BioNTech präsentiert auf der WCLC 2026 Fortschritte ihrer spätklinischen Pipeline bei Lungenkrebs und erste globale Daten zur innovativen Behandlungskombination aus Pumitamig und Elfetabart Drozuntecan 20.08.2026, 11:35 Uhr von dpa-AFX Jetzt kommentieren: 0

* Pumitamig in Kombination mit dem gegen B7H3 gerichteten Elfetabart
    Drozuntecan liefert die ersten Daten bei Lungenkrebs für die Kombination
    eines bispezifischen PD-(L)1xVEGF-Immunmodulators mit einem Antikörper-
    Wirkstoff-Konjugat und unterstreicht damit BioNTechs Fokus auf innovative
    Kombinationstherapiestrategien
  * Aktualisierte Daten zum Gesamtüberleben für Gotistobart aus der klinischen
    Phase-3-Studie PRESERVE-003 erweitern die wachsende Evidenzbasis für diesen
    Chemotherapie-freien Behandlungsansatz in der Zweit- und Spätlinientherapie
    des fortgeschrittenen Plattenepithelkarzinoms der Lunge nach vorangegangener
    Immuntherapie
  * BioNTech treibt ein diversifiziertes Entwicklungsprogramm zur Behandlung von
    Lungenkrebs voran, das mehr als 16 laufende klinische Studien über
    verschiedene Subtypen, Biomarker und Behandlungsszenarien hinweg umfasst,
    darunter fünf laufende klinische Phase-3-Studien sowie zwei Studien zu
    innovativen Kombinationstherapien
MAINZ,            Deutschland,           20. August           2026 - BioNTech SE
(https://www.biontech.com/de/de/home.html)  (Nasdaq: BNTX,  ?BioNTech" oder ?das
Unternehmen")  wird auf  der World  Conference on  Lung Cancer (?WCLC") 2026 der
International  Association for the Study of Lung Cancer (?IASLC") neue klinische
Daten  aus  ihrer  diversifizierten  Pipeline  zur  Behandlung  von  Lungenkrebs
präsentieren.  Die  Konferenz  findet  vom  12. bis 15. September 2026 in Seoul,
Südkorea, statt.
Die  Bandbreite der präsentierten Daten  unterstreicht die jüngsten Fortschritte
bei  den strategisch wichtigsten  Produktkandidaten Pumitamig (BNT327/BMS986545)
und     Gotistobart     (BNT316/ONC-392) sowie     bei     den    mRNA-basierten
Krebsimmuntherapieansätzen  von BioNTech. Sie  verdeutlichen zudem das Potenzial
von  BioNTechs  Pipeline  im  Bereich  der Lungenkrebsbehandlung. In einer Late-
Breaking-Präsentation   werden   darüber  hinaus  Daten  aus  einer  Studie  zur
innovativen  Kombination der zwei  Therapieansätze Pumitamig und  dem gegen B7H3
gerichteten  Antikörper-Wirkstoff-Konjugat-Kandidaten  (antibody-drug conjugate,
?ADC")  Elfetabart Drozuntecan  (Elfe-D oder  BNT324/DB-1311) vorgestellt. Diese
Daten  sind die ersten Ergebnisse für eine Kombinationstherapie bei Lungenkrebs,
die einen bispezifischen PD-(L)1xVEGF-Immunmodulator und einen ADC kombiniert.
?Fortschritte  in  der  Behandlung  von  Lungenkrebs bedeuten für uns zweierlei:
Behandlungsergebnisse  für  Patientinnen  und  Patienten  verbessern  sowie neue
Perspektiven für diejenigen, die auf heutige Standardtherapien nicht ausreichend
ansprechen",  sagte  Prof.  Dr.  Özlem  Türeci,  Mitgründerin  und Chief Medical
Officer   von   BioNTech.   ?Die  Daten,  die  wir  auf  der  diesjährigen  WCLC
präsentieren,   liefern   weitere  klinische  Daten  für  unsere  spätklinischen
Entwicklungsprogramme  Gotistobart und Pumitamig. Zugleich  tragen sie dazu bei,
die  Rolle  innovativer  Immunmodulatoren  in  Bereichen  mit  hohem ungedecktem
medizinischem  Bedarf  beim  Lungenkrebs  weiter  zu  definieren. Darüber hinaus
stellen   wir  erstmals  klinische  Daten  zur  Kombination  zweier  innovativer
Therapieansätze  beim Lungenkrebs vor. Diese Daten sind Teil unserer Evaluierung
von  Pumitamig als potenzielle  Schlüsseltherapie für Kombinationsstrategien mit
komplementären  Wirkmechanismen. Insgesamt bilden die auf der WCLC vorgestellten
Daten  eine wichtige Grundlage  für die nächsten  Schritte in unseren klinischen
Entwicklungsprogrammen  und unterstützen zugleich unser übergeordnetes Ziel, die
Behandlungsmöglichkeiten  für  Patientinnen  und  Patienten  mit  Lungenkrebs zu
erweitern."
Highlights aus BioNTechs Präsentationen auf der WCLC 2026:
Innovative  Kombinationsstudie mit Pumitamig, das  in Zusammenarbeit mit Bristol
Myers Squibb Company (?BMS") entwickelt wird, und Elfetabart Drozuntecan, das in
Kollaboration  mit Duality Biologics (Suzhou) Co. Ltd. (?DualityBio") entwickelt
wird:
  * Fortgeschrittener/metastasierter kleinzelliger und nicht-kleinzelliger
    Lungenkrebs: Erste Daten aus der globalen Phase-1/2-Studie (NCT06892548
    (http://clinicaltrials.gov/study/NCT06892548)) werden vorgestellt, in der
    der innovative Kombinationsansatz aus Pumitamig und dem gegen B7H3
    gerichteten Antikörper-Wirkstoff-Konjugat-Kandidat Elfetabart Drozuntecan
    bei Patientinnen und Patienten mit fortgeschrittenem oder metastasiertem
    kleinzelligem Lungenkrebs (small-cell lung cancer, ?SCLC") oder nicht-
    kleinzelligem Lungenkrebs untersucht wird. Die Daten unterstreichen
    BioNTechs Fokus auf innovative Kombinationstherapiestrategien.
Gotistobart - ein Kandidat für die selektive Eliminierung von regulatorischen T-
Zellen   in  der  Mikroumgebung  des  Tumors,  der  auf  CTLA-4 abzielt  und  in
Zusammenarbeit mit OncoC4, Inc. (?OncoC4") entwickelt wird:
  * Zweit- und spätere Behandlungslinien beim Plattenepithelkarzinom der Lunge:
    Aktualisierte Daten zum Gesamtüberleben (overall survival) aus dem ersten
    Teil der Phase-3-Studie PRESERVE-003 (NCT05671510
    (https://clinicaltrials.gov/study/NCT05671510)) mit Gotistobart bei
    Patientinnen und Patienten mit Plattenepithelkarzinom der Lunge (squamous
    non-small cell lung cancer, ?squamous NSCLC"), deren Erkrankung nach einer
    vorangegangenen Anti-PD-(L)1-Therapie fortgeschritten war, vorgestellt. Die
    Ergebnisse erweitern die wachsende Evidenzbasis Afür diesen Chemotherapie-
    freien Behandlungsansatz. Der zweite, zulassungsrelevante Teil der Studie
    läuft derzeit.
Alle     Abstracts     sind     auf     der     Webseite    des WCLC-Kongresses
(https://cattendee.abstractsonline.com/meeting/21487?view=appendToCards&initialS
earchId=3&searchId=3)verfügbar.  Weitere Informationen zu  BioNTechs Pipeline im
Bereich Lungenkrebs sind hier zu finden.
Alle Details zu den Präsentationen:
+-----------------------+---------------------------+--------------------------+
                                                  Abstract-Nummer/Details   
Produktkandidat        Abstract-Titel             der Präsentation          
+-----------------------+---------------------------+--------------------------+
                                                  Abstract # OA14.01        
                       Pumitamig (PD-L1 x VEGF-A  Oral Presentation         
                       bsAb) + Elfetabart         The Breakthrough          
                       Drozuntecan (Elfe-D, B7H3  Immunotherapy for Advanced
                       ADC) in Patients with      NSCLC                     
Pumitamig + Elfetabart Advanced/Metastatic Lung   15.09.2026; 12:30 - 13:45 
Drozuntecan            Cancer (NSCLC or SCLC)     KST                       
+-----------------------+---------------------------+--------------------------+
                                                  Abstract #MO04.09         
                                                  Mini-Oral-Session         
                       First-line Pumitamig (PD-L1Novel Therapeutics and    
                       × VEGF-A bsAb) Plus        Molecular Insights in     
                       Chemotherapy in            Thymic Malignancies and   
                       Unresectable Malignant     Pleural Mesothelioma      
                       Mesothelioma: Long-term PFS13.09.2026; 16:45 - 18:00 
                       and OS                     KST                       
                       +---------------------------+--------------------------+
                                                  Abstract #P2.330          
                       ROSETTA Lung?201: A Phase  Poster                    
                       3 Trial of Pumitamig       Clinical Trials in        
                       Monotherapy vs Durvalumab  Progress                  
                       in Unresectable Stage III  14.09.2026; 10:30 - 12:00 
                       NSCLC Post-Chemoradiation  KST                       
                       +---------------------------+--------------------------+
                                                  Abstract #P2.355          
                       ROSETTA Lung-202: A Phase  Poster                    
                       3 trial of first-line      Clinical Trials in        
                       pumitamig monotherapy vs   Progress                  
                       pembrolizumab in locally   14.09.2026; 10:30 - 12:00 
Pumitamig              advanced/metastatic NSCLC  KST                       
+-----------------------+---------------------------+--------------------------+
                                                  Abstract #MO07.04         
                       Gotistobart vs Docetaxel inMini-Oral-Session         
                       Metastatic Squamous NSCLC  Novel Immunotherapeutic   
                       After PD-(L)1 Progression: Strategies in mNSCLC      
                       Updated Overall Survival of14.09.2026; 17:00 - 18:15 
Gotistobart            the stage 1 of PRESERVE-003KST                       
+-----------------------+---------------------------+--------------------------+
                                                  Abstract #MO06.03         
                                                  Mini-Oral-Session         
                                                  Emerging Precision        
                                                  Approaches in             
                                                  Perioperative Therapy for 
                                                  Resectable NSCLC          
                                                  Integrating Targeted      
                       Neoadjuvant BNT116 +       Therapy, Immunotherapy,   
                       Cemiplimab + Carboplatin + Biomarkers, and Multimodal
                       Paclitaxel in Resectable   Strategies                
                       NSCLC: Preliminary Results 14.09.2026; 15:30 - 16:45 
BNT116                 From a Phase I Trial       KST                       
+-----------------------+---------------------------+--------------------------+
About BioNTech in Lung Cancer Treatment
Lung cancer is one of BioNTech's key focus areas. Through a diversified
portfolio of investigational next-generation immunomodulators, ADCs and mRNA-
based cancer immunotherapies, the Company is pursuing multiple approaches
designed to address significant unmet needs for patients across lung cancer
subtypes, histologies and treatment settings. BioNTech's clinical pipeline
encompasses both monotherapies and combinations with standard of care
treatments, as well as novel-novel combination regimens aimed at delivering
differentiated therapeutic profiles for the treatment of patients with lung
cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and
two novel-novel combination trials, BioNTech is advancing a comprehensive
development strategy with the aim of improving outcomes for patients across the
continuum of lung cancer.
About BioNTech
BioNTech  is a global next generation biopharmaceutical company pioneering novel
investigative  therapies  for  cancer  and  other serious diseases. In oncology,
BioNTech  is committed to transforming how cancer is treated. Its ambition is to
develop  innovative medicines with pan-tumor or synergistic potential to address
cancer  from multiple angles and  across the full continuum  of the disease from
early-  to  late-stage.  Its  growing  late-stage  oncology  pipeline  comprises
complementary  treatment  approaches  spanning  immunomodulators,  antibody drug
conjugates,  and  mRNA  cancer  immunotherapies.  BioNTech  has  partnered  with
multiple   global   and   specialized  pharmaceutical  collaborators  leveraging
complementary  expertise  and  resources  to  accelerate  innovation  and  drive
progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member
of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For       more       information,       please       visit      www.BioNTech.com
(https://www.biontech.com/int/en/home.html).
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, including, but not
limited  to, statements concerning: the initiation, timing, progress and results
of  BioNTech's  research  and  development  programs  in oncology, including the
targeted  timing  and  number  of  additional potentially registrational trials;
BioNTech's  and its collaborators'  current and future  preclinical and clinical
trials  in  oncology,  including  the investigational bispecific immunomodulator
pumitamig   (BNT327/BMS986545)   in  unresectable  malignant  mesothelioma,  the
investigational  anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in metastatic
squamous  NSCLC,  the  investigational  B7H3-targeted ADC elfetabart drozuntecan
(BNT324/DB-1311) in   combination   with   pumitamig   in   (N)SCLC,   and   the
investigational  mRNA cancer immunotherapy candidate BNT116 in resectable NSCLC;
the  nature  and  characterization  of  and  timing for release of clinical data
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You  should review the risks and uncertainties described under the heading "Risk
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SEC's                           website                           at www.sec.gov
(https://www.globenewswire.com/Tracker?data=wWX397YTcxvvpWa69qHeCa3ocwICL3LKkCFv
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CONTACTS
Media Relations
Jasmina Alatovic
Media@biontech.de (mailto:Media@biontech.de)
Investor Relations
Douglas Maffei, PhD
Investors@biontech.de (mailto:Investors@biontech.de)
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