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150

AbClon Enters into Clinical Trial Agreement with Korea Drug …

AbClon announced on the 17th that it has signed a clinical trial agreement with the Korea Drug Development Fund (KDDF) for a Phase 2 trial of its novel CD19 epitope-targeting CAR-T therapy, AT101.   This Phase 2 trial is part of the National New Drug Development Project and will receive funding for two years. The primary objective is to evaluate the objective response rate, and secondary objectives include assessing tolerability, efficacy, and pharmacokinetic properties.   AT101 is a CAR-T therapy targeting CD19 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It has demonstrated promising results in a previous Phase 1 trial, also supported by the KDDF, showing a high initial response rate and encouraging follow-up data.   Currently, the Phase 2 trial is being conducted at seven hospitals across South Korea. AbClon claims that AT101 has shown superior efficacy and durability compared to existing global CAR-T therapies, with higher initial response rates and encouraging long-term follow-up data. The unique mechanism of action of AT101, incorporating the h1218 antibody in its CAR-T construct, has been published in the prestigious journal Molecular Cancer.   "We are committed to maximizing the potential of AT101 as a globally competitive new drug by also securing treatment results for patients who are refractory to or relapse after existing CAR-T therapies," said a representative from AbClon. "Based on the clinical trial results, we will strive for expedited approval from the Ministry of Food and Drug Safety."   Meanwhile, in the Phase 1 trial, AT101 achieved a complete remission (CR) in all patients who received medium and high doses. The low-dose cohort consisted of six participants, accounting for half of the overall responses. Despite including patients who received a minimal dose—approximately 4% of the planned Phase 2 dosage—AT101 demonstrated outstanding outcomes, with an overall survival (OS) rate of 82.5% and a progression-free survival (PFS) rate of 66.7%.  

2024-06-17 164
149

Groundbreaking CD30 CAR-T Therapy Research Published in Natu…

AbClon announced on June 5, 2024, that the research findings of a novel immunoregulatory CAR-T (Chimeric Antigen Receptor T-cell) therapy, conducted with the research team at the University of Pennsylvania, have been published in the June issue of Nature Immunology (Impact Factor: 30.5), a globally renowned journal in the field of immunology. The research team conducted single-cell RNA-sequencing and identified the dominant interactions of immunosuppressive cellular compartments and effector T cells in a patient with malignant tumor Hodgkin's lymphoma. Through this study, they discovered that cancer cells evade immune cell therapy by establishing a sophisticated immune escape mechanism through the binding of BTLA (B- and T-lymphocyte attenuator) on healthy immune cells and HVEM (Herpesvirus entry mediator) on cancer cells. Their findings demonstrated that the BTLA-HVEM axis functions as a critical immune checkpoint in CAR-T therapy for both hematologic and solid tumors. To verify the anti-cancer efficacy in Hodgkin's lymphoma, the team developed a CAR-T therapy targeting CD30, a well-known marker for activated T cells. However, conventional anti-CD30 antibody-based therapies have been associated with fratricide, a phenomenon where T cells attack and kill each other due to self-recognition. To address this, the research team identified and engineered a CD30-targeting antibody that does not induce fratricide, enabling the development of a more effective CAR-T therapy. Based on these findings, they further engineered a BTLA knockout CD30 CAR-T therapy using gene-editing technology, thereby overcoming the immune escape mechanism of cancer cells and enhancing therapeutic efficacy compared to conventional CAR-T therapies. An AbClon representative stated, "We jointly filed a US patent with the University of Pennsylvania last year to secure intellectual property rights and are currently in proceeding with an international patent application (PCT). Moving forward, we will expand our collaborative research and development with the University of Pennsylvania for CD30 CAR-T therapy while strengthening discussions on commercialization, including potential technology transfer."  

2024-06-05 149
148

Henlius’ Global Phase 3 Trial Approved by FDA

On the 8th, AbClon announced that China’s Henlius Biotech (Henlius) has received approval from the U.S. Food and Drug Administration (FDA) for the submission of an Investigational New Drug (IND) application for its Phase 3 clinical trial of HLX22. HLX22 is based on AC101, which AbClon licensed to Henlius in 2016. It is being developed as a first-line treatment for HER2-positive locally advanced and metastatic gastric cancer and is currently undergoing a Phase 2 clinical trial in combination with Herceptin and chemotherapy. The Phase 2 trial is expected to be completed this year. According to Henlius, this therapy can target areas that immune checkpoint inhibitors fail to reach. HLX22 has demonstrated more than three times the efficacy of standard therapy in terms of objective response rate (ORR), a key indicator of treatment effectiveness. The median progression-free survival (mPFS) for HLX22 was confirmed to be at least 15.1 months, significantly outperforming competing treatments. In comparison, the current standard therapy has an mPFS of 6.7 months, while the combination therapy with Keytruda achieves 10.8 months. Additionally, the median duration of response (mDOR) for the HLX22 regimen was recorded at a minimum of 12.4 months, compared to 6.9 months for standard therapy and 11.2 months for the Keytruda combination. With its differentiation from global treatments, HLX22 has demonstrated the potential to become a First & Best-in-Class therapy. An AbClon representative stated, “If the results of AC101’s Phase 2 clinical trial are validated, this will bring great hope to gastric cancer patients as a global first-line treatment for HER2-positive gastric cancer.” Meanwhile, on January 22, SangSangIn Investment & Securities Co.,Ltd. reported that AbClon’s AT101 pipeline is expected to bring global licensing opportunities upon successful clinical results. AbClon plans to present follow-up data from its AT101 Phase 1 clinical trial at the upcoming American Society of Clinical Oncology (ASCO) meeting in June. 

2024-05-08 132
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Investigator-initiated trial (IIT) of AT101 for relapsed/ref…

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2024-04-30 112
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First patient dosed in Phase 2 clinical trial

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2023-12-12 123
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AbClon's AT101 Featured in Molecular Cancer Journal

AbClon announced on the 11th that the unique mechanism of action and Phase 1 clinical trial results of AT101, its novel CAR-T therapy, have been published in Molecular Cancer (Impact Factor: 37), one of the prestigious journal in oncology.   Molecular Cancer ranks among the top 1% of cancer research journals worldwide. The corresponding authors of the study include Professor Marco Ruella from the Center for Cellular Immunotherapies at the University of Pennsylvania, Professor Dok Hyun Yoon, Director of the CAR-T Center at Asan Medical Center, Professor Junho Chung of the Cancer Research Institute at Seoul National University College of Medicine, and Dr. Jong-Seo Lee, CEO of AbClon.   The published study highlights three distinct features of AT101, a novel CAR-T therapy independently developed by AbClon, along with its unique efficacy demonstrated in Phase 1 clinical trial.   First, AT101 maximizes the cancer cell killing effect by binding more closely to the patient’s cancer cells than conventional CAR-T therapies. Second, it responds more quickly to cancer cells with a quick "hit and run" mechanism, enabling continuous attacks without exhaustion. This sustained cancer cell killing reaction allows AT101 to maintain a prolonged and potent anti-cancer effect in the patient's body, distinguishing it from existing CAR-T therapies. Third, AT101 uses a humanized antibody instead of a murine-derived one, extending the lifespan of CAR-T cells and enhancing therapeutic durability.   Due to these characteristics, AT101 demonstrated remarkable clinical outcomes in the Phase 1 trial conducted on blood cancer patients. Among the mid- and high-dose cohorts, all six patients achieved complete remission (CR). At the time of publication, patients had maintained their remission for a period ranging from six to 18 months without any relapse. This is a stark difference from conventional CAR-T therapies, where nearly half of the patients experience relapse within six months post-treatment.   Beyond its potency and durability, the study also highlights AT101’s effectiveness against patient-derived models resistant to CAR-T therapies using the FMC63 antibody, which is utilized in Novartis' Kymriah and Gilead’s Yescarta. Unlike these therapies, which failed to show any initial efficacy in certain resistant patient-derived models, AT101 successfully demonstrated therapeutic effects.   The findings on AT101 have also been covered by leading international media outlets and featured as a major news update on the University of Pennsylvania’s official website. According to the report, Professor Marco Ruella commented, "AT101 has the potential to address blood cancer patient populations that existing CAR-T therapies have failed to treat."   An AbClon representative stated, “The publication of this study confirms the outstanding therapeutic potential of AT101 in blood cancers. It also serves as an opportunity to showcase AT101 and AbClon to the global medical and biotech industries. With exclusive patent rights that do not infringe on existing CAR-T therapy patents, we are now more confident in driving AT101’s global expansion."   Professor Dok Hyun Yoon of Asan Medical Center, who participated as a co-corresponding author, remarked, "AT101 is a novel CD19 CAR-T therapy optimized for antigen binding using a humanized antibody. Its distinctive properties, validated through experimental studies and a Phase 1 clinical trial, provide strong evidence of its safety and therapeutic potential."   Professor Junho Chung of Seoul National University College of Medicine, who also participated as a co-corresponding author, added, "Developing antibodies for CAR-T therapies requires advanced technical expertise. Until now, all approved CD19 CAR-T therapies have utilized the same murine-derived antibody. However, AbClon has developed a CAR-T therapy using a novel humanized antibody. This achievement highlights AbClon’s outstanding technological capabilities and raises expectations for the development of its next-generation CAR-T therapies." 

2023-12-11 139
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AbClon’s AM109 Project Selected for KDDF Program

AbClon announced on the 6th that its AM109 project has been selected for the third round of the 2023 National New Drug Development Program, led by the Korea Drug Development Fund (KDDF). AM109 is a T cell engager therapy specifically targeting refractory prostate cancer by targeting the PSMA and 4-1bb on tumor cells and T cells respectively, utilizing the company's proprietary AffiMab platform technology. Refractory (castration-resistant) prostate cancer is the most severe stage of prostate cancer, where the tumor has metastasized beyond the prostate to other parts of the body. According to the National Cancer Information Center, the average survival time for patients with this condition is only 2-3 years, and current treatment options remain limited in both availability and efficacy. The results of an international clinical trial reported in August showed that the combination of the immune checkpoint inhibitor Keytruda (pembrolizumab) and chemotherapy for metastatic castration-resistant prostate cancer did not show significant improvement as expected AbClon utilizes its unique AffiMab bispecific antibody platform, which leverages affibody that are 1/25 the size of conventional antibodies to recruit T cells. This affibody is then linked to an antibody that specifically targets prostate cancer cells, maximizing the anti-cancer effect. AbClon is also developing AM105, an innovative bispecific antibody therapy for colorectal cancer, using the same platform technology. A company representative stated, "With the support of the Korea Drug Development Fund, we will be able to accelerate research on this new pipeline," adding, "We are committed to developing bispecific antibody therapies that can significantly enhance treatment efficacy and survival rates for prostate cancer patients."   

2023-12-06 115
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