XYA02 / XYone Therapeutics - LARVOL DELTA

Evaluation of XYA02 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=190 | Not yet recruiting | Sponsor: XYone Therapeutics, Inc

New P1/2 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Refractory Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR

MUC1-C-directed exatecan ADC induces genotoxic stress and transcriptional suppression of UPR-inflammatory pathways in metastatic colorectal cancer (AACR 2026) - "XYA02-8, a first-in-class MUC1-C-directed exatecan ADC, demonstrates potent and selective antitumor activity driven by efficient internalization, high DAR stability, and targeted induction of DNA-damage and replication-stress programs. Its robust efficacy across CDX and PDX models, coupled with minimal systemic toxicity at supra-therapeutic doses, positions XYA02-8 as a strong candidate for clinical translation in MUC1-positive mCRC.* https://patents.google.com/patent/US20230265208A1/en"

ADC • Metastases • Colorectal Cancer • Oncology • Solid Tumor • DDIT4 • MUC1 • STC2

A MUC1-C-targeting ADC exhibits potent antitumor activity against neuroendocrine prostate cancer in both intact and testosterone-depleted preclinical models (AACR 2026) - "XYA02-8-ADC demonstrates strong antitumor activity with a favorable safety profile in CRPC/NEPC models. Notably, its ability to retain efficacy even under testosterone-replete conditions highlights an important therapeutic opportunity: targeting MUC1-C with XYA02-8-ADC without relying on androgen-deprivation strategies. These findings open a promising avenue for developing effective treatments that avoid the systemic adverse effects associated with hormonal deprivation.* https://patents.google.com/patent/US20230265208A1/en"

ADC • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Genitourinary Neuroendocrine Carcinoma • Oncology • Prostate Cancer • Solid Tumor • MUC1

Comparative efficacy of MUC1-C (XYA02) and MUC1-N (PankoMab, DS-3939a analog) antibody-drug conjugates in preclinical NSCLC (AACR 2026) - "Our findings demonstrate that targeting the membrane-tethered MUC1-C subunit with XYA02 provides superior antitumor efficacy compared with MUC1-N-directed DS-3939a analog in preclinical NSCLC models. Enhanced efficacy appears to be driven by uniform antigen binding and potential avoidance of MUC1-N-mediated antigen sink effects. These data support prioritizing MUC1-C-selective ADCs for clinical development in NSCLC and other MUC1-driven malignancies.* https://patents.google.com/patent/US20230265208A1/en"

ADC • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC1

Development of a MUC1-C–targeted ADC as a promising therapeutic strategy for rare solid tumors (Sarcoma-RC 2026) - "Methods We have developed a novel ADC (XYA02) to selectively deliver Exatecan, which specifically recognizes the extracellular domain of MUC1-C, binding with high affinity to the α4 helix (7B8*) on the cell surface...Legal entity responsible for the study Xyone Therapeutics Inc. Funding Xyone Therapeutics Inc."

ADC • Biliary Cancer • Cholangiocarcinoma • Oncology • Sarcoma • Solid Tumor • MUC1

Novel MUC1-C-ADC exhibits remarkable anti-tumor potency in the treatment of triple-negative breast cancer (TNBC) (ESMO 2025) - "Based on these, the final ADC candidate, XYA02, was selected...Phase I clinical trials are scheduled to initiate in mid-2026. Legal entity responsible for the study Xyone Therapeutics Inc."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • MUC1