Drugs / BNT324
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06892548 | May 2025 → Sep 2028 expected | lung cancer | BioNTech SE | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07365995 | Apr 2026 → Feb 2031 expected | prostate carcinoma | BioNTech SE | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | DualityBio Inc. | Regulatory DualityBio and BioNTech’s B7-H3 ADC Elfetabart Drozuntecan Granted China NMPA Breakthrough Therapy Designation for Metastatic Castration-Resistant Prostate Cancer dualitybiologics.com ↗
We are delighted to see elfetabart drozuntecan receive its first BTD from China's NMPA. |
| 2025-12-10 | DualityBio Inc. | Results Preliminary Phase 1/2 Clinical Data for DualityBio and BioNTech B7H3-Targeting ADC Candidate DB-1311/BNT324 in Advanced Gynecological Cancers Presented at ESMO ASIA 2025 dualitybiologics.com ↗
Among the 30 efficacy-evaluable patients with advanced CC, the confirmed objective response rate (cORR) was 33.3%, the disease control rate (DCR) was 86.7%, and the median progression-free survival (PFS) was 7.0 months. |
| 2025-06-05 | DualityBio Inc. | Results Preliminary Data from Two Clinical Trials with ADC Candidates were Presented Orally at the 2025 ASCO Annual Meeting dualitybiologics.com ↗
The data indicated early clinical activity and a manageable safety profile with low discontinuation rates. |
| 2025-05-27 | BioNTech SE | Results BioNTech to Present Progress Across Diversified Oncology Pipeline at the 2025 ASCO Annual Meeting biontech.com ↗
The data indicated early clinical activity and a manageable safety profile. |
| 2025-04-29 | DualityBio Inc. | Results DualityBio Presented Early Clinical and Preclinical Data for Novel ADC Therapy Candidates at AACR 2025 dualitybiologics.com ↗
The preclinical data indicate anti-tumor activity compared to each candidate alone in tumor models. |
| 2024-12-06 | DualityBio Inc. | Results Duality Biologics and BioNTech Presented Positive Interim Data for Investigational B7-H3 Antibody-Drug Conjugate BNT324/DB-1311 in Advanced Solid Tumors at the ESMO Asia Congress 2024 dualitybiologics.com ↗
In patients with SCLC with at least one post-baseline tumor assessment and who had received prior immunotherapy but no prior topoisomerase 1 inhibitor, the unconfirmed objective response rate ("uORR") was 70.4% at the BNT324/DB-1311 9 mg/kg dose level. |
| 2024-06-24 | BioNTech SE | Regulatory BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer biontech.com ↗
BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer (“CRPC”) who have progressed on or after standard systemic regimens. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BNT324 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06892548 ↗ |
| Modality | Other / unclassified | “BNT324, a B7-H3 antibody-drug conjugate (ADC)” NCT06892548 ↗ |
| Route | Intravenous | “Intravenous infusion” NCT06892548 ↗ |