On November 14, 2022 GICELL reported the data from the preclinical studies on T.O.P. NK (Tumor targeting, Optimally Primed NK), an allogeneic NK cell therapy which had been presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held in Boston, MA, US (Press release, GICELL, NOV 14, 2022, View Source [SID1234624049]). The SITC (Free SITC Whitepaper) is one of the world’s top three cancer societies and has been known as the largest conference in the field of immuno-oncology.
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The company presented the preclinical study results as a poster titled "Highly potent Tumor-targeting Optimally Primed Natural Killer cells produced under feeder-cell free conditions in a 50L-scale bioreactor with cytokine-fusion proteins elicits robust anti-tumor response in preclinical study."
In general, cancer cell-derived feeder cell culture is a common method for NK cell expansion, but GICELL is harnessing its wholly-owned platform to culture NK cells on a large scale without feeder cells which is a safer and simpler way for NK cell therapy. One of the key features of T.O.P. NK cell is the mass cultivation of NK cells from healthy donors. T.O.P. NK showed high expression rates of activating receptors, cytotoxic proteins, and chemokine receptors that are important for anti-tumor activity. In particular, T.O.P. NK displays a high expression rate of CCR5 and CXCR4 among chemokine receptors. Through this, the company explained that it is expected to have excellent targeting and anti-tumor abilities against solid tumors expressing the chemokine ligands.
Cryopreservation technology for long-term storage and distribution is the key to the commercialization of allogeneic NK cell therapy. GICELL also proved its cryopreservation technology with no significant difference expression rate of the functional markers and viability of T.O.P. NK even after freezing and thawing.
T.O.P. NK shows excellent anticancer activity in tumor-bearing animal models. According to the data in immunodeficient mice (NOG mice) implanted with human cancer cell lines, the growth of various solid tumors (4 types of colorectal cancer, 1 type of head and neck cancer, 1 type of breast cancer) was significantly inhibited by T.O.P. NK administrated via intravenous route compared to the control. In addition, there were no treatment-related adverse events in the toxicity study performed at a Good Laboratory Practice (GLP) institution.
Based on these preclinical data, GICELL submitted an IND for a phase 1 clinical trial for patients with solid tumors and hematologic cancer to the Ministry of Food and Drug Safety (MFDS) in September. Through this clinical trial, GICELL will evaluate the safety, tolerability, and efficacy of T.O.P. NK.
Chun Pyo Hong, CEO of GICELL, said, "There are many other companies that are developing off-the-shelf cell therapies but we find there are still unmet needs in cell therapies that can be manufactured on a large scale. We expect to initiate phase 1 clinical trial in earlier 2023 and hope to treat patients with malignant tumors as soon as possible."
GICELL has recently signed the R&D partnership agreements of CAR-NK with HK inno.N Corp. and Cartexell Inc. based on its outstanding immune cell expansion technology.