BNT324 / DualityBio, BioNTech - LARVOL DELTA

BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=594 | Recruiting | Sponsor: BioNTech SE | N=112 ➔ 594

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=112 | Recruiting | Sponsor: BioNTech SE | N=82 ➔ 112

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A global, phase 1/2 study of DB‑1311/BNT324 (a novel B7H3 ADC) monotherapy in patients with previously treated advanced cervical cancer or platinum-resistant recurrent ovarian cancer: Outcomes by prior treatment (SGO 2026) - No abstract available

ADC • Clinical • Metastases • Monotherapy • P1/2 data • Platinum resistant • Cervical Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD276

BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: BioNTech SE | N=52 ➔ 82

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

DB‑1311/BNT324 (a novel B7H3 ADC) in patients with heavily pretreated castrate-resistant prostate cancer (CRPC). (ASCO 2025) - P1/2 | " This phase 1/2 study (NCT05914116) enrolled pts with advanced/metastatic solid tumors, including previously treated CRPC (post docetaxel/hormonal therapy). DB-1311/BNT324 showed encouraging efficacy and a manageable safety profile in heavily pretreated CRPC and is currently being evaluated in post Lu-177 CRPC and in taxane-naïve CRPC."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

DB-1311/BNT324 (a novel B7H3 ADC) in patients with heavily pretreated mCRPC from a phase 1/2 study: Analyses according to prior treatment with lutetium 177 (177Lu)-PSMA-617. (ASCO-GU 2026) - P1/2 | "DB-1311/BNT324 showed encouraging durable efficacy in heavily pretreated mCRPC including patients who were previously treated with 177Lu-PSMA-617 with no new safety signals reported. Further development of DB-1311/BNT324 in mCRPC is warranted."

Clinical • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • CD276

BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: BioNTech SE | N=26 ➔ 52

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BNT324-01: A clinical study to investigate the efficacy and safety of an investigational combination therapy with BNT324 and BNT327 in patients with advanced lung cancer (clinicaltrialsregister.eu) - P1/2 | N=26 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Activity of BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors: Early preclinical and clinical evidence to support BNT327 + ADC combinations (AACR 2025) - P1/2 | "Emerging data suggest that IO-ADC combinations may lead to better patient outcomes. Early clinical data showed successful dose escalation allowing enrollment to NSCLC, TNBC, ovarian, and cervical cancer expansion cohorts, with updated clinical data planned to be presented. Further evaluation is ongoing of BNT327 with ADCs against HER2 (BNT323/DB-1303), B7H3 (BNT324/DB-1311) and HER3 (BNT326/YL202), with a focus on tumors where early monotherapy efficacy has been observed with these ADCs."

Combination therapy • IO biomarker • Preclinical • Breast Cancer • Cervical Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • B2M • CD276 • ERBB3 • HER-2

A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=736 | Not yet recruiting | Sponsor: BioNTech SE

New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase I/II multicenter, first-in-human study of DB-1311/BNT324 (a novel B7H3 ADC) in patients with advanced solid tumors (ESMO Asia 2024) - P1/2 | "In pts with SCLC (n=33), unconfirmed ORR was 45.5% with higher ORR in pts without prior topotecan (56.0%, n=25) or prior IO (55.6%, n=9). PRs were also observed in 3 pts with CRPC, 3 pts with NSCLC and 1 pt with BTC. Conclusions DB-1311/BNT324 had a manageable safety profile with low rates of G≥3 hematological events and promising antitumor activity, particularly in pts with advanced/metastatic SCLC."

Clinical • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

BNT324: Initiation of P3 trial for 1L mCRPC in 2026 (BioNTech, 44th Annual J.P. Morgan Healthcare Conference)

New P3 trial • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

BNT324: Initiation of P3 trial for 1L mCRPC in 2026 (BioNTech, 44th Annual J.P. Morgan Healthcare Conference)

New P3 trial • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

BNT324: “BNT324/DB-1311 shows a favorable safety profile across tumors”; Castration resistant prostate cancer (44th Annual J.P. Morgan Healthcare Conference, BioNTech) - “BNT324/DB-1311 mCRPC data demonstrates strong antitumor activity”

P1/2 data • Castration-Resistant Prostate Cancer • Oncology • Solid Tumor

BNT324: “BNT324/DB-1311 shows a favorable safety profile across tumors”; Castration resistant prostate cancer (44th Annual J.P. Morgan Healthcare Conference, BioNTech) - “BNT324/DB-1311 mCRPC data demonstrates strong antitumor activity”

P1/2 data • Castration-Resistant Prostate Cancer • Oncology • Solid Tumor

In 2026, BioNTech plans to initiate six additional Phase 3 clinical trials, bringing the total number of anticipated Phase 3 clinical trials to 15... (The Manila Times)

New P3 trial • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Squamous Cell Carcinoma of Head and Neck

DB-1311/BNT324 (a novel B7H3 ADC) in patients with advanced cervical cancer or platinum-resistant recurrent ovarian cancer (ESMO Asia 2025) - P1/2, P2 | "DB-1311/BNT324 showed encouraging efficacy in previously treated CC and PROC. The safety profile in these pts was manageable and consistent with previous reports. A phase 2 study of DB-1311/BNT324 plus pumitamig (BNT327, a PD-L1 x VEGF-A bsAb with activity in gynecological cancers; ASCO 2024 #5524) is currently enrolling pts with CC or PROC (DB-1311-201; NCT06953089)."

Clinical • Metastases • Platinum resistant • Castration-Resistant Prostate Cancer • Cervical Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • CD276 • PD-L1

DB-1311-O-1001: A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=862 | Recruiting | Sponsor: DualityBio Inc. | Trial completion date: Jan 2028 ➔ May 2028 | Trial primary completion date: Sep 2027 ➔ Dec 2027

First-in-human • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • CD276 • EGFR • KRAS • MET • NTRK1 • NTRK2 • NTRK3 • ROS1

A phase II trial of DB-1311/BNT324 (B7H3 ADC) combined with BNT327 (PD-L1 x VEGF-A bsAb) or DB-1305/BNT325 (TROP2 ADC) in advanced/metastatic solid tumors (ESMO 2025) - P2 | "Funding DUALITYBIO INC. & BioNTech SE."

Metastases • P2 data • Cervical Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD276 • PD-L1 • VEGFA

Title: Early preclinical and clinical evidence to support the combination of BNT327 (PD-L1 x VEGF-A bispecific antibody) with antibody-drug conjugates (CICON 2025) - P1/2, P2 | "Preclinical data indicate that combining BNT327 with ADCs targeting TROP2, B7H3, HER2, or HER3 leads to superior anti-tumor effects compared to each drug alone. A manageable safety profile, with few overlapping toxicities and clinical activity, was observed in pts with PROC when treated with BNT327 plus the TROP2-ADC DB-1305/BNT325. Studies evaluating BNT327 with ADCs are enrolling: BNT323-03 (NCT06827236), BNT324-01 (NCT06892548), and DB-1311-201 (NCT06953089)."

Preclinical • Breast Cancer • Dental Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • Stomatitis • Triple Negative Breast Cancer • CD276 • ERBB3 • HER-2

BNT324-01: A Phase 1b/2 Trial of BNT324/DB-1311 (B7H3 ADC) With BNT327 (PD-L1 x VEGF-A bsAb) in Lung Cancer (SCLC or NSCLC) (IASLC-WCLC 2025) - P1/2 | "Part 2 primary endpoint is safety and ORR in DO Cohorts 1&2 to determine the optimal dose, and ORR in Cohorts 3-7. Enrollment is ongoing."

IO biomarker • P1/2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276 • PD-L1 • VEGFA

Recent advances in antibody-drug conjugates for metastatic castration-resistant prostate cancer. (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban) - P3 | "Among prostate-specific membrane antigen (PSMA)-targeted ADCs, ARX517 demonstrates superior safety and more significant prostate-specific antigen (PSA) reductions compared to earlier agents such as MLN2704, PSMA-ADC, and MEDI3726. ADCs targeting B7-H3, such as MGC018 and DB-1311, have also shown antitumor activity. ADCs targeting other antigens, including six-transmembrane epithelial antigen of the prostate (STEAP)1 (DSTP3086S), trophoblast cell surface antigen (TROP)2 (sacituzumab govitecan), and solute carrier (SLC) 44A4 (ASG-5ME), have shown preliminary antitumor activity in early trials but face challenges with insufficient efficacy or toxicity. Tisotumab vedotin (targeting tissue factor) has shown no significant therapeutic response in mCRPC. Meanwhile, disitamab vedotin (HER2-targeted), ABBV-969 (dual PSMA/STEAP1-targeted), and DXC008 (dual PSMA/STEAP1-targeted) are currently under evaluation. Notably, the B7-H3-targeted ADC ifinatamab deruxtecan has initiated..."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2 • SLC44A4 • SLC4A4 • STEAP1

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=492 | Recruiting | Sponsor: DualityBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase Ib/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, pharmacokinetics, and recommended combination dose of BNT324 with BNT327 in participants with advanced lung cancer (ChiCTR) - P1/2 | N=594 | Not yet recruiting | Sponsor: Jilin Cancer Hospital; Jilin Cancer Hospital

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • HER-2 • KRAS • NTRK • ROS1

DB-1311-O-1001: A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=750 | Recruiting | Sponsor: DualityBio Inc. | Trial completion date: Sep 2026 ➔ Jan 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • CD276 • EGFR • KRAS • MET • NTRK1 • NTRK2 • NTRK3 • ROS1