APX-343A / AptaBio - LARVOL DELTA

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