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ABL Bio and Yuhan Presents Poster on YH32364 (ABL104) at AACR
- Presentation on Grabody-T based Bispecific Antibody Poster April 10, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, announced that it will present preclinical data on YH32364 (ABL104) in poster format at the American Association for Cancer Research (AACR) annual academic conference. The poster will be jointly presented by ABL Bio and its partner company, Yuhan Corporation. The AACR annual academic conference is one of the most prestigious cancer conferences in the world, held regularly each year. It brings together global pharmaceutical and biotech companies as well as industry experts to share the latest research outcomes. This year's AACR is taking place from April 25th to 30th (local time) in Chicago, USA. The bispecific antibody YH32364 (ABL104), to be presented by ABL Bio and Yuhan, simultaneously targets Epidermal Growth Factor Receptor (EGFR) and 4-1BB, a co-stimulatory receptor involved in T cell activation. EGFR, when mutated, can activate tumor cell signaling pathways and promote tumor growth, making it a key target in cancer drug development. The title of the ABL104 poster is "YH32364 (ABL104), a bispecific antibody against EGFR and 4-1BB, demonstrates potent anti-tumor efficacy through tumor-directed 4-1BB agonism," and is scheduled to be unveiled on April 29th. Sang Hoon Lee, CEO of ABL Bio said “We are pleased to introduce our pipeline incorporating Grabody-T, ABL Bio’s 4-1BB-based bispecific antibody platform, at AACR. Grabody-T is designed to activate T cells only within the tumor microenvironment, where tumor cells are present, reducing the inherent side effects of 4-1BB monoclonal antibodies while enhancing anti-tumor efficacy. Please look forward to this year’s AACR.”
2025-04-10ablbio
ABL Bio Announces Grabody-B Brain Delivery Platform License Agreement with GSK to Develop No...
- ABL Bio and GSK enter into a multi-program agreement to develop novel medicines for neurodegenerative diseases- Programs will leverage ABL Bio’s Grabody-B platform technology to effectively deliver molecules across the blood-brain barrier- ABL Bio to receive up to £77 million in upfront and near-term payments April 7, 2025, SEONGNAM, South Korea - ABL Bio Inc. (KOSDAQ: 298380), a clinical-stage biotech company developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio’s blood-brain barrier (BBB) shuttle platform, Grabody-B. The agreement aims to develop multiple programs for novel targets across therapeutic modalities including antibody, polynucleotide or oligonucleotides, such as siRNA and ASOs, to address significant unmet medical needs of patients suffering from neurodegenerative conditions. The blood-brain barrier (BBB) serves as a protective barrier that restricts the entry of harmful substances and agents into the brain and is considered a significant obstacle in the development of treatments for neurological diseases. ABL Bio's Grabody-B was developed to overcome the limitations of existing drugs that have difficulty crossing the BBB by targeting the Insulin-like Growth Factor 1 Receptor (IGF1R), facilitating drug penetration across the BBB and enabling efficient delivery into the brain. Under the terms of the agreement, ABL Bio will receive up to £77.1 million in upfront and near-term payments, including an immediate upfront payment of £38.5 million, research milestones and potential program expansion. In total, ABL Bio is eligible to receive up to £2.075 billion in research, development, regulatory and commercialization milestone payments across multiple potential programs. ABL Bio will receive tiered royalties on net sales if products are successfully commercialized. As part of the agreement, ABL Bio will transfer Grabody-B-related technology and know-how to GSK, while GSK will assume responsibility for preclinical and clinical development, manufacturing, and commercialization. Christopher Austin, SVP of Research Technologies, GSK, said “There is a critical need for new therapeutics to treat neurodegenerative brain diseases, which are rapidly increasing in prevalence due to the aging of the population. Many of the most promising new therapies are antibodies, which cannot efficiently reach the brain without a shuttle to get them across the BBB. This agreement reflects our commitment to innovative platform technologies to overcome the BBB and thus open entirely new opportunities for treating these devastating diseases, an important component of our emerging pipeline." Sang Hoon Lee, CEO of ABL Bio said “This agreement underscores ABL Bio's leadership in BBB technology and its commitment to advancing transformative therapeutics in neurodegenerative diseases through strategic partnership with global pharmaceutical leaders like GSK. Additionally, this agreement will serve as a great opportunity to strengthen ABL Bio's position in the neurodegenerative disease treatment market through the potential commercialization of Grabody-B and to expand the modality areas where Grabody-B can be utilized. Given the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases, we hope this partnership will accelerate the development of innovative treatments and bring renewed hope to patients worldwide.” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001 (tovecimig), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111 (givastomig), co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-07ablbio
ABL Bio’s Partner, Compass Therapeutics, Announces Top-line Results from Phase 2/3 Clinica...
- 17.1% ORR, the primary endpoint, confirmed by independent central radiology review- Full clinical results, including OS, PFS, and full safety data are expected to be announced later this year Pangyo (South Korea) – April 1, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner, Compass Therapeutics presented the top-line data from the Phase 2/3 clinical trial of ABL001/tovecimig (CTX-009/HDB001A), COMPANION-002, in patients with advanced biliary tract cancer. Tovecimig (ABL001), originally developed by ABL Bio, is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4). It inhibits angiogenesis within tumor tissues, thereby inducing cancer cell death. Compass Therapeutics, which holds global rights, took over the Phase 2 clinical trial conducted in South Korea by Handok, which holds the Korean rights, and is currently conducting the Phase 2/3 clinical trial (COMPANION-002) in the United States. COMPANION-002 is a clinical trial designed to evaluate the potential of tovecimig (ABL001) as a second-line treatment for patients with biliary tract cancer. The study aims to compare the safety and efficacy of the combination therapy of tovecimig (ABL001) and paclitaxel with paclitaxel monotherapy. The primary endpoint of COMPANION-002 is the objective response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), and duration of response (DoR). According to the top-line data from the Phase 2/3 clinical trial announced by Compass Therapeutics, the ORR of the combination therapy of tovecimig (ABL001) and paclitaxel was 17.1%, compared to a 5.3% ORR for the paclitaxel monotherapy arm, and this difference was statistically significant (p=0.031). Notably, the ORR for the combination therapy of tovecimig (ABL001) and paclitaxel was also higher than the ORR of 4.9% observed in a separate study for FOLFOX, another treatment regimen that is used in the second line setting for biliary tract cancer. The study also showed differences between treatment arms for other efficacy measures, including progressive disease (PD) rates of 16.2% in patients on tovecimig (ABL001) in combination with paclitaxel versus 42.1% in patients on paclitaxel alone. Compass Therapeutics plans to announce the full clinical results of COMPANION-002, including secondary endpoints such as PFS, OS and DoR, by the end of this year. Sang Hoon Lee, CEO of ABL Bio said, “We are very pleased that ABL001 has shown promising results in the Phase 2/3 clinical trial for patients with biliary tract cancer. The true incidence of biliary tract cancer is underappreciated; most patients suffer from advanced or metastatic forms that are not amenable to surgical treatment, leaving them with limited therapeutic options. Considering the high unmet medical need, ABL001 received Fast Track designation from the U.S. Food and Drug Administration (FDA) last year. We hope that the positive clinical data will enable a path to approval and commercialization." As background, biliary tract cancer is a malignant tumor that occurs in the cells of the bile ducts, gallbladder, or the ampulla of Vater, where the bile duct and pancreas connect to the small intestine. Compass Therapeutics estimates that approximately 23,000 patients are diagnosed with biliary tract cancer annually in the United States, with the second-line treatment market size expected to exceed $1 billion. In addition to COMPANION-002, Compass Therapeutics is also supporting an Investigator Sponsored Trial (IST) to evaluate ABL001 as a first-line treatment for biliary tract cancer. This trial is being led by MD Anderson Cancer Center at the University of Texas and is investigating the addition of tovecimig (ABL001) to the standard treatment regimen of gemcitabine, cisplatin, and durvalumab. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-02ablbio
ABL Bio Submits an Additional Clinical Trial Amendment to Evaluate ABL103 in a Phase 1b/2 St...
- ABL103 in combination with KEYTRUDA and Taxane will be evaluated for safety and efficacy in South Korea, the United States, and Australia Pangyo (South Korea) – March 20, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has submitted an additional clinical trial amendment for the Phase 1b/2 study of ABL103 in combination with MSD’s (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and Taxane as a triple combination therapy. ABL103 is a bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio’s 4-1BB based bispecific antibody platform ‘Grabody-T’ has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, potentially reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity. A Phase 1 clinical trial evaluating ABL103 monotherapy is currently underway in the United States and South Korea. ABL Bio plans to amend the investigational new drug (IND) application for this Phase 1 trial to include a Phase 1b/2 study assessing combination therapy in South Korea, the United States, and Australia. The Phase 1b/2 study will consist of two safety lead-in parts to determine the appropriate dosage for the triple combination therapy, as well as one dose expansion part. Through this study, ABL Bio aims to evaluate the safety and efficacy of the ABL103 triple combination therapy. Sang Hoon Lee, CEO of ABL Bio said “with the submission of this clinical trial amendment, the journey to evaluate ABL103 combination therapy in solid tumor patients has officially begun. We hope that ABL103 will demonstrate strong efficacy in combination with KEYTRUDA and Taxane. Along with ABL103, clinical trials for 4-1BB-based bispecific antibodies, including ABL111/Givastomig, ABL503/Ragistomig, and ABL105, are progressing smoothly. Among them, ABL111/Givastomig is advancing the fastest in clinical development and is expected to announce the top-line results of its Phase 1b combination study this year. We appreciate your continued interest and support in our progress.” Meanwhile, ABL Bio entered a clinical trial collaboration and KEYTRUDA supply agreement with MSD in October last year to evaluate ABL103 combination therapy in patients with advanced or metastatic solid tumors. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2025-03-20ablbio
ABL Bio to Host ADC Symposium
- Global ADC development experts invited as speakers to enhance ADC R&D capabilities March 10, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, announced that it will host an ‘Antibody-Drug Conjugate (ADC) Symposium’ for biotech industry officials on March 14th. The symposium is held to enhance ADC development capabilities, which are increasingly gaining attention in the field of oncology drug development and facilitate collaboration among domestic and international ADC experts. Renowned scientists with experience developing ADCs at global pharmaceutical biotech companies will participate as session speakers. The first session, titled ‘The Past, Present, and Future of ADCs,’ will be led by Dr. Mark Sliwkowski, a former scientist at Genentech and member of the Roche Group. Dr. Sliwkowski will share insights into the history of ADCs, the success of HER2-targeted ADC Kadcyla (T-DM1), and lessons learned from past ADC development failures. The second session, titled ‘ADCs for Cancer Treatment,’ will feature Dr. Peter Senter, former scientist of Seagen and Bristol Myers Squibb, who played a key role in the development and approval of ADCs such as Padcev and Tivdak. The third session, "Insights into Clinical ADC Development," will be presented by Dr. Patrick Zweidler-McKay, a former executive at ImmunoGen, the company behind Elahere, a folate receptor alpha (FRα)-targeting ADC. Dr. Zweidler-McKay, now a consultant at his own firm, will discuss ADC clinical development for solid tumors and the therapeutic advantages of ADCs. In the fourth session, Dr. Morris Rosenberg, who previously worked at Immunomedics (developer of the TROP2-targeting ADC Trodelvy) and Seagen, will share strategies for late-stage development of ADC pipelines. The fifth and sixth sessions will cover key considerations in preclinical ADC development and clinical pharmacology of ADCs. Speakers include Dr. Laurie Tatalick, co-founder of ProfoundBio, and Dr. Tae Han, former expert of Seagen. The seventh session will feature Kai Ming-Pu, a consultant from Clearview, a global healthcare consulting firm, who will present emerging trends in ADC development. Last July, ABL Bio announced the full-scale launch of its bispecific ADC development program and secured KRW 140 billion through a third-party allotment capital increase. The company is currently recruiting executives and ADC experts for its U.S. subsidiary, ABL Bio USA, which will spearhead bispecific ADC development. ABL Bio plans to begin IND submissions for its bispecific ADC pipeline starting later this year. Sang Hoon Lee, CEO of ABL Bio said, “As the importance of ADCs in cancer drug development continues to grow, we have invited top international experts to help strengthen the capabilities of our researchers and others in the biotech industry. We’ve prepared this event to be practically helpful for ADC R&D, so we ask for a great deal of interest and participation.”
2025-03-10ablbio
ABL Bio Publishes ABL112 Study in Prestigious Journal JITC
- Activates CD8+ T cells in the tumor microenvironment like other Grabody-T-based bispecific antibodies- Lead 4-1BB bispecific antibody ABL111/Givastomig to release triple combination therapy data this year March 4, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, announced on the 4th that it has published a research paper on its bispecific immuno-oncology candidate ABL112 in the Journal for ImmunoTherapy of Cancer (JITC), an international journal issued by the Society for Immunotherapy of Cancer (SITC). JITC is a prestigious international journal with an Impact Factor of 10.3, featuring a wide range of studies related to tumor immunology and immunotherapy. The title of the paper published by ABL Bio is: "Fc-competent TIGITx4-1BB bispecific antibody exerts potent long-lasting antitumor activity by potentiating CD8+ T cell activity and Fcγ receptor-mediated modulation of the tumor microenvironment." ABL112 is an immuno-oncology bispecific antibody developed using Grabody-T, ABL Bio’s proprietary 4-1BB-based bispecific antibody platform. Grabody-T is designed to activate CD8+ T cells selectively within the tumor microenvironment, minimizing the liver toxicity typically associated with 4-1BB monoclonal antibodies, while enhancing anti-tumor efficacy. ABL112 simultaneously targets TIGIT (T cell immunoreceptor with Ig and ITIM domains), an immune checkpoint on T cells, and 4-1BB. According to the paper, ABL112 blocks the interaction between TIGIT and CD155, which suppresses T cell activity, thereby restoring CD8+ T cell function. Unlike TIGIT-targeting monoclonal antibodies, ABL112 demonstrated long-lasting therapeutic effects. The study also confirmed strong anti-tumor activity both as a monotherapy and in combination with PD-(L)1 inhibitors. Sang Hoon Lee, CEO of ABL Bio, stated, “We are proud to publish our ABL112 research in JITC, a leading international journal that plays a key role in the field of immuno-oncology. This publication, along with other journal articles and conference presentations, helps demonstrate the excellence of ABL Bio’s 4-1BB bispecific antibody programs. This year, we look forward to sharing clinical data from our fastest advancing Grabody-T based pipeline, ABL111/Givastomig—a Claudin18.2 x 4-1BB bispecific antibody—being tested in triple combination with nivolumab and chemotherapy. We appreciate your continued interest and support.”
2025-03-05ablbio
ABL Bio Attends J.P. Morgan Healthcare Conference
- Focused discussions on BBB shuttle platform and clinical-stage immuno-oncology pipeline expected to take place January 6, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, announced on the 6th that it will participate in the 43rd Annual J.P. Morgan Healthcare Conference, taking place from January 13th to 16th in San Francisco, USA, to continue discussions on various partnership opportunities. J.P. Morgan Healthcare Conference is one of the world’s largest healthcare investment events, bringing together pharmaceutical and biotech companies, medical professionals, investment banks, and venture capitalists to share the latest therapeutic technologies and explore a wide range of investment and partnership opportunities. ABL Bio has been invited to attend the conference every year since its founding, and this marks its ninth participation. During the event, ABL Bio plans to hold follow-up meetings with global pharmaceutical and biotech companies it has been in partnership talks with, while also keeping up with global trends in next-generation drug development. In particular, active discussions are anticipated around Grabody-B, the company’s Blood-Brain Barrier (BBB) shuttle platform for the treatment of neurodegenerative diseases. This focus comes in the wake of positive early results from Trontinemab, a BBB shuttle-conjugated version of Roche’s anti-amyloid beta monoclonal antibody Gantenerumab, in a Phase 1/2 clinical trial for Alzheimer’s disease- despite Gantenerumab’s prior standalone failure- making BBB shuttles a key to success in treating neurodegenerative diseases. In the field of oncology, ABL Bio will share the latest clinical data on its immuno-oncology therapeutics utilizing its Grabody-T platform, a 4-1BB-based bispecific antibody. Givastomig, currently in development for gastric cancer, is undergoing a Phase 1b trial to evaluate the safety of a triple combination therapy with chemotherapy and PD-1 inhibitor Nivolumab. Top-line data from this trial is expected in the second half of 2025. Meanwhile, Ragistomig and ABL103 are progressing smoothly in monotherapy Phase 1 clinical trials, with ABL103 set to begin early trials for combination therapy later this year. Sang Hoon Lee, CEO of ABL Bio, stated, “Since Roche’s Trontinemab opened a new era for BBB shuttles in the neurodegenerative disease treatment market, global interest in this technology has surged. As clinical data from our immuno-oncology pipeline continues to emerge, our discussions with global partners are also making remarkable progress. ABL Bio will continue to seek various growth opportunities at this conference and do our best to deliver good news soon.”
2025-01-06ablbio
ABL Bio to Participate in the 2024 Pharmaceutical Bioindustry Innovation Forum
- Accelerating development of bispecific ADCs based on bispecific antibody expertise- Aiming to submit up to three INDs for bispecific ADCs next year November 25, 2024, ABL Bio (CEO Sang Hoon Lee), ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibodies, announced that it will attend the "2024 Pharmaceutical & Bioindustry Innovation Forum: Antibody-Drug Conjugate (ADC) Development Trends and Strategies", hosted by the Korea Health Industry Development Institute (KHIDI) on November 27th. At the forum, the company will present its strategies and progress in developing bispecific ADCs. ADCs are a cutting-edge modality in oncology that combine an antibody targeting specific tumor antigens with a highly potent cytotoxic payload to selectively kill cancer cells. Since AstraZeneca and Daiichi Sankyo achieved global success with their HER2-targeting ADC (Enhertu), ADCs have become a focal point of drug development efforts among pharmaceutical and biotech companies worldwide, including Korea. Building on its bispecific antibody expertise and experience co-developing the ROR1-targeting ADC ABL202 (CS5001/LCB71) with LigaChem Biosciences, ABL Bio is currently developing bispecific ADCs. Compared to traditional monoclonal ADCs, bispecific ADCs offer enhanced efficacy and safety by improving the precision of payload delivery to tumor cells. Global interest in bispecific ADCs is growing rapidly—Bristol Myers Squibb recently acquired a U.S.-based Phase 1-stage bispecific ADC asset with an upfront payment of $800 million (approximately 1 billion KW), and companies like Sotio and IDEAYA Biosciences have secured bispecific ADC technologies through licensing deals. At the forum, Vice President Weon Kyoo You of ABL Bio will present on the strengths, potential, and pipeline of the company’s bispecific ADCs currently in the preclinical stage. Sang Hoon Lee, CEO of ABL Bio, stated, “ADCs have now become one of the most important modalities in oncology. We are pleased to join this event to share the latest insights and developments with leading domestic and global ADC innovators. ABL Bio is intensifying its R&D efforts with the goal of submitting up to three Investigational New Drug (IND) applications for bispecific ADCs in 2025. Since the bispecific ADC field is still in its early stages, we are committed to becoming a market leader through rapid development and early entry.”
2024-11-25ablbio
ABL Bio/I-Mab Present ABL111/Givastomig Data at SITC 2024
- ABL111/givastomig is a bispecific antibody targeting Claudin 18.2 (CLDN 18.2)-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, with potential CLDN 18.2 specificity even in tumors with low levels of CLDN 18.2 expression- Poster highlights Phase 1 pharmacokinetic modeling data for dose optimization of givastomig- The optimal dose of ABL111/givastomig is identified as 8-12 mg/kg dosed every two weeks (Q2W) ABL Bio (CEO Sang Hoon Lee, “ABL”), a company specializing in bispecific antibodies, today announced that its partner I-Mab presented the Phase I pharmacokinetic modeling clinical of ABL111/givastomig (TJ033721), at the 39th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2024) 2024, held in Houston, Texas from November 8th through 10th. Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. It is being evaluated in ongoing Phase 1b dose expansion and combination studies in treatment-naive metastatic gastric cancers. The poster highlighted the dose optimization analysis for givastomig monotherapy using data from three clinical studies and non-clinical experiments. The poster entitled “Optimal dose estimation using an integrated approach from Phase I data of givastomig, a novel Claudin18.2×4-1BB bispecific antibody” was presented on November 9, 2024, in the Poster Hall of the George R. Brown Convention Center. The studies demonstrated a dose-response relationship for givastomig and identified 8-12 mg/kg Q2W as the optimal monotherapy dose range for gastric cancer patients. ABL Bio and I-Mab are currently conducting a Phase 1b study evaluating givastomig in combination with nivolumab plus chemotherapy in patients with treatment-naïve Claudin18.2-positive metastatic gastric cancers. “ABL111/givastomig is an investigational agent that was developed based on the company’s Grabody-T platform. Our Grabody-T platform has led to promising product candidates, enhanced by our efforts to advance and optimize the 4-1BB technology in our bispecific antibodies,” said Sang Hoon Lee, CEO of ABL Bio. “Givastomig appears to maintain strong tumor binding and anti-tumor activity, while minimizing liver toxicity and systemic immunotoxicity commonly seen with other emerging 4-1BB-based product candidates. Top line data are expected in H2 2025 from the Phase 1b dose escalation clinical trial evaluating the combination of givastomig plus nivolumab and chemotherapy.” About ABL111/givastomig Givastomig (TJ033721/ABL111) is a bispecific antibody targeting Claudin (CLDN) 18.2-positive tumor cells. It conditionally activates T cells in the tumor microenvironment where CLDN18.2 is expressed using 4-1BB. Activated T cells attack Claudin 18.2-positive tumor cells while preserving normal cells, potentially avoiding potential for serious liver toxicity. . In March 2022, ABL111/givastomig received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) as a treatment for gastric cancer (including gastroesophageal junction cancer). Givastomig, is being jointly developed through a global partnership with I-Mab. ABL shares worldwide rights with I-Mab equally, excluding China and South Korea, where ABL retains full rights. About ABL Bio ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 programs, including ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, ABL301, and ABL103, are directed at important cancer targets such as PD-L1, Claudin 18.2, B7-H4 and HER-2, and are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer, and the top-line data will be disclosed in 2025. In addition, encouraging Phase 1 data were just presented at the European Society of Medical Oncology (ESMO2024) for ABL111/givastomig, in development with I-Mab for gastric cancers (including gastroesophageal junction, GEJ). Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean language document prevails.
2024-11-13ablbio