GI Cell has won approval for phase 1 IND (investigational new drug) for allogeneic NK cell therapy. The company will also push for its combined administration with immunotherapy candidate substance of its affiliate, GI Innovation. GI Cell said Monday that it has obtained approval for the phase 1 clinical trial of its allogeneic NK cell therapy, GIC-102 (T.O.P. NK), from the Ministry of Food and Drug Safety. Large medical institutions, including Korea University Anam Hospital, Seoul National University Hospital, and Asan Medical Center, will conduct the clinical trial beginning in the first half year.In phase 1 clinical trial, GI Cell plans to confirm the safety, drug resistance, and pharmacokinetics/pharmacodynamics of GIC-102 in patients with progressive solid cancers, recurrent/refractory non-Hodgkin lymphoma, and multiple myeloma.According to GI Cell, GIC-102 is a next-generation NK cell therapy that maximizes tumor-targeting function and cancer cell-killing efficiency. Its mass culture with high purity is also possible using immune cell pure expander, GI Cell’s technology to mass-culture immune cells.GI Cell has proved GIC-102’s efficacy in various solid cancers through non-clinical trials using a humanized mouse, particularly its consistent cancer-growth-suppressing efficacy in the mouse transplanted with various types of colorectal cancer cell lines.In phase 1 clinical trial, GI Cell will evaluate not only the administration of GIC-102 alone but also its combined administration with GI Innovation’s double fusion protein, GI-101. GI-101, for which a phase 1/2 clinical trial is underway, is a fusion protein of CD80 that targets immune cells and IL-2v, an IL-2 variation that has overcome the disadvantages of IL-2.“GI-101 proliferates and activates NK cells by uniquely binding to receptors expressed in NK cells and is expected to show superior synergy in various solid cancers, including colorectal cancer, through a combined therapy with T.O.P. NK,” said GI Innovation Chairman Chang Myeong-ho said. “NK cells activated by GI-101 induce the expression of chemokine receptors that help smooth infiltration into tumor cells.”GI Cell CEO Hong Cheon-pyo said, “We have moved one step closer to our goal of providing a new treatment option for patients who do not respond to standard treatments. The combined therapy of T.O.P. NK and GI-101 has shown unparalleled durability and efficacy, so we will go all out to win approval as soon as possible by proving their efficacy in clinical trials.”GI Cell said it has a GMP facility of 3,300 square meters to manufacture and supply clinical samples independently. Besides, the company has won permits to manufacture high-technology biopharmaceutical products and to manage human cells and aims to get permission for a cell disposal facility within the first half of this year.link: https://www.koreabiomed.com/news/articleView.html?idxno=20903

- Data supporting high expression of activation and tumor targeting markers of NK cells mass cultured without feeder cells- Proved the excellent anti-tumor efficacy in various solid tumor-bearing animal model- Submitted an IND for phase 1 trial for T.O.P. NK to MFDS last SeptemberSEONGNAM, South Korea--(BUSINESS WIRE)--GICELL announced 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) held in Boston, MA, US. The SITC is one of the world's top three cancer societies and has been known as the largest conference in the field of immuno-oncology. 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.Link: https://www.businesswire.com/news/home/20221113005163/en/GICELL-Announces-the-Preclinical-Research-Data-Demonstrating-the-Superiority-of-the-NK-Cell-Mass-Culture-Platform-at-the-Society-for-Immunotherapy-of-Cancer

GI CELL announced research and development collaboration for allogenic CAR-NK candidates with HK inno.N on August 29th, 2022.The companies plan to advance the development of numerous CAR-NK therapies by harnessing GICELL's outstanding research competency and HK inno.N's extensive experience in development and commercialization of anticancer therapies. As part of this agreement, the companies may open up a discussion on further developments, including clinical development and commercialization, if they succeed in discovering CAR-NK cell product candidates and producing non-clinical samples.GICELL, pioneering novel technology for large-scale immune cell manufacturing, expects to demonstrate its technology on scalable culture under this research agreement.In February, GICELL set a new world record in culturing highly active natural killer cells with 200 liters. The company's manufacturing technology obtained a patent registration decision in Taiwan in July, following the corresponding patent registration in Korea at the beginning of the year.HK inno.N, a company deeply committed to the development of breakthrough therapies and biopharmaceutical products with high market value, has developed K-CAB Tablet, a new blockbuster drug, and is enjoying unbeatable shares in basic fluid and anti-hangover beverage markets. Currently, the company has established GMP facilities based on its belief in the anticancer therapeutic potential of cell and gene therapy products as a future growth engine and seeks to secure its core competitiveness by developing a wide range of pipelines.Sung Yoo Cho, CSO and Vice President of GICELL, a global expert on CAR-NK, confidently commented, "Allogeneic NK cells developed by GICELL have joined the lead group in the CAR-NK field by avoiding NK cell exhaustion through the adjustment of binding force of cytokine receptors during the cell culture and markedly improving the efficiency of CAR gene introduction in NK cells, which are generally known as challenging for gene expression, compared to T cells."Sung Yong Won, Head of the Bio Research Center and Managing Director of HK inno.N said, "HK inno.N is conducting research with many companies possessing technological competitiveness in cell therapy products to accelerate the development of anticancer immune cell therapy products. The company will continue to develop its promising CAR-NK pipelines through this research and development collaboration with GICELL."GICELL and HK inno.N will co-develop CAR-NK programs with the aim of initiating the clinical phase of CAR-NK cell therapy products by 2024.Link: https://www.asiatoday.co.kr/view.php?key=20220829000939567

GI-Cell partners with Helixmith and Cartexell to develop cell therapy technologyGI-Cell, a South Korean developer of immune cell therapy products, has partnered with DNA and protein-based therapeutics companies to jointly develop cell therapy technologies involving immune cells to enhance disease-fighting abilities of target patients. GI-Cell has signed a memorandum of understanding with Helixmith and Cartexell to develop cell therapy medicine based on an immune cell expander platform. GI-Cell hopes to target the global immune cell therapy market through collaboration. "We will do our best to come up with successful achievements in the cell therapy sector through collaboration with Helixmith and Catexell with full experience, technology, and manpower," GI-Cell CEO Hong Chun-pyo said in a statement on April 28. Link: https://www.ajudaily.com/view/20220429145108970

GI Innovation·GI Cell·Yonsei University Health System, Signed MoU to establish a cell therapy center for advanced biopharmaceutical (x-from left)Jun-Ho Hong CEO of GI Innovation, Dong-Sup Yoon President & CEO of Yonsei University Health System, Chun-Pyo Hong CEO of GI Cell-GI Innovation·GI Cell, respectively establishing a cell therapy center at Severance Hospital·Songdo Severance Hospital(tentative named) -Establishment of the seamless process for research, production, clinical trials, Regulatory affair (RA), and etc. of advanced biopharmaceutical GI Innovation, a new innovative drug development company, announced on March 3rd that it has signed MoU with its allied company, GI Cell and Yonsei University health System (YUHS) for establishment of cell therapy center for advanced biopharmaceutical. The MoU ceremony was held on 2nd in YUHS and Myong-Ho Jang Chairman, Jun-Ho Hong CEO of GI Innovation and Chun-Pyo Hong CEO, Sung-Yoo Cho CSO of GI Cell and Dong-Sup Yoon President & CEO of Yonsei University Health System, Dae-Hyun Lew Dean of Yonsei University College of Medicine, Jong-Won Ha General Director of Severance Hospital etc. have attended. Through the MoU, GI Innovation and GI Cell will increase production capability of advanced biopharmaceutical with YUHS through establishing GMP facilities, etc. in Severance Hospital and Songdo Severance Hospital(tentative named).In addition, they will progress joint research, research facilities and equipment, academic conferences, seminars, and etc. that are essential towards advanced biopharmaceuticals such as cell therapy, protein new drugs, antibody drugs, and etc. Accordingly, it will be possible to establish seamless process such as research, production, clinical trials, and RA of innovative cell therapy through the collaboration with GI Innovation’s knowhow on a new innovative drug, GI Cell’s differentiated immune cell culture- technology and YUHS which has high clinical trials, treatment and research capabilities. Myung-Ho Jang, Chairman of GI Innovation, said, “We were secured a base camp to provide hope for terminal cancer patients who do not have any treatment options through establishing a GMP facility in Severance Hospital, x-where clinical doctors x-from all over the world are stationed. We will do our best to maximize innovative efforts and efficiency through close cooperation.” Chun-Pyo Hong, CEO of GI Cell, said, “Through the establishment of cell· gene therapy integrated production center, YUHS and GI Group, we are prepared to accelerate clinical trials and research. We will continue to make active efforts to create platform which can grow sustainably through a joint cooperation system.” Dong-Sup Yoon President & CEO of Yonsei University Health System, said, “This MoU is a springboard to overcome an incurable disease. We will make opportunities to each organizer as well as the entire domestic bio industries through implementing of industry-academic collaboration model, medicine development and production, clinical application that organically connects.” GI 혁신의 회장 인 명호 장은 "우리는 전 세계의 임상 의사가있는 퇴직 병원에서 GMP 시설을 갖춘 치료 옵션이없는 터미널 암 환자에게 희망을 제공하기 위해 기본 캠프를 확보했습니다. 주둔다.

GI Cell sets new record in culturing highly active natural killer cellsGI Cell, a South Korean developer of immune cell therapy products, claimed to have set a new world record in culturing highly active natural killer cells with 200 liters. Natural killer (NK) cells are a type of white blood cell and are seen as a promising tool for use in adoptive immunotherapy because they efficiently attack cancer cells or cells infected with viruses or bacteria.Because NK cells are the most powerful immune cells in the human body and are extremely safe due to not inducing immune rejection when other people's cells are transplanted, many companies are striving to develop NK cell therapy products in an off-the-shelf form. GI Cell, affiliated with South Korea's bio-venture company GI Innovation, said that the culturing of 200 liters of NK cells has not been officially reported by any leading domestic and international NK cell therapy companies. Link: https://www.ajudaily.com/view/20220216150445371

GICELL, selected as a company to present ‘Biotech Showcase 2022’- Given the opportunity to introduce a core technology and major pipelines to participating global pharmaceutical companies- Actively seeking investment attraction and strategic partnerships ahead of clinical entry GICELL was selected as a presentation company at the Biotech Showcase 2022, x-x-where executives and potential partners of global pharmaceutical companies and investment companies worldwide come together. Dr. Hee Hyung Lee, Vice President and Chief Business Officer of GICELL, will present an overview of the company and pipelines as well as provide more detail on the technology. Biotech Showcase 2022 will be held through online meeting x-x-from January 10 to 12 and 17 to 19. This event, hosted by Demy-Colton and EBG Group since 2008, brings an exchanging and communication platform and investment opportunities for innovative pharmaceuticals and investors. It is held annually on a similar schedule with JP Morgan Healthcare Conference, the largest healthcare investment conference worldwide. GICELL will ‘showcase’ its differentiated core culturing technology using ancillary proteins and the pipelines including allogeneic NK cell therapy (T.O.P. NK). In addition, it plans to hold one-on-one partnering meetings with multinational companies and investors to discuss investment attraction and strategic partnerships. Dr. Chun Pyo Hong, CEO of GICELL, remarked, "Biotech Showcase 2022 is a great opportunity to introduce our various immune cell therapy pipelines under development and our strengths to potential investors and partners", and then added, "We hope to expand investment and partnering opportunities through this event and see good results." GICELL's cell therapy candidate, T.O.P. NK is a high-purity, highly active NK cell that targets cancer and cultured under optimized conditions. GICELL plans to submit an IND application for Phase 1 clinical trial. Our competitors produce NK cells by co-culturing cancer cell-derived feeder cells or genetically modifying them to enhance their performance. In contrast, GICELL applied the proprietary ‘Immune Cell Pure Expander Platform’ using ancillary proteins without cancer cell-derived feeder cells or genetic modification to grow NK cells with augmented performance without safety concerns. The company has proven world-class culturing technologies by successfully scaling up its technology for the 50L culture process. While the indications for current cell therapies are mainly applicable for hematologic cancers, the efficacy of T.O.P. NK is expected to expand its potential to treat solid cancers.

GICELL acquired a manufacturing license for advanced biopharmaceuticals and is selected as an eligible entity for the Smart Factory Construction and Advancement Project by the Ministry of SMEs and Startups.- Recognized for its manufacturing base of advanced biopharmaceuticals by obtaining the manufacturing license - Establishment of a smart factory crystallized with cutting-edge technology and quality advancement GICELL’s GMP facilities (Photo provided by GICELL) GICELL acquired a manufacturing license for advanced biopharmaceuticals x-x-from the Ministry of Food and Drug Safety. The ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ (Advanced Regenerative Bio Act), which took effect in August last year, stipulates that companies obtain a manufacturing license for advanced biopharmaceuticals to manufacture advanced biopharmaceuticals such as cell therapy products and gene therapy products. GICELL's GMP(Good Manufacturing Practices for Good Manufacturing Practices), completed in June to manufacture advanced biopharmaceuticals, was built on a total area of 3,400m2 and a total budget of 20 B KRW is planned to be invested in cell therapy products and protein production facilities. In particular, the facilities have been constructed so that allogeneic NK cell therapy (T.O.P. NK) applied with a ‘feeder free’ culture system without cancer-derived feeder cells can be cultured at the current level of 50L. This is the world's largest scale in the 'feeder free' method and plans to expand the scale to a maximum of 500L in the future to enable large-scale culture. This system is an innovative system that maximizes the safety and cost-effectiveness of NK cell therapy in a way that does not use cancer-derived feeder cells, which are commonly used to activate NK cells in the culture process. GICELL and Kiadis Pharma, which was acquired by global pharmaceutical company Sanofi, are representative of the companies possessing the ‘feeder free’ NK cell culture technology. The company plans to expand its manufacturing facilities for regulatory T cells and cytotoxic T lymphocyte. In addition, the recombinant protein production line for ‘Ancillary Protein’, a unique culture material of GICELL, is also designed to produce up to 200L. The company plans to stride x-x-x-into the CDMO(contract development and manufacturing organizations) business for bio start-ups that develop protein and antibody drugs using the protein GMP facilities. In the GMP facilities, employees with a substantial understanding of pipeline processes directly perform technology transfer and investigational product manufacturing. In addition, all products x-x-from ancillary proteins, the core of the immune cell platform, to various immune cell therapies under development are all manufactured independently. Therefore, the company has the advantage of manufacturing high-quality investigational products promptly instead of reaching out to a CMO(contract manufacturing organization) of cell therapy products that fiercely compete to secure slots. Hyung Min Kim, Head of GMP, explained, “By obtaining this manufacturing license, our facilities have been proven to meet the requirements of the advanced GMP level in the manufacturing facilities, equipment, instrument, quality and operating systems to manufacture advanced biopharmaceuticals.”, and then continued, “Using these facilities, we can also manufacture immune cell-based commercial-grade pharmaceuticals, and as the first step, we will deliver high-quality samples for T.O.P. NK phase-1 clinical trial.” The process of APV for 50L culture of NK cells using a bioreactor (Photo provided by GICELL) Separately, GICELL was finally selected as an eligible entity for the '2021 Smart Factory Foundation and Advancement Project Phase II x-from the Smart Manufacturing Innovation Team of the Ministry of SMEs and Startups, after winning the 10:1 competition. The Smart Manufacturing Innovation Team of the Ministry of SMEs and Startups supports capital expenditures to domestic small and medium-sized manufacturing companies depending on the availability of a smart factory and whether a security solution has been connected, if not established. Upon this selection, GICELL is to receive various forms of advanced support such as smart factory solution construction and automation equipment readied with advanced technology. “The goal is to accelerate the development of GICELL’s excellent cell therapy products by using our recently-approved GMP facilities and to provide treatment options to suffering patients as soon as possible,” said Byeong-Cho Min, chief operating officer. Then, he remarked, “We will grow x-into the world's top-notch immune cell therapy company based on our world-class cell culture technology through our state-of-the-art smart factory facilities."Link for press release (KR version): http://medipana.com/news/news_viewer.asp?NewsNum=290416&MainKind=A&NewsKind=5&vCount=12&vKind=1

GI-Cell opens the way for autoimmune disease treatments by obtaining patent for regulatory T cell large-scale culture technology GI-Cell, a South Korea-based company specializing in immune cell therapy, announced on November 29 that it obtained a domestic patent for a large-scale culture technology of regulatory T cells for the treatment of autoimmune diseases. With this patent, GI-Cell is expected to become a leader in the autoimmune disease space in the country.Regulatory T cells maintain immune system homeostasis through immunosuppression regulation. Regulatory T cells have been in the spotlight as a therapeutic agent for diseases caused by imbalance of the immune system, such as autoimmune diseases. However, the proportion of regulatory T cells among the total T cells is only about 2-3%, making it difficult to separate and culture cells. It is also difficult to develop therapeutic agents because the characteristic properties of regulatory T cells are easily lost during the culturing process. However, GI-Cell succeeded in maintaining highly functional regulatory T cells through its unique and differentiated culture technology with improved productivity.Link: http://www.thebell.co.kr/free/Content/ArticleView.asp?key=202111291753495280109296&svccode=06

GI-Cell, IVI sign MOU to develop next-generation COVID-19 vaccine -To cooperate in clinical development of COVID-19 vaccine candidate-GI-Cell aims to prioritize supplying to Korea and developing countries by developing a vaccine that accommodates mass supply, viral mutation response, safety, convenience of patients From left: Dr. Jae Chan Park, Director of Discovery Team and Dr. Dr. Chun-pho Hong, CEO from GI-Cell; Dr. Jerome Kim, Director General, and Dr. Manki Song, Deputy Director General from IVI at the MOU signing ceremony at IVI Headquarters.GI-Cell, an affiliate of GI-Innovation, a biotechnology company for cell therapy development, signed a memorandum of understanding (MOU) with the International Vaccine Institute (IVI) to develop a COVID-19 vaccine candidate. An MOU signing ceremony was held at IVI headquarters on January 25 with Dr. Myoung-ho Jang, Chairman of GI Group, and Dr. Chun-pyo Hong, CEO of GI-Cell, as well as IVI’s Director General Dr. Jerome Kim, and Deputy Director General of Science Dr. Manki Song in attendance. Under this agreement, GI-Cell will work with IVI on the clinical development of its COVID-19 vaccine candidate. Currently, GI-Cell is developing a COVID-19 vaccine GIC-1114/1114m using GI-COV-VAX, its proprietary protein vaccine development platform. GIC-1114/1114m can not only generate neutralizing antibodies but also induce T-cell responses against SARS-CoV-2 that will hopefully provide better protection against future mutant COVID-19 viruses and is designed to significantly increase the duration of protection. A monkey experiment has confirmed that a single dose induces neutralizing antibody and T-cell responses, which is considered advantageous compared to other products in terms of public health benefit, convenience, side-effects and cost. In particular, with the aim of receiving approval on Phase 1/2 clinical trial in the second half of this year, GIC-1114/1114m will be formulated as multivalent subunit vaccine, a method that is relatively safe and easier to store than other COVID-19 vaccine development techniques.Participants pose for a commemorative photo at the MOU signing ceremony between GI-Cell and the International Vaccine Institute at IVI headquarters on January 25, 2021.“As a next-generation vaccine combining two antigens, we hope that GI-Cell’s COVID-19 vaccine will be able to address various mutations and mutants. We also hope to overcome the polarization of vaccine supply around the world by producing enough vaccine for 2 billion people,” said Dr. Myoung-ho Jang, Chairman of GI Group and the vaccine’s discoverer. “Through joint research and clinical development with talented researchers at IVI, we will successfully develop a safe and effective vaccine for humanity.” IVI Director General Dr. Jerome Kim said, “IVI is pleased to partner with GI-Cell to test novel technology to develop a COVID-19 vaccine. The world needs sufficient supply of safe and effective vaccines to end the pandemic and should be better prepared for evolving mutations of the COVID-19 virus. IVI will continue to expand collaboration with partners around the world to accelerate innovative vaccine technology.” Meanwhile, GI-Innovation, GI-Cell’s parent company that exchanged an MOU with IVI in April last year, is actively conducting R&D activities to develop a COVID-19 vaccine adjuvant based on bilateral collaboration.

GI Innovation Co., Ltd. (CEO Myung-Ho Jang and Su-Youn Nam), GI Cell Co., Ltd. (CEO Cheon-Pyo Hong), GI Biome Co., Ltd. (CEO Bo-Gi Yang), and Yonsei University Medical School Severance Hospital (Hospital director Jong-Won Ha) signed a joint research and academic cooperation MOU for Innovative New Drug Development. The signing ceremony was held at Severance Hospital on the 5th, Young-Jun Koh, head of GI Innovation Discovery Division, Cheon-Pyo Hong, CEO of GI Cell, Bo-Gi Yang, CEO of GI Biome, Jong-won Ha, Head of Severance Hospital, Bo Young Jung, and Eun-Jik Lee, professor of Yonsei University Medical School. This MOU is designed to result in the innovative success of new drug development based on the organic connection of basic-intermediation-clinical trial research.Through this, GI group will lead a study with Severance Hospital to develop protein new drugs and antibody drugs by GI Innovation, innovative immune cell therapy by GI Cell and synbiotics treatment by GI Biome through research unit research task of research-oriented hospital fostering R&D project organized by the Ministry of Health and Welfare. Besides, both organizations will push for the establishment of a joint research center for diagnostic tech, treatment development and hold academic conferences and seminars jointly. "GI wants to challenge the industry's first triple combined therapy by utilizing the three companies' core pipelines," said Myung-Ho Jang, CEO of GI. To treat incurable diseases such as terminal solid tumor, non-alcoholic fatty hepatitis, and Crohn's disease, the combination of antibody drugs, cell therapy, and microbiome will be a groundbreaking treatment. "We expect various clinical experience and research infrastructures to contribute exceedingly to the success of innovative drugs."Jong-Won Ha, head of Severance Hospital, said, "We expect that this agreement will allow us to expand cooperative research and development with GI Group such as GI Innovation and GI Cell, which directly participate in research projects for research-oriented hospitals, furthermore, development of innovative new drugs with global competitiveness and the unmet medical needs will be visible.”