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- BCG016 / Biocytogen
A novel bispecific antibody-drug conjugate, BCG016, that targets 5T4 and MUC1, demonstrates robust preclinical antitumor activity (Section 6) - Mar 17, 2026 - Abstract #AACR2026AACR_9827;
BCG016, in combination with a TOP1 inhibitor linker-payload (BLD1102), exhibited enhanced efficacy in PDX models compared to parental ADCs, significantly outperforming benchmark ADCs targeting 5T4 and MUC1.ConclusionIn summary, we have developed a novel bispecific ADC that targets both 5T4 and the membrane-bound MUC1-C. BCG016 showed superior anti-tumor efficacy in PDX models, underscoring its potential as a new therapeutic option for tumors that co-express 5T4 and MUC1.
- XYA02 / XYone Therap
MUC1-C-directed exatecan ADC induces genotoxic stress and transcriptional suppression of UPR-inflammatory pathways in metastatic colorectal cancer (Section 11) - Mar 17, 2026 - Abstract #AACR2026AACR_8493;
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
- XYA02 / XYone Therap
A MUC1-C-targeting ADC exhibits potent antitumor activity against neuroendocrine prostate cancer in both intact and testosterone-depleted preclinical models (Section 16) - Mar 17, 2026 - Abstract #AACR2026AACR_7621;
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
- PankoMab-GEX (gatipotuzumab) / Daiichi Sankyo, XYA02 / XYone Therap, DS-3939 / Daiichi Sankyo
Comparative efficacy of MUC1-C (XYA02) and MUC1-N (PankoMab, DS-3939a analog) antibody-drug conjugates in preclinical NSCLC (Section 19) - Mar 17, 2026 - Abstract #AACR2026AACR_6414;
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
- CAT-09-833 / Catalent, DS-3939 / Daiichi Sankyo
DB-1326, a novel dual-payload TA-MUC1-directed antibody-drug conjugate, shows potent antitumor efficacy in pre-clinical tumor model (Section 49) - Mar 17, 2026 - Abstract #AACR2026AACR_4255;
It displayed high tumor cell selectivity and superior anti-tumor effects in preclinical studies. These findings support the potential of DB-1326 as a promising advanced therapeutic candidate for tumors.
- DS-3939 / Daiichi Sankyo
Results of first-in-human administration study of DS-3939a (anti-TA-MUC1 antibody drug conjugate) in patients with advanced/recurrent solid tumors (first report) (Room 13 | Pacifico Yokohama North 4F G403) - Mar 2, 2026 - Abstract #JSMO2026JSMO_1121;
P1/2
DS-3939 showed manageable safety/tolerability and an early clinical activity signal in pretreated pts. Part 2 is currently enrolling.
- DS-3939 / Daiichi Sankyo
DS-3939, a tumor-associated mucin 1 (TA-MUC1) (Bremen Auditorium - Hall 6.2) - Jul 24, 2025 - Abstract #ESMO2025ESMO_1630;
P1/2
Table: 917O n (%) Dose level Total (N=47) 1 (n=3) 2 (n=3) 3 (n=14) 4 (n=14) 5 (n=12) 6 (n=1) Ongoing treatment 0 1 (33.3) 6 (42.9) 6 (42.9) 6 (50.0) 1 (100) 20 (42.6) TEAE Any 3 (100) 3 (100) 13 (92.9) 14 (100) 12 (100) 1 (100) 46 (97.9) G3+ 0 0 5 (35.7) 6 (42.9) 7 (58.3) 1 (100) 19 (40.4) Drug-related (DR) 2 (66.7) 3 (100) 9 (64.3) 14 (100) 10 (83.3) 1 (100) 39 (83.0) DR G3+ 0 0 2 (14.3) 5 (35.7) 5 (41.7) 1 (100) 13 (27.7) Led to discontinuation 0 1 (33.3) 2 (14.3) 0 2 (16.7) 0 5 (10.6) DLT 0 0 1 (7.1) G3 anemia needing transfusion 1 (7.1) G3 abdominal pain 1 (8.3) G4 platelet count decreased 0 3 (6.4) Adjudicated DR interstitial lung disease* 0 1 (33.3) G2 2 (14.3) G1, G3 0 3 (25.0) all G2 0 6 (12.8) *2 cases at dose level 3 were adjudicated after DCO Conclusions DS-3939 showed manageable safety/tolerability and an early signal of clinical activity in pretreated pts. Part 2 is currently enrolling.
- | DS-3939 / Daiichi Sankyo
Journal: DS-3939a: A TA-MUC1-directed Antibody-Drug Conjugate with Broad Anti-Tumor Activity. (Pubmed Central) - Jul 10, 2025
P1/2
Moreover, DS-3939a elicited strong tumor regression in several xenograft models even following treatment with other cytotoxic ADCs, likely through its efficient payload delivery. Overall, these data provide evidence for the potential utility of DS-3939a for the treatment of TA-MUC1-expressing tumors and support the rationale for the ongoing phase I/II clinical study (NCT05875168).
- MRTX1133 / BMS
MUC1-C is a target for antibody-drug conjugate treatment of MRTX1133-resistant KRAS G12D mutant pancreatic ductal adenocarcinomas (Section 20; Poster Board No: 6) - Mar 25, 2025 - Abstract #AACR2025AACR_4286;
Overall, these data provide evidence for the potential utility of DS-3939a for the treatment of TA-MUC1-expressing tumors and support the rationale for the ongoing phase I/II clinical study (NCT05875168). These findings indicate that MUC1-C confers resistance of PDAC KRAS G12D mutant cells to MRTX1133 and identify MUC1-C as a target for ADC treatment of patients refractory to MRTX1133 treatment.
- MUC1*-ADC / Minerva Biotech, Herceptin (trastuzumab) / Roche
MUC1*-deruxtecan kills tumors that have acquired resistance to trastuzumab containing therapeutics (Section 24; Poster Board No: 20) - Mar 25, 2025 - Abstract #AACR2025AACR_3021;
However, most patients, develop resistance to HER2-directed therapies and experience progressive disease leaving them with few treatment options. Here we've shown that HER2 positive breast cancer cells acquire resistance to trastuzumab by increasing expression of the powerful growth factor receptor MUC1*.
- 3D1-MMAE / Genus Oncology
Development of novel MUC1-C targeting antibody-drug conjugate for pancreatic cancer treatment. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4657;
Anti-MUC1 antibody-drug conjugates (ADCs) were generated by coupling monomethyl auristatin E (3D1-MMAE, 7B8-MMAE) via V-C-PAB linker and characterized for anti-tumor activity against pancreatic cancer cells including MIA PaCa-1, CAPAN2 and HAPF-II... Targeted delivery of MMAE toxin to the pancreatic cancer cells presents an exciting opportunity for a novel therapeutic intervention for the treatment of pancreatic cancer patients with MUC1 over expression in tumors.
- DS-3939 / Daiichi Sankyo
A phase 1/2, first-in-human study of DS-3939a in patients with advanced solid tumors: A new DXd ADC targeting TA-MUC1. (Hall A; Poster Bd #: 307b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2136;
P1/2
Part 2 will also evaluate efficacy by objective tumor response rate per RECIST version 1.1 as a primary endpoint. Secondary endpoints include the disease control rate, duration of response, time to response, progression-free survival, overall survival, TA-MUC1 expression (detected by immunohistochemistry), the pharmacokinetic profile of DS-3939a, and the number of patients with anti-drug antibodies against DS-3939a.
- DS-3939 / Daiichi Sankyo
DS-3939a, a novel TA-MUC1-targeting antibody-drug conjugate (ADC) with a DNA topoisomerase I inhibitor DXd, exhibits potent antitumor activity in preclinical models (Room 30 - Upper Level - Convention Center) - Mar 5, 2024 - Abstract #AACR2024AACR_8813;
P1/2
Based on these preclinical results, DS-3939a could provide valuable therapy with potential benefits for patients with TA-MUC1-expressing tumors. A first-in-human phase 1/2 study in patients with advanced solid tumors is currently in progress (NCT05875168).
- DS-3939 / Daiichi Sankyo
A phase 1/2, first-in-human study of DS-3939a in patients with advanced solid tumors: A new DXd ADC targeting TA-MUC1 (Section 50) - Mar 5, 2024 - Abstract #AACR2024AACR_7922;
A first-in-human phase 1/2 study in patients with advanced solid tumors is currently in progress (NCT05875168). Abstract is embargoed at this time.
- BCG016 / Biocytogen
BCG016, a first-in-class bispecific antibody-drug conjugate targeting 5T4 and MUC1, demonstrates potent preclinical anti-tumor activity (Section 2) - Mar 5, 2024 - Abstract #AACR2024AACR_5572;
Cytotoxicity assays indicate that BCG016 improved tumor cell killing in vitro compared to benchmark ADCs, and in vivo efficacy studies showed superior anti-tumor efficacy of BCG016 in patient-derived NSCLC xenografts compared to benchmark ADCs and parental ADC combination therapy.In summary, we have generated a novel bispecific ADC targeting 5T4 and the cleaved MUC1-C protein, which remains membrane-bound on tumor cells. The 5T4-MUC1 bsADC showed superior anti-tumor efficacy in PDX models and has the potential to be a novel therapeutic for 5T4 and MUC1 co-expressing tumors.
- DXC-005 / Hangzhou DAC Biotech
A MUC1 antibody-conjugated with a tubulysin B analog, DXC005, demonstrates excellent synergistic effect in combination with gemcitabine for treatment of pancreatic tumors (Section 22) - Mar 5, 2024 - Abstract #AACR2024AACR_3944;
The preferred regimen includes gemcitabine combined with albumin paclitaxel or FOLFIRINOX (5-FU+Oxaliplatin+Irinotecan)...All groups of treatment are tolerated well, no abnormal animal behavior and body weight loss were observed in the study. The above results concluded that DXC005 combined with Gemcitabine can achieve synergistic effect even with reduced dose of Gemcitabine, which will serve as a support for synergistic application in clinical studies.
- M1231 / EMD Serono
Translational PK/PD/efficacy modeling and efficacious human dose prediction for a first-in-class MUC1-EGFR (M1231) bispecific antibody drug conjugate (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6886;
P1
The above results concluded that DXC005 combined with Gemcitabine can achieve synergistic effect even with reduced dose of Gemcitabine, which will serve as a support for synergistic application in clinical studies. The quantitative systems pharmacology model-based efficacious dose prediction range of 2.4 mg/kg to 4.3 mg/kg dosed Q3W informed the design of the ongoing M1231 first-in-human trial (NCT04695847).