BioNTech (NASDAQ: BNTX) details late-stage oncology pipeline data for ASCO 2026
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
BioNTech SE is using the 2026 ASCO Annual Meeting to showcase progress in its late-stage oncology pipeline. The company will present new clinical data and trial updates for key assets, including the bispecific immunomodulator pumitamig and the CTLA-4 antibody gotistobart, plus several antibody-drug conjugate programs.
Interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer showed encouraging anti-tumor activity for pumitamig plus chemotherapy and are informing the ongoing pivotal Phase 3 part. Phase 2 data for gotistobart in heavily pre-treated, platinum-resistant ovarian cancer showed durable anti-tumor activity and clinically meaningful overall survival with a manageable safety profile.
Overall, BioNTech highlights more than 25 Phase 2 and Phase 3 trials, including 13 pivotal studies and multiple novel-novel combination trials across major tumor types, underscoring a broad late-stage oncology strategy spanning immunomodulators, ADCs, and mRNA cancer immunotherapies.
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Key Figures
ASCO 2026 dates: May 29 to June 2, 2026
Oral presentations: 2 presentations
Trial-in-progress posters: 4 posters
+4 more
7 metrics
ASCO 2026 dates
May 29 to June 2, 2026
American Society of Clinical Oncology Annual Meeting schedule
Oral presentations
2 presentations
New data for pumitamig and gotistobart at ASCO 2026
Trial-in-progress posters
4 posters
Pivotal and novel-novel combination oncology trials at ASCO 2026
Late-stage oncology trials
More than 25 trials
Phase 2 and Phase 3 clinical trials across tumor types
Pivotal trials
13 ongoing trials
Ongoing pivotal oncology studies in BioNTech pipeline
ROSETTA Lung-02 phase
Phase 2/3
Global trial of pumitamig plus chemotherapy in 1L NSCLC
PRESERVE-004 phase
Phase 2
Gotistobart plus pembrolizumab in platinum-resistant ovarian cancer
Key Terms
non-small cell lung cancer, platinum-resistant ovarian cancer, antibody-drug conjugates, bispecific immunomodulator, +2 more
6 terms
non-small cell lung cancer medical
"first-line non-small cell lung cancer ("NSCLC"). The trial evaluated pumitamig"
A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.
platinum-resistant ovarian cancer medical
"Phase 2 PRESERVE-004 clinical trial ... in heavily pre-treated patients with platinum-resistant ovarian cancer"
A form of ovarian cancer that stops responding to standard platinum-based chemotherapy, typically when the disease returns within about six months after treatment; think of it like a pest becoming resistant to a once-effective pesticide. It matters to investors because this resistance creates a large unmet medical need, shaping demand for new drugs, clinical trial strategies, regulatory priority and potential pricing — all of which can materially affect company value and market opportunity.
antibody-drug conjugates medical
"including antibody-drug conjugates ("ADC")."
A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.
bispecific immunomodulator medical
"an investigational bispecific immunomodulator combining PD-L1 checkpoint inhibition and VEGF-A neutralization"
A bispecific immunomodulator is a type of drug, usually a protein, engineered to attach to two different molecules at once and adjust how the immune system works. Think of it as a two-headed key that can unlock or block two locks to steer the immune response more precisely than single-target drugs. Investors care because this dual-action design can boost effectiveness or reduce side effects, but it also adds development complexity, clinical risk, and potential regulatory hurdles that affect value.
pivotal trials financial
"more than 25 Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials"
Pivotal trials are the large, definitive clinical studies designed to show whether a drug or medical device works and is safe enough for regulatory approval. Investors watch them like a final exam for a product: passing typically clears the way to sell the therapy and generate revenue, while failing can delay or block approval and sharply reduce a company's value.
mRNA cancer immunotherapies medical
"spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies"
mRNA cancer immunotherapies use short snippets of genetic instructions (mRNA) delivered into the body to teach a patient’s own cells to make proteins that flag cancer cells for the immune system. Think of the mRNA as a temporary recipe given to factory workers (cells) so they can produce a custom signal that helps the immune system find and attack tumors. Investors watch these therapies because they promise targeted, fast-to-develop treatments and scalable manufacturing, but carry high research risk and regulatory uncertainty.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF MAY 2026
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K
On May 22, 2026, BioNTech SE announced that it will present new clinical data and trial updates from its late-stage oncology pipeline and innovative combination programs at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, IL, from May 29 to June 2. The press release is attached as Exhibit 99.1.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioNTech SE | ||||||||||||||
By: | /s/ Ramon Zapata-Gomez | By: | /s/ Dr. Sierk Poetting | |||||||||||
Name: Ramon Zapata-Gomez | Name: Dr. Sierk Poetting | |||||||||||||
Title: Chief Financial Officer | Title: Chief Operating Officer | |||||||||||||
Date: May 22, 2026
EXHIBIT INDEX
Exhibit | Description of Exhibit | ||||
99.1 | BioNTech to Showcase Progress Across Late-Stage Oncology Pipeline at the 2026 ASCO Annual Meeting | ||||
Exhibit 99.1
BioNTech to Showcase Progress Across Late-Stage Oncology Pipeline at the 2026 ASCO Annual Meeting
•Pumitamig data from the ongoing Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig in combination with chemotherapy
•Gotistobart Phase 2 overall survival data in patients with platinum-resistant ovarian cancer add to the growing body of evidence supporting its potential as a chemotherapy-free treatment option
•Continued advancement of late-stage oncology pipeline with 25+ Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials as well as novel-novel combination trials across major cancer types
MAINZ, Germany, May 22, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data and trial updates from its late-stage oncology pipeline and innovative combination programs at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting held in Chicago, from May 29 to June 02. Two oral presentations will highlight new data for key strategic assets pumitamig and gotistobart. In addition, four trial in progress poster presentations will illustrate advancement of the Company’s ongoing pivotal trials and novel-novel combination trials, including antibody-drug conjugates (“ADC”).
“Achieving more for patients with cancer through translating science into innovative therapies is our unwavering ambition at BioNTech,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “At this year’s ASCO, our presentations underscore our oncology strategy of building a diversified portfolio of complementary modalities delivering differentiated therapeutic profiles across tumor types with high unmet medical need. We are focused on accelerating key strategic programs, both as monotherapies and combinations with standard of care treatments, to deliver our first wave of oncology innovations to patients. Simultaneously, and building on this momentum, we are advancing novel-novel combination approaches, including ADC-based regimens, to unlock the full synergistic potential of our pipeline.”
Highlights of BioNTech’s late-stage oncology programs to be presented at ASCO 2026:
Pumitamig (BNT327/BMS986545) – an investigational bispecific immunomodulator combining PD-L1 checkpoint inhibition and VEGF-A neutralization, developed in collaboration with Bristol Myers Squibb Company (“BMS”):
•1L NSCLC: Data from the interim analysis of the Phase 2 dose-optimization part of the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) showed encouraging anti-tumor activity in first-line (“1L”) non-small cell lung cancer (“NSCLC”). The trial evaluated pumitamig plus chemotherapy in patients with non-squamous and squamous NSCLC without actionable genomic alterations and across PD-L1 expression levels. These data mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig plus chemotherapy, adding to the reported global data in small cell lung cancer and triple-negative breast cancer. The results inform the ongoing pivotal Phase 3 part of ROSETTA Lung-02 evaluating pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Updated data from a later cut-off date will be presented in a rapid oral presentation.
Gotistobart (BNT316/ONC-392) – an investigational tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”):
•PROC: Data from the Phase 2 PRESERVE-004 clinical trial (NCT05446298) evaluating gotistobart plus pembrolizumab in heavily pre-treated patients with platinum-resistant ovarian cancer (“PROC”) showed durable anti-tumor activity and clinically meaningful overall survival outcomes. Together with a manageable safety profile, the results add to the growing body of
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evidence supporting gotistobart’s potential as a chemotherapy-free treatment option, complementing the recently announced data in second and later line squamous non-small cell lung cancer.
BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel treatment combination approaches. With more than 25 Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials as well as novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early to late-stage conditions.
All abstracts are available on the ASCO website. Further information on BioNTech’s late-stage oncology portfolio can be accessed here.
Full presentation details:
Medicine | Abstract Title | Abstract Number/Presentation Details | ||||||
Pumitamig | Phase 2 data from ROSETTA Lung-02, a global randomized Phase 2/3 trial of pumitamig (PDL1 × VEGF-A bsAb) + chemotherapy in 1L NSCLC | Abstract #8513 Rapid Oral Abstract Session Lung Cancer - Non-Small Cell Metastatic May 30, 2026, 1:15 - 2:45pm CDT | ||||||
Phase 2/3 trial of pumitamig (PD-L1 ×VEGF-A bsab) plus chemotherapy versus bevacizumab plus chemotherapy in previously untreated, unresectable, or metastatic colorectal cancer (ROSETTA CRC-203) | Abstract #TPS3672 Poster Session Genitourinary Cancer - Prostate, Testicular, and Penile Poster Board: 229a May 31, 2026: 9:00am-12:00pm CDT | |||||||
Gotistobart | Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab | Abstract #5511 Rapid Oral Abstract session Gynecologic Cancer May 30, 2026: 8:00 - 9:30am CDT | ||||||
BNT326/YL202 | BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors | Abstract #TPS3160 Poster Session Developmental Therapeutics -Molecularly Targeted Agents and Tumor Biology Poster Board: 294b May 30, 2026: 1:30 - 4:30pm CDT | ||||||
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BNT324/DB-1311 | BNT324-03: A Phase 3, randomized, open-label trial of BNT324/DB-1311, a B7H3 ADC, versus docetaxel in patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC) | Abstract #TPS5137 Poster Session Genitourinary Cancer - Prostate, Testicular, and Penile Poster Board: 229a May 31, 2026: 9:00am - 12:00pm CDT | ||||||
Trastuzumab pamirtecan (BNT323/DB-1303) | Fern-EC-01 (BNT323-01): A phase 3 trial of trastuzumab pamirtecan (HER2 ADC) versus investigator’s choice of chemotherapy in patients with previously treated, HER2-expressing, recurrent endometrial cancer (EC) | Abstract #TPS5645 Poster Session Gynecologic Cancer Poster Board: 302b June 1, 2026: 9:00am - 12:00pm CDT | ||||||
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 multiple indications, the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in multiple indications, the investigational B7H3-targeted ADC BNT324/DB-1311 in metastatic castration-resistant prostate cancer, the investigational HER2-targeted ADC trastuzumab pamirtecan (BNT323/DB-1303) in recurrent endometrial cancer, and the investigational HER3-targeted ADC BNT326/YL202 as monotherapy and in combination with pumitamig in NSCLC and advanced solid tumors; 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.
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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; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; 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 March 31, 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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FAQ
What did BioNTech (BNTX) announce in its May 2026 Form 6-K?
BioNTech reported it will present new clinical data and trial updates from its late-stage oncology pipeline at the 2026 ASCO Annual Meeting. Highlights include key data for pumitamig, gotistobart, and several antibody-drug conjugate programs across multiple cancer types and trial stages.
Which key cancer drugs from BioNTech (BNTX) will feature at ASCO 2026?
BioNTech will showcase pumitamig, a PD-L1 × VEGF-A bispecific immunomodulator, and gotistobart, a CTLA-4–targeting candidate. Additional presentations cover HER3-, B7H3- and HER2-targeted antibody-drug conjugates, reflecting a diversified late-stage oncology portfolio across several solid tumor indications.
What are the main pumitamig data BioNTech (BNTX) is presenting at ASCO?
Interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer showed encouraging anti-tumor activity for pumitamig plus chemotherapy. These results help guide the ongoing pivotal Phase 3 comparison against pembrolizumab plus chemotherapy in this setting.
What does the gotistobart trial show for BioNTech (BNTX) in ovarian cancer?
Phase 2 PRESERVE-004 results in heavily pre-treated platinum-resistant ovarian cancer showed durable anti-tumor activity and clinically meaningful overall survival with gotistobart plus pembrolizumab. Combined with a manageable safety profile, the data support its potential as a chemotherapy-free treatment option.
How extensive is BioNTech’s (BNTX) late-stage oncology pipeline?
BioNTech states it has more than 25 Phase 2 and Phase 3 oncology trials underway, including 13 pivotal studies. These span next-generation immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies, using both monotherapies and novel combination approaches across major cancer types.
When and where will BioNTech (BNTX) present its ASCO 2026 oncology data?
Presentations will take place at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago, held from May 29 to June 2. BioNTech’s program includes two rapid oral presentations and multiple poster sessions covering lung, ovarian, prostate, endometrial, and advanced solid tumors.