BioNTech to Present Clinical and Preclinical Data Across mRNA and Next-Generation Immuno-Oncology Priority Programs at AACR 2025
BioNTech (NASDAQ: BNTX) will showcase data from its oncology pipeline at the AACR Annual Meeting in Chicago (April 25-30, 2025). The presentations will feature:
1. BNT327: A next-generation bispecific antibody showing superior anti-tumor activity in preclinical studies when combined with antibody-drug conjugates (ADCs)
2. BNT116: Phase 1 clinical trial data in combination with cemiplimab for non-small cell lung cancer (NSCLC), demonstrating anti-tumor activity and manageable safety profile
3. BNT314/GEN1059: Preclinical data showing enhanced anti-tumor activity when combined with PD-1 inhibition
The company's oncology portfolio includes mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, with over 20 active Phase 2 and 3 trials. Multiple data readouts are expected in 2025 and 2026.
BioNTech (NASDAQ: BNTX) presenterà i dati della sua pipeline oncologica all'AACR Annual Meeting di Chicago (25-30 aprile 2025). Le presentazioni includeranno:
1. BNT327: un anticorpo bispecifico di nuova generazione che mostra un'attività antitumorale superiore negli studi preclinici, soprattutto in combinazione con coniugati anticorpo-farmaco (ADC)
2. BNT116: dati della fase 1 della sperimentazione clinica in combinazione con cemiplimab per il carcinoma polmonare non a piccole cellule (NSCLC), che evidenziano attività antitumorale e un profilo di sicurezza gestibile
3. BNT314/GEN1059: dati preclinici che mostrano un aumento dell'attività antitumorale in combinazione con l'inibizione di PD-1
Il portafoglio oncologico dell'azienda comprende immunoterapie a mRNA contro il cancro, immunomodulatori di nuova generazione e terapie mirate, con oltre 20 studi di fase 2 e 3 attivi. Sono previsti numerosi aggiornamenti sui dati nel 2025 e 2026.
BioNTech (NASDAQ: BNTX) presentará datos de su pipeline oncológica en la Reunión Anual de AACR en Chicago (del 25 al 30 de abril de 2025). Las presentaciones incluirán:
1. BNT327: un anticuerpo bispecífico de próxima generación que muestra una actividad antitumoral superior en estudios preclínicos cuando se combina con conjugados anticuerpo-fármaco (ADC)
2. BNT116: datos del ensayo clínico de fase 1 en combinación con cemiplimab para cáncer de pulmón no microcítico (NSCLC), demostrando actividad antitumoral y un perfil de seguridad manejable
3. BNT314/GEN1059: datos preclínicos que muestran una mayor actividad antitumoral cuando se combina con inhibición de PD-1
La cartera oncológica de la compañía incluye inmunoterapias contra el cáncer basadas en ARNm, inmunomoduladores de próxima generación y terapias dirigidas, con más de 20 ensayos activos de fase 2 y 3. Se esperan múltiples resultados de datos en 2025 y 2026.
BioNTech (NASDAQ: BNTX)는 2025년 4월 25일부터 30일까지 시카고에서 열리는 AACR 연례 회의에서 자사의 종양학 파이프라인 데이터를 공개할 예정입니다. 발표 내용은 다음과 같습니다:
1. BNT327: 항체-약물 접합체(ADC)와 병용 시 전임상 연구에서 우수한 항종양 활성을 보이는 차세대 이중특이성 항체
2. BNT116: 비소세포폐암(NSCLC) 치료를 위한 세밀리맙과의 병용 1상 임상시험 데이터로, 항종양 활성 및 관리 가능한 안전성 프로파일을 입증
3. BNT314/GEN1059: PD-1 억제제와 병용 시 향상된 항종양 활성을 보이는 전임상 데이터
회사의 종양학 포트폴리오에는 mRNA 암 면역치료제, 차세대 면역조절제, 표적 치료제가 포함되어 있으며, 20개 이상의 2상 및 3상 임상시험이 진행 중입니다. 2025년과 2026년에 다수의 데이터 발표가 예상됩니다.
BioNTech (NASDAQ : BNTX) présentera des données de son pipeline oncologique lors de la réunion annuelle de l’AACR à Chicago (du 25 au 30 avril 2025). Les présentations incluront :
1. BNT327 : un anticorps bispécifique de nouvelle génération montrant une activité antitumorale supérieure dans des études précliniques lorsqu’il est combiné à des conjugués anticorps-médicament (ADC)
2. BNT116 : données d’un essai clinique de phase 1 en association avec cemiplimab pour le cancer du poumon non à petites cellules (NSCLC), démontrant une activité antitumorale et un profil de sécurité gérable
3. BNT314/GEN1059 : données précliniques montrant une activité antitumorale renforcée en combinaison avec une inhibition de PD-1
Le portefeuille oncologique de l’entreprise comprend des immunothérapies anticancéreuses à ARNm, des immunomodulateurs de nouvelle génération et des thérapies ciblées, avec plus de 20 essais actifs de phases 2 et 3. Plusieurs résultats de données sont attendus en 2025 et 2026.
BioNTech (NASDAQ: BNTX) wird Daten aus seiner Onkologie-Pipeline auf dem AACR Annual Meeting in Chicago (25.-30. April 2025) vorstellen. Die Präsentationen umfassen:
1. BNT327: Ein bispezifischer Antikörper der nächsten Generation, der in präklinischen Studien in Kombination mit Antikörper-Wirkstoff-Konjugaten (ADCs) eine überlegene antitumorale Aktivität zeigt
2. BNT116: Daten aus der Phase-1-Studie in Kombination mit Cemiplimab bei nicht-kleinzelligem Lungenkrebs (NSCLC), die antitumorale Aktivität und ein gut handhabbares Sicherheitsprofil belegen
3. BNT314/GEN1059: Präklinische Daten, die eine verbesserte antitumorale Aktivität in Kombination mit PD-1-Inhibition zeigen
Das Onkologie-Portfolio des Unternehmens umfasst mRNA-Krebsimmuntherapien, Immunmodulatoren der nächsten Generation und zielgerichtete Therapien mit über 20 aktiven Phase-2- und Phase-3-Studien. Für 2025 und 2026 werden mehrere Datenauswertungen erwartet.
- Multiple promising drug candidates showing enhanced anti-tumor activity in combination therapies
- Over 20 active Phase 2 and 3 clinical trials advancing across multiple solid tumor indications
- BNT116 demonstrated positive preliminary efficacy and safety data in NSCLC patients
- Strategic pipeline expansion towards becoming a multi-product oncology company
- Most presented data is still in preclinical stages
- Clinical efficacy data to early-phase trials
- Dependency on combination therapies may increase treatment complexity and costs
Insights
BioNTech's oncology pipeline shows promising early results across multiple programs, reinforcing their strategy beyond COVID vaccines.
BioNTech's upcoming presentations at AACR 2025 provide valuable visibility into their diversified oncology pipeline, marking important progress in their strategic pivot beyond COVID-19 vaccines. The company has structured their approach around two strategic pillars: mRNA cancer immunotherapies and next-generation immunomodulators, with over 20 active Phase 2 and 3 trials currently ongoing.
The data for BNT327, their PD-L1xVEGF-A bispecific antibody, demonstrates the scientific rationale behind their combination strategy. Preclinical results show this dual-targeting approach produced superior anti-tumor activity compared to single-agent treatments targeting either pathway alone. This supports BioNTech's thesis that novel immunotherapy backbones combined with complementary mechanisms could drive synergistic effects.
Most notably, the Phase 1 LuCa-MERIT-1 trial data for BNT116 (mRNA cancer immunotherapy) combined with cemiplimab in advanced NSCLC patients shows preliminary anti-tumor activity with manageable safety in a population of frail patients ineligible for platinum chemotherapy. This represents a potentially valuable treatment approach for an underserved patient population with options.
The company's collaboration strategy is also evident, with presentations featuring candidates developed with partners like DualityBio (ADCs) and Genmab (BNT314/GEN1059). These partnerships extend BioNTech's reach across multiple modalities including antibody-drug conjugates, which have shown significant commercial success in oncology recently.
With multiple data readouts planned for 2025-2026, these presentations offer a preview of BioNTech's broader ambition to evolve into a multi-product oncology company with a diversified revenue base beyond their COVID vaccine franchise.
BioNTech's dual-mechanism immunotherapies show promising activity in difficult-to-treat cancer populations, with rational combination strategies.
The preliminary data from BioNTech's oncology pipeline demonstrates scientifically sound approaches to overcoming common resistance mechanisms in cancer treatment. Their BNT327 bispecific antibody tackles two critical pathways simultaneously: PD-L1 checkpoint inhibition and VEGF-A neutralization. This is mechanistically compelling as tumor angiogenesis (via VEGF) often creates an immunosuppressive microenvironment that can limit efficacy of checkpoint inhibitors alone.
The combination of BNT327 with antibody-drug conjugates represents a rational approach that pairs immunotherapy with targeted cytotoxic delivery. Early preclinical data suggesting superior tumor growth inhibition with this combination aligns with emerging understanding that ADCs can induce immunogenic cell death, potentially enhancing checkpoint inhibitor activity.
For the BNT116 mRNA cancer immunotherapy, the focus on frail NSCLC patients ineligible for platinum chemotherapy addresses a significant unmet need. These patients typically have treatment options and poor outcomes. The observed anti-tumor activity with manageable safety profile in this vulnerable population is clinically meaningful, particularly if it can provide disease control without chemotherapy-associated toxicities.
The EpCAMx4-1BB bispecific antibody (BNT314/GEN1059) represents another sophisticated approach, using conditional 4-1BB co-stimulation to potentially enhance T-cell activation specifically in the tumor microenvironment. The data showing activity in models unresponsive to single-agent treatment suggests potential utility in overcoming primary resistance to PD-1 blockade.
BioNTech's multi-modal strategy tackling various aspects of anti-tumor immunity (antigen presentation, T-cell activation, immune suppression, vascular normalization) demonstrates a sophisticated understanding of tumor immunology and resistance mechanisms.
MAINZ, Germany, April 24, 2025 -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research (“AACR”) Annual Meeting held in Chicago, Illinois from April 25-30, 2025. The oral and poster presentations underline both the progress of BioNTech’s advanced priority oncology programs as well as the execution of the Company’s combination strategy in oncology, with first data to be presented for the combination of the PD-L1xVEGF-A bispecific antibody candidate BNT3271 plus antibody-drug conjugates (“ADCs”).
“We believe that the future standard of care for the treatment of advanced cancers will be combinations with novel immuno-oncology backbones,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “Our data presentations at this year’s AACR support our approach to combine complementary mechanisms of action with the aim of driving synergistic anti-tumor activity. The data we present indicate that we are well positioned to work towards our vision of improving outcomes for patients across the full continuum of cancer disease.”
Highlights of BioNTech’s oncology programs to be presented at AACR 2025:
- BioNTech will present preclinical data characterizing the mode of action of BNT327. BNT327 is an investigational next-generation bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization. BNT327 showed a high binding affinity to PD-L1 and VEGF-A and efficient blocking of PD-1/PD-L1 and VEGF-A/VEGFR2 signaling. Anti-tumor activity superior to single PD-1/PD-L1 blockade or anti-VEGF-A treatment was observed in multiple tumor models.
- First data for the combination of BNT327 with various ADC candidates, which are being jointly developed by BioNTech and Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), will be presented. The presentation will include preclinical evaluation of BNT327 plus ADCs, showing inhibition of tumor growth that is superior to each candidate alone. Further, early clinical data of the ongoing global Phase 1/2 trial (NCT05438329) of BNT327 in combination with BNT325/DB-1305, a TROP2-targeting ADC candidate, including safety and early efficacy data, will be presented in the poster session.
- BioNTech will present data from the Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) for its mRNA cancer immunotherapy candidate BNT116 in combination with the anti-PD1 cemiplimab in an oral presentation. The update includes safety and clinical activity data, along with biomarker data from a cohort of frail patients with advanced or metastatic non-small cell lung cancer (“NSCLC”) who were not eligible for platinum-based chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction, and a manageable safety profile.
- Preclinical data for the EpCAMx4-1BB antibody candidate BNT314/GEN1059, which is being developed in collaboration with Genmab S/A (“Genmab”), will be presented in a poster session. BNT314/GEN1059 was evaluated in combination with PD-1 inhibition in a tumor model unresponsive to each single treatment. The data showed anti-tumor activity, delayed tumor outgrowth and prolonged survival for the combination treatment compared to both single treatments. The immunomodulatory activity of BNT314/GEN1059 was further potentiated in combination with PD-1 blockade.
BioNTech has established a diversified oncology portfolio including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, comprising ADCs and cell therapies, to develop novel treatment approaches for patients living with cancer. The Company is further maturing its clinical oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.
The full abstracts are available on the AACR Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.
Full presentation details:
Oral presentation
Asset: BNT116
Session Title: “ADCs and Immunooncology-focused Biological Approaches”
Abstract Title: “Phase I trial evaluating BNT116, a TAA-encoding mRNA vaccine, in combination with cemiplimab in frail patients with advanced non-small cell lung cancer (NSCLC)”
Abstract Number: CT013
Location: Room S100 A (Grand Ballroom A)
Date: Sunday, April 27, 2025
Time: 4:20 PM - 4:30 PM CDT
Poster presentations
Asset: BNT327 + BNT325/DB-1305
Session Title: “Combination Immunotherapies”
Abstract Title: “Activity of BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors: Early preclinical and clinical evidence to support BNT327 + ADC combinations”
Poster Number: 648 / 14
Location: Section 28
Date: Sunday, April 27, 2025
Time: 2:00 PM - 5:00 PM CDT
Asset: BNT327
Session Title: “Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators”
Abstract Title: “Dual PD-L1 blockade and VEGF-A neutralization with the bispecific antibody BNT327/PM8002 shows potent antitumor activity in preclinical models”
Poster Number: 6061 / 2
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM - 5:00 PM CDT
Asset: BNT314/ GEN1059
Session Title: “Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators”
Abstract Title: “The combination of an EpCAMx4-1BB bispecific antibody with PD-1 blockade exhibits antitumor activity in a murine tumor model unresponsive to each individual antibody”
Poster Number: 6075 / 16
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM - 5:00 PM CDT
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
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 studies and clinical trials in oncology, including the investigational lipoplex-formulated uridine mRNA immunotherapy BNT116, the investigational bispecific antibodies BNT327 and BNT314/GEN1059, and the investigational ADC therapy BNT325/DB-1305; 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; the ability of BioNTech’s mRNA technology to demonstrate clinical efficacy outside of BioNTech’s infectious disease platform; 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, 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 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; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; 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, if approved, its product candidates; BioNTech’s ability to manage its development and expansion; regulatory developments in the United States and other countries and regions; 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 20-F for the period ended December 31, 2024 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
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Media@biontech.de
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Investors@biontech.de
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1 BNT327, formerly also known as PM8002, was initially jointly developed by BioNTech and Biotheus Inc (“Biotheus”). Since February 2025, Biotheus is a member of the BioNTech Group.
FAQ
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