elfetabart drozuntecan (BNT324) / DualityBio, BioNTech - LARVOL DELTA

Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC) (IASLC-WCLC 2026) - P1/2 | "At C3D1, 96% (22/23) evaluable patients had confirmed ctDNA reduction vs baseline, with a ctDNA clearance rate of 39% (9/23). Conclusions : In these first data reporting on a PD(L)1×VEGF bsAb + ADC in lung cancer, pumitamig+elfe-D showed a manageable safety profile with encouraging early efficacy in SCLC, supporting further clinical development."

ADC • Clinical • Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276 • DLL3 • PD-L1 • VEGFA

BNT324-03: Phase 3, randomized, open-label trial of BNT324/DB-1311, a B7H3 ADC, versus docetaxel in patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2026) - P1/2, P3 | "A phase 1/2 study (DB-1311-O-1001, NCT05914116) is currently enrolling several prostate cancer cohorts: post Lutetium-177 [¹⁷⁷Lu]-PSMA-617 radioligand (RLT) (Lu 177-RLT) mCRPC, taxane-naïve mCPRC, and castration-sensitive prostate cancer (CSPC) with suboptimal PSA response, with patients receiving BNT324/DB-1311 alone or with abiraterone or enzalutamide...Approximately 736 patients will be randomized 1:1 to receive either BNT324 or docetaxel (+ prednisone/prednisolone)...Secondary endpoints include time to first subsequent therapy, ORR and DOR by BICR, time to pain progression, time to first symptomatic skeletal-related event, PSA response and time to PSA progression, and safety. Enrollment is ongoing globally."

ADC • Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

BNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients (pts) with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC) (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

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

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."

ADC • Bispecific • Combination therapy • First-in-human • 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

The investigational combination of pumitamig and elfetabart drozuntecan (elfe-D) demonstrated a manageable safety profile and encouraging early antitumor activity in patients with small cell lung cancer (SCLC), according to first clinical data from the ongoing Phase Ib/II BNT324-01 trial presented at the International Association for the Study of Lung Cancer (IASLC) 2026 (Medical Xpress) - "Among 71 efficacy-evaluable patients with SCLC as of July 7, 2026, one patient achieved a complete response, 49 achieved partial responses and 16 had stable disease...The overall objective response rate across all doses was 70.4%, and the disease control rate was 93.0%...Response rates varied by treatment line: 92.3% in first-line SCLC, 77.3% in second-line disease and 52.4% in patients treated in the third line or later."

P1/2 data • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

Anti-B7-H3 ADCs Take Center Stage against SCLC at WCLC. (PubMed, Cancer Discov) - "Separate phase III trials of the anti-B7-H3 antibody-drug conjugates tambotatug pelitecan and risvutatug rezetecan significantly improved overall survival, progression-free survival, and objective response rates compared with topotecan in patients with relapsed small-cell lung cancer. In a third trial, the combination of the investigational PD-L1 x VEGF-A bispecific antibody pumitamig plus the anti-B7-H3 ADC elfetabart drozuntecan showed encouraging early efficacy in SCLC across lines of therapy and doses. The studies were presented at the 2026 World Congress on Lung Cancer in Seoul, Republic of Korea."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

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

Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) in patients with platinum-resistant ovarian cancer (PROC): Efficacy and safety data from a Phase 2 dose optimization cohort (ESMO 2026) - No abstract available

ADC • Clinical • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • CD276

Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) + pumitamig (PD-L1 x VEGF-A bsAb) in patients with advanced solid tumors: First results from a global phase 2 trial (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P2 data • Oncology • Solid Tumor • CD276 • PD-L1 • VEGFA

BioNTech SE…will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer ("WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026. (The Manila Times) - "The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate ("ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311)..."

Clinical data • P1/2 data • P3 data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

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

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 | Trial completion date: Jun 2031 ➔ May 2032 | Trial primary completion date: Aug 2027 ➔ Sep 2028

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of DB-1311 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: DualityBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • ALK • BRAF • CD276 • EGFR • KRAS • MET • NTRK1 • NTRK2 • NTRK3 • ROS1

DB-1311-201: DB-1311 in Combination with BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=102 | Not yet recruiting | Sponsor: Dualitybio Inc. | N=57 ➔ 102

Enrollment change • Cervical Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

The efficacy and safety of 177Lu-PSMA-617 in metastatic castration resistant prostate cancer (mCRPC): Single-institution, real-world data. (ASCO 2026) - "The most common prior LOTs received were androgen deprivation therapy (84%), chemotherapy (82%), ARPI (72%), and radium-223 (19%)...Among the most common subsequent LOT received are cabazitaxel (12%), DB-1311 (9%), immunotherapy (7%), chemotherapy (5%)... We reviewed the real-world efficacy and safety of177-Lu PSMA-617 in mCRPC at our institution. We found that chemotherapy naïve patients had a longer PFS, but the OS was not reached in either subgroup."

Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hepatology • Infectious Disease • Inflammation • Musculoskeletal Pain • Oncology • Prostate Cancer • Renal Disease • Solid Tumor • Xerostomia

DB-1311-201: DB-1311 in Combination with BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=57 | Not yet recruiting | Sponsor: Dualitybio Inc.

New P1/2 trial • Cervical Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pumitamig + BNT324: Data from P1/2 trial (NCT06892548) for advanced lung cancer in 2026 (BioNTech) - Q1 2026 Results: Data from P2 trial (NCT06953089) for solid tumors in 2026

P1/2 data • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BNT324: Data from P3 trial (NCT07365995) for 1L CRPC in 2029 (BioNTech) - Q1 2026 Results

P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer

BNT324-03: A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=736 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 3 clinical trial (NCT07365995) to evaluate BNT324/DB-1311 compared to docetaxel in patients with mCRPC, is expected to initiate in 2026. (BioNTech Press Release)

Trial status • Castration-Resistant Prostate Cancer

Novel B7H3 ADC Yields Responses in Cervical Cancer and Platinum-Resistant Ovarian Cancer (Cancer Network) - "Across patients with second- and third-line cervical cancer (n = 33), the overall response rate (ORR) was 42.4% (95% CI, 25.5%-60.8%), the disease control rate (DCR) was 81.8% (95% CI, 64.5%-93.0%), and the median progression-free survival (PFS) was 7.0 months (95% CI, 4.4-not evaluable [NE])....Across the entire PROC cohort (n = 30), the ORR, DCR, and median PFS were 53.3% (95% CI, 34.3%-71.7%), 83.3% (95% CI, 65.3%-94.4%), and 9.5 months (95% CI, 6.3-NE), respectively. Best overall responses were complete response (CR) in 6.7%, partial response (PR) in 46.7%, stable disease (SD) in 30.0%, and progressive disease (PD) in 10.0%."

P1/2 data • Platinum resistant • Cervical Cancer • Ovarian Cancer

A phase 1/2a, multicenter, open-label, first-in-human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1311 (a B7-H3-targeting ADC) in patients with advanced/metastatic solid tumors (AACR 2024) - P1/2 | "The study plans to enroll approximately 90 pts in Phase 1 and 190 in Phase 2a from locations including but not limited to Australia, United States, China, and Taiwan. To the data cut-off 05 Dec 2023, 11 pts have been enrolled in the study."

ADC • Clinical • First-in-human • IO biomarker • Metastases • P1/2 data • PK/PD data • Castration-Resistant Prostate Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • 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=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