BioNTech Advances PD-L1/VEGF Bispecific Antibody with Encouraging Breast Cancer Trial Results

Acquisition and Strategy:
BioNTech acquired Biotheus to boost its oncology strategy, gaining full global rights to BNT327/PM8002, an investigational PD-L1 x VEGF-A bispecific antibody1.

Clinical Trials:
BioNTech plans to initiate multiple registrational trials with BNT327/PM8002 in late 2024 and 2025 for various solid tumor indications, including small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer1.

Efficacy and Safety:
BNT327/PM8002 has shown encouraging efficacy and tolerability in patients across various tumor types, with over 700 patients treated in clinical trials to date1.

Combination Therapies:
Additional trials will explore combining BNT327/PM8002 with BioNTech’s proprietary antibody-drug conjugates (ADCs), such as BNT325/DB-1305, a TROP2-targeted ADC candidate1.

Breast Cancer Data:
Phase Ib/II data presented at the 2024 San Antonio Breast Cancer Symposium showed a confirmed overall response rate of 73.8% and a disease control rate of 95.2% in patients with locally advanced or metastatic triple-negative breast cancer treated with BNT3274.

Market Potential:
Analysts expect $2 billion in sales for BNT327 by 2032, based on indications that BioNTech could develop4.

Competitive Landscape:
The PD-1/VEGF bispecific class of drugs, including BNT327 and ivonescimab, is closely watched for its potential to challenge Keytruda’s dominance in cancer treatment45.

Sources:

1. https://investors.biontech.de/news-releases/news-release-details/biontech-acquire-biotheus-boost-oncology-strategy

4. https://www.biospace.com/drug-development/biontech-builds-case-for-pd-l1-vegf-bispecific-with-promising-breast-cancer-data

5. https://dailyreporter.esmo.org/esmo-congress-2024/breast-cancer/clinical-activity-reported-for-novel-first-line-combination-strategies-in-advanced-triple-negative-breast-cancer