herlev)

Novoleucel next generation manufacturing protocol (Cbio proprietary)

Investigator-led studies based on first-generation TIL protocol

TIL product: CB-104

*Head & Neck, NSCLC, Cervical, Colorectal, Cholangiocarcinoma, Leiomyosarcoma, Uveal Melanoma, Adreno-corticoid Carcinoma, Thyroid Cancer

Cbio-company sponsored confirmatory studies based on next-gen protocol

TIL product: CB-105

Pre-clinical study with Odense University Hospital

TIL product: CB-105

Publications/key references

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2020

CTLA-4 blockade boosts the expansion of tumor-reactive CD8+ Tumor Infiltrating Lymphocytes in ovarian cancer, Friese, C. et al, Nature SR (2020)

Article investigating the effect of adding a αCTLA-4 during the initial TIL culture, which favors the expansion of CD8+ TILs from ovarian tumor fragments. Adding αCTLA-4 resulted in more potent anti-tumor TILs in comparison to standard TIL cultures, which may improve clinical outcome of TIL-based ACT in ovarian cancer.

Article investigating the effect of adding a αCTLA-4 during the initial TIL culture, which favors the expansion of CD8+ TILs from ovarian tumor fragments. Adding αCTLA-4 resulted in more potent anti-tumor TILs in comparison to standard TIL cultures, which may improve clinical outcome of TIL-based ACT in ovarian cancer.

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2021

High-dose Tumor Infiltrating Lymphocyte product with improved phenotype and functionality, Friese, C et al. SITC 2021 conference (abstract # 175)

Poster illustrating that improving the initial TIL culture conditions results in a shortened expansion time while simultaneously improving the characteristics of the TIL product with a high dose of functional CD8+ T cells with potential anti-tumor activity

Poster illustrating that improving the initial TIL culture conditions results in a shortened expansion time while simultaneously improving the characteristics of the TIL product with a high dose of functional CD8+ T cells with potential anti-tumor activity

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2016

Long-lasting complete responses in patients with metastatic melanoma after ACT with TILs. Andersen, R. et al. (Clin Cancer Research, 2016)

Article investigating safety and efficacy in 25 patients with progressive treatment-refractory metastatic melanoma. The TIL therapy as demon

Article investigating safety and efficacy in 25 patients with progressive treatment-refractory metastatic melanoma. The TIL therapy as demon

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2021

Adoptive cell therapy with TILs supported by CPIs across multiple solid cancer types. Kverneland, AH et al (J ImmunoTher. Cancer, 2021)

Article showing the results of a clinical trial with 25 patients covering 10 different cancer diagnoses treated TIL therapy. Tumor regressions combined with CPIs were demonstrated in several cancer types supported by in vitro antitumor reactivity of the TILs.

Article showing the results of a clinical trial with 25 patients covering 10 different cancer diagnoses treated TIL therapy. Tumor regressions combined with CPIs were demonstrated in several cancer types supported by in vitro antitumor reactivity of the TILs.

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2020

Future role for adoptive T-cell therapy in checkpoint inhibitor-resistant metastatic melanoma, Borch, TH et al, (J ImmunoTher Cancer, 2020):

Article investigating the positioning of TIL therapy vs. CPIs. Even in the hard-to-treat population of patients who progressed on anti-PD- 1, an objective response rate of 32% was achieved, including durable responses.

Article investigating the positioning of TIL therapy vs. CPIs. Even in the hard-to-treat population of patients who progressed on anti-PD- 1, an objective response rate of 32% was achieved, including durable responses.

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