BNT325 / DualityBio, BioNTech - LARVOL DELTA

BioNTech Announces First Quarter 2025 Financial Results and Corporate Update (GlobeNewswire) - P1/2a | N=1,123 | NCT05438329 | Sponsor: DualityBio Inc. | "Interim data from the ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT327 with BNT325/DB-1305, a TROP2-targeting ADC candidate being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ('DualityBio', in patients with advanced/metastatic solid tumors showed a manageable safety profile and early signs of anti-tumor activity in a cohort with patients with platinum-resistant ovarian cancer ('PROC'). Across the 13 efficacy evaluable patients with PROC, seven patients achieved partial response and three stable disease. Responses were also observed in patients with non-small cell lung cancer ('NSCLC') or triple-negative breast cancer ('TNBC')."

P1/2 data • Platinum resistant • Non Small Cell Lung Cancer • Ovarian Cancer • Triple Negative Breast Cancer

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

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=440 | Not yet recruiting | Sponsor: DualityBio Inc.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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

DB-1305/BNT325 (a novel TROP-2 ADC) in patients with ovarian cancer: Efficacy and safety data from a phase 1/2 study (SGO 2025) - No abstract available

Clinical • P1/2 data • Oncology • Ovarian Cancer • Solid Tumor

BioNTech Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "A global randomized Phase 3 clinical trial evaluating BNT327/PM8002 in first line triple-negative breast cancer ('TNBC') is on track to start in 2025. Plan to initiate additional clinical trials exploring novel combinations of BNT327/PM8002 with ADCs BNT323/DB-1303 (trastuzumab pamirtecan), BNT324/DB-1311 and BNT326/YL202 in 2025. Plan to present first clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating BNT327/PM8002 plus BNT325/DB-1305 in multiple solid tumors in 2025. Plan to present clinical data from the ongoing global Phase 2 dose optimization trials evaluating BNT327/PM8002 plus chemotherapy in advanced TNBC (NCT06449222) and first line SCLC (NCT06449209) in 2025."

New P3 trial • New trial • P2 data • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=842 | Recruiting | Sponsor: DualityBio Inc. | N=607 ➔ 842

Enrollment change • Metastases • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=607 | Recruiting | Sponsor: DualityBio Inc. | N=345 ➔ 607

Enrollment change • Metastases • Gastrointestinal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BioNTech and DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305 (GlobeNewswire) - "BioNTech SE...and Duality Biologics (Suzhou) Co., Ltd...announced that the U.S. Food and Drug Administration ('FDA') granted Fast Track designation for BNT325/DB-1305 for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. BNT325/DB-1305 is a next-generation antibody-drug conjugate ('ADC') candidate targeting the trophoblast cell-surface antigen 2 ('TROP2'), a protein which is overexpressed on a range of tumor types. The candidate is currently being evaluated in an ongoing Phase 1/2 study (NCT05438329) in patients with TROP2-expressing advanced solid tumors."

Fast track designation • Trial status • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

First-in-human Study of DB-1305 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=345 | Recruiting | Sponsor: DualityBio Inc. | N=255 ➔ 345

Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BioNTech to Present Multiple Program Updates Across Modalities at ESMO Congress 2023 (GlobeNewswire) - P1/2 | N=235 | NCT05438329 | Sponsor: DualityBio Inc. | "The Company will present first-in-human data of BNT325 (DB-1305) (NCT05438329), a next-generation Trop-2-targeting antibody-drug conjugate ('ADC')...Initial data with this candidate show encouraging preliminary efficacy and a manageable safety profile in patients with advanced/metastatic non-small cell lung cancer (NSCLC)....A trial in progress poster will inform on the ongoing EMPOWERVAX Lung 1 Phase 2 trial (NCT05557591)...evaluating the efficacy and safety of BioNTech’s fully-owned off-the-shelf mRNA cancer vaccine candidate BNT116 in combination with cemiplimab versus cemiplimab alone in the first-line treatment of patients with advanced NSCLC and PD-L1 expression ≥50%."

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

DB-1305 (a Trop-2 targeted antibody-drug-conjugate [ADC]) in patients (pts) with advanced solid tumors: Preliminary clinical results from the phase (Ph) I/IIa study (ESMO 2023) - P1/2 | "Encouraging efficacy signals were observed in the NSCLC. Study continues to identify dose(s) of DB-1305."

Clinical • Metastases • Fallopian Tube Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DualityBio Expands Global Strategic Partnership with BioNTech to Accelerate Development of a Third Antibody-Drug Conjugate Therapeutics for Solid Tumors (PRNewswire) - "Duality Biologics...announced that the company has expanded its collaboration with BioNTech SE to develop, manufacture and commercialize a third ADC candidate DB-1305 globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region....Under the terms of the agreements, DualityBio will receive upfront payments, additional development, regulatory and commercial milestone payments, and single-digit to low-double digit tiered royalties on net sales of DB-1305. BioNTech will hold commercial rights globally (excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region), while DualityBio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region."

Licensing / partnership • Oncology • Solid Tumor

First in human trial of DB1305 in patients with advanced malignant solid tumors (AACR 2023) - P1/2 | "Exploratory objectives include the assessment of pharmacodynamic biomarkers and Exposure-Response correlation. As of 19 Dec 2022, 20 patients have been enrolled in the dose escalation part."

Clinical • Metastases • P1 data • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

"And I also forgot DB-1305 from Duality Biologics (https://t.co/xXfXIEWZMR)" (@Raffaele_1985)

First-in-human Study of DB-1305 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=235 | Recruiting | Sponsor: DualityBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

The Trop-2-targeting antibody drug conjugate DB-1305 has higher anti-tumor activity and a potentially better safety profile compared with DS-1062 (AACR-NCI-EORTC 2022) - "Taken together, this study has demonstrated higher efficacy and a potentially better safety profile of DB-1305 compared with DS-1062, supporting further clinical development of DB-1305 and indicating the great potential of DB-1305 in the treatment of Trop-2-positive cancers. No"

Clinical • Oncology

First-in-human Study of DB-1305 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=235 | Not yet recruiting | Sponsor: DualityBio Inc.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer