trastuzumab pamirtecan (BNT323) / DualityBio, BioNTech - LARVOL DELTA

Trastuzumab Pamirtecan (DB-1303/BNT323) in patients with previously treated HER2-expressing advanced/metastatic endometrial cancer: First global clinical Phase 2 data (SGO 2026) - No abstract available

Clinical • Metastases • P2 data • Endometrial Cancer • Oncology • Solid Tumor • HER-2

Antibodies to watch in 2026. (PubMed, MAbs) - "In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab...Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by..."

Journal • Review • Oncology

BNT323-03: A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=380 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (clinicaltrials.gov) - P3 | N=541 | Active, not recruiting | Sponsor: DualityBio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • mTOR • PGR

BNT323-03: A clinical study to find the optimal dose of an investigational treatment called BNT323 when used in combination with another investigational treatment, BNT327, and to test if that combination treatment is safe and beneficial for patients with advanced breast cancer (clinicaltrialsregister.eu) - P1/2 | N=95 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • HER-2

BNT323-01: A phase 3 trial of trastuzumab pamirtecan (HER2 ADC) versus investigator's choice of chemotherapy in pretreated patients with HER2-expressing recurrent endometrial cancer (EC) (ESGO 2026) - P1/2 | "Approximately 504 pts with previously treated HER2-expressing EC will be randomized 2:1 to receive T-Pam IV every 3 weeks, or physicians' choice chemotherapy (doxorubicin or weekly paclitaxel) until RECIST v1.1-defined progressive disease, unacceptable toxicity, or withdrawal of consent. Primary endpoint is progression-free survival (PFS) by blinded independent central review (BICR) in patients with prior ICI treatment. Secondary endpoints are PFS by BICR in all pts, overall survival (OS), PFS by investigator, ORR, duration of response, and safety.Enrollment has been initiated globally.Results NAConclusion NA"

Clinical • IO biomarker • P3 data • Endometrial Cancer • Oncology • Solid Tumor • HER-2

BNT323-01: A clinical study of the anti-cancer effects of an investigational therapy or chemotherapy in patients with recurring uterine cancer (clinicaltrialsregister.eu) - P2/3 | N=222 | Recruiting | Sponsor: BioNTech SE

New P2/3 trial • Endometrial Cancer • Oncology • Solid Tumor • Uterine Cancer • HER-2

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

Safety and efficacy of DB-1303 in patients with advanced/metastatic solid tumors: A multicenter, open-label, first-in-human, phase 1/2a study. (ASCO 2023) - P1/2 | "DB-1303 was well tolerated with encouraging preliminary antitumor activity in heavily pretreated pts with advanced/metastatic solid tumors, especially in pts with HER2+ BC and brain metastasis as well as in HER2-low BC. Expansion is ongoing in selected tumor pts treated at the RP2D. Clinical trial information: NCT05150691."

Clinical • Metastases • P1/2 data • Alopecia • Anemia • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastrointestinal Cancer • Hematological Disorders • HER2 Breast Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor

BioNTech Provides Strategic Business Update and Outlines 2026 Areas of Focus at 44th Annual J.P. Morgan Healthcare Conference (The Manila Times) - "Expected 2026 oncology milestones include seven late-stage data readouts...Additional late-stage trial readouts through 2030+ set to create multiple launch opportunities across tumor types, building BioNTech into a multi-product oncology company."

Clinical data • New P3 trial • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Hepatocellular Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

BNT323-01: A phase III trial of trastuzumab pamirtecan (HER2 ADC) versus investigator's choice of chemotherapy in pretreated patients with HER2-expressing recurrent endometrial cancer (EC) (ESMO Asia 2025) - P1/2, P3 | "Approximately 504 pts with previously treated HER2-expressing EC will be randomized 2:1 to receive T-Pam IV every 3 weeks, or physicians' choice chemotherapy (doxorubicin or weekly paclitaxel) until RECIST v1.1-defined progressive disease, unacceptable toxicity, or withdrawal of consent. Secondary endpoints are PFS by BICR in all pts, overall survival (OS), PFS by investigator, ORR, duration of response, and safety. Enrollment has been initiated at several sites globally."

Clinical • IO biomarker • P3 data • Endometrial Cancer • Oncology • Solid Tumor • HER-2

Antibody-Drug Conjugates: Trastuzumab pamirtecan (BNT323/DB-1303)… (GlobeNewswire) - "A global Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337) for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer is ongoing. Data are expected in 2026."

P3 data • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer

BNT323-03: A phase I/II trial of BNT323/DB-1303 (HER2 ADC) with BNT327 (PD-L1 x VEGF-A) in patients (pts) with advanced breast cancer (BC) (ESMO 2025) - P1/2 | "We anticipate enrolling up to 320 pts globally (NCT06827236). Enrollment is ongoing."

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • VEGFA

Dynasty-Breast01: A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer (clinicaltrials.gov) - P3 | N=228 | Active, not recruiting | Sponsor: DualityBio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

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

BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer (BioNTech Press Release) - "Based on the results from the interim analysis which were shared by the Independent Data Monitoring Committee (IDMC) with DualityBio and evaluated by the Blinded Independent Central Review (BICR), DualityBio plans to discuss the next steps with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China regarding the submission of a Biologics License Application (BLA) of trastuzumab pamirtecan."

P3 data • HER2 Positive Breast Cancer

A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=380 | Recruiting | Sponsor: BioNTech SE | Trial completion date: Sep 2032 ➔ May 2029

Trial completion date • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

ENGOT- en25: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov) - P3 | N=504 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Endometrial Cancer • Oncology • Solid Tumor • Uterine Cancer

A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

ENGOT- en25: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov) - P3 | N=504 | Not yet recruiting | Sponsor: BioNTech SE | Trial completion date: Aug 2029 ➔ Jan 2030 | Trial primary completion date: Oct 2027 ➔ Mar 2028

Trial completion date • Trial primary completion date • Endometrial Cancer • Oncology • Solid Tumor • Uterine Cancer

BioNTech Announces Fourth Quarter and Full Year 2024 Financial Results and Corporate Update (GlobeNewswire) - "BNT323/DB-1303 is being evaluated in a Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent or metastatic HER2-expressing solid tumors. Data from patients with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) advanced endometrial carcinoma are expected in 2025. A confirmatory Phase 3 clinical trial (NCT06340568) is planned to start in 2025. Preparation of a potential Biologics License Application ('BLA') submission for BNT323/DB-1303 as a second line or subsequent therapy in HER2-expressing advanced endometrial cancer in 2025....BNT211: A pivotal Phase 2 clinical trial in patients with testicular germ cell tumors is expected to start in 2025 based on encouraging clinical activity observed in this patient population in the ongoing Phase 1 clinical trial."

FDA filing • New P2 trial • P1/2 data • Trial status • Endometrial Cancer • Testicular Cancer

BioNTech Announces Fourth Quarter and Full Year 2024 Financial Results and Corporate Update (GlobeNewswire) - "First clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating the combination of BNT327 and BNT325/DB-1305, a TROP2-targeted antibody-drug conjugate ('ADC') candidate, are planned to be published in 2025. Additional clinical trials exploring novel combinations of BNT327 with the ADC candidates BNT323/DB-1303 (trastuzumab pamirtecan) targeting HER2, BNT324/DB-1311 targeting B7-H3 or BNT326/YL202 targeting HER3 are planned to start in 2025."

New trial • P1/2 data • Oncology • Solid Tumor

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (clinicaltrials.gov) - P3 | N=532 | Recruiting | Sponsor: DualityBio Inc. | Trial primary completion date: Dec 2025 ➔ May 2026

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

Trastuzumab Pamirtecan (DB-1303/BNT323) In Patients With Previously Treated HER2-Expressing Advanced/Metastatic Endometrial Cancer: First Clinical Data From A Global Phase 2 Study [WITHDRAWN] (ESGO 2025) - No abstract available

Clinical data • Metastases • P2 data • Endometrial Cancer • Oncology • Solid Tumor • HER-2

ENGOT- en25: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov) - P3 | N=468 | Not yet recruiting | Sponsor: BioNTech SE | Trial completion date: Mar 2029 ➔ Aug 2029 | Initiation date: Jan 2025 ➔ Jun 2025 | Trial primary completion date: May 2027 ➔ Oct 2027

Trial completion date • Trial initiation date • Trial primary completion date • Endometrial Cancer • Oncology • Solid Tumor • Uterine Cancer