Investigator-initiated trial (IIT) of AT101 for relapsed/ref…

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First patient dosed in Phase 2 clinical trial

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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." 

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."   

Promising Efficacy of AT101 CAR-T for Blood Cancer

SEOUL, South Korea, April 17, 2023 /PRNewswire/ -- AbClon, a South Korean biotech firm, presented non-clinical and phase 1 interim results of its AT101 novel CAR-T therapy at the annual 2023 AACR conference. AT101 targets the CD19 protein for treatment of blood cancer.AT101 demonstrated superior anti-cancer efficacy compared to FMC63-based CAR-T therapies in non-clinical data. AT101 utilizes the h1218 antibody, developed through AbClon's Novel Epitope Screening Technology (NEST), and binds in a unique manner to CD19. AT101 demonstrated efficacy even in CD19 mutant cancer cell models that did not respond to FMC63-based CAR-T therapies. Overall, AT101 has the potential to provide new treatment opportunities for patients including those who do not respond to currently available CAR-T therapies.An open-label, non-randomized, multicenter phase 1 study was conducted at three different dose levels in patients with relapsed / refractory B-NHL. The results of the first two dose levels in Phase 1, low and medium, have been determined. For medium dose, although the dosage administered to patients is lower than that of currently available CAR-T therapies, all three patients achieved complete response (CR) four weeks after administration. Even at 5-fold lower dosage to medium dose, CR was observed in 3 out of 6 patients and partial response (PR) was observed in 2 patients. Cytokine release syndrome (CRS) and neurotoxicity (ICANS), which appear as side effects of CAR-T therapy, were also observed at low levels of 11.1% and 22.2%. In particular, the rate of 3 or higher grade on side effects was 11.1%, showing encouraging signs with regard to safety. Clinical trial of high dosage level is currently in progress.AT101 was administered to patients with diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL). Effective responses to AT101 potentiate the application of AT101 for different types of hematologic malignancies.Research teams led by Professor Marco Ruella of Perelman School of Medicine at University of Pennsylvania, Professor Junho Chung of Seoul National University College of Medicine, and Professor Dok hyun Yoon of Asan Medical Center are participating in this study.AbClon owns independent intellectual property rights for the technologies applied to AT101 and is currently building channels for global expansion with local partners. AT101 patent registration has been completed in U.S., Canada, Japan, and South Korea. Further registrations are underway in Europe and China.Jong-Seo Lee, CEO of AbClon, said, "AT101 showed promising results in r/r B-NHL patients, including multiple CRs in the dose escalation stage and excellent safety. We are hopeful for ongoing trials of AT101 to provide more affordable and effective treatment opportunities to patients fighting blood cancer."For more information on the ongoing trial, refer to the ClinicalTrials.gov Identifier: NCT05338931Details of the presentation are as follows:• Presentation Title: An open label, dose escalation, phase 1 study of AT101, a novel CD19-directed CAR-T cell therapy targeting a membrane-proximal epitope of CD19, in patients with relapsed or refractory B cell non-Hodgkin lymphoma• Session Title: Phase I Clinical Trials in ProgressAbout AT101AT101 is a CAR-T therapy that targets CD19 protein for blood cancer.AbClon has initiated a Phase 1/2 clinical study of AT101 in adults with relapsed or refractory B-cell non-Hodgkin lymphoma (NCT05338931)Phase 1/2 study is being conducted in Asan Medical Center and Ulsan University Hospital under the support of the Korea Drug Development Fund (KDDF) in Korea.About AbClonAbClon is a biopharmaceutical company with a robust, wholly owned R&D pipeline in oncology. It is headquartered in Seoul, South Korea. Further information about the company and its drug development programs and capabilities may be found online at https://www.abclon.com/en/

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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."