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164

AbClon, The CAR-T cell therapy AT101 'Nespe-cel' has been of…

AbClon announced on the 2nd that its CAR-T (Chimeric Antigen Receptor T-cell) therapy AT101 has been approved by the World Health Organization (WHO) with the International Nonproprietary Name (INN) 'Nespecabtagene autoleucel’ (Nespe-cel). This signifies the official registration of the therapeutics and 'Nespe-cel' will be used as the official name when AT101 is commercialized in the global market in the future.   The International Nonproprietary Name is officially approved by the WHO for specific ingredients or substances to prevent misuse of medicines and to enhance information delivery and ease of use. This name is utilized as a unique identifier in the approval processes and commercialization stages of each country. 'Nespe-cel' embodies the meaning of a CAR-T therapy derived from AbClon's proprietary antibody platform technology 'NEST (Novel Epitope-Screening Technique)'.   AbClon is currently conducting a Phase 2 clinical trial in South Korea for Nespe-cel in patients with diffuse large B-cell lymphoma (DLBCL) across seven institutions, with research funding of 7 billion KRW supported by the Korea Drug Development Fund. DLBCL accounts for approximately 50% of non-Hodgkin's lymphoma (NHL). Following an interim analysis of the clinical trial results, the company plans to apply for accelerated approval in June and is also establishing strategies for domestic commercialization. Recently, AbClon announced the initiation of clinical strategies to expand the treatment to patient groups with follicular lymphoma (FL) and marginal zone lymphoma (MZL), which account for approximately 30% of NHL.   To strengthen the competitiveness of its CAR-T therapy in the global market, AbClon is pursuing the grant of an independent patent in overseas countries. As a result of this effort, the company signed an agreement on April 28th with TCT Health Technology (TCT) in Türkiye (formerly Turkey) for the commercialization of Nespe-cel in Türkiye, aiming to accelerate its entry into the European and Middle Eastern markets.   Through this collaboration, AbClon plans to establish clinical and production infrastructure for Nespe-cel in Türkiye and pursue the approval process for blood cancer treatment. Given the recent active support of the Turkish government for the advanced biopharmaceutical industry, the collaboration between AbClon and TCT is expected to create positive synergy. Following education and production preparation, the first patient is expected to receive Nespe-cel treatment in 2026.   An official from AbClon stated, "The technology transfer agreement to TCT is a significant milestone for entering into the European and Middle Eastern markets, leveraging Türkiye as a hub," and added, "We are simultaneously pursuing technology transfer globally and country-specific strategies as well."   Meanwhile, TCT is building a CAR-T therapy manufacturing facility in collaboration with global company Cytiva. Through this, they plan to establish the production system for Nespe-cel win near future. Support from the Turkish government is also expected to be a crucial foundation for the rapid and stable production of Nespe-cel.   End. 

2025-05-02 47
163

AbClon, Henlius, Expectation for AC101 as a Global Blockbust…

AbClon announced on the 28th that its Chinese partner, Henlius successfully held ‘2025 Global R&D Day’ event under the slogan of "Collaborate to Create."   The event was attended by Henlius key executives, academic experts, and multinational investors, who shared the latest research achievements, strategic visions, and the current status of advanced technology and therapeutic development. At the event, Henlius presented AC101 (Henlius code name HLX22) as a core innovative pipeline and emphasized its differentiated mechanism of action and clinical data.   During the presentation by Jason Zhu, CEO of Henlius, he stated that HLX22 has high potential to expand as a pan-tumor therapy covering a broad range of solid tumors, including HER2-positive gastric and breast cancers. He expressed confidence in developing it into a blockbuster drug, setting a future global market size of over $10 billion (approximately 14 trillion KRW) annually. Henlius is accelerating its global growth strategy centered on HLX22 by strengthening its development and commercialization capabilities in major markets such as the United States, China, and Japan.   HLX22 is a novel monoclonal antibody being clinically developed as a first-line treatment for HER2-positive metastatic gastric cancer, characterized by its binding to a different epitope compared to trastuzumab. Notably, gastric and gastroesophageal junction (G∙GEJ) cancer occurs in approximately 1 million cases annually, ranking as the fifth most common cancer worldwide. Among these, HER2-positive patients, accounting for about 12-23%, have a relatively poor prognosis.   Currently, HLX22 has entered into a global Phase 3 clinical trial (HLX22-GC301) as a first-line treatment in combination with trastuzumab and XELOX chemotherapy. The randomized, double-blind study is being conducted up to 550 patients across Asia, Europe, and North America. Earlier Phase 2 clinical trial (HLX22-GC201) results showed that the progression-free survival (PFS) in the combination therapy group was significantly longer compared to the control group, with a tumor response rate reaching 87.1% and demonstrating favorable safety.   Particularly encouraging is the more significant response observed in the Asian patient population, where the efficacy of pembrolizumab is limited, raising high expectations for HLX22. The market impact is also expected to be substantial, given the potential for indication expansion to HER2-expressing solid tumors beyond gastric cancer, such as breast, lung, and pancreatic cancers. The interim results of the global Phase 3 trial of HLX22 are scheduled to be presented at the American Society of Clinical Oncology (ASCO) in 2025.   A representative from AbClon stated, "As the company holding the original technology for HLX22, we anticipate securing both high technical value and revenue potential along with the global clinical progress of this product. We will continue to strengthen global partnerships and expand our position in the antibody therapeutics market."   End. 

2025-04-28 40
162

AbClon, AC101, First Patient Dosed in Phase 2 Clinical Trial…

AbClon announced on the 18th of April that the first patient in China has been dosed in a Phase 2 clinical trial evaluating 'AC101' in combination with Enhertu for the treatment of HER2-low, hormone receptor (HR)-positive, locally advanced or metastatic breast cancer.   The company stated that this trial shall expand the treatment scope of AC101 to the entire breast cancer area from the currently proved HER2-positive gastric cancer field, and provide new treatment options for a broader group of cancer patients.   According to GLOBOCAN, a cancer data research platform, breast cancer is the second most frequently diagnosed cancer worldwide, with approximate 2.3 million new cases diagnosed in 2022. HER2-low breast cancer accounts for 45-55% of all breast cancer cases, but currently lacks targeted therapies, relying mainly on endocrine therapy or chemotherapy. Although Enhertu has recently been approved, there is still a high demand for safe and effective treatments.   The Phase 3 clinical trial (AC101-GC-301) of AC101 in combination with trastuzumab and chemotherapy for gastric cancer patients has been approved in major countries including China, the United States, Japan, and Australia. The first patient has been dosed along with IND approvals in major countries, and the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the treatment of gastric cancer last month.   Based on the significant results in HER2-positive gastric cancer, AC101 is expanding its treatment area to various HER2-expressing solid tumors. Last year, Phase 2 clinical trials of AC101 in combination with trastuzumab and chemotherapy, or in combination with Enhertu, were approved in China and are currently underway.   An AbClon official said, "We expect Henlius continue to attempt to expand the treatment and market for anti-HER2 targeted therapies, and accelerate the global development of AC101. We will strive to provide more effective and economical treatment options."   Meanwhile, at the Henlius 2025 R&D Conference held in Shanghai on the 15th, CEO Jason Zhu cited AC101 as one of the key assets in Henlius for the future, expressing confidence in its success. Professor Lin Shen, who is conducting the clinical trials, predicted that AC101 will show great therapeutic effects in patients worldwide with various solid tumors, including HER2-positive gastric cancer and breast cancer. 

2025-04-18 66
161

AbClon pursue strategy for next-generation CAR T-cell therap…

AbClon announced on the 14th that it has secured preclinical-stage technology for CAR-T (Chimeric Antigen Receptor T-cell) therapy targeting solid tumors, in addition to its efforts in blood cancer. This endeavor aims to provide a treatment for solid tumor patients who have suffered the limits of existing anticancer treatments with AbClon's next-generation CAR-T therapy.   AbClon is currently conducting a Phase 2 clinical trial in South Korea for its first CAR-T therapy, AT101, targeting hematologic malignancies. The company recently completed a technology transfer to Turkey and plans to expand its indications to the solid tumor field based on the success of its blood cancer treatment.   As part of this strategy, the company is co-developing a Claudin18.2-targeting CAR-T therapy with Professor Chung Joon-ho's research team at Seoul National University College of Medicine. This CAR-T targets a protein highly expressed in refractory solid tumors such as gastric and pancreatic cancers. The currently available treatments in this area have low response rates and significant drug resistance issues, leading to high unmet medical needs.   Professor Chung's research team developed antibodies specific to Claudin18.2 based on VHH (single-domain antibody) and scFv (single-chain antibody) obtained from specialized animal immunization and antibody gene technology. AbClon explained that it has confirmed the preclinical potential of the CAR-T therapy for solid tumors using these antibodies.   The company is also developing AT501, a next-generation switchable CAR-T therapy targeting HER2. AT501 is a platform that allows precise control of CAR-T cell activation when administered with a specific switch protein. This switch technology, which selectively targets HER2, has demonstrated excellent anticancer efficacy in animal models and has the advantage of enhancing anticancer effects with switch re-administration even in responsive/relapsed models. The company stated that this technology has drawn significant interest from overseas companies and research institutes.   In addition, AbClon is developing a CAR-T therapy targeting CD30 for patients with relapsed or refractory lymphoma. This is being done in collaboration with Dr. Marco Ruella's research team at the University of Pennsylvania (UPENN) School of Medicine and is expected to provide a new option for patients who do not respond to existing treatments. In particular, this therapy is being developed as a next-generation CAR-T therapy to overcome the tumor microenvironment (TME) by utilizing BTLA (B and T Lymphocyte Attenuator) gene editing technology.   An AbClon official stated, "We plan to continuously expand the indications for refractory solid tumors by integrating our antibody platform technology and cell therapy development capabilities." They added, "We will continue to pursue a differentiated new drug development strategy in the global anticancer market and become a leading company in the next-generation immuno-oncology field." End.   

2025-04-14 111
160

AbClon’s CAR-T Therapy ‘AT101’ Expands Blood Cancer Indicati…

AbClon to Expand Indications of CAR-T Therapy ‘AT101’ into Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL), Aiming for IND Approval This Year   April 10th – AbClon (CEO Lee Jong-seo) announced that the company will expand the indications of its CAR-T (Chimeric Antigen Receptor T-cell) therapy ‘AT101’ into follicular lymphoma (FL) and marginal zone lymphoma (MZL). AbClon aims to obtain Investigational New Drug (IND) approval in Korea within this year.   Currently, AT101 is in Phase 2 clinical trial in Korea for diffuse large B-cell lymphoma (DLBCL), a subtype of blood cancer. Through this expansion of indications, AbClon aims to strengthen its competitiveness and position in domestic and international CAR-T therapy markets. The company anticipates that this study will provide broader treatment options for domestic hematologic cancer patients and secure an advantageous position in global technology transfer negotiations by the enhancement of platform's value.   ‘AT101’, a CD19 CAR-T therapy independently developed in Korea, is based on AbClon's proprietary platform technology. The Phase 2 clinical trial targeting DLBCL patients, who account for over 40% of non-Hodgkin lymphoma (NHL) patients, is progressing smoothly, and the company plans to pursue accelerated approval within the first half of this year.   Separately, FL and MZL account for over 25% of NHL cases worldwide, with approximately 1,500 new patients diagnosed annually in Korea. Both are CD19-expressing hematologic cancers, making them potential targets for CAR-T therapy. AbClon believes that AT101 can secure a relative therapeutic advantage based on its efficacy and mechanism of action, potentially becoming an effective treatment for both domestic medical institutions and patients.   Regarding its global technology transfer strategy, the company stated that this expansion of indications offers significant meaning. While the global CD19 CAR-T therapy market is experiencing a high compound annual growth rate of over 30%, CAR-T therapy has not yet actively penetrated the FL and MZL sectors. If AT101 secures clinical evidence for FL and MZL in addition to DLBCL, it can maximize its competitiveness in global licensing-out negotiations as a platform technology covering multiple indications with a single pipeline.   An AbClon representative stated, "The expanded application of efficacy, securing original technology, and flexibility in clinical trial design are key factors that will allow Abclon to gain a strategic advantage in the global market." They added, "AT101 is a next-generation gene-modified cell therapy that overcomes the fundamental limitations of CAR-T therapies."   The representative further emphasized, "This expansion of indications is part of multi-purpose strategy to broaden treatment opportunities for domestic patients as well as laying a practical foundation for global technology export." [End]   

2025-04-10 102
159

AbClon, " Presents Latest Research on AM105: Overcoming EGFR…

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. 

2025-03-31 128
158

AbClon’s AC101, Dosed to the First Patient Dosed in Japan: P…

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."   

2025-03-27 182
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