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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 and I-Mab to Present Phase 1b Clinical Data of Givastomig/ABL111 Combination Therapy...
- New Givastomig/ABL111 combination data selected for Mini Oral presentation at ESMO GI, being held July 2-5 in Barcelona, Spain- The Phase 1b trial is currently ongoing in the U.S., with data from the ongoing dose-expansion cohorts (n=40) expected to be released in 1H 2026 Seoul (South Korea) – June 24, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its partner I-Mab (NASDAQ: IMAB) will present Phase 1b clinical data of Givastomig/ABL111 in a Mini Oral presentation at the European Society of Medical Oncology (“ESMO”) Gastrointestinal (“GI”) Cancers Congress 2025, being held July 2-5 in Barcelona, Spain. The oral presentation on Givastomig/ABL111 at ESMO GI 2025 is titled “Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)” and will cover data from the dose escalation cohort of the Phase 1b trial. The presentation will be delivered by Dr. Samuel J. Klempner, Associate Professor of Medicine, Massachusetts General Hospital, on Wednesday, July 2nd at 16:50 CEST (10:50 am EST). The ongoing Phase 1b study is evaluating Givastomig/ABL111 for the treatment of gastric cancer in the first line setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). Data from the ongoing dose-expansion cohorts are expected to be released in 1H 2026. The study builds on positive Phase 1 monotherapy data. Givastomig/ABL111 is a pipeline candidate co-developed by ABL Bio and I-Mab, and is one of the bispecific antibodies based on ABL Bio’s proprietary 4-1BB bispecific antibody platform, Grabody-T. The antibody is designed to activate immune T cells only within the tumor microenvironment where Claudin 18.2—an established tumor antigen—is expressed. The activated T cells selectively target and attack Claudin 18.2-positive cancer cells while sparing healthy tissue, thereby minimizing the risk of on-target, off-tumor toxicity. Sang Hoon Lee, CEO of ABL Bio, stated, “The Phase 1b results of Givastomig/ABL111 mark the first clinical data from a combination therapy among our Grabody-T-based 4-1BB bispecific antibody pipelines. Going forward, we will continue to advance the global development of Givastomig/ABL111 in close collaboration with I-Mab, while also accelerating the research and development of other Grabody-T-based bispecific antibodies to further enhance their value as next-generation immuno-oncology therapeutics.” 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, will present 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).
2025-06-24ablbio
ABL Bio Receives MFDS Clearance of IND Application for Phase 1b/2 Clinical Trial of ABL103 i...
- ABL103 in combination with KEYTRUDA® (pembrolizumab) and Taxane will be evaluated for safety and efficacy in South Korea and the United States Pangyo (South Korea) – May XX, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has received MFDS clearance of IND application for the Phase 1b/2 study of ABL103 in combination with MSD’s (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, and with the recent IND clearances in South Korea and the U.S., a Phase 1b/2 study of the triple combination therapy is expected to follow. The Phase 1b/2 study consists of two safety lead-in parts to determine the optial dose 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, stated, “We have received MFDS and FDA clearance to proceed with a clinical trial evaluating the safety and efficacy of ABL103 in a triple combination therapy in South Korea and the United States. We hope that the combination of ABL103, KEYTRUDA, and Taxane will offer a new treatment option for patients with difficult-to-treat solid tumors.” He added, “Clinical development of our 4-1BB-based bispecific antibodies, including ABL103, is progressing smoothly. We will continue to do our utmost in R&D to deliver more positive updates like today’s IND clearance for the Phase 1b/2 trial of ABL103.” 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, 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. 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.
2025-06-04ablbio
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
ABL Bio’s Partner Compass Announces First Patient Dosed in IST Evaluating Tovecimig as a F...
- Tovecimig will be evaluated in combination with the standard first-line treatment for patients with biliary tract cancer… Six-month PFS, safety, and tolerability to be assessed Pangyo (South Korea) – April 23, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that the first patient has been dosed in an Investigator Sponsored Trial (IST) of tovecimig (ABL001/CTX-009/HDB001A), currently being conducted at The University of Texas MD Anderson Cancer Center. The news was announced on the 21st by ABL Bio’s global partner, Compass Therapeutics. In the MD Anderson-led, open-label trial, tovecimig is being added to a standard first-line regimen of gemcitabine, cisplatin, and durvalumab in an estimated 50 patients with unresectable or metastatic biliary tract cancer (BTC). The study will have a standard safety run-in phase in 12 patients followed by an expansion phase in which 38 additional patients will be treated. The primary objectives in the study are to assess 6-month progression-free survival, to assess the tolerability and safety of this combination, and to determine the maximum tolerated dose of tovecimig in this combination. Secondary objectives include overall response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS). “This first-line study of tovecimig in patients with BTC represents a significant step forward and we are deeply grateful to the dedicated team at MD Anderson for their leadership in conducting this trial,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “The IST complements our ongoing second-line Phase 2/3 study of tovecimig in patients with biliary tract cancer; importantly, we recently announced that tovecimig met the primary endpoint in our Phase 2/3 Study. We expect to report results of the secondary endpoints in the Phase 2/3 Study, including progression-free survival (PFS) and overall survival (OS), in the fourth quarter of this year.” Sang Hoon Lee, CEO of ABL Bio, stated, “The IST to evaluate tovecimig as a first-line treatment has officially begun. In a previously announced Phase 2/3 top-line result, tovecimig demonstrated a higher overall response rate (ORR) compared to FOLFOX, another treatment regimen that is used in the second-line setting for biliary tract cancer, successfully meeting its primary endpoint. The clinical benefit rate (CBR) also showed a promising result at 61.2 %, highlighting the strong potential of tovecimig. We look forward to sharing the upcoming PFS and OS data in the second half of this year.” Tovecimig, developed by ABL Bio, is a bispecific antibody that simultaneously blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. The mechanism of action of tovecimig, which simultaneously inhibits DLL4 and VEGF-A, contributes to the suppression of tumor growth and demonstrates strong anti-tumor efficacy. Compass Therapeutics, which holds the global rights to tovecimig except South Korea, is currently conducting COMPANION-002, a Phase 2/3 clinical trial comparing the combination of tovecimig and paclitaxel to paclitaxel monotherapy. The trial targets patients with previously treated, unresectable metastatic or recurrent biliary tract cancer. Meanwhile, ABL 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, ABL104, 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. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-23ablbio