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ABL Bio to Present Posters on ABL206 (NEOK001) and ABL209 (NEOK002) at AACR
- The posters will be disclosed on April 20- Both programs recently received U.S. Phase 1 IND approvals… Initial clinical data expected to be presented in 2027 Seoul (South Korea) – March 19, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it will participate in the American Association for Cancer Research (AACR) Annual Meeting and present non-clinical data on ABL206 (NEOK001) and ABL209 (NEOK002) in poster sessions. The AACR Annual Meeting is a global event where pharmaceutical and biotech companies, researchers, healthcare professionals, and patients gather to share the latest research findings. This year’s meeting will be held from April 17 to 22 at the San Diego Convention Center in California, USA. ABL206 (NEOK001) and ABL209 (NEOK002), which will be introduced in poster presentations at the event, are bispecific antibody-drug conjugate (ADC) pipelines developed by ABL Bio. NEOK Bio, which holds the clinical development and global development rights rights to both pipelines, is rapidly initiating clinical development for both programs after receiving Investigational New Drug (IND) approvals for Phase 1 trials from the U.S. Food and Drug Administration (FDA). ABL206 (NEOK001) targets both B7-H3 and ROR1, while ABL209 (NEOK002) targets EGFR and MUC1. Both pipelines utilize a payload based on a topoisomerase I inhibitor. The posters for ABL206 (NEOK001) and ABL209 (NEOK002) will be presented on April 20 during the session titled “Antibody-Drug Conjugates and Linker Engineering 2.” According to the abstracts, in preclinical studies, ABL206 (NEOK001) demonstrated improved efficacy and safety compared to single-antibody ADCs targeting either ROR1 or B7-H3 in both in vitro and in vivo settings. It also showed overall favorable tolerability in GLP toxicity studies conducted in non-human primates. ABL209 (NEOK002) likewise exhibited strong anticancer activity while reducing EGFR-related toxicity. CEO Sang Hoon Lee of ABL Bio stated, “ABL206 (NEOK001) and ABL209 (NEOK002) are promising next-generation ADC pipelines with encouraging preclinical data. Clinical development of both programs is being carried out by NEOK Bio in the United States. NEOK Bio, together with ADC development experts, has established an optimal clinical strategy and aims to present initial Phase 1 clinical data in 2027. In addition, ABL Bio is actively advancing next-generation ADC research to follow ABL206 (NEOK001) and ABL209 (NEOK002), and we will accelerate R&D efforts to disclose subsequent pipelines as soon as possible.” 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.
2026-03-19ablbio
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 Receive U.S. IND Clearance for Phase 1 Clinical Trial of ABL209 (NEOK002)
- Phase 1 clinical trials of ABL206 and ABL209 to be initiated by NEOK Bio in 1H2026 Seoul (South Korea) – March 3, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1 clinical trial of ABL209 (NEOK002). ABL209 is a bispecific antibody-drug conjugate (ADC) candidate that targets EGFR and MUC1 and is conjugated with a Topoisomerase I inhibitor. By simultaneously targeting two complementary antigens, ABL209 is expected to overcome the limitations of competing candidates that target either EGFR or MUC1 alone. The development of ABL209, along with ABL206 (NEOK001)—another bispecific antibody-drug conjugate (ADC) that previously received U.S. IND clearance for a Phase 1 clinical trial—will be led by NEOK Bio, which holds the global development and commercialization rights to both candidates. NEOK Bio plans to initiate Phase 1 trials in 1H2026 and disclose initial clinical data for ABL206 and ABL209 in 2027. Sang Hoon Lee, CEO of ABL Bio, stated, “Following ABL206, the FDA’s clearance of the IND for ABL209 marks the full-scale initiation of our next-generation ADC development program. NEOK Bio has already completed clinical preparations, led by experts with extensive experience in ADC development. Given their strong global reputation, we have high expectations for the upcoming clinical development of ABL206 and ABL209.” Mayank Gandhi, CEO of NEOK Bio, commented, “Bispecific ADCs represent a novel solution that could expand the therapeutic window of conventional monospecific ADCs. We will advance the clinical development of ABL206 and ABL209 swiftly and efficiently to deliver innovative treatments that address the unmet medical needs of patients with solid tumors.” 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 ten 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) has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ABL111 (Givastomig), which is being co-developed with NovaBridge, has reported encouraging interim results from a Phase 1b study evaluating a triple combination regimen with nivolumab and chemotherapy. Additional data are expected to be presented at a global scientific conference in the second half of this year.In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
2026-03-03ablbio
ABL Bio–NEOK Bio Submit U.S. IND for Phase 1 Clinical Trial of ABL209 (NEOK002)
- Further development of ABL209 (NEOK002) to be led by NEOK Bio and Phase 1 trial is expected to begin by mid-2026 in the U.S. ABL Bio announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on January 30 for a Phase 1 clinical trial of ABL209 (NEOK002). ABL209 is a bi-specific antibody–drug conjugate (ADC) candidate that combines an EGFR- and MUC1-targeting bispecific antibody with a topoisomerase I inhibitor. In preclinical studies, ABL209 demonstrated superior efficacy compared to monospecific antibody ADCs. By simultaneously targeting two complementary antigens, ABL209 is expected to demonstrate improved efficacy and safety compared to competing agents that target only EGFR or MUC1. NEOK Bio is a bispecific ADC clinical development company established by ABL Bio in the United States and holds global development and commercialization rights to ABL209, as well as another bi-specific ADC candidate, ABL206 (NEOK001). ABL206’s Phase 1 IND was approved by the FDA on January 16, 2026. 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, “NEOK Bio has already completed preparations for clinical development together with an advisory group with extensive experience in ADC development and clinical research organizations (CROs). Following IND approval, NEOK plans to promptly enter full-scale clinical trials. Global interest in bispecific ADCs is currently very high, and we held numerous related meetings together with NEOK at the recent JPM Healthcare Conference. We ask for continued interest in ABL Bio’s next-generation ADC development, which will be advanced through ABL206 and ABL209.” Mayank Gandhi, CEO of NEOK Bio, said, “Recent IND approval of NEOK001 followed quickly by NEOK002 IND submission reflects our commitment to rapidly and efficiently advance ADC innovation. We can’t wait to initiate a robust clinical development plan for both NEOK001/002 and demonstrate the value of our differentiated bispecific ADCs in patients with solid tumors.” About ABL BioABL Bio is developing a wide range of clinical and preclinical pipelines based on its proprietary bi-specific antibody platforms, including Grabody. A total of nine pipeline programs—ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), ABL206 (NEOK001)—are currently in clinical development across multiple countries, including the United States, China, Australia, and South Korea. Follow-up clinical development of ABL301 (SAR446159), which has completed Phase 1, will be conducted by Sanofi, while ABL001 (tovecimig) has received Fast Track designation from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has reported encouraging interim Phase 1b data in a triple-combination regimen with nivolumab and chemotherapy, with additional data to be presented at a global scientific conference in the second half of this year. In addition, multiple preclinical programs, including bispecific ADCs and dual-payload ADCs, are under continuous research and development.
2026-02-02ablbio
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 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