ragistomig (ABL503) / ABL Bio, NovaBridge Biosciences, Handok - LARVOL DELTA

NovaBridge Presents Positive Ragistomig Phase 1 Dose Expansion Data at ESMO-IO (GlobeNewswire) - "Ragistomig Phase 1 Monotherapy Q6W Data (per October 22, 2025 data cut-off): Ragistomig demonstrated comparable anti-tumor efficacy for the Q6W dose schedule compared to the Q2W regimen (58.8% disease control rate (DCR) at Q6W compared to 64.3% at Q2W)....Safety Data, based on 20 evaluable patients receiving 3 mg/kg Q6W v. 15 evaluable patients with 3 mg/kg Q2W: An improved safety profile was observed with the 3 mg/kg Q6W regimen; The 3 mg/kg Q6W regimen was identified as an optimal potential regimen for combination strategies."

P1 data • Solid Tumor

Phase I 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 (ESMO-IO 2025) - P1 | "Mean PK exposure was comparable AUC1008h 8470 hr*μg/mL (Q6W) and AUC336h 7280 hr*μg/mL(Q2W).Conclusions The ragistomig Q6W has manifested favorable safety, while maintaining antitumor activity. This favorable safety–efficacy balance supports 3 mg/kg Q6W for further development, especially in combination.Clinical trial identification NCT04762641.Legal entity responsible for the study ABL BIO Inc."

Clinical • P1 data • Head and Neck Cancer • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8 • PD-1 • TNFRSF9

NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO (GlobeNewswire) - "The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile. The interim results, including immunological data on CD8+ cell proliferation and memory T-cell activation, are expected to be presented in a poster session at ESMO-IO on December 10, 2025."

P1 data • Solid Tumor

Ragistomig…,an anti-PD-L1 X 4-1BB bispecific antibody (GlobeNewswire) - "...An ongoing Phase 1b study designed to expand the therapeutic index is expected to yield results in 2H 2026."

P1 data • Solid Tumor

Upcoming Potential Clinical Milestones (GlobeNewswire) - "I-Mab anticipates updates in 2026 for ragistomig (PD-L1 x 4-1BB bispecific) and uliledlimab (monoclonal antibody targeting CD73), which are currently under development by ABL Bio and TJ Biopharma, respectively."

Clinical data • Solid Tumor

Everest Medicines Expands Strategic Investment in I-MAB (PRNewswire) - "Everest Medicines...announced that it has made a strategic equity investment in I-Mab, ('I-Mab')....I-Mab today announced an underwritten offering of 33,333,334 American Depositary Shares (the 'ADSs') representing 76,666,668 ordinary shares at an offering price of $1.95 per ADS, for total gross proceeds of approximately US$65 million. Under the arrangement of this offering, Everest will subscribe for 15,846,154 ADSs (the 'Subscription'), with an aggregate consideration of US$30.9 million....There are three pipeline products of I-Mab in clinical stage, Givastomig (Claudin 18.2 x 4-1BB bispecific antibody), Ragistomig (PD-L1 x 4-1BB bispecific antibody) and Uliledlimab (CD73 antibody)."

Financing • Oncology

ABL Bio's dual antibody ABL503 receives patents in the US and Canada. [Google translation] (HIT News) - "ABL Bio...announced on the 31st that the material patent for the PD-L1 and 4-1BB dual antibody 'ABL503 (ragistomig)' has been decided in the United States and Canada....This patent was filed internationally in February 2019, and has been registered in Colombia, China, Malaysia, Indonesia, Eurasia, Japan, Chile, South Africa, and New Zealand, in addition to the United States. The patent is guaranteed until 2039."

Patent • Solid Tumor

I-Mab Reports First Quarter 2025 Financial Results and Provides Business Update (I-Mab Biopharma) - "Presentation of new givastomig dose escalation combination data on U.S. patients at the European Society of Medical Oncology ('ESMO') Gastrointestinal ('GI') Cancers Congress 2025, being held July 2-5 in Barcelona, Spain; 1H 2026: Presentation of data from givastomig dose expansion cohorts (n=40); Enrollment in the ongoing dose expansion study for givastomig is progressing ahead of schedule. In addition, the Company anticipates updates in 2026 for two programs being developed with its partners: uliledlimab (monoclonal antibody targeting CD73); and ragistomig (PD-L1 x 4-1BB bispecific)...As of March 31, 2025, the Company had cash and cash equivalents, and short-term investments of $168.6 million. The Company’s current cash position is expected to fund the givastomig Phase 1b study through anticipated dose expansion data readouts and further development initiatives into 2027."

Clinical • Commercial • Enrollment status • P1 data • Gastroesophageal Cancer

ABL503-1001: This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: ABL Bio, Inc. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Conditional activation of T cell in the tumor microenvironment by a Novel 4-1BB T cell engaging BsAb (Grabody T) and phase 1 trial efficacy and safety of ragistomig (ABL503/TJ-L14B; PD-L1x4-1BB BsAb) and givastomig (ABL111/TJ-CD4B; Claudin18.2x4-1BB BsAb) (AACR-KCA 2024) - No abstract available

Biomarker • Clinical • P1 data • Tumor microenvironment • Oncology • CLDN18

ABL Bio, '4-1BB Single Antibody' Patent Decision in the US and Australia [Google translation] (HIT News) - "ABL Bio...announced on the 30th that its patent for the 4-1BB monoclonal antibody and its uses has been granted in the United States and Australia. The patent was applied for internationally in December 2019, and ABL Bio can protect its rights to the 4-1BB monoclonal antibody until 2039...The 4-1BB monoclonal antibody has a mechanism that activates T cells, one of the immune cells, and causes the T cells to attack cancer cells....Representative pipelines to which Grabody-T is applied include ABL503 (Ragistomig), ABL111 (Givastomig), ABL103, and ABL105."

Patent • Oncology • Solid Tumor

Updated safety and efficacy from the phase I study of givastomig, a novel claudin 18.2/4-1BB bispecific antibody, in claudin 18.2 positive advanced gastroesophageal carcinoma (GEC) (ESMO 2024) - P1 | "Background: Givastomig/ABL503 (Giva) is a first-in-class, bispecific antibody targeting Claudin (CLDN) 18.2 and engaging 4-1BB through a unique conditional activation mechanism in tumor sites to avoid systemic toxicities. Giva was well tolerated up to 15 mg/kg Q2W and has shown encouraging activity in heavily pre-treated GEC patients with a wide range of CLDN18.2 expression. The current optimal dose range was determined to be 8-12 mg/kg Q2W. A study of Giva in combination with standard of care treatment in 1L metastatic GEC is ongoing."

Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

ABL Bio, Dual Antibody 'ABL503' Patented in Indonesia and China [Google translation] (HIT News) - "ABL Bio...announced on the 1st that it has completed registration of a patent (anti-PD-L1·anti-4-1BB bispecific antibody and its use) for ABL503 (ragistomig), which it is jointly developing with global partner I-Mab, in Indonesia and China....ABL Bio has already registered the relevant patents in Eurasia, Japan, Chile, and South Africa, and with the additional acquisition of patents in Indonesia and China, the global rights to ABL503 will be protected in 13 countries around the world until 2039. Patent examination is currently underway in Europe, the United States, Canada, and other countries."

Patent • Oncology • Solid Tumor

ABL Bio Completes Third-Party Allocation Paid-in Capital Increase for Development of Next-Generation Dual Antibody ADC [Google translation] (ABL Bio Press Release) - "ABL Bio...announced on the 11th that it has completed payment for a third-party allocation paid-in capital increase worth 140 billion won....Meanwhile, the existing 4-1BB-based dual antibody immunotherapy and blood-brain barrier (BBB) ​​shuttle platform 'Grabody-B' are planned to be developed with the technology fee (milestone) that ABL Bio is scheduled to receive in the future and the contract fee for additional technology transfer. The representative 4-1BB-based dual antibodies ABL503 and ABL111 are currently undergoing clinical phase 1 tumor expansion part and triple combination therapy (ABL111 + nivolumab (Opdivo) + chemotherapy) evaluation clinical trials, respectively. Another 4-1BB dual antibody ABL103's domestic phase 1 clinical trial and ABL105's Korean and Australian phase 1 clinical trials, which were transferred to Yuhan-Yanghaeng and are currently under development, are also progressing smoothly."

Commercial • Oncology • Solid Tumor

I-Mab’s management team undergoes another major reshuffle: only three innovative pipelines remain, and the shadow of CD47 target failure remains [Google translation] (Sina Corp) - "After announcing the divestment of its assets in China, the official website of listed company I-Mab currently only has three innovative pipelines left, namely uliledlimab (CD73 antibody), givastomig (Claudin 18.2 x 4-1BB bispecific antibody) and ragistomig (PD-L1 x 4-1BB bispecific antibody)....I-Mab said it will launch a Phase III clinical trial of uliledlimab combined with chemotherapy and immune checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC) in the second half of 2024."

New P3 trial • Pipeline update • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ABL Bio holds a meeting to share dual antibody ADC development strategy [Google translation] (BioTimes) - "ABL Bio...announced on the 26th that it will hold an analyst meeting on Wednesday, July 3 and an online meeting through YouTube..,This meeting was organized to share the company's next-generation dual antibody ADC (Antibody Drug Conjugate) development strategy and to introduce the interim clinical phase 1 data of 'ABL503 (TJ-L14B, Ragistomig)' and 'ABL202 (LCB71, CS5001)' that were announced at the American Society of Clinical Oncology (ASCO) this year....The online meeting is scheduled to be broadcast for approximately 1 hour and 30 minutes starting at 8:40 AM."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

Lee Sang-hoon, CEO of ABL, “Securing 400 billion + α funds… Focusing on ’dual antibody ADC’“ [Google translation] (Money Today) - "The company plans to secure a total of 400 billion won in funds by the end of next year. In addition to the previously completed 140 billion won paid-in capital increase and approximately 60 billion won in milestones...related to technology transfer contracts with Sanofi and Yuhan Corporation (KRW 79,900...it plans to raise funds through at least two new technology transfers from this year to next year. Currently, ABL Bio is discussing a term sheet (negotiation of detailed terms before the main contract) contract based on a dual antibody platform with a global pharmaceutical company, and it expects at least one new technology transfer to be made this year...In order to achieve external growth, the main pipeline 'ABL503' as well as the biliary tract cancer and colon cancer treatment 'ABL001' are expected to play a major role. ABL503 is being jointly developed with global collaborator I-Mab...ABL001....accelerated approval is planned for next year for biliary tract cancer indications."

FDA approval • Financing • Licensing / partnership • Biliary Tract Cancer • Cholangiocarcinoma • Colon Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ABL Bio-KAIST publishes ABL503 paper in a global academic journal (HIT News) - "ABL Bio...and the research team of Professor Soo-hyung Park of the KAIST (President Gwang-hyung Lee) Graduate School of Medical Sciences have published a study in the international academic journal ‘Clinical Cancer Research (CCR)’ published by the American Association for Cancer Research (AACR). )' announced on the 20th that it had published a paper on non-clinical research on ABL503 (Ragistomig)....According to the company, the title of the paper published in CCR is '4-1BB and PD-L1 bispecific antibody (Anti-4-1BB 'PD-L1 Bispecific Antibody Reinvigorates Tumor-Specific Exhausted CD8+ T Cells and Enhances the Efficacy of Anti-PD-1 Blockade', introduces translational research data on ABL503 combination therapy confirmed through in vitro and in vivo experiments...'The non-clinical data published in the paper suggests that ABL503 can improve the anticancer efficacy of existing PD-(L)1 inhibitors, and we plan to use ABL503 and PD-(L)1 inhibitors in future clinical trials.'"

Preclinical • Oncology

Phase 1 trial safety and efficacy of ragistomig, a bispecific antibody targeting PD-L1 and 4-1BB, in advanced solid tumors. (ASCO 2024) - P1 | "ABL503 had a manageable safety profile and demonstrated promising anti-tumor activity, with objective responses in 6 out of 39 efficacy-evaluable patients across multiple tumor types in heavily pre-treated patients, including patients previously treated with checkpoint inhibitors. The data support continued development of ABL503 alone and in combination with other compounds, as a potential therapeutic option for patients with solid tumor cancers."

Clinical • IO biomarker • Metastases • P1 data • Esophageal Cancer • Fatigue • Gastrointestinal Cancer • Head and Neck Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

ABL Bio announces interim results of phase 1 clinical trial of ABL503 at ASCO 2024 [Google translation] (Pharm News) - P1 | N=100 | NCT04762641 | Sponsor: ABL Bio, Inc. | "ABL Bio...announced interim data from the phase 1 clinical trial of ABL503 (TJ-L14B, ragistomig) conducted at the American Society of Clinical Oncology (ASCO) 2024....The ABL503 poster was unveiled at ASCO's 'Developmental Therapeutics Immunotherapy' session on June 1 (local time)....As a result of analyzing 44 patients out of 53 for whom effectiveness could be evaluated, one complete response (CR) and six partial responses (PR) were confirmed in the phase 1 clinical trial of ABL503....All 7 CR and PR patients received the effective doses of 3 mg/kg and 5 mg/kg, and the overall response rate (ORR) of ABL503 at the effective dose was 26.9% (7/26), clinical The Clinical Benefit Rate (CBR) was found to be 69.2% (18/26). Additionally, as a result of biomarker analysis, it was confirmed that memory T cells are activated for a long period of time in CR and PR patients."

P1 data • Solid Tumor

I-Mab Announces Encouraging Phase 1 Clinical Data of PD-L1x4-1BB Bispecific Antibody Ragistomig at ASCO 2024 (GlobeNewswire) - P1 | N=100 | NCT04762641 | Sponsor: ABL Bio, Inc. | "I-Mab...announced that Gerald Falchook, MD, and the team at I-Mab’s partner for ragistomig...will present a poster related to Phase 1 data for ragistomig at the 2024 American Society for Clinical Oncology Annual Meeting...The main observations from the study include: A manageable safety profile...Overall response rate of 25% at 5 mg/kg, based on 3 partial responses (PR) out of 12 patients with median progression free survival (PFS) of 15.6 weeks; Clinical benefit rate of 75% at 5 mg/kg, based on 3 PRs and 6 stable disease (SD); 71.4% of responders had received prior anti-PD-(L1) inhibitors and were all relapsed or refractory to anti-PD-(L1) inhibitors; and A complete response (CR) was seen in one heavily pretreated patient (7 prior lines of therapy, ovarian cancer) at 3 mg/kg."

P1 data • Oncology • Solid Tumor

Anti-4-1BB×PD-L1 Bispecific Antibody Reinvigorates Tumor-Specific Exhausted CD8+ T Cells and Enhances the Efficacy of Anti-PD-1 Blockade. (PubMed, Clin Cancer Res) - "ABL503-a PD-L1 and 4-1BB dual-targeting bispecific antibody-elicits pronounced additive tumor growth inhibition, with increased infiltration and functionality of exhausted CD8+ T cells, which in turn enhances the anti-cancer effects of anti-PD-1 blockade. These promising findings suggest that ABL503 (TJ-L14B) in combination with PD-1 inhibitors will likely further enhance therapeutic benefit in clinical trials."

Journal • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor

Anti-4-1BB×PD-L1 Bispecific Antibody Reinvigorates Tumor-Specific Exhausted CD8+ T Cells and Enhances the Efficacy of Anti-PD-1 Blockade (Clin Cancer Res) - "Importantly, compared to anti-PD-1 blockade alone, the combination of ABL503 and anti-PD-1 blockade further enhanced the functional restoration of human CD8+ TILs in vitro. Consistently, the combination of ABL503 with anti-PD-1 in vivo significantly alleviated tumor growth, and induced enhanced infiltration and activation of CD8+ TILs."

Preclinical • Oncology

ABL Bio participates in ‘Bio Korea 2024’ exhibition [Google translation] (ABL Bio Press Release) - "ABL Bio...announced on the 2nd that it plans to participate in the exhibition program of the 'BIO Korea 2024 International Convention' and showcase its bispecific antibody technology....Through this booth exhibition, ABL Bio introduces its dual antibody-based immuno-anticancer drug and blood-brain barrier (BBB) ​​shuttle 'Grabody-B' through posters. The immunotherapy pipeline being introduced this time includes ABL503, ABL111, ABL103, and ABL105 using the 4-1BB-based dual antibody platform 'Grabody-T..."

Clinical • Oncology • Solid Tumor

I-Mab Reports Full Year 2023 Financial Results and Business Update (PRNewswire) - "Pipeline Overview and Upcoming Milestones:...(i) Upon the receipt of the investigational new drug (IND) approval, the Company plans to initiate the triplet study for uliledlimab in combination with chemotherapy and checkpoint inhibitors in newly diagnosed patients with advanced NSCLC in the second half of 2024; (ii) Ragistomig (PD-L1 x 4-1BB bispecific antibody):...Top-line Phase 1 dose escalation and dose expansion results are expected to be presented at a major medical conference in the first half of 2024."

New trial • P1 data • Non Small Cell Lung Cancer