APX-343A / AptaBio - LARVOL DELTA

Pharmacokinetics and pharmacodynamics evaluation in phase I trial of APX-343A, selective NOX inhibitor targeting CAF-mediated immunosuppression in patients with advanced solid tumors. (ASCO 2026) - P1 | " This is a Phase 1, dose-escalation study (NCT07123415) evaluating the safety, tolerability, PK, PD, and preliminary antitumor activity of orally administered APX-343A as monotherapy (Part A; 100–600 mg BID) and in combination with pembrolizumab (Part B; 200–600 mg BID) in patients with advanced solid tumors. This ongoing Phase 1 trial of APX-343A is actively enrolling, with Part A dose-escalation cohorts underway. Integrated PK and PD assessments are designed to establish translational evidence of NOX target engagement and CAF modulation, providing a mechanistic foundation for dose selection and rational combination strategies with ICI."

Clinical • IO biomarker • Metastases • P1 data • PK/PD data • Fibrosis • Immune Modulation • Immunology • Oncology • Solid Tumor • CAFs • CCL2

CAF-mediated cancer immunotherapy resistance can be overcome via selective inhibition of NOX1, 2 and 4 (AACR 2026) - "This open-label, dose-escalation study is designed to evaluate the safety, tolerability, PK, and preliminary efficacy of Com-19 as monotherapy (Part A) and in combination with pembrolizumab (Part B) in patients with advanced solid tumors. The study aims to identify the MTD and/or RP2D of Com-19."

IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • CAFs • CD8 • NOX4

CAF-mediated cancer immunotherapy resistance can be overcome via selective inhibition of NOX 2 and 4 (AACR 2025) - "Therefore, com-19 can potentiate cancer immunotherapy by overcoming CAF-Mediated ICIs resistance. GLP safety/toxicity studies of com-19 have been completed and phase 1 clinical studies are scheduled in 1Q, 2025."

IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • CAFs • CD8

NOX2 plays a key role in M2 polarization of macrophages associated with cancer-associated fibroblast in tumor microenvironment (AACR 2025) - "Taken together, we confirmed that CAFs and TAMs interact closely and NOX2 inhibition could be a potential therapeutic target for CAF- and TAM-mediated immunosuppression, especially for M2-polarization of macrophages in the TME. Furthermore, com-19 can provide a novel approach to overcome immunosuppressive barriers by interrupting their interaction in the TME, offering the potential for more effective combination therapies in cancer treatment."

Biomarker • Tumor microenvironment • Oncology • CAFs • CSF1

APX-343A-101: A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Aptabio Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Oncology • Solid Tumor

AptaBio begins phase 1 dosing of its immunotherapy candidate, APX-343A. [Google translation] (HIT News) - "This clinical trial aims to evaluate the safety, tolerability, and early anticancer efficacy of APX-343A monotherapy and combination therapy with pembrolizumab (original Keytruda) in patients with advanced solid tumors."

Trial status • Solid Tumor

APX-343A-101: A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Aptabio Therapeutics, Inc.

Monotherapy • New P1 trial • Oncology • Solid Tumor

AbtaBio, Immune Oncology Candidate 'APX-343A' Designated as Orphan Drug by US FDA [Google translation] (BioTimes) - "AptaBio...announced on the 30th that its immunotherapy candidate 'APX-343A' was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) on the 29th. Through this orphan drug designation, 'APX-343A' has been officially recognized for its innovation and market potential as a cancer-associated fibroblast (CAF)-targeting immunotherapy, and will establish a foundation for development and global market entry by utilizing various support systems of the FDA in the future."

Orphan drug • Oncology • Solid Tumor

Next-gen Korean cancer fighters to showcase innovation at ASCO 2025 (Korea Biomedical Review) - "Onconic Therapeutics...will present two trial designs for its investigational dual-target PARP inhibitor, nesuparib. One study is focused on metastatic pancreatic cancer, and the other is an investigator-led phase 2 trial in endometrial cancer evaluating nesuparib with Keytruda. Both studies aim to address indications with high unmet needs and limited therapeutic options; Early-stage trial designs will also be presented by Ligachem Biosciences, which is jointly developing an ADC candidate, LNCB74, with U.S.-based NextCure. The program targets B7-H4 and is currently in phase 1; Aptabio will present the design of a first-in-human study for APX-343A, a novel immunotherapy in development for advanced solid tumors, both as monotherapy and in combination with Keytruda."

Clinical protocol • pMMR • Endometrial Cancer • Pancreatic Cancer • Solid Tumor

AptaBio Announces Results of Three Studies at AACR, Including CAF Targeting Therapy and Blood Cancer Treatment [Google translation] (BioTimes) - "At this AACR, AptaBio plans to present the research results of its anticancer drug ‘APX-343A’ with a CAF inhibition mechanism, as well as the first study to elucidate the mechanism of action of NOX2, which plays a critical role in regulating CAF and M2 macrophages in the tumor microenvironment (TME). In addition, it plans to disclose the scientific evidence supporting the claim that ‘Apta-16’, an innovative treatment applied with the Aptamer-drug conjugate (Apta-DC) platform technology, can provide a new treatment option for patients with relapsed and refractory acute myeloid leukemia."

Preclinical • Acute Myelogenous Leukemia

AptaBio, Immunotherapy Anticancer Drug ’APX-343A’ Acquires Patents in Japan and Mexico Simultaneously [Google translation] (BioTimes) - "AptaBio...announced on the 10th that it has simultaneously acquired material patents for its immunotherapy drug (APX-343A) in Japan and Mexico. This is the first patent acquisition in Australia, Russia, Chile, and the United States."

Patent • Oncology