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ABL Bio-NovaBridge Confirm Productive FDA Type B Meeting on Potential for FDA Accelerated Ap...
- Type B meeting with the FDA completed based on positive Phase 1b data, written meeting minutes received Seoul (South Korea) – March 17, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its partner NovaBridge Biosciences (NASDAQ: NBP) has confirmed the possibility of an accelerated approval pathway for givastomig (ABL111), a gastric cancer treatment under development, during a meeting with the U.S. Food and Drug Administration (FDA). The meeting was conducted based on positive data from a Phase 1b clinical trial evaluating the combination therapy of givastomig (ABL111) with the PD-1 inhibitor nivolumab and chemotherapy. NovaBridge held a Type B meeting with the FDA and subsequently received written meeting minutes outlining the potential pathways toward an accelerated approval for givastomig. In addition, the companies aim to initiate a registrational clinical trial as early as Q4 2026, with the final study design to be determined through further discussions with the FDA. “Givastomig (ABL111) has demonstrated strong efficacy and safety not only in tumors with high Claudin18.2 expression but also in those with low expression, giving it broader market potential than currently approved Claudin18.2 therapies. Givastomig is expected to generate $3 billion in sales in the first-line gastric cancer market across the United States, European 5 countries, and Japan alone, and $5 billion if its indications are expanded to other Claudin18.2-positive tumors. Through close collaboration with NovaBridge, we will accelerate development and aim to become a leader in the Claudin18.2 therapeutic market” Said Sang Hoon Lee, CEO of ABL Bio. “We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “This important regulatory milestone builds on compelling Phase 1b givastomig results, that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and bringing givastomig to patients as quickly as possible.” Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. Givastomig is being jointly developed through a global partnership with NovaBridge Biosciences, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio. 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 being evaluated in a Phase 2/3 clinical trial for patients with biliary tract cancer, has received Fast Track Designation from the U.S. Food and Drug Administration (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. About NovaBridge NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines 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, Claudin 18.2 X 4-1BB bispecific antibody, and VIS-101, purpose-designed to be a best-in-class dual VEGF-A X ANG-2 inhibitor.
2026-03-17ablbio
ABL Bio–NEOK Bio, FDA Approves IND for Phase 1 Clinical Trial of ABL206 (NEOK001) in the U...
- Phase 1 clinical development to be initiated by NEOK Bio in the U.S. by the first half of this year - Initial clinical data will be disclosed in 2027 ABL Bio today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a Phase 1 clinical trial of ABL206 (NEOK001). ABL206 is a first-in-class bispecific antibody–drug conjugate (ADC) targeting B7-H3 and ROR1 , conjugated with a topoisomerase I inhibitor payload via a linker. Leveraging its proprietary bispecific antibody technology and extensive experience in monoclonal antibody ADC development, ABL Bio is advancing next-generation ADC programs, including bispecific ADCs. Among these, ABL206 is the first candidate from ABL Bio’s next-generation ADC pipeline to enter the clinical stage. The clinical development of ABL206 will be conducted by NEOK Bio, a bispecific ADC-focused biotechnology company established by ABL Bio in the United States. NEOK Bio holds global development and commercialization rights to ABL206 as well as another bispecific ADC candidate, ABL209 (NEOK002). NEOK Bio plans to initiate the Phase 1 clinical trial for both programs in the first half of this year and aims to disclose initial clinical data in 2027. Sang Hoon Lee, CEO of ABL Bio, stated, “With ABL206, our first bispecific ADC candidate, entering Phase 1 clinical trials, we have taken the first step in our journey toward developing next-generation ADCs. We are very pleased to have successfully obtained IND approval without any issues, thanks to the close collaboration and dedicated R&D efforts of ABL Bio and NEOK Bio. We will continue to accelerate our research and development to introduce a diverse range of next-generation ADC candidates following ABL206.” Mayank Gandhi, CEO of NEOK Bio, said, “The timely IND submission and approval represents a significant milestone in NEOK Bio’s evolution into a clinical-stage company and reflects the strong collaboration between ABL Bio and NEOK Bio. We are excited to advance a rigorous clinical development program and look forward to demonstrating the differentiated potential of this novel bispecific ADC for patients with solid tumors of high unmet need” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 9 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), ABL206(NEOK001) are underway for different indications in various countries, including the United States, China, Australia, and Korea. Following the completion of the Phase 1 clinical trial of ABL301 (SAR446159), Sanofi will conduct the subsequent 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 addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2026-01-19ablbio
ABL Bio’s Partner Compass to Deliver IR Presentation at JPM Healthcare Conference
- On-site presentation scheduled for 7:30 a.m. on the 14th; recorded version to be released online Seoul (South Korea) – January 9, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its licensing partner for tovecimig, Compass Therapeutics, will deliver a presentation at the JPM Healthcare Conference 2026, taking place from January 12 to 15. Compass Therapeutics is a Boston-based, clinical-stage biotechnology company in the United States. The company has licensed tovecimig, a bispecific antibody developed by ABL Bio, and is developing it as a treatment for biliary tract cancer. Compass Therapeutics’ presentation will be held on January 14 at 7:30 a.m. and will discuss the development status and business strategies of tovecimig, along with updates on its other pipeline assets. A recorded version of the presentation will also be made available on the Compass Therapeutics website. ABL Bio CEO Sanghoon Lee stated, “Our partner Compass Therapeutics will be presenting to global pharmaceutical and biotechnology stakeholders, and tovecimig, originally developed by ABL Bio, will be highlighted on the global stage. tovecimig has received Fast Track designation from the U.S. Food and Drug Administration (FDA) and Compass Therapeutics plans to submit a Biologics License Application (BLA) based on Phase 2/3 clinical data. Starting with this presentation, we ask for continued interest in tovecimig throughout the year.” Tovecimig, originally developed by ABL Bio, is a bispecific antibody that simultaneously blocks the signaling pathways of DLL4 (Delta-like ligand 4) and VEGF-A (Vascular Endothelial Growth Factor-A), both of which play key roles in angiogenesis and tumor vascular formation. Preclinical and clinical evidence supports the hypothesis that concurrent inhibition of DLL4 and VEGF-A yields anticancer efficacy by suppressing tumor growth. Compass Therapeutics is currently conducting the Phase 2/3 COMPANION-002 clinical trial, which compares a combination therapy of tovecimig and paclitaxel with paclitaxel monotherapy. The company plans to release clinical results from COMPANION-002, including overall survival (OS) and progression-free survival (PFS), in the first half of this year. 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. Following the completion of the Phase 1 clinical trial of ABL301 (SAR446159), Sanofi will conduct the subsequent 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 addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2026-01-09ablbio
ABL Bio and NovaBridge Present Positive ABL111/Givastomig Dose Expansion Data from the Phase...
- 77% ORR observed at 8 mg/kg and 73% ORR observed at 12 mg/kg, across a wide range of PD-L1 and CLDN18.2 expression levels- Best-in-class potential as first-line standard-of-care treatment for HER2-negative, Claudin 18.2-positive, metastatic gastric cancers Seoul (South Korea) – January 7, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that positive antitumor efficacy was confirmed in the Phase 1b dose expansion cohort of ABL111/Givastomig, which is being co-developed with U.S.-based biotech company, NovaBridge Biosciences. The newly released data are from patients with HER2-negative, Claudin 18.2-positive, metastatic gastric cancers receiving first-line standard of care (nivolumab and mFOLFOX6) plus ABL111/Givastomig. ABL111/Givastomig is a bispecific antibody that simultaneously targets Claudin 18.2 and 4-1BB. It is currently being evaluated in a Phase 1b clinical trial in the United States in combination with the PD-1 inhibitor nivolumab and chemotherapy (mFOLFOX6). The Phase 1b study of the ABL111/Givastomig combination therapy is being conducted in patients with Claudin 18.2-positive gastric cancer and consists of both dose escalation and dose expansion cohorts. The newly announced data represent an integrated analysis of patients who received ABL111/Givastomig at either 8 mg/kg or 12 mg/kg across both the dose escalation and dose expansion cohorts. The results showed an observed objective response rate (ORR) of 77% (20/26) in the 8 mg/kg cohort and 73% (19/26) in the 12 mg/kg cohort. The ABL111/Givastomig combination therapy demonstrated consistent responses regardless of patients’ PD-L1 or Claudin 18.2 expression levels. In addition, the safety profile was comparable to that of current first-line standard therapies, showing overall favorable tolerability. The median progression-free survival (PFS) was 16.9 months at 8 mg/kg. PFS data for the 12 mg/kg cohort has not yet matured due to a relatively shorter follow-up period and are expected to be disclosed later in 2026. ABL Bio CEO Sang Hoon Lee stated, “These data further confirm the potential of ABL111/Givastomig to become a best-in-class, first-line standard-of-care therapy. Given that gastric cancer represents a global market opportunity of approximately USD 12 billion, both companies will continue to accelerate the clinical development of ABL111/Givastomig. We also plan to expand combination therapy studies for other 4-1BB bispecific antibodies under development, including ABL503/Ragistomig.” “The dose expansion data reinforce the strong signals we observed in dose escalation. The efficacy is clear at 8 mg/kg, with robust ORRs, including in subgroups defined by low PD-L1 and/or CLDN18.2 expression. The PFS data are very promising and continue to mature. Emerging efficacy data at 12 mg/kg are also strong and similar in terms of ORR. The 12 mg/kg cohort was enrolled after the 8 mg/kg cohort, so follow-up is shorter and PFS is less mature. We expect to report this data later in 2026. We remain enthusiastic about the 12 mg/kg dose because exposure analysis shows higher exposure is consistently associated with a higher probability of response, without a higher probability of toxicity,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. The full data set from the Phase 1b study of ABL111/Givastomig is scheduled to be presented at a global scientific conference in 2026. In addition, ABL Bio and NovaBridge plan to initiate a global randomized Phase 2 trial in the first quarter of 2026, comparing two doses of ABL111/Givastomig—8 mg/kg and 12 mg/kg—against existing standard-of-care treatments. 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. Following the completion of the Phase 1 clinical trial of ABL301 (SAR446159), Sanofi will conduct the subsequent 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 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, Claudin 18.2 x 4-1BB bispecific antibody, 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. For more information, please visit www.novabridge.com and follow us on LinkedIn.
2026-01-07ablbio
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’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
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