NEOK002 / ABL Bio, NEOK Bio - LARVOL DELTA

NEOK002 (ABL209): Redesigning an EGFRxMUC1 bispecific TOP1i ADC with promising anti-tumor activity and enhanced therapeutic window (AACR 2026) - "The in vivo potency of NEOK002 was also assessed on CFPAC-1, NCI-H1373, and an osimertinib-resistant PDX model...NEOK002 did not inhibit proliferation of human epidermal keratinocytes in vitro, unlike cetuximab-based ADC molecules...Co-treatment of the KRAS-mutant NCI-H1373 model with the KRAS G12C inhibitor sotorasib demonstrated rapid and prolonged tumor regression, which was sustained up to Day 57...The HNSTD of NEOK002 in cynomolgus monkeys was established at 40 mg/kg, which is associated with a free exatecan Cmax of <3 ng/mL. NEOK002 is a potential best-in-class bispecific EGFRxMUC1 ADC effectively leveraging the benefits of co-targeting these antigens yielding enhanced antitumor activity across a wide range of tumors, and reducing the liabilities through attenuated EGFR-related toxicity and reduced impact of binding to shed MUC1."

ADC • Bispecific • Bladder Cancer • Oncology • Solid Tumor • KRAS • MUC1

NEOK Bio Secures FDA IND Clearance for NEOK002, a Novel EGFR/MUC1 Bispecific ADC for Treatment of Solid Tumors (Businesswire) - "Second candidate in NEOK’s differentiated ADC pipeline to enter the clinic in 2026; Company plans to initiate a Phase 1 clinical study for NEOK002 in 2Q2026 and share data in 2027​."

IND • New P1 trial • P1 data • Solid Tumor

ABL Bio wins US FDA nod for Phase 1 of bispecific ADC ABL206 (Chosun Biz) - "Clinical development of ABL206 will be handled by NeocBio, a bispecific ADC company that ABL Bio established in the United States. NeocBio also holds global development and commercialization rights for another bispecific ADC candidate, ABL209. NeocBio aims to start phase 1 trials for the two candidates in the first half of this year and release early clinical data next year."

IND • New P1 trial • P1 data • Solid Tumor

ABL Bio files FDA IND for bispecific ADC ABL206; NEOK Bio to run phase 1 (Korea Biomedical Review) - "The Korean biotech said it submitted the IND to the FDA last Friday local time, setting up a phase 1 study in solid tumors that it expects to begin in 2026....NEOK plans to file an IND for ABL209 in early 2026, initiate phase 1 trials for both candidates in 2026 and release initial clinical data in 2027, ABL Bio said."

IND • New P1 trial • P1 data • Solid Tumor

ABL Bio develops bispecific ADCs to boost Korea’s cancer drug leadership (Chosun Biz) - "ABL Bio, through its U.S. subsidiary Neoc Bio, is preparing phase 1 clinical trials in the United States for the bispecific ADC molecules ABL206 and ABL209. It plans to submit investigational new drug (IND) applications to the FDA for phase 1 on late this year and early next year, respectively."

IND • Solid Tumor

ABL Bio raises 42 billion won for U.S. subsidiary NeokBio to advance ADC trials (Chosun Biz) - "NeokBio to fund IND filing and phase 1 trials for ABL206 and ABL209 within the year"

Commercial • New P1 trial • Solid Tumor

ABL Announces Dual Antibody ADC with 'Year-End IND' at WorldADC [Google translation] (Biospectator) - "At this event, ABL Bio will present the differentiation of dual antibody ADC, non-clinical development strategy, etc. under the theme of 'Discovery and non-clinical development of dual antibody ADC candidate ABL206'....ABL Bio plans to submit an investigational new drug (IND) application for the US Phase 1 clinical trial of its dual antibody ADC ABL206 (target undisclosed) and ABL209 (target undisclosed) later this year."

Preclinical • Oncology

ABL206 & ABL209: Bispecific ADC as Next Generation of ADC May Overcome Current Clinical Limitations (ADC London 2025) - "• Investigating synergistic cancer-killing effect by targeting two different targets on cancer cells • Outlining recent discovery research of bispecific ADC • Contrasting advantages and challenges of bispecific ADC development against traditional ADC design"

Clinical • Oncology

ABL Bio accelerates R&D of 'dual antibody ADC'… Aiming to dominate the market [Google translation] (Medipana) - "To this end, the company plans to apply for INDs for two key pipelines in the second half of this year and one in the first half of next year, centered around its US corporation...'Among the three key candidates, 'ABL206' and 'ABL209' are scheduled to submit an IND (investigational new drug application) in the second half of this year, and 'ABL210' next year,' adding, 'We expect to quickly establish a position in the global dual antibody market.'"

IND • Oncology

ABL, which pulled in 140 billion, has a reason to believe? 'New drug royalty' [Google translation] (HIT News) - "The dual antibody ADC pipeline being developed through this paid-in capital increase includes ABL206; ABL209; ABL210, etc. The company plans to establish an early market in this field, submit a phase 1 clinical trial plan (IND) by the end of next year, and conduct phase 1 clinical trials starting in 2026."

IND • New P1 trial • Oncology • Solid Tumor

Lee Sang-hoon, CEO of ABL, “Securing 400 billion + α funds… Focusing on ’dual antibody ADC’“ [Google translation] (Money Today) - "ABL Bio...an 'ADC (antibody-drug conjugate) powerhouse', has presented a new vision for the future. It is a leap forward to 'ABL 2.0' that will increase the scale of technology transfer by raising the clinical stage to mid- and late-stage. The goal is to secure KRW 400 billion in funds by 2025 and continuously maintain the scale of 'KRW 400 billion + α' thereafter to increase the speed of pipeline development...On the 3rd, ABL Bio held online and offline corporate briefings and unveiled its future vision, 'ABL 2.0'...ABL Bio's dual antibody ADC pipeline consists of three: 'ABL206', 'ABL209', and 'ABL210'....The company plans to complete the IND (clinical trial plan) submission for the pipeline by the end of next year and begin intensive development through its U.S. corporation in 2026."

Financing • IND • Bladder Cancer • Colon Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer