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    DRUG:

    BNT327

    i
    Other names: BNT327, PM8002, PM 8002, PM-8002, BNT 327, BNT-327
    Company:
    BioNTech
    Drug class:
    PD-L1 inhibitor, VEGF-A inhibitor
    Related drugs:
    6d
    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, BioNTech SE | Trial completion date: Sep 2032 --> May 2029
    Trial completion date
    |
    trastuzumab pamirtecan (BNT323) • BNT327
    2ms
    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, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    trastuzumab pamirtecan (BNT323) • BNT327
    2ms
    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, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BNT327 • BNT324
    3ms
    BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=70, Recruiting, BioNTech SE | Trial completion date: Jan 2027 --> Sep 2028 | Trial primary completion date: Mar 2025 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    carboplatin • gemcitabine • paclitaxel • albumin-bound paclitaxel • Halaven (eribulin mesylate) • BNT327
    3ms
    BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=110, Active, not recruiting, BioNTech SE | Trial completion date: Aug 2026 --> May 2028 | Trial primary completion date: Mar 2025 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    carboplatin • paclitaxel • etoposide IV • topotecan • BNT327
    3ms
    DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=440, Not yet recruiting, DualityBio Inc.
    New P2 trial
    |
    BNT327 • BNT324
    4ms
    A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov)
    P2, N=64, Active, not recruiting, Biotheus Inc. | Phase classification: P2/3 --> P2 | N=374 --> 64 | Trial primary completion date: Mar 2025 --> Sep 2024
    Phase classification • Enrollment change • Trial primary completion date
    |
    EGFR mutation
    |
    carboplatin • pemetrexed • BNT327
    4ms
    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, Not yet recruiting, BioNTech SE
    New P1/2 trial
    |
    BNT327 • BNT324
    4ms
    Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy (clinicaltrials.gov)
    P2, N=60, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    docetaxel • BNT327
    4ms
    PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Biotheus Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • BNT327
    4ms
    A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Biotheus Inc. | Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P2 | N=445 --> 50 | Trial primary completion date: Jun 2025 --> May 2024
    Enrollment closed • Phase classification • Enrollment change • Trial primary completion date
    |
    etoposide IV • BNT327
    4ms
    PM8002-B004C-TNBC-R: A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC (clinicaltrials.gov)
    P1/2, N=42, Active, not recruiting, Biotheus Inc. | Recruiting --> Active, not recruiting | N=60 --> 42
    Enrollment closed • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    albumin-bound paclitaxel • BNT327
    5ms
    BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=110, Active, not recruiting, BioNTech SE | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    carboplatin • paclitaxel • etoposide IV • topotecan • BNT327
    5ms
    Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, BioNTech SE
    New P2 trial
    |
    docetaxel • BNT327
    5ms
    Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel • BNT327
    5ms
    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, Not yet recruiting, BioNTech SE
    New P1/2 trial
    |
    trastuzumab pamirtecan (BNT323) • BNT327
    6ms
    BioNTech Completes Acquisition of Biotheus (GlobeNewswire)
    "BioNTech SE...announced today the completion of the acquisition of Biotheus...The acquisition was announced on November 2024 and builds on the successful collaboration on the late-stage clinical asset BNT327, an investigational bispecific antibody targeting PD-L1 and VEGF-A, and other bispecific antibody candidates. The transaction is part of BioNTech’s oncology strategy, aimed at expanding the Company’s capabilities to research, develop and commercialize BNT327 as a pan-tumor technology platform for combination therapies. With this completion of the acquisition, BioNTech obtains full global rights to BNT327 and rights to all other candidates of Biotheus’ pipeline as well as to its in-house antibody generation platform and bispecific antibody drug conjugate capability."
    M&A
    |
    BNT327
    6ms
    Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (clinicaltrials.gov)
    P2/3, N=982, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • BNT327
    6ms
    Safety and Effectiveness of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer (clinicaltrials.gov)
    P3, N=439, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • BNT327
    7ms
    A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC (clinicaltrials.gov)
    P2, N=99, Active, not recruiting, Biotheus Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2024 --> Apr 2025
    Enrollment closed • Trial primary completion date • Combination therapy
    |
    paclitaxel • BNT327
    7ms
    PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=404, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • topotecan • BNT327
    7ms
    PM8002-A001: PM8002 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=380, Recruiting, Biotheus Inc. | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    BNT327
    8ms
    Safety and Effectiveness of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer (clinicaltrials.gov)
    P3, N=439, Not yet recruiting, BioNTech SE
    New P3 trial • Combination therapy
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • BNT327
    8ms
    Safety, Effectiveness, and Pharmacokinetics (the Movement of Drug Into, Through and Out of the Body) of BNT327 (an Investigational Therapy) in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (clinicaltrials.gov)
    P2/3, N=982, Not yet recruiting, BioNTech SE
    New P2/3 trial • Combination therapy
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • BNT327
    8ms
    PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (ChiCTR2400091077)
    P3, N=404, Recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
    New P3 trial • Combination therapy
    |
    paclitaxel • topotecan • BNT327
    9ms
    Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated wtih First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study. (SABCS 2024)
    In pts with LA/mTNBC, first-line therapy with PM8002/BNT327 combined with nab-paclitaxel showed clinically meaningful survival outcomes and antitumor activity regardless of PD-L1 status, together with a manageable safety profile. No new safety signals were observed beyond those typically described for anti-PD-1/PD-L1 and anti-VEGF therapies and nab-paclitaxel. A randomized controlled Phase III clinical trial (NCT06419621) of first-line treatment of TNBC in China and a global Phase II trial (NCT06449222) are ongoing in TNBC.
    Combination therapy • P1/2 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 expression
    |
    AmoyDx® PD-L1 Expression Detection Kit
    |
    albumin-bound paclitaxel • BNT327
    10ms
    PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=404, Not yet recruiting, Biotheus Inc.
    New P3 trial • Combination therapy
    |
    paclitaxel • topotecan • BNT327
    11ms
    A Clinical Trial to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC (clinicaltrials.gov)
    P1/2, N=140, Not yet recruiting, Biotheus Inc.
    New P1/2 trial • Metastases
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • BNT327
    11ms
    BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=110, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    BNT327
    11ms
    BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=60, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    BNT327
    11ms
    A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov)
    P2/3, N=374, Active, not recruiting, Biotheus Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • IO biomarker • Metastases
    |
    carboplatin • pemetrexed • BNT327
    12ms
    PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=360, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    albumin-bound paclitaxel • BNT327
    1year
    Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=110, Not yet recruiting, BioNTech SE | Trial completion date: Apr 2026 --> Aug 2026
    Trial completion date • Combination therapy
    |
    BNT327
    1year
    BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, BioNTech SE | Trial completion date: Apr 2026 --> Jan 2027
    Trial completion date • Combination therapy
    |
    BNT327
    1year
    First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=842, Recruiting, DualityBio Inc. | N=607 --> 842
    Enrollment change • Metastases
    |
    Keytruda (pembrolizumab) • BNT327
    1year
    Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=110, Not yet recruiting, BioNTech SE
    New P2 trial • Combination therapy
    |
    BNT327
    1year
    Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, BioNTech SE
    New P2 trial • Combination therapy
    |
    BNT327
    1year
    PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=360, Not yet recruiting, Biotheus Inc.
    New P3 trial • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    albumin-bound paclitaxel • BNT327
    over1year
    A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov)
    P2/3, N=445, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Tecentriq (atezolizumab) • etoposide IV • BNT327
    2years
    A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC (clinicaltrials.gov)
    P2/3, N=374, Recruiting, Biotheus Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 expression • EGFR mutation
    |
    carboplatin • pemetrexed • BNT327
    2years
    A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM (clinicaltrials.gov)
    P2, N=55, Recruiting, Biotheus Inc.
    New P2 trial • Combination therapy
    |
    cisplatin • carboplatin • pemetrexed • BNT327
    2years
    PM8002 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=380, Recruiting, Biotheus Inc.
    New P1/2 trial • Metastases
    |
    BNT327