^* 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-L1|Novel Therapeutics and |
| |× VEGF-A bsAb) Plus |Molecular Insights in |
| |Chemotherapy in |Thymic Malignancies and |
| |Unresectable Malignant |Pleural Mesothelioma |
| |Mesothelioma: Long-term PFS|13.09.2026; 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 in|Mini-Oral-Session |
| |Metastatic Squamous NSCLC |Novel Immunotherapeutic |
| |After PD-(L)1 Progression: |Strategies in mNSCLC |
| |Updated Overall Survival of|14.09.2026; 17:00 - 18:15 |
|Gotistobart |the stage 1 of PRESERVE-003|KST |
+-----------------------+---------------------------+--------------------------+
| | |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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and market interpretation; the planned next steps in BioNTech's pipeline
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for initiation or enrollment of clinical trials, or submission for and receipt
of product approvals and potential commercialization with respect to BioNTech's
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The forward-looking statements in this press release are based on BioNTech's
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BioNTech at this time.
You should review the risks and uncertainties described under the heading "Risk
Factors" in BioNTech's Report on Form 6-K for the period ended June 30, 2026 and
in subsequent filings made by BioNTech with the SEC, which are available on the
SEC's website at www.sec.gov
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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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