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AbClon, " Presents Latest Research on AM105: Overcoming EGFR Resistance in Existing Colorectal and Lung Cancer Treatments at AACR 2025"
AbClon announced on the 31st that it will present the latest research findings on its immuno-oncology drug candidate AM105 at the American Association for Cancer Research (AACR) Annual Meeting 2025. AACR, the world's largest cancer research conference, will be held in Chicago, USA, from April 25th to 30th. Experts from the global pharmaceutical and biotech industries will gather to present research results and explore global collaborations. The bispecific antibody therapy AM105 is composed of a novel monoclonal antibody based on AffiMab technology and Affibody. It is a next-generation immuno-oncology antibody platform that effectively eliminates cancer cells by simultaneously targeting EGFR, a major tumor target in colorectal and lung cancer, and CD137, the co-stimulatory factors of T-cell. AbClon will present differentiated mechanisms of action and animal study results based on the superior efficacy of AM105. In particular, the company plans to demonstrate the potential of its bispecific antibody platform AffiMab to overcome resistance, focusing on its superior anti-cancer effects compared to existing EGFR-targeted therapies. This is expected to provide new treatment options for patients whose response to existing therapies has diminished due to resistance. Furthermore, AM105 demonstrates potential anti-cancer effects not only in patients with limited response to representative antibody therapies such as Cetuximab and Panitumumab, but also in patients with resistance to EGFR inhibitors such as Gefitinib and Erolotinib. The company explained that this differentiated mechanism of action suggests the potential for AM105 to expand into various cancer types, including colorectal and lung cancer, and is attracting attention as an innovative approach to overcoming EGFR resistance. An AbClon representative stated, "We will pursue collaboration with global pharmaceutical companies and explore various collaboration opportunities such as technology transfer and joint development. We will strive to widely publicize the potential of AM105 as a next-generation therapy for colorectal and lung cancer, and to provide new hope for patients with intractable cancers who lack treatment options due to EGFR resistance." Lung cancer is the most common cancer worldwide, with approximately 2.5 million new cases occurring annually, accounting for 12.4% of all cancers. Colorectal cancer also has 1.9 million new cases annually, accounting for 9.6% of all new cancer cases. The lung cancer treatment market is projected to reach $56 billion by 2030, and the colorectal cancer treatment market is expected to reach $18.1 billion. 2025-03-31
AbClon’s AC101, Dosed to the First Patient Dosed in Japan: Progress Following dosing in the US and China, Accelerating Global Phase 3 Clinical Trials
On the 27th, AbClon announced the first patient dosing in Japan for the international multicenter Phase 3 clinical trial (HLX22-GC-301) of AC101 in combination with trastuzumab and chemotherapy. AC101, which was licensed out by AbClon to Henlius, is being developed under the code name HLX22 as a first-line treatment for HER2-positive advanced gastric cancer and gastroesophageal junction (G∙GEJ) cancer. The principal investigator of the clinical trial is Professor Lin Shen from Peking University Cancer Hospital. In China the first patient dosing of HLX22 has already carried out and the global Phase 3 trial is also underway in the United States. Particularly in Japan, patient dosing proceeded rapidly after a recent investigator meeting, which the company demonstrated high interest and active commitment to the clinical trial. To date, no dual HER2 blockade therapy like this has been commercially approved worldwide for HER2-positive gastric cancer. Gastric and gastroesophageal junction cancer still remain as a global health problem. In 2022, approximately 1 million new cases occurred worldwide, and in Japan, gastric cancer ranked the third in incidence and mortality among all cancers. In the same year, about 127,000 new cases were reported in Japan, with 44,000 deaths. Gastric and gastroesophageal junction cancers are often diagnosed at an advanced stage, leading to poor prognosis, with a 5-year relative survival rate of only 6%. Among gastric cancer patients, about 12-23% are HER2-positive, which is known to have a worse prognosis than HER2-negative cases. The current standard first-line treatment for HER2-positive locally advanced or metastatic cancer is a combination of trastuzumab and chemotherapy, with immunotherapy additionally recommended based on PD-L1 expression (CPS (Combined Positive Score) >1). However, there are still limitations in improving treatment effectiveness and prognosis. HLX22 is an innovative anti-HER2 monoclonal antibody developed by AbClon, which binds to a different site from trastuzumab (HER2 extracellular domain IV) and simultaneously inhibits HER2 homodimers and HER2∙EGFR heterodimers. This mechanism facilitates HER2 receptor internalization and dimer breakdown, maximizing anticancer effects. In Phase 2, HLX22 was administered in combination with HLX02 (trastuzumab biosimilar) and XELOX (chemotherapy) as a first-line treatment for HER2-positive locally advanced/metastatic gastric cancer, resulting in improved treatment efficacy and manageable safety. These study results were officially presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) this year. The Phase 3 trial is a double-blind, randomized, controlled, multicenter study. It aims to compare the efficacy and safety of the HLX22+trastuzumab+chemotherapy combination group versus the trastuzumab+chemotherapy (±pembrolizumab) control group in patients with HER2-positive locally advanced or metastatic gastric and gastroesophageal junction cancers. Participants are randomly assigned in a 1:1 ratio to either the experimental group (HLX22 15mg/kg intravenous infusion + trastuzumab + chemotherapy) or the control group (placebo + trastuzumab + chemotherapy ± pembrolizumab). The primary endpoints are progression-free survival (PFS) and overall survival (OS) assessed by the Independent Radiological Review Committee (IRRC) according to RECIST 1.1 (latest version), and secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DOR), quality of life, safety, immunogenicity, and pharmacokinetic characteristics. The company stated, "With the rapid progress of this clinical trial, Henlius' stock price has also been rising recently, reflecting expectations for HLX22's clinical trial results. Industrial interest is growing as to whether it can establish itself as a new treatment option that complements the limitations of existing HER2 therapies." They added, "Depending on the results of this Phase 3 trial, its potential for future commercialization is also drawing attention." Furthermore, they emphasized, "HLX22's innovative approach, which precisely blocks cancer cell growth signals, has the potential to change the paradigm of cancer treatment. In particular, it can offer hope to cancer patients who have difficulty seeing results with existing treatments." 2025-03-27
AbClon’s HLX22 Expanded Its Development from Gastric Cancer to Breast Cancer Treatment – Expecting Candidate as Diverse Cancer Treatment Options.
AbClon announced on the 26th that HLX22 shall be an innovative new drug with higher efficacy than existing standard treatments and also being developed as a treatment for breast cancer with high HER2 expression. According to Henlius's business report published recently, HLX22 belongs to a key pipeline that shows higher efficacy than existing standard treatments. It is an antibody therapy based on AC101, which AbClon licensed out in 2016, and AbClon is eligible to receive milestones upon clinical trial stages and royalties upon commercialization. HLX22 is an antibody that targets a specific part of the HER2 protein on cancer cells. Unlike existing antibody treatments, it affects cancer cells more appropriately and efficiently by differentiating the antigen-binding site of HER2. When it binds to HER2 along with trastuzumab (HLX02), it has shown to more effectively remove HER2 protein from the cancer cell surface, inhibiting cancer cell growth signals. The combination therapy of HLX22 and trastuzumab showed superior efficacy in gastric cancer treatment compared to the existing combination therapy of trastuzumab and pertuzumab, and showed therapeutic effects regardless of PD-L1 expression levels. In particular, severe diarrhea, which is reported as a frequent adverse event in existing first-line HER2-positive gastric cancer treatments, was not observed with HLX22, indicating positive evaluations in terms of safety. Currently, the standard therapy for metastatic gastric cancer and gastroesophageal junction cancer is the combination therapy of trastuzumab and anticancer chemotherapy, approved in 2010. This therapy showed a progression-free survival of 6.7 months, an overall survival of 13.8 months, and a response duration of 6.9 months. In contrast, the HLX22 combination therapy demonstrated outstanding clinical efficacy, with unreached progression-free survival, overall survival, and response duration as of the 20.3-month median follow-up period. Meanwhile, HLX22 is also being developed as a treatment for breast cancer with high HER2 expression rates, which is expected to further expand its application range. HER2-positive breast cancer accounts for approximately 15-20% of all breast cancers, with 2.3 million new cases occurred annually, and be a key market for HER2-targeted therapies along with gastric cancer. Based on such diverse treatment potential, HLX22 is expected to become a new standard in solid tumor treatment. An AbClon official said, "Following the outstanding efficacy of HLX22 in gastric cancer treatment, HLX22 is showing potential for application in other solid tumor treatments such as breast cancer, and expected to play a crucial role in targeting HER2-positive cancers. We expect HLX22 to provide an important treatment option in more cancer treatment markets in the future." They further emphasized, "HLX22 is innovative approach, which precisely blocks cancer cell growth signals, and has a high potential to change the paradigm of cancer treatment in the future. It can bring hope to cancer patients who do not respond to existing treatments." 2025-03-26
AbClon HLX22 Received FDA Orphan Drug Designation During Phase 3 Trials, Signaling Green Light for Global Commercialization
AbClon's AC101 (HLX22) Received FDA Orphan Drug Designation for HER2-Positive Locally Advanced and Metastatic Gastric Cancer, Signaling a Green Light for Global Commercialization. AbClon announced on the 25th that its AC101 (Henlius’s code name HLX22), an antibody therapy licensed to Henlius in 2016, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive locally advanced and metastatic gastric cancer. FDA ODD status provides various research and development support benefits, including up to 25% tax credits for R&D expenses, grant on clinical trial, exemption from FDA application fees, and eligibility for priority review and accelerated approval (Fast Track). Furthermore, seven years of market exclusivity shall be granted on FDA orphan drug approval, enhancing commercial competitiveness. ODD is considered a significant certification that indicates innovative potential and global R&D competitiveness of a drug candidate, beyond mere regulatory advantages. HER2-positive gastric cancer affects approximately one million new patients worldwide annually and has a poor prognosis with a 5-year survival rate of only 6% due to difficulties in early diagnosis. While the combination therapy of trastuzumab (Herceptin) and XELOX (capecitabine + oxaliplatin) is currently the standard treatments, the need for new treatment options persists due to its limited efficacy in some patients. Recent clinical studies have demonstrated that the combination therapy of HLX22 + trastuzumab + XELOX significantly improved survival rates compared to the group treated with trastuzumab + XELOX. The 24-month progression-free survival (PFS) rate was 61.5% in the HLX22 group and 25% in the standard treatment group. The overall survival rate was not reached in the HLX22 group and was reported to be 22 months in the standard treatment group, indicating the superiority of HLX22 combination therapy over the existing standard treatment. Currently, the Investigational New Drug (IND) application for the HLX22-GC-301 Phase 3 clinical trial, which combines HLX22 with trastuzumab and chemotherapy, has been approved in several countries including China, the United States, Japan, and Australia. The study has commenced in multiple countries and carried out the first patient dosing. In addition to gastric cancer, research on HLX22 is being expanded to breast cancer treatment, potentially offering new treatment options to more patients. An AbClon representative stated, "This orphan drug designation has further increased the potential for HLX22's entry into the global market and officially is recognized as an innovative therapeutic drug candidate. We will continue to focus on research and development to strengthen our competitiveness in the global market and provide effective treatment options for cancer patients." They emphasized, "We will continue to develop innovative anticancer therapies through ongoing research and collaboration, and accomplish a significant role in the global healthcare market." AbClon's AC101 (HLX22) Received FDA Orphan Drug Designation for HER2-Positive Locally Advanced and Metastatic Gastric Cancer, Signaling a Green Light for Global Commercialization. AbClon announced on the 25th that its AC101 (Henlius’s code name HLX22), an antibody therapy licensed to Henlius in 2016, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive locally advanced and metastatic gastric cancer. FDA ODD status provides various research and development support benefits, including up to 25% tax credits for R&D expenses, grant on clinical trial, exemption from FDA application fees, and eligibility for priority review and accelerated approval (Fast Track). Furthermore, seven years of market exclusivity shall be granted on FDA orphan drug approval, enhancing commercial competitiveness. ODD is considered a significant certification that indicates innovative potential and global R&D competitiveness of a drug candidate, beyond mere regulatory advantages. HER2-positive gastric cancer affects approximately one million new patients worldwide annually and has a poor prognosis with a 5-year survival rate of only 6% due to difficulties in early diagnosis. While the combination therapy of trastuzumab (Herceptin) and XELOX (capecitabine + oxaliplatin) is currently the standard treatments, the need for new treatment options persists due to its limited efficacy in some patients. Recent clinical studies have demonstrated that the combination therapy of HLX22 + trastuzumab + XELOX significantly improved survival rates compared to the group treated with trastuzumab + XELOX. The 24-month progression-free survival (PFS) rate was 61.5% in the HLX22 group and 25% in the standard treatment group. The overall survival rate was not reached in the HLX22 group and was reported to be 22 months in the standard treatment group, indicating the superiority of HLX22 combination therapy over the existing standard treatment. Currently, the Investigational New Drug (IND) application for the HLX22-GC-301 Phase 3 clinical trial, which combines HLX22 with trastuzumab and chemotherapy, has been approved in several countries including China, the United States, Japan, and Australia. The study has commenced in multiple countries and carried out the first patient dosing. In addition to gastric cancer, research on HLX22 is being expanded to breast cancer treatment, potentially offering new treatment options to more patients. An AbClon representative stated, "This orphan drug designation has further increased the potential for HLX22's entry into the global market and officially is recognized as an innovative therapeutic drug candidate. We will continue to focus on research and development to strengthen our competitiveness in the global market and provide effective treatment options for cancer patients." They emphasized, "We will continue to develop innovative anticancer therapies through ongoing research and collaboration, and accomplish a significant role in the global healthcare market." 2025-03-25
AbClon Successfully Concludes First In-Person Investigator Meeting in Japan for AC101 Combination Clinical Trial... Accelerating Global Clinical Resea…
AbClon announced on the 6th that Henlius successfully held a face-to-face investigator meeting for clinical research in Japan on the AC101 (code name HLX22) combination therapy, which was licensed out to Henlius. The meeting focused on discussions regarding the global Phase 3 clinical trial (HLX22-GC-301) to evaluate the combination therapy consisting of HLX22, trastuzumab, and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer. Over 50 oncologists and researchers from more than 20 clinical institutions in Japan attended the meeting and intensively discussing the clinical advantages of HLX22 and its development strategy in Japan. Dr. Ken Kato of the National Cancer Center Japan stated, "This meeting was very productive, and we expect meaningful progress through collaboration among researchers." Dr. Hiroshi Imamura of Toyonaka Municipal Hospital said, "Through in-depth discussions on the clinical trial, we have increased the understanding of the research and will try to enroll the patients at our institution." Japan belongs to countries with the highest rates of gastric cancer incidence and mortality. HER2-positive patients account for approximately 12-23% of all gastric cancer patients. Currently, the standard first-line treatment for HER2-positive locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer is trastuzumab combined with chemotherapy. While the addition of immunotherapy is recommended for PD-L1-positive (PD-L1 CPS ≥1) patients, there remains a need for improved long-term treatment efficacy and prognosis. In the global market, dual HER2-targeted therapies for HER2-positive gastric cancer have not yet been approved. HLX22 is an innovative anti-HER2 monoclonal antibody (mAb) that binds to the HER2 extracellular domain IV, with a mechanism that promotes HER2 internalization and degradation by binding to a different site than trastuzumab. Clinical data have shown that adding HLX22 significantly improves survival and antitumor effects in HER2-positive gastric cancer patients, with a manageable safety profile. The HLX22-GC-301 study is a multinational Phase 3 clinical trial to evaluate the efficacy and safety of HLX22, trastuzumab, and chemotherapy combination therapy as a first-line treatment for HER2-positive metastatic gastric/gastroesophageal junction cancer patients. Japan is one of the key countries in this study. The meeting provided an in-depth discussion of patient characteristics, diagnostic and treatment criteria, and clinical trial protocols in Japan, which is expected to facilitate efficient study progress. An AbClon representative stated, "Our goal is to provide better treatment options to patients worldwide through the development of innovative antibody therapeutics. We hope that the successful progress of the HLX22 clinical trial will bring new hope to HER2-positive gastric cancer patients." They further emphasized, "We will continue to develop innovative anticancer therapeutics through ongoing research and collaboration, and play a significant role in the global healthcare market." 2025-03-06
AbClon initiates overseas commercialization of advanced CAR-T therapy AT101.
AbClon, a leading South Korean biotech company, has announced the first official step into the overseas market with its innovative CAR-T cell therapy, AT101. On 4th April, the company revealed that it had finalized a license agreement with TCT Health Technology (TCT), a Turkish company, in Istanbul on March 28th (local time). This agreement marks AbClon's entry into the Turkish hematologic cancer treatment market and lays the foundation for expanding its presence in Europe and the Middle East. The signing ceremony was attended by key figures from AbClon, TCT, and a range of Turkish health and medical industry organizations. Global life science company, Cytiva also participated as a partner to TCT. The Turkish Ministry of Health and Health Institute are committed to their full support for the clinical trials and rapid market entry of AT101. Cytiva will be responsible for the manufacturing process, aiming to enable Turkish patients to receive treatment with locally manufactured AT101 as soon as possible. TCT will bear all commercialization costs, including clinical trials and production for AT101 in Turkey. AbClon will receive an upfront payment and royalties based on net sales. AT101 is a CD-19 CAR-T cell therapy developed using AbClon's proprietary NEST technology platform. It features a differentiated antibody (1218) that has demonstrated high efficacy and safety, positioning it as a strong competitor in the global market. Currently, AT101 is undergoing Phase 2 clinical trials in South Korea, with plans to apply for conditional accelerated approval in the first half of this year. The Phase 1 trials showed remarkable treatment responses in over 90% of patients, garnering attention through presentations at international conferences and publications in prestigious journals. In Turkey, approximately 10,000 patients die from hematologic cancers annually, indicating a substantial patient population that could benefit from AT101. Turkey's strategic location as a medical hub connecting Europe and the Middle East, along with the increasing number of patients from Middle Eastern countries like Saudi Arabia and the UAE seeking medical services, is expected to positively impact AT101's adoption in the region. AbClon plans to establish CAR-T treatment centers in major Turkish hospitals and provide medical staff support to maximize patient treatment outcomes. An AbClon representative stated, "We will work closely with the TCT to ensure the swift approval and commercialization of AT101. This collaboration is a significant first step in demonstrating AbClon's technology and competitiveness in the global CAR-T market." The agreement is expected to provide innovative treatment options for hematologic cancer patients in Turkey and the Middle East. AbClon will continue to pursue overseas market expansion through technology transfer agreements with global pharmaceutical companies and direct market entry strategies. 2025-03-04
AbClon, Develops mRMab Antibody Discovery Platform
AbClon Inc. announced that it has developed and launched ‘mRMab’, a differentiated antibody therapy platform that integrates messenger RNA (mRNA) technology with existing antibody discovery techniques. RNA technology has emerged as a new paradigm in the medical field and has played a key role in the COVID-19 vaccine that has saved millions of lives worldwide. The core principle of this technology is to design mRNA corresponding to a specific disease-related protein and induce an immune response in animals. When the disease protein is naturally produced in the body, the immune system recognizes it and produces antibodies specific to that protein. Traditional antibody development methods rely on externally synthesized proteins, which often differ in structure from those naturally produced in the body. This discrepancy makes it difficult to develop antibodies for intractable diseases, often leading to failure. Additionally, the preparation of synthetic proteins requires significant time and cost. In contrast, the mRMab approach enables the in vivo production of disease-related proteins, allowing complex protein structures to form naturally. According to AbClon, this advancement facilitates the effective development of therapeutic antibodies for proteins associated with intractable diseases that were previously difficult to target using conventional methods. According to Global Market Insights, the global monoclonal antibody therapeutics market, a leading segment of antibody-based therapies, was valued at over USD 186.6 billion in 2022. It is expected to reach over USD 609 billion by 2032, growing at a compound annual growth rate (CAGR) of 12.5%. Monoclonal antibody therapeutics are continuously evolving into bispecific antibodies, antibody-drug conjugates (ADCs), and chimeric antigen receptor (CAR) T-cell therapies. AbClon plans to operate a differentiated new drug platform to provide new drug development and antibody development services to pharmaceutical companies, research institutes, and hospitals worldwide. An AbClon representative stated, " The mRMab platform is expected to bring groundbreaking innovation to therapeutic antibody development, surpassing existing methods. It will play a crucial role in developing antibody therapies for intractable diseases like cancer and new infectious diseases." 2024-12-24
The Ministry of Health and Welfare's Presidential Commendation for Health Industry and Medicine
Antibody therapy company AbClon announced on the 29th that its CEO Lee Jong-Seo received the Presidential Commendation at the '2024 Government Awards for Healthcare Technology Advancement'. The Government Awards for Healthcare Technology Advancement, hosted by the Ministry of Health and Welfare, recognize individuals who have made significant contributions to the advancement of healthcare technology in Korea every year. Dr. Lee received the award for his contribution to widely publicizing the excellence of Korean pharmaceuticalㄴ and biotechnology in the global new drug market. Dr. Lee developed over 80,000 research antibodies through the 'Human Protein Atlas Project', a joint research project of the Royal Swedish Academy of Sciences, by establishing advanced antibody development technology. In particular, his technology transfer achievements include the antibody 'AC101 (Chinese name: HLX22)' for the first-line gastric cancer treatment and an antibody that specifically binds to anti-HER2 (human epidermal growth factor receptor type 2) that is highly expressed in gastric cancer cells. In addition, AbClon is currently developing a blood cancer CAR-T (chimeric antigen-T) cell therapy equipped with its proprietary antibody and bi-specific antibodies for solid cancers based on the AffiMab platform. These technological advances have been acknowledged through the filing of over 80 domestic and international patents applications. Dr. Lee said, “About 80% of AbClon’s employees are researchers, and the company is deeply committed to investing in technological advancements,” and “We aim to grow into an innovative pharmaceutical company that can maximize the treatment effect and ultimately achieves a complete cure for patients with intractable cancers.” End 2024-11-29
Henlius Begins First Patient Dosing in Global Phase 3 Trial
On the 26th, AbClon announced that the first patient has been dosed in the phase 3 international multi-center clinical trial (HLX22-GC-301) for AC101 (Henlius’ codename HLX22). The HLX22-GC-301 trial, which evaluates the combination of trastuzumab and chemotherapy, has received Phase 3 clinical trial approvals in China, the United States, and Japan. HLX22 is a candidate for global first-line treatment for HER2 (human epidermal growth factor receptor 2)-positive advanced gastric and gastroesophageal junction (GEJ) cancer, based on AC101, which was licensed to Henlius Biotech (Henlius) in 2016. To date, no dual HER2 blockade therapy for HER2-positive gastric cancer has received global commercialization approval. A company representative stated, "HER2-positive gastric and gastroesophageal junction cancer is a major global health issue, with approximately one million new cases reported annually." They further noted, "This disease is often diagnosed at an advanced stage, leading to poor prognosis, with a five-year survival rate of only 6%." Patients with HER2-positive gastric cancer generally have worse prognoses than those with HER2-negative disease. Although trastuzumab in combination with chemotherapy is the current standard treatment, its efficacy and outcomes require further improvement. HLX22 is an antibody designed to bind to HER2 proteins alongside trastuzumab, promoting HER2 internalization and degradation, thereby enhancing anti-tumor activity. Preclinical and Phase 1 trial results have demonstrated that the combination of HLX22 and trastuzumab produces a synergistic effect, leading to tumor suppression, cancer cell apoptosis, and a favorable safety profile. The ongoing clinical trial is evaluating progression-free survival (PFS) and overall survival (OS) as its primary efficacy endpoints, comparing HLX22 to existing treatment regimens. Meanwhile, on the 17th, AbClon was recognized as a "Global Outstanding Partner" at the 30th anniversary ceremony of China’s Fosun Pharma Group, held in Shanghai, highlighting 2024-11-26
AbClon Enters into Clinical Trial Agreement with Korea Drug Development Fund (KDDF) for AT101 Phase 2 Trial)
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
Groundbreaking CD30 CAR-T Therapy Research Published in Nature Immunology
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
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
Investigator-initiated trial (IIT) of AT101 for relapsed/refractory patients on CAR-T
N/A 2024-04-30
First patient dosed in Phase 2 clinical trial
N/A 2023-12-12
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
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
With diverse technologies ranging from NEST to CAR-T platforms, AbClon is focused
on the development of innovative antibody therapeutics. AbClon’s mission is to
push the boundaries of science to develop therapeutics that demonstrate
better efficacy and target once incurable diseases.
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AbClon creates new therapeutic opportunities 
