HomeInvestors & MediaNews
ABL Bio Receives Upfront Payment for License, Research and Collaboration Agreement for Grabo...
- Secured a total of 55 million in R&D funding, including 40 million in upfront payment and 15 million in equity investment- Accelerating R&D on core technologies, including expansion of indications for the Grabody platform Seoul (South Korea) – December 26, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that ABL Bio will receive a USD 40 million upfront payment for the license, research and collaboration agreement for its Grabody platform, and a USD 15 million equity investment from Eli Lilly and Company (“Lilly”). ABL Bio and Lilly are currently conducting joint research and development on multiple therapeutic candidates leveraging the Grabody platform across various modalities. In parallel with strengthening its collaboration with Lilly, ABL Bio plans to accelerate R&D on its core technologies—including the bispecific antibody platform ‘Grabody’, bispecific ADCs, and dual-payload ADCs—using the newly secured funding. Sang Hoon Lee, CEO of ABL Bio said, “With the completion of the relevant administrative procedures, including the HSR Act, ABL Bio will receive the upfront payment and equity investment from Lilly. The company plans to use the newly secured funding to expand the indications of its Grabody platform into high-unmet-need areas such as obesity and muscle disorders. ABL Bio also intends to extend clinical development of its bispecific immuno-oncology candidates into combination therapies and focus on advancing next-generation ADC programs.” Meanwhile, on November 12 and 14, ABL Bio signed a license, research and collaboration agreement for Grabody platform with Lilly valued at USD 2.602 billion (including a USD 40 million upfront payment), as well as a USD 15 million equity investment agreement. Based on these agreements, ABL Bio explores a broad range of collaborative opportunities with Lilly to develop therapies from a long-term perspective. 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 ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-12-26ablbio
ABL Bio and NEOK Bio submit IND application in the U.S. for ABL206 (NEOK001)
- Further development of ABL206 (NEOK001) to be led by NEOK Bio and Phase 1 trial is expected to begin by mid-2026 in the U.S. ABL Bio, a company specializing in bispecific antibodies (CEO Sang Hoon Lee), announced that an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial of ABL206 (NEOK001) was submitted on December 19. ABL206 is a bispecific antibody ADC candidate developed by ABL Bio. It is a conjugate in which a topoisomerase I inhibitor is linked to a bispecific antibody targeting ROR1 and B7-H3. In non-clinical studies, ABL206 demonstrated improved efficacy and safety compared to conventional monoclonal antibody ADCs, and it is expected to be developed into an innovative new therapy for patients with various solid tumors through future clinical trials. ABL Bio has overseen the progression from non-clinical research to the IND submission for ABL206, and NEOK Bio will now take full charge, starting with the initiation of Phase 1 clinical trial. NEOK Bio is a U.S.-based company established by ABL Bio specializing in the development of bispecific antibody ADCs, and it fully owns the global development and commercialization rights for ABL206 as well as ABL209 (NEOK002), another bispecific antibody ADC candidate. The IND submission for ABL209’s is scheduled for early next year. NEOK Bio plans to initiate Phase 1 trials for both candidates by mid-2026 and to disclose initial clinical data in 2027. Sang Hoon Lee, CEO of ABL Bio, said, “With the IND submission for ABL206’s Phase 1 trial, the bispecific antibody ADC development programs of ABL Bio and NEOK Bio have officially begun in earnest. Since announcing our next-generation ADC development plan last year, we have dedicated our efforts to entering the bispecific ADC market swiftly, and as a result, we were able to complete clinical preparation according to schedule.” He continued, “Within ABL Bio, we are actively conducting research and development on various platforms—including bispecific ADCs and dual-payload ADCs—as part of our efforts to advance next-generation ADC technologies. We ask for your continued interest and support.” Mayank Gandhi, CEO of Neok Bio, said, “IND submission of NEOK001 is an important step towards our journey to becoming a clinical stage company and an outcome of strong collaboration between ABL and NEOK teams. We are excited about executing on a robust clinical development plan for NEOK001 and look forward to demonstrating the value of our differentiated bispecific ADCs in patients with solid tumors.” 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).
2025-12-22ablbio
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 to Present a Poster on ABL503/Ragistomig at ESMO IO
- Safety and efficacy data released on the adjustment of ABL503/ragistomig monotherapy dosing interval- Dosing-interval adjustment improves safety while maintaining strong anti-tumor efficacy Seoul (South Korea) – December 5, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it will attend the European Society for Medical Oncology Immuno-Oncology Congress (ESMO IO) 2025, which will be held from December 10 to 12, and present a poster on the interim results of a new dosing regimen being evaluated in the ongoing Phase 1 clinical trial of ABL503/ragistomig. ABL503/ragistomig is a PD-L1/4-1BB bispecific antibody candidate being co-developed by ABL Bio and NovaBridge Biosciences (NASDAQ: NBP). It was designed to overcome the limitations of existing PD-(L)1 therapies, such as resistance and low response rates, and is currently being evaluated in ongoing Phase 1 clinical trials in the United States and South Korea. ABL503/ragistomig previously presented clinical data on the bi-weekly (Q2W) monotherapy regimen at the American Society of Clinical Oncology (ASCO) annual meeting last year, where one complete response and six partial responses were observed. Based on these data, ABL Bio additionally evaluated a six-week monotherapy dosing regimen of ABL503/ragistomig to further improve the therapeutic index. ESMO IO is an international academic congress that shares a broad spectrum of scientific knowledge in the field of immuno-oncology, ranging from basic research to clinical development. This year’s meeting will be held in London, UK. At the event, ABL Bio will present Phase 1 clinical data evaluating the safety, efficacy, and pharmacokinetics (PK), pharmacodynamics (PD) of the ABL503/ragistomig monotherapy administered every six weeks (Q6W). The poster to be presented at ESMO IO is titled ‘Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells’, which will be released on December 10. Sang Hoon Lee, CEO of ABL Bio said, “Extending the dosing interval of ABL503/ragistomig’s effective dose (3 mg/kg) from every two weeks to every six weeks improved safety while maintaining strong anti-tumor efficacy. The next clinical strategy for ABL503/ragistomig is to expand into combination therapies. ABL503/ragistomig is one of the candidates developed using Grabody-T, a 4-1BB–based bispecific antibody platform. Another Grabody-T–based candidate, ABL111/givastomig, has shown encouraging results in a Phase 1b trial as part of a triple combination with chemotherapy and a PD-1 inhibitor. ABL503/ragistomig is likewise expected to become a strong partner for combination treatment.” 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.
2025-12-04ablbio
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