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:
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:
Alle Abstracts sind auf der Webseite des WCLC-Kongresses verfügbar. Weitere Informationen zu BioNTechs Pipeline im Bereich Lungenkrebs sind hier zu finden.
Alle Details zu den Präsentationen:
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.
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 across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to 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. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
CONTACTS
Media Relations
Jasmina Alatovic
Media@biontech.de
Investor Relations
Douglas Maffei, PhD
Investors@biontech.de
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