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ABL Bio-NovaBridge Successfully Finished Poster Presentations on ABL111 and ABL503 at ESMO 2...
- 8 mg/kg selected as the dose for further clinical development of givastomig, with an ORR of 79% observed in the 8 mg/kg cohort of the Phase 1b study Seoul (South Korea) – October 26, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has successfully concluded the presentation of clinical data on givastomig (ABL111) and ragistomig (ABL503), two 4-1BB-based bispecific immuno-oncology therapies, at the European Society for Medical Oncology (ESMO) Congress 2026. Givastomig and ragistomig are both developed using Grabody-T, ABL Bio’s proprietary 4-1BB-based bispecific antibody platform. Givastomig targets Claudin18.2, which is overexpressed in certain cancers, including gastric and pancreatic cancers, while ragistomig targets the immune checkpoint PD-L1. Both candidates are being co-developed with NovaBridge Biosciences, a U.S.-based biotechnology company. At this year's ESMO Congress, the two companies presented additional analyses of data from a total of 71 patients enrolled in the Phase 1b study of givastomig, including 31 patients treated at 8 mg/kg and 40 patients treated at 12 mg/kg. Based on a comprehensive evaluation of efficacy, safety, and long-term follow-up data from the Phase 1b study, 8 mg/kg was selected as the dose for further clinical development of givastomig. In the 8 mg/kg cohort, givastomig demonstrated an objective response rate (ORR) of 79% (23/29) and a disease control rate (DCR) of 97% (28/29). An analysis of patients in the 8 mg/kg cohort by Claudin18.2 expression level also showed encouraging antitumor activity. The ORR was 82% (14/17) in patients with Claudin18.2 expression of 75% or higher and 75% (9/12) in those with expression levels ranging from 1% to 74%. In terms of safety, the additional Phase 1b analysis confirmed that givastomig demonstrated a manageable safety profile, with no Grade 4 or Grade 5 treatment-related adverse events reported. Immune-related adverse events were infrequent, except for gastritis, which was predominantly Grade 2 in severity. ABL Bio and NovaBridge have been engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding the further clinical development of givastomig and have reached alignment on key elements of the design of a global registrational Phase 3 study. Givastomig has previously received Orphan Drug Designation and Fast Track Designation from the FDA, and the two companies plan to leverage these designations to advance its clinical development. Ragistomig, which was also featured in a poster presentation at this year's ESMO alongside givastomig, demonstrated an improved safety profile and sustained antitumor activity in a Phase 1 monotherapy study when the dosing interval was extended from every two weeks (Q2W) to every six weeks (Q6W). The incidence of Grade 3 or higher treatment-related adverse events was lower in the Q6W group compared to the Q2W group. Despite reduced drug exposure resulting from the extended dosing interval, activation of key CD8+ T cells was sustained. Meanwhile, immunosuppressive regulatory T cells (Tregs) remained at baseline levels, suggesting the potential to create an immunological environment favorable for antitumor immune responses. The objective response rate (ORR) was 11.8% (2/17) in the ragistomig 3 mg/kg Q6W group and 21.1% (4/19) in the 5 mg/kg Q6W group. Ragistomig demonstrated antitumor activity across various solid tumors, including in patients who had failed prior immune checkpoint inhibitor therapy. Notably, 84.6% (11/13) of patients who responded to treatment were refractory to prior PD-(L)1 inhibitor therapy or had experienced disease recurrence following treatment. ABL Bio and NovaBridge expect ragistomig to emerge as a new treatment option for patients with high unmet medical needs who are refractory to or have relapsed following prior immune checkpoint inhibitor therapy. Sang Hoon Lee, CEO of ABL Bio, said, “The long-term follow-up data presented at this year's ESMO Congress have further strengthened our confidence in the durability of givastomig's efficacy and its safety profile. We have also made meaningful progress in our discussions with the FDA, laying the groundwork for further clinical development. We will work closely with NovaBridge to accelerate preparations for the Phase 3 study of givastomig. At the same time, we plan to actively advance the ongoing clinical development of ragistomig in combination with a PD-1 inhibitor, building on the dosing schedule optimization results demonstrated in this study.” About ABL BioABL Bio is developing a variety of preclinical and clinical-stage pipelines utilizing its BBB shuttle platform Grabody-B and its 4-1BB-based bispecific antibody platform Grabody-T, among others. Clinical projects for pipelines such as ABL111 (Givastomig), ABL503 (Ragistomig), ABL103, ABL105 (Nesfrotamig), ABL104 (YH32364), ABL206 (NEOK001), ABL209 (NEOK002), ABL202 (CS5001/LCB71), and ABL301 (SAR446159) are underway across various countries, including the US, China, Australia, Japan, and South Korea. ABL301 has completed its Phase 1 clinical trial in the US, with subsequent trials to be conducted by Sanofi. ABL111 is being co-developed with NovaBridge and has received Fast Track Designation and Orphan Drug Designation from the FDA. ABL111 is currently undergoing Phase 2 clinical trial for combination therapy with nivolumab and chemotherapy in patients with 1L metastatic gastroesophageal cancer. In addition, several preclinical pipelines, including bispecific antibody ADCs and dual-payload ADCs, are continuously under research and development.
2026-10-26ablbio
ABL Bio’s Partner Compass Therapeutics Receives FDA Orphan Drug Designation for Biliary Tr...
- OS and PFS data to be announced in April- Compass plans to continue expedited discussions with the FDA using Fast Track and Orphan Drug Designations Seoul (South Korea) – April 8, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner Compass Therapeutics has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for tovecimig (ABL001), a treatment for biliary tract cancer currently under development. Orphan Drug Designation is a system designed to encourage the development of treatments for rare diseases with patient populations under 200,000, where drug development is typically limited. Drugs granted this designation receive various benefits in the U.S., including market exclusivity for a certain period (typically 7 years), tax credits, partial exemption from FDA review fees, clinical trial grants, and regulatory support. Tovecimig is a bispecific antibody originally developed by ABL Bio and licensed to Compass Therapeutics. It simultaneously inhibits the DLL4 (Delta-like ligand 4) and VEGF-A (Vascular Endothelial Growth Factor-A) signaling pathways, both of which play key roles in angiogenesis and tumor vascular formation. Preclinical and clinical findings have shown that dual inhibition of DLL4 and VEGF-A suppresses tumor growth, resulting in strong anticancer activity. Currently, Compass Therapeutics is conducting the Phase 2/3 COMPANION-002 clinical trial in second-line biliary tract cancer patients, combining tovecimig with the chemotherapy drug paclitaxel. Key efficacy data, including Overall Survival (OS) and Progression-Free Survival (PFS), which are critical for FDA approval, are expected to be released this month. CEO Sang-Hoon Lee of ABL Bio stated, “Compass Therapeutics previously received Fast Track Designation from the FDA for tovecimig in April 2024 and has been leveraging its benefits in clinical development. Based on the COMPANION-002 clinical data, Compass Therapeutics plans to engage with the FDA following the OS and PFS readout on next steps. We hope that this Orphan Drug Designation, following Fast Track Designation, will positively impact the approval process of tovecimig.” About ABL BioABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea. Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (tovecimig), currently in Phase 2/3 trial for biliary tract cancer patients, has received both Fast Track and Orphan Drug Designations from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year. In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
2026-04-08ablbio
ABL Bio Successfully Finished ESMO IO Poster Presentation for ABL503/Ragistomig
- Significant improvement in the overall safety profile of ABL503/ragistomig administered as a monotherapy at a 6-week interval- Enhanced T-cell immune memory along with favorable modulation of the tumor microenvironment Seoul (South Korea) – December 12, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it successfully finished the poster presentation for ABL503/ragistomig at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO IO) 2025, held on December 10. ABL503/ragistomig is a PD-L1/4-1BB bispecific antibody co-developed by ABL Bio and NovaBridge Biosciences. It is designed to activate immune cells through 4-1BB only within the PD-L1–expressing tumor microenvironment. While PD-1/PD-L1 blockade inhibits cancer cells, 4-1BB is a target involved in activating T-cell proliferation and immune-memory function. The 6-week interval (Q6W) monotherapy regimen of ABL503/ragistomig was evaluated in 20 patients with relapsed or refractory solid tumors who had previously received immuno-oncology (IO) therapy and exhibited PD-L1 expression. Among them, 17 patients were included in the efficacy analysis set. These participants represented a high unmet medical need population with no remaining standard treatment options. “According to the poster presented at the conference, encouraging antitumor activity was maintained even when the dosing interval of ABL503/ragistomig was extended from every 2 weeks (Q2W) to every 6 weeks (Q6W), with a Disease Control Rate (DCR) of 58.8%. Among patients who had previously been exposed to PD-(L)1 inhibitors but had relapsed or were refractory, two cases of Partial Response (PR) were reported. In addition, the 6-week interval monotherapy of ABL503/ragistomig demonstrated a markedly improved overall safety profile, with treatment-related adverse events of Grade 3 or higher occurring in 15% (3/20) of patients and Grade ≥3 elevations in liver function tests observed in 5% (1/20). No patients discontinued the trial due to treatment-emergent adverse events while receiving ABL503/ragistomig on the Q6W schedule, and notably, no cases of cytokine release syndrome (CRS) were reported. Sang Hoon Lee, CEO of ABL Bio, stated, “What is particularly noteworthy in this data presentation is that despite the reduced drug exposure resulting from the extended dosing interval, we observed enhanced T-cell immune-memory function as well as favorable modulation of the tumor microenvironment, which had previously hindered T-cell activation.” He continued, “Based on these results, the 6-week dosing of ABL503/ragistomig at 3 mg/kg is a candidate dose level for future combination-therapy development. After completing another dose cohort (5 mg/kg Q6W), ABL Bio plans to expand the clinical strategy of ABL503/ragistomig into combination therapies and identify the most suitable development partners.” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), are underway for different indications in various countries, including the United States, China, Australia, and Korea. Currently, ABL Bio and Sanofi are in the process of transferring the clinical trial sponsorship of ABL301 (SAR446159) to Sanofi to conduct following clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). About NovaBridgeNovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. We combine deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB), and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer. VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a large, randomized, dose-ranging Phase 2 study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.
2025-12-12ablbio
ABL Bio Announces Equity Investment Agreement with Lilly
- Under the agreement, 175,079 common shares will be issued at KRW 125,900 won per share, raising a total of KRW 22 billion won - The funds will be invested in the research and development of ABL Bio’s core technologies, including the expansion of indications for its Grabody Platform Seoul (South Korea) – November 14, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that ABL Bio has entered into an equity investment agreement worth KRW 22 billion won with Eli Lilly and Company (“Lilly”). ABL Bio will issue 175,079 common shares to Lilly. The issue price is KRW 125,900 won per share, which was calculated in accordance with the regulations on the issuance and disclosure of securities. The payment date is expected to occur following the receipt of U.S. Hart-Scott-Rodino Antitrust Improvements Act (HSR Act) approval and the completion of relevant administrative procedures. The newly issued common shares will be subject to a one-year lock-up through the Korea Securities Depository. ABL Bio plans to use the investment proceeds to advance its core technologies, including its Grabody Platform and bispecific ADCs. Through this initiative, ABL Bio aims to strengthen its drug development capabilities and, from a long-term perspective, explore a broad range of collaborative opportunities with Lilly to develop therapies. Sang Hoon Lee, CEO of ABL Bio, said “We are very pleased to secure a strategic equity investment following our license agreement with Lilly, a global leader in innovative drug development. ABL Bio plans to expand the indications of its Grabody Platform into areas of high unmet medical need, such as obesity and muscle diseases. We expect that this collaboration with Lilly will serve as an important milestone in delivering innovative treatment options to patients worldwide” Meanwhile, ABL Bio entered license, research and collaboration agreement with Lilly valued at up to $2.602 billion, which includes an upfront payment of $40 million. Under this agreement, both companies will collaborate to develop multiple therapeutics across modalities & therapeutic areas utilizing the Grabody Platform. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. Currently, ABL Bio and Sanofi are in the process of transferring the clinical trial sponsorship of ABL301 (SAR446159) to Sanofi to conduct following clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-11-14ablbio
ABL Bio Announces License, Research and Collaboration Agreement for its Grabody Platform wit...
- ABL Bio and Lilly enter a multi-program agreement to develop multiple therapeutics across modalities & therapeutic areas utilizing ABL’s Grabody Platform. Seoul (South Korea) – November 12, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that ABL Bio has entered license, research and collaboration agreement with Eli Lilly and Company (“Lilly”) for the development of therapeutics by utilizing ABL Bio’s Grabody Platform. ABL Bio and Lilly will collaborate to develop multiple therapeutics across modalities & therapeutic areas utilizing the Grabody Platform. Under the terms of the agreement, ABL Bio will receive an upfront payment of USD $40 million within 10 days following the completion of the administrative procedures under the Hart–Scott–Rodino Antitrust Improvements Act (HSR Act). In addition to the upfront payment, ABL Bio is eligible to receive up to USD $2.562 billion in development, regulatory, and commercial milestone payments as well as tiered royalties on net sales. Sang Hoon Lee, CEO of ABL Bio, said “This agreement not only validates the business potential of the Grabody Platform, but also demonstrates the continued expansion of modalities to which Grabody can be applied. We believe Grabody has already established a strong foothold, and we intend to build on this momentum by broadening its indications into therapeutic areas with high unmet medical needs, including obesity and muscle diseases.” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. Currently, ABL Bio and Sanofi are in the process of transferring the clinical trial sponsorship of ABL301 (SAR446159) to Sanofi to conduct following clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-11-12ablbio
ABL Bio Announces Results of Phase 1 US Clinical Trial for ABL301 (SAR446159)
- Confirmed safety and tolerability of ABL301 (SAR446159) in healthy adults- Sanofi to conduct following clinical study of ABL301 (SAR446159) after transfer of sponsorship Seoul (South Korea) – September 1, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has confirmed safety and tolerability of ABL301 (SAR446159), a bispecific antibody candidate for the treatment of neurodegenerative diseases such as Parkinson’s disease, in Phase 1 U.S. clinical trial in healthy adults. ABL Bio conducted Phase 1 clinical trial from December 2022 to April 2025 in 91 healthy adults to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ABL301 (SAR446159) administered via intravenous injection. The Phase 1 study consisted of two parts: a Single Ascending Dose (SAD) study and a Multiple Ascending Dose (MAD) study, enrolling 56 and 35 participants respectively. The primary endpoints were safety and tolerability, which were assessed based on indicators such as treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). According to the clinical study report, ABL301 (SAR446159) demonstrated safety and tolerability in both the SAD and MAD studies, with no deaths or serious adverse events (SAEs) reported in any participants. In the SAD analysis, 4 out of 56 participants (7.1%) experienced at least one treatment-related adverse event (TRAE), and 2 of those 4 participants were in the placebo group. Additionally, 39 out of 56 participants (69.6%) reported at least one treatment-emergent adverse event (TEAE), all of which were classified as Grade 1 or Grade 2. In the MAD study, 2 out of 35 participants (5.7%) experienced at least one treatment-related adverse event (TRAE), while treatment-emergent adverse events (TEAEs) were reported in 20 out of 35 participants (57.1%). All TEAEs reported in the MAD study were also classified as Grade 1 or Grade 2. In January 2022, ABL Bio entered into a licensing agreement with the biopharma company Sanofi, granting Sanofi exclusive rights for the development and commercialization of ABL301 (SAR446159). Currently, the two companies are in the process of transferring the clinical trial sponsorship of ABL301 to Sanofi to conduct following clinical studies. Sang Hoon Lee, CEO of ABL Bio said, “The results of this Phase 1 trial provided supporting evidence for Sanofi’s decision to advance the following clinical development of ABL301 (SAR446159). Neurodegenerative diseases such as Parkinson’s disease seriously threaten the quality of life of patients and their families, yet there are still no fundamental treatments available, resulting in a significant unmet need. We hope that ABL301 will offer Parkinson’s patients a new treatment option and become an innovative therapy that improves their lives.” ABL301 is a bispecific antibody developed using ABL Bio’s ‘Grabody-B’ platform technology, which has the potential to effectively deliver antibodies into the brain to inhibit the accumulation of alpha-synuclein—the cause of Parkinson’s disease—thereby potentially enhancing therapeutic efficacy. The Grabody-B platform utilizes the Insulin-like Growth Factor 1 Receptor (IGF1R) to maximize the potential penetration of various neurodegenerative disease drug candidates across the blood-brain barrier (BBB). About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with I-Mab, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-09-01ablbio
ABL Bio and I-Mab Complete Mini Oral Presentation at ESMO GI 2025 Givastomig/ABL111 Combina...
- At the 8 mg/kg and 12 mg/kg dose levels currently being evaluated in ongoing dose expansion studies, an ORR of 83% (10/12) was observed- Phase 1b dose expansion data for Givastomig/ABL111 combination therapy is expected to be disclosed in the first quarter of 2026 Seoul (South Korea) – July 7, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its partner I-Mab (NASDAQ: IMAB) successfully completed a Mini Oral presentation on new Givastomig/ABL111 Phase 1b clinical data at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025), held on July 2. Givastomig/ABL111 is a bispecific antibody co-developed by ABL Bio and I-Mab that simultaneously targets Claudin 18.2 and 4-1BB. Givastomig/ABL111 is currently being evaluated in combination with standard-of-care therapies—nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy—as a potential first-line treatment for patients with metastatic gastric cancers. At ESMO GI 2025, I-Mab presented encouraging data from the dose escalation portion of the Phase 1b study evaluating Givastomig/ABL111 in combination with nivolumab plus chemotherapy. According to the Mini Oral presentation at ESMO GI 2025, Givastomig/ABL111 combination therapy demonstrated promising efficacy, with an objective response rate (ORR) of 71% (12/17) and a disease control rate (DCR) of 100% (17/17) across the three dose levels. Notably, in the 8 mg/kg and 12 mg/kg cohorts—currently being evaluated as optimal doses in the dose expansion arms—an ORR of 83% (10/12) was observed. In addition, Givastomig/ABL111 showed favorable tolerability across the 5 mg/kg, 8 mg/kg, and 12 mg/kg cohorts, with limited Grade 3+ TRAEs and no events of Grade 3+ nausea or vomiting. The ongoing Phase 1b study is underway in the United States, targeting patients who are HER2-negative, Claudin 18.2-positive (defined as >1+ intensity in >1% of tumor cells) regardless of PD-L1 expression levels. The study consists of three dose escalation cohorts and two dose expansion cohorts. The primary endpoint is safety, while secondary endpoints include objective response rate (ORR), pharmacokinetics/pharmacodynamics (PK/PD), and duration of response (DoR). Enrollment for the 8 mg/kg cohort in dose expansion has been completed. Sang Hoon Lee, CEO of ABL Bio, stated, “Currently, the monoclonal antibody zolbetuximab is the only Claudin 18.2-targeted therapy approved in key global markets for gastric cancer patients. Considering that the ORR of zolbetuximab in combination with mFOLFOX6 chemotherapy was 40.3% in the SPOTLIGHT trial, the 83% ORR observed with Givastomig/ABL111 at the doses selected for expansion studies is highly encouraging.” He added, “Among our bispecific antibodies based on the Grabody-T platform, Givastomig/ABL111 is the most advanced in clinical development. The ESMO GI 2025 presentation highlights its potential as a first-line treatment for gastric cancers; we hope that other Grabody-T-based bispecific antibodies will also demonstrate strong outcomes in combination settings.” Givastomig/ABL111 is a bispecific antibody developed using ABL Bio’s proprietary 4-1BB bispecific antibody platform, Grabody-T, and is the most advanced candidate within the Grabody-T pipeline. It is designed to activate immune T cells only within the tumor microenvironment where Claudin 18.2 is expressed. The activated T cells selectively attack Claudin 18.2-positive cancer cells while sparing healthy tissue, thereby minimizing the risk of on-target, off-tumor toxicity. Virtual KOL Webinar: Register for the post-ESMO GI 2025 Webinar here. A replay of the webinar will be accessible on the News & Events page of the I-Mab website (www.i-mabbiopharma.com) for 90 days. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), 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, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy at ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). About I-MabI-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain strong tumor-binding and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with Claudin 18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents.
2025-07-07ablbio
ABL Bio and I-Mab Publish ABL111/Givastomig Monotherapy Data in Clinical Cancer Research
- Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy Seoul (South Korea) – July 2, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced its partner I-Mab published clinical data on ABL111/Givastomig, a bispecific antibody targeting Claudin18.2 and 4-1BB, in Clinical Cancer Research, a journal of the American Association for Cancer Research (CCR). The paper presents promising efficacy and safety data from a Phase 1 study of ABL111/Givastomig monotherapy in patients with Claudin18.2-positive gastric cancers. Phase 1 data on ABL111/Givastomig monotherapy was previously presented in poster format at the European Society for Medical Oncology (ESMO) congresses in 2023 and 2024. The study enrolled a total of 75 patients with solid tumors, including gastric cancers. Among them, 43 patients were efficacy-evaluable with CLDN18.2-positive advanced or metastatic gastroesophageal carcinoma (GEC) who received ABL111/Givastomig monotherapy at doses ranging from 5 to 18 mg/kg. Based on the data, seven out of the 43 patients achieved a partial response (PR), resulting in an objective response rate (ORR) of 16% (7/43) for ABL111/Givastomig monotherapy. Following the data cutoff presented at ESMO 2024, two additional patients were enrolled in the study, and one of them achieved a PR, raising the ORR to 18% (8/45). The disease control rate (DCR) was 49% (21/43), including 14 patients who achieved stable disease (SD). Most adverse events were mild, categorized as Grade 1 or 2. Among patients who responded to ABL111/Givastomig monotherapy, Claudin18.2 expression levels ranged from 11% to 100%, suggesting that ABL111/Givastomig may offer therapeutic benefit even in patients with low Claudin18.2 expressions. Sang Hoon Lee, CEO of ABL Bio, stated, “We are pleased to have the clinical data on ABL111/Givastomig monotherapy published for the first time in the prestigious international Clinical Cancer Research (CCR) journal. Moving forward, we will continue to work closely with I-Mab to successfully advance the global clinical development of ABL111/Givastomig and generate meaningful results from the combination therapy trials. Our goal is to provide a new treatment option for patients with gastric cancers.” ABL111/Givastomig is a bispecific antibody that targets Claudin18.2-positive tumors and is designed to selectively activate T cells through the 4-1BB pathway only within the tumor microenvironment where Claudin18.2 is expressed. The antibody is currently being evaluated in a Phase 1b clinical trial in combination with the immune checkpoint inhibitor, nivolumab and chemotherapy, with the goal of developing it as a first-line treatment for gastric cancers. In the Phase 1 monotherapy study, ABL111/Givastomig demonstrated potent anti-tumor activity through the localized interaction between Claudin18.2 and 4-1BB, while minimizing the toxicity typically associated with conventional 4-1BB antibodies. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), 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, presents encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-07-02ablbio
ABL Bio Participates in BIO KOREA 2025
- Exhibiting at Booth C11, Hall C, 3F, COEX April 30, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, announced that it will participate in BIO KOREA 2025, which will be held at COEX from May 7th to May 9th. BIO KOREA marks its 20th anniversary this year as a major biotech event, attended by investors, industry professionals, and researchers. The exhibition program will be held at Hall C, 3rd floor of COEX in Seoul, with ABL Bio’s booth located at C11. During the event, ABL Bio will present posters highlighting its four key business areas: the Blood-Brain Barrier (BBB) shuttle platform, novel drug candidates, oncology therapeutics, and Antibody-Drug Conjugates (ADC). ABL Bio owns Grabody-B, a BBB shuttle platform aimed at developing treatments for neurodegenerative diseases. On the 7th, the company signed a license agreement with GSK for the Grabody-B platform, which includes an upfront payment and near-term milestones totaling 77.1 million GBP, with the potential deal value reaching up to 2.14 billion GBP, marking the official start of Grabody-B commercialization. Among ABL Bio’s pipeline, Tovecimig is emerging as a promising drug candidate for second-line treatment of bile duct cancer. Tovecimig is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4), designed to suppress tumor angiogenesis and induce cancer cell death. In a U.S.-based Phase 2/3 trial conducted by Compass Therapeutics, which holds the global rights to Tovecimig, the drug achieved an Overall Response Rate (ORR) of 17.1% and a Clinical Benefit Rate (CBR) of 61.3% (68/111), meeting the primary endpoint. In the immuno-oncology field, ABL Bio is developing therapies using its 4-1BB-based bispecific antibody platform, Grabody-T. 4-1BB is a protein involved in activating immune T cells. The lead candidate from this platform, Givastomig, is expected to present Phase 1b topline results this year from a combination trial with nivolumab and chemotherapy. Moreover, ABL Bio has been accelerating its bispecific ADC development since last year. The company has reinforced its U.S. subsidiary, Neok Bio, by appointing a new CEO and recruiting ADC experts. Clinical trial applications (IND) submissions for the bispecific ADC programs are planned to begin sequentially starting later this year. Sang Hoon Lee, CEO of ABL Bio said “Through BIO KOREA, we are raising awareness of ABL Bio among domestic and international stakeholders in the bio industry. This year, we aim to highlight our expertise in bispecific antibodies through our booth and poster presentations as well.” He added, “ABL Bio is pursuing sustainable growth centered around four key pillars. We will continue to focus on research and development to deliver good news.”
2025-04-30ablbio