LC autologous blood origin T lymphocyte

YONGIN, South Korea, July 21, 2024 /PRNewswire/ -- GC Cell Corporation (hereinafter referred to as "GC Cell"; 144510:KOSDAQ) and Lukas Biomedical Co., Ltd. (hereinafter referred to as "Lukas," TWSE 6814) has formally signed an international strategic cooperation agreement. GC Cell is a fully integrated pioneer in cell and gene therapy and a subsidiary of the renowned Korean-listed pharmaceutical group Green Cross Corporation, which has a market value of approximately 1.3 trillion Korean won (around 1 billion US dollars). Continue Reading This collaboration aims to increase awareness of autologous T cell therapy as well as to expand the patient access market through leveraging each other's strengths in innovative cell treatment areas. By sharing cutting-edge research projects, clinical trial data, regulatory knowledge across multiple countries, and exploring clinical research, market development, and various activities for cancers and other challenging diseases, both parties strive to accelerate drug development and establish a platform for precision medicine solutions. This partnership seeks to bring the benefits of innovative cell therapy to a wider range of patients. Having successfully completed clinical trials in Japan and Korea, GC Cell's Immuncell-LC autologous T cell therapy obtained approval from the Ministry of Food and Drug Safety (MFDS) in 2007 following favorable Phase IV trials. With a track record of over 10,000 treatment cases, GC Cell has been obtaining successful clinical and commercial records in Korea. Lukas's LuLym-T memory T cell cultivation technology originated from Japanese National Cancer Center and GC LTEC, formerly Lymphotec, a subsidiary of Green Cross Group. Based on the licensing agreement with originator of the technology and the tech transfer from the company, Lukas has brought this technology to Taiwan for market expansion and further enhancement. Taiwan's government has demonstrated significant commitment to the advancement of the regenerative medicine sector. Following the implementation of the Special Regulations on Regenerative Medicine, the Regenerative Medicine Act was enacted on June 4 this year. Lukas's LuLym-T cell therapy technology, supported by international clinical trials and evidence-based data generated by GC Cell, aligns closely with Taiwan governmental policies and regulations. It appears poised to secure a five-year conditional approval under the new regulations, thus establishing Lukas as a prominent player in Taiwan's cell therapy landscape, with a focus on domestic growth and global market expansion. Presently, Lukas has entered agreements with 13 medical institutions, including National Taiwan University Hospital, Chang Gung Memorial Hospital, and Taipei Veterans General Hospital, to conduct Phase II clinical trials focused on preventing liver cancer recurrence and exploring combined immunotherapy with chemotherapy/radiotherapy for head and neck cancer at Taipei Veterans General Hospital. Lukas' Chairman, Dr. Eric Tang, highlighted that GC Cell and Lukas will collaborate through a Joint Committee (JC) to exchange expertise and experience in researching memory T cell technology for various cancers in their respective countries. This collaboration involves sharing clinical and commercial knowledge, insights, and strategies, as well as exploring opportunities for cross-licensing and conducting joint clinical trials (IITs and SITs) in each other's regions. Moreover, they aim to discuss the opportunities to jointly explore new international markets, joint investment and beyond. James Park, CEO of GC Cell, stated, "This strategic cooperation agreement represents a pivotal milestone in accelerating the advancement of innovative cell therapies in Korea and Taiwan and also in establishing global network and ecosystem of Cell and Gene Therapy. Looking ahead, we are committed to accelerating the global expansion of Immuncell-LC through the continuous exchange of clinical research data and the establishment of a strong, long-term partnership between our two companies." Dr. Eric Tang, Chairman of Lukas stated that: "In addition to our clinical trial for preventing liver cancer recurrence, the Taiwanese government's implementation of the Special Regulations on Regenerative Medicine has allowed us to apply our LuLym-T cell technology on advanced stage cancer patients with various types of solid tumors. We have accumulated vast clinical experience in concomitant use of LuLym-T cell together with conventional treatment, such as: chemotherapy, radiotherapy, and checkpoint inhibitors. We are able to achieve significant prognostic improvements using a multi-modality treatment paradigm for advanced stage cancers and we hope we will be able to help more cancer patients in need by sharing our experience with other countries". This strategic cooperation represents a significant step toward a shared vision of improving patient outcomes through innovative cell therapies and precision medicine. About Immuncell-LC Immuncell-LC is the only commercially available treatment option of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events.  About GC Cell   With a core focus on cell therapy, GC Cell offers complete bio healthcare solutions from diagnosis to treatment, and the brand's comprehensive value chain spans R&D, production, commercialization, and distribution. More info: About Lukas Biomedical Lukas is dedicated to advancing its LuLym-T cell therapy R&D and clinical advancements, enhancing clinical trials and technologies, and expanding into foreign markets. Lukas has already attracted interest in Southeast Asia and is in talks and finalizing cooperation agreements with medical teams in the region. With a steady cash flow from its e-commerce business and hospital management platform, Lukas is well-positioned to expand its "LuLym-T" cell therapy business and, generating optimum value for shareholders and employees. SOURCE GC Cell

Collaboration explores the potential synergistic effects of Checkpoint’s anti-PD-L1, cosibelimab, in combination with the autologous T cell therapy, Immuncell-LC YONGIN, South Korea and WALTHAM, Mass., July 15, 2024 (GLOBE NEWSWIRE) -- GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics ("Checkpoint") (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint’s anti-PD-L1 antibody with dual mechanism of action, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer (“CIK”) T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction. Positive preliminary data from these studies could potentially pave the way for future in vivo research and clinical studies. The anticipated synergy between cosibelimab’s antibody-dependent cellular cytotoxicity (“ADCC”) mechanism of action and Immuncell-LC’s robust autologous CIK T cell response is supported by extensive research. This combination is expected to leverage immune system components more effectively in targeting and eliminating cancer cells. James Park, CEO of GC Cell, highlighted the agreement's potential: "This collaboration is a pivotal step towards significant technological collaborations. The integration of cosibelimab's clinical efficacy and safety profile with our Immuncell-LC could set new therapeutic standards in immuno-oncology. We are optimistic that this partnership will lead to effective commercial licensing or joint development in the future." James F. Oliviero, CEO of Checkpoint Therapeutics, concurred: "Both cosibelimab, with its dual mechanism of action, and Immuncell-LC show great promise as potential immuno-oncologic therapies. We are pleased to work in collaboration with GC Cell to determine if using the two therapies in combination may offer even greater potential benefits than being used singly." About Immuncell-LCImmuncell-LC stands as the sole commercially approved adoptive T cell therapy for hepatocellular carcinoma adjuvant treatment. Comprising autologous, significantly expanded CIK (Cytokine Induced Killer) T lymphocytes, it has demonstrated proven efficacy in a large-scale Phase 3 clinical trial—reducing the risk of recurrence by 37% and decreasing mortality by 79% compared to the active surveillance group. Administered to over 10,000 patients in South Korea, Immuncell-LC has shown an excellent safety profile without treatment-related serious adverse events. About CosibelimabCosibelimab is a potential differentiated, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (“PD-L1”) and blocks the PD-L1 interaction with the programmed death receptor-1 (“PD-1”) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained high tumor target occupancy of PD-L1 to reactivate an antitumor immune response and the additional potential benefit of a functional Fc domain capable of inducing ADCC for potential enhanced efficacy. About GC Cell With a core focus on cell therapy, GC Cell offers complete bio healthcare solutions from diagnosis to treatment, and the brand's comprehensive value chain spans research and development, production, commercialization, and distribution. More info: https://gccell.com/ About Checkpoint TherapeuticsCheckpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential differentiated anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cutaneous squamous cell carcinoma (“cSCC”). Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com. Checkpoint Therapeutics’ Forward‐Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies and the dual mechanism of action of cosibelimab translating into potential enhanced efficacy, and the potential to realize synergies and greater potential benefits in combining cosibelimab with Immuncell-LC than being used singly. Factors that could cause our actual results to differ materially include the following: the risks and uncertainties associated with the regulatory review process for cosibelimab; whether or not the U.S. Food and Drug Administration (“FDA”) will determine that the cosibelimab Biologics License Application (“BLA”) resubmission is complete and acceptable for review; uncertainties regarding the timeline of FDA review of the resubmitted BLA, if accepted for review; any inability to successfully work with the FDA to find a satisfactory solution to address any concerns in a timely manner or at all during the review process for the BLA, including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA; our ability and the ability of our third party contract manufacturing organization (“CMO”) to adequately address the issues raised in the complete response letter; any potential facility inspection or re-inspection that may be required regarding our third party CMO or otherwise; whether the FDA accepts the data and results as included in the BLA resubmission at levels consistent with the published results, or at all; our ability to execute a partnering relationship for commercialization of cosibelimab, if approved, on acceptable terms, if at all; the risk that our third-party CMO will not meet deadlines, and/or comply with applicable regulations; the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Checkpoint Contact:Jaclyn JaffeCheckpoint Therapeutics, Inc.(781) 652-4500ir@checkpointtx.com Checkpoint Investor Relations Contact:Ashley R. RobinsonManaging Director, LifeSci Advisors, LLC(617) 430-7577arr@lifesciadvisors.com Checkpoint Media Relations Contact:Katie KennedyGregory FCA610-731-1045Checkpoint@gregoryfca.com