ABL103 / ABL Bio, Handok - LARVOL DELTA

ABL103, a bispecific antibody targeting B7-H4 and 4-1BB, shows synergistic immune responses with combination of pembrolizumab in the immunosuppressive tumor microenvironment (AACR 2025) - "These results support the interactive immune activation of ABL103 and pembrolizumab, which leads to synergistic activation of T cells and transition of cold TME to inflammatory TME. Overall, our study suggests that ABL103 could be a promising therapeutic antibody as monotherapy as well as combination strategy with pembrolizumab by reinvigorating immune responses in the immunosuppressive TME."

Biomarker • IO biomarker • Tumor microenvironment • Breast Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • CD8 • ITGAM • PD-L1 • TNFRSF9 • VTCN1

ABL Bio Submits an Additional Clinical Trial Amendment to Evaluate ABL103 in a Phase 1b/2 Study (ABL Bio Press Release) - "ABL Bio...today announced that it has submitted an additional clinical trial amendment for the Phase 1b/2 study of ABL103 in combination with...KEYTRUDA (pembrolizumab) and Taxane as a triple combination therapy...A Phase 1 clinical trial evaluating ABL103 monotherapy is currently underway in the United States and South Korea. ABL Bio plans to amend the investigational new drug (IND) application for this Phase 1 trial to include a Phase 1b/2 study assessing combination therapy in South Korea, the United States, and Australia. The Phase 1b/2 study will consist of two safety lead-in parts to determine the appropriate dosage for the triple combination therapy, as well as one dose expansion part."

IND • Trial status • Solid Tumor

ABL103-1001: A Study with ABL103 in Subjects with Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: ABL Bio, Inc. | Trial primary completion date: Nov 2024 ➔ Jun 2025

Trial primary completion date • Oncology • Solid Tumor

ABL Bio Announces Clinical Collaboration to Evaluate ABL103 in Combination with KEYTRUDA (pembrolizumab) in Patients with Solid Tumors (ABL Bio Press Release) - "ABL Bio...announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), to evaluate ABL103 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced or metastatic solid tumors. Under the terms of the agreement, ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA. In this combination study, MSD will supply KEYTRUDA."

Commercial • Solid Tumor

[Hankyung Eureka Featured Stock] ABL Bio, Expected New Drug Development Momentum Until Next Year [Google translation] (Hankyung) - "In addition, 'ABL105 (breast cancer/stomach cancer)' and 'ABL103 (breast cancer/solid cancer)' are scheduled to announce phase 1 clinical data in 2025, and it was announced that many R&D momentums are valid next year as well."

P1 data • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

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

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

A Phase 1 Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: ABL Bio, Inc.

Metastases • New P1 trial • Oncology • Solid Tumor

ABL Bio presents ABL103 and ABL102 posters at PEGS Europe [Google translation] (ABL Bio Press Release) - "ABL Bio...as a poster at the 15th Protein & Antibody Engineering Summit (PEGS Europe)...At this event, ABL Bio will disclose the anticancer effect of ABL103 according to the level of B7-H4 expression and non-clinical data analyzing B7-H4 expression in various cancer types. Based on these data, we plan to emphasize that ABL103 can be an effective treatment for breast and ovarian cancer, including triple negative breast cancer (TNBC)....At the same time, ABL Bio also discloses non-clinical data on ABL102, a dual antibody targeting ROR1 and 4-1BB, through a poster. ABL102 has the characteristic of enhancing T cell activity by inducing a decrease in regulatory T cells (Treg) in tumors, which limit T cell responses. The ABL102 poster will also be introduced in a separate oral presentation session."

Preclinical • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

ABL Bio administers ABL103 to first patient in domestic phase 1 clinical trial [Google translation] (ABL Bio Press Release) - "ABL Bio...announced that it completed the administration of ABL103 to the first patient in the domestic phase 1 clinical trial for patients with advanced and metastatic solid cancer on the 7th....Phase 1 clinical trials of ABL103 are being conducted in Korea and the United States. The dose escalation part, which monitors adverse reactions while increasing the dose, will be conducted at a domestic institution, and the subsequent tumor expansion part will be carried out simultaneously in Korea and the United States."

Trial status • Oncology • Solid Tumor

GenScript ProBio Congratulates ABL Bio’s IND Clearance of ABL103 Program from MFDS (PRNewswire-Asia) - "Recently, ABL Bio, a partner of GenScript ProBio, announced the Ministry of Food and Drug Safety (MFDS) cleared of its clinical trial application for innovative bispecific antibody program (B7H4x4-1BB) in solid tumor....In this ABL103 program, GenScript ProBio provided the service of process development & optimization, clinical material manufacturing, and CTD documentation preparation for MFDS IND filing....In 2024, GenScript ProBio will launch its commercial manufacturing facility with 8*2000L singe use bioreactors, offering a one-stop solution from target discovery to BLA submission and commercial manufacturing."

Commercial • New trial • Solid Tumor

ABL Bio, ABL103 Domestic Phase 1 Approval [Google translation] (ABL Bio Press Release) - "ABL Bio...announced on the 9th that it had received approval from the Ministry of Food and Drug Safety (MFDS) for a domestic phase 1 clinical trial (IND) for ABL103 , a bispecific antibody immuno-oncology drug . The approval process, which normally takes up to three months, was completed in about a month, which is considered a good start....In this clinical trial, ABL103 is administered alone to patients with advanced or metastatic solid cancer with ongoing disease, and dose increase and tumor expansion tests are conducted. Dose and 2- phase recommended dose will be determined. The tumor expansion part is currently planned for 60 patients, and the number of patients will be finalized based on the data of the dose increase part ."

New P1 trial • Oncology • Solid Tumor

ABL103, A novel T-cell engaging bispecific antibody, exhibits potent in vitro and vivo antitumor activity and low toxicity via B7-H4 dependent 4-1BB activation in tumor microenvironment (AACR 2022) - "Overall, ABL103 has a strong in vitro and vivo anti-tumor activity and good safety profile via B7-H4-dependent 4-1BB activation. This strongly suggests ABL103 is a promising therapeutic agent potentially benefitting patients with B7-H4 overexpression."

IO biomarker • Preclinical • Tumor microenvironment • Breast Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • VTCN1