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Last update 14 Nov 2025
Pumitamig
Last update 14 Nov 2025
Overview
Basic Info
Drug Type Bispecific antibody |
Synonyms BMS986545, BNT327, PM 8002 + [2] |
Target |
Action inhibitors |
Mechanism PDL1 inhibitors(Programmed death-ligand 1 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Breakthrough Therapy (China) |
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Structure/Sequence
Sequence Code 41637L
Source: *****
Sequence Code 1034049463H
Source: *****
Related
41
Clinical Trials associated with PumitamigNCT07221149
ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
Start Date09 Mar 2026 |
Sponsor / Collaborator |
NCT07221357
ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
Start Date04 Mar 2026 |
Sponsor / Collaborator |
NCT07173751
A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
Start Date01 Oct 2025 |
Sponsor / Collaborator  BioNTech SE [+1] |
100 Clinical Results associated with Pumitamig
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100 Translational Medicine associated with Pumitamig
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100 Patents (Medical) associated with Pumitamig
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88
News (Medical) associated with Pumitamig13 Nov 2025
This week, BioNTech presented the industry’s most in-depth look so far at
how PD-(L)1xVEGF bispecifics
are being developed in cancer at its R&D Day in New York City.
Following the event,
Endpoints News
sat down with two of the company’s co-founders, CEO Uğur Şahin and CMO Özlem Türeci. The discussion covered BioNTech’s partnership with Chinese biotech Biotheus on the experimental cancer drug pumitamig, how Şahin and Türeci measure success, and why BioNTech ultimately decided to buy out its partner.
Şahin and Türeci also talked about turning that buyout around into a $11 billion-plus licensing deal with Bristol Myers Squibb, an agreement that has the companies set to significantly compete in this new immuno-oncology space. The following interview has been edited substantially for length and clarity.
Max Gelman:
I wanted to start with the Biotheus buyout: Was there something that made you want to acquire it instead of just partnering? And how did that come about?
Uğur Şahin:
It was a combination of things. We had a great experience in the collaboration with Biotheus, and we learned relatively quickly that this is a very competent team. We also understood during the process that this asset (pumitamig) has really a huge opportunity, huge potential. And we wanted to ensure that we can control everything.
Özlem Türeci:
It was clear that we would proceed with the asset, and milestone payments would be an ongoing topic, and it was easier to buy Biotheus instead of pay that amount.
Gelman:
After the acquisition, you made a pretty quick licensing deal with Bristol Myers. Why was it important to do this quickly, and were there any other discussions with other potential partners?
Şahin:
It was because it was two sequential steps. Beginning in 2025, we realized this is really bigger than what we can do alone. We had already started preparation for three registrational trials, but going through the list of potential indications, we came up with 15 potential indications, and we were interested in combinations. We said, if we partner, one key reason is accelerating. Therefore, waiting until the end of 2025, or the beginning of 2026, was just too late.
Gelman:
At the beginning of 2025, was this realization something that happened because of the acquisition, or were you already starting to consider it earlier?
Şahin:
You can say this was a bold move to acquire the company. But at the end of the day, it was completely logical. What was also interesting is that in the first six months of 2025, more and more datasets matured, making it very clear that this is something which is a class of molecules.
Gelman:
Were there other interested parties who wanted to take a more slow, deliberate approach? Or was Bristol Myers’ ability to accelerate the deciding factor in finding a partner?
Şahin:
We were really interested in a foundational partnership, and during the conversation with BMS, it turned out that this partner really checked all the boxes. That does not mean that the other partners would not have qualified in the same way. But at the end of the day, you sign as you proceed, and BMS was just very quick.
Gelman:
How many companies did you end up talking to for a partnership?
Türeci:
No comment. (laughs)
Şahin:
Yeah, no comment. It was significant.
Gelman:
Is there a ballpark estimate you can say?
Şahin:
No, you’d have to define “talking to.” We had significant conversations, but not too many, really. If you take our criteria for a partnership, there are not that many that can fulfill that.
Gelman:
Okay, switching gears now. Can you contextualize these bispecifics with regard to immuno-oncology as a whole? Is this something that’s going to be the next frontier of I-O, or is it more seeing some exciting early data but maybe it doesn’t fully pan out, like
TIGIT
or
CD47
?
Türeci:
It is the next-gen I-O in a very broad sense, that’s how we view it. After the PD-1s and PD-L1s brought all this progress, the next question was, “What is the next-gen I-O?” The TIGIT molecules and so on were not the right thing because of the lack of the pan-tumor aspect. With this class now — and this is not only our opinion — it’s ripe for broad pan-tumor development, and could replace the first-generation PD-1s and PD-L1s.
Gelman:
Why do you feel that combinations are the most potent approach here?
Türeci:
In many indications, there’s a paradigm of combining the I-O with chemotherapy. When we say combine, that means with novel-novel combinations, we want to address these two components of a validated duo. It’s also not sufficient to have just an incremental benefit; it’s really about going beyond this incremental effect. This will be only feasible by combinations which are rationally designed and synergistic.
Gelman:
Is there a number that you would consider to be more-than-incremental, in terms of extending survival times?
Şahin:
It’s the hazard ratio, every hazard ratio which goes below 0.7 is significant. If you can get something which goes to 0.6 or 0.5, it’s transformative. But can we come into a cancer area where we see a stabilization of deaths? In most indications, we are ending up with 20, 30, 40% stability. And the question is, can you go higher? Can you create a stable stabilization at a higher level?
(Editor’s note: In oncology trials, hazard ratios measure the impact on survival times of an experimental drug, when compared to a placebo or control. For example, when looking at progression-free survival, a hazard ratio of 0.7 means the experimental drug improved the risk of disease progression or death by 30%, relative to the comparator. A hazard ratio of 0.6 equals a 40% improvement, 0.5 equals a 50% improvement, and so on.)
Gelman:
Would you consider, then, the 0.7 hazard ratio to be the benchmark for success for pumitamig’s studies?
Şahin:
Success is if you have a hazard ratio which is below 0.8 because, formally, you usually have two endpoints: progression-free survival and overall survival. For PFS, the bispecific class in many indications is in the range of 0.6 or 0.5 hazard ratio, and for OS, if you have a better disease control, this is already a success.
If you can combine that — a better OS reached in a fully powered clinical trial, and a hazard ratio below something like 0.8 — you would say, I have something new. So this is what we want to accomplish. But is it the end of what we want to accomplish? I don’t think so. In our view, it’s a beginning, bringing in a new backbone into immuno-oncology.
Gelman:
You’re testing pumitamig in triple-negative breast cancer, an area where other developers have not disclosed plans and where anti-VEGF therapy has not traditionally been used. How do you see pumitamig’s potential here?
Türeci:
This was already in the package when we started our cooperation with Biotheus. We have seen clear, compelling data in the Biotheus dataset. So this evidence, which we also published, was the reason why we moved ahead with TNBC.
Gelman:
Is there any irony you see in that you’re now competing with Pfizer after having developed the Covid-19 vaccine with them? This was one of the most fruitful pharma collaborations ever, and now in this next frontier of I-O, you’re competing against them.
Şahin:
No, it’s just likely that this happens. If you have such a compound that ultimately could become the next-generation compound, you will compete against the largest pharmaceutical companies. So therefore the likelihood is high that you compete against Pfizer as well.
(Editor’s note: Endpoints spoke with BioNTech on Tuesday. And on Thursday, Bloomberg reported that Pfizer is looking to sell its remaining stake in the biotech.)
VaccineAcquisitionLicense out/inImmunotherapy
12 Nov 2025
The competitive landscape for PD-(L)1xVEGF bispecifics is finally taking shape.
For the last couple years, much of the attention has focused on Summit Therapeutics and its lead drug ivonescimab. Now, two other challengers are revving their engines, setting up a race that may shape the future of immuno-oncology. If successful, the companies could bring new treatments to a plethora of cancer patients in the next decade.
The biggest impact will likely be in areas like colorectal cancer, where PD-(L)1 checkpoint inhibitors are not widely used and some experts
see untapped potential
. But each bispecific will also be attempting to replace those PD-(L)1 drugs, like Merck’s $30-billion-a-year blockbuster Keytruda, in certain cancers where they’ve long been the standard.
Summit’s first rival is the team of Pfizer and 3SBio, which
signed a licensing deal
for a PD-1xVEGF bispecific called SSGJ-707 earlier this year. Pfizer unveiled the first look at its clinical development plan in a
presentation with analysts
on Monday for the newly named PF’4404. Among other trials, that candidate will be in a Phase 3 study in first-line metastatic colorectal cancer and a Phase 3 non-small cell lung cancer study evaluating both squamous and non-squamous tumors.
Jeff Legos, Pfizer’s chief oncology officer, took note of the “substantial opportunity” in colorectal cancer on the analyst call. He also emphasized roughly 95% of colorectal cancer patients aren’t eligible to receive checkpoint inhibitors like Keytruda.
“These patients will be the focus of our planned ‘4404 Phase 3 studies in metastatic CRC,” Legos said.
The other main competitors, Bristol Myers Squibb and BioNTech, teamed up this past June for a deal worth up to $11.1 billion. The pair is advancing a PD-L1xVEGF program called pumitamig that BioNTech
acquired in its Biotheus buyout
. After Bristol Myers
outlined a suite of five mid- and late-stage studies
during an earnings call last month, BioNTech went further at its R&D Day on Tuesday and provided perhaps
the most in-depth look
at what’s coming next.
Beyond colorectal and triple-negative breast cancer — where other companies have not disclosed trial plans — BioNTech is looking at an amalgam of studies in difficult indications. That includes pancreatic cancer, ovarian cancer and glioblastoma, where BioNTech plans to start Phase 1 or Phase 2 studies in the coming years.
Both the Pfizer-3SBio and BMS-BioNTech groups are planning to use their respective pipelines at their disposal to create what they hope are potent combination therapies. Pfizer is planning on testing PF’4404 with the antibody-drug conjugates it got from Seagen,
Endpoints News
previously reported
, while BMS and BioNTech have flexibility in their deal to run studies combining pumitamig with experimental drugs in each of their portfolios.
For pumitamig, that will involve combo therapies with BioNTech’s in-house assets, as well as other partnered drugs from DualityBio, OncoC4 and MediLink, BioNTech CEO Uğur Şahin told Endpoints in an interview on Tuesday. Bristol Myers will also be able to run trials with pumitamig and some of its own pipeline programs.
“Both parties have the opportunity to develop, and even do registrational trials, with their own compound combinations,” Şahin said. “But both partners have also the ability to join into existing combination trials of the other party. So this is a really permissive approach for drug development, and does not rely on having to discuss everything and agree on every detail before you start something.”
Despite all the momentum this year, whether these development plans work may not be known for a while.
Summit plans to file for an ivonescimab approval in a certain form of non-small cell lung cancer, though the market size is estimated to be about just $500 million. Summit also
announced last month
it would start its own colorectal cancer trial and plot a course of combination therapy studies; enrollment in colorectal cancer is slated to start by the end of the year.
Meanwhile, the earliest Phase 3 pumitamig data from BMS-BioNTech are not expected until 2028. Additionally, results from the two PF’4404 Phase 3 trials Pfizer announced won’t come until
2029
or
2030
, according to the ClinicalTrials.gov database.
Although those data are a few years away, they are coincidentally timed to read out around when Keytruda will fall off-patent in 2028. (Merck also has its own PD-1xVEGF bispecific
partnership
with LaNova Medicines, but that program is in a much earlier stage of development — it just started a Phase 1 China trial last year.)
Other earlier-stage trials for PF’4404 may report results in the meantime, potentially giving the industry its first clues as to whether this new class of drugs can work outside lung cancer. Pfizer didn’t provide an exact timeline for data, saying only that Phase 1/2 studies in liver, urothelial and kidney cancers will start in 2026.
Pumitamig, however, will certainly have additional data by the time Keytruda falls off-patent. Phase 2 results in first-line lung cancer are expected next year, and a Phase 3 China study in triple-negative breast cancer should also read out in 2026.
Even though positive China data might not correlate to a similar result in Western patients — Summit
faced scrutiny
over this issue in its lung cancer studies — BioNTech executives are confident breast cancer can be different.
“We believe there should be no difference in other indications,” Ilhan Celik, VP of clinical development, said at the BioNTech R&D Day on Tuesday. “This will be, again, guided by the data, but there is no reason to believe that there are significant differences regarding the response and the efficacy. Safety, by the way, is also very similar.”
TD Cowen analyst Yaron Werber wrote in a note to investors Wednesday morning that the key for BioNTech will be ensuring it can stay on these timelines, particularly since most of the spaces they’re playing in are very competitive.
“There is a lot here to drive interest, but we note that the company has historically had some slippage of timelines (including global dose finding readouts for pumi) or outright attrition for pipeline assets,” Werber wrote. “Hence, we will be looking to see whether mgmt will be able to keep to the schedule they set forward.”
Editor’s note: This article has been updated to correct that the total value of BioNTech and Bristol Myers’ collaboration is $11.1 billion, not $10.6 billion.
License out/inPhase 3Phase 2Phase 1ADC
03 Nov 2025
Continued clinical execution of oncology strategy with focus on two pan-tumor programs, including combination approaches to address the full continuum of cancer from early to late disease stagesDemonstrated encouraging anti-tumor activity and manageable safety profile of pumitamig (BNT327/BMS986545), a bispecific antibody candidate targeting PD-L11 and VEGF-A, in first disclosed interim data from global Phase 2 trial in extensive-stage small cell lung cancer Plan to initiate additional pivotal trials for pumitamig in first-line microsatellite stable colorectal cancer and first-line gastric cancerLaunched variant-adapted COVID-19 vaccine for the 2025/2026 vaccination season in multiple regionsThird quarter 2025 revenues of €1.5 billion2, net loss of €28.7 million and basic and diluted loss per share of €0.12 ($0.143)Strengthened financial position to €16.7 billion in cash, cash equivalents and security investments4; received $1.5 billion payment from Bristol Myers Squibb (“BMS”) partnershipIncreased revenue guidance range of €2.6-2.8 billion and lowered expense guidance ranges for R&D to €2.0-2.2 billion, for SG&A to €550-650 million, and for capital expenditures for operating activities to €200-250 million5 Conference call and webcast scheduled for November 3, 2025, at 8:00 a.m. EST (2:00 p.m. CET) MAINZ, Germany, November 3, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three and nine months ended September 30, 2025 and provided an update on its corporate progress. “In the third quarter, we made substantial progress in executing against our oncology strategy. We advanced our priority pan-tumor programs, mRNA cancer immunotherapies and pumitamig. Simultaneously, we further broadened these programs to include evaluation of novel combinations with the aim to deliver differentiated or best-in-class therapeutic profiles,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “Our collaboration with Bristol Myers Squibb on pumitamig is already demonstrating the strength of this partnership, with multiple additional pivotal trials in preparation with pumitamig planned to start this and next year. This illustrates our commitment to delivering truly transformative options for patients in need.” Financial Review for Third Quarter and Year-to-Date 2025
in millions €, except per share data Third Quarter 2025 Third Quarter 2024 Year-to-date2025 Year-to-date2024Revenues 1,518.9 1,244.8 1,962.5 1,561.1Net profit / (loss) (28.7) 198.1 (831.1) (924.8)Basic earnings / (loss) per share (0.12) 0.82 (3.45) (3.83)Diluted earnings / (loss) per share (0.12) 0.81 (3.45) (3.83) Revenues for the three months ended September 30, 2025, were €1,518.9 million, compared to €1,244.8 million for the comparative prior year period. For the nine months ended September 30, 2025, revenues were €1,962.5 million, compared to €1,561.1 million for the comparative prior year period. The increases in both quarterly and year-to-date revenues compared to the prior year were primarily driven by revenues related to BioNTech’s collaboration with BMS that were recognized in the third quarter of 2025. This increase was partially offset by lower sales volumes of BioNTech’s COVID-19 vaccines. Research and development (“R&D”) expenses were €564.8 million for the three months ended September 30, 2025, compared to €550.3 million for the comparative prior year period. For the nine months ended September 30, 2025, R&D expenses were €1,599.5 million, compared to €1,642.4 million for the comparative prior year period. Year-to-date R&D expenses were mainly driven by the start of late-stage trials for immuno-oncology (“IO”) and antibody-drug conjugate (“ADC”) development programs and partly offset by cost savings resulting from active portfolio management. Sales, general and administrative (“SG&A”) expenses, in total, amounted to €148.5 million for the three months ended September 30, 2025, compared to €150.5 million for the comparative prior year period. For the nine months ended September 30, 2025, SG&A expenses were €406.5 million, compared to €466.9 million for the comparative prior year period. The year-to-date and quarter-to-quarter decreases were mainly driven by lower external costs, partially compensated by an ongoing commercial build-up. Other operating result amounted to negative €704.2 million during the three months ended September 30, 2025, compared to negative €354.6 million for the comparative prior year period. For the nine months ended September 30, 2025, other operating result amounted to negative €730.1 million compared to negative €616.9 million for the prior year period. The increase in other operating expenses compared to the third quarter of 2024 was primarily influenced by the settlement of a contractual dispute. Net loss was €28.7 million for the three months ended September 30, 2025, compared to a net income of €198.1 million for the comparative prior year period. For the nine months ended September 30, 2025, net loss was €831.1 million, compared to a net loss of €924.8 million for the comparative prior year period. Basic and diluted loss per share was €0.12 for the three months ended September 30, 2025, compared to a basic earnings per share of €0.82 and diluted earnings per share of €0.81 for the comparative prior year period. For the nine months ended September 30, 2025, basic and diluted loss per share was €3.45, compared to a basic and diluted loss per share of €3.83 for the comparative prior year period. Cash and cash equivalents plus security investments as of September 30, 2025, reached €16,704.9 million, comprising €10,092.9 million in cash and cash equivalents, €4,275.6 million in current security investments and €2,336.4 million in non-current security investments. Shares outstanding as of September 30, 2025, were 240,455,450, excluding 8,096,750 shares held in treasury. “The receipt of $1.5 billion from our partnership with Bristol Myers Squibb further underscores the strategic value of our collaborations not only in the long but also in the short term,” said Ramón Zapata, Chief Financial Officer at BioNTech. “We are increasing our 2025 full year revenue guidance to €2.6-2.8 billion. At the same time, we continue to optimize our cost base to support a sustainable development trajectory and ensure operational efficiency.” 2025 Financial Year Guidance5: FY Guidance March 2025 FY Guidance November 2025 Revenues for the 2025 financial year €1,700 - €2,200 million €2,600 - €2,800 million BioNTech has increased its previous revenue guidance and now expects its revenues for the full 2025 financial year to be in the range of €2,600 - €2,800 million. With regards to COVID-19 vaccine franchise, the guidance reflects the following assumptions: relatively stable COVID-19 vaccine pricing and market share as compared to 2024; inventory write-downs and other charges estimated to be approximately 15% of BioNTech’s share of gross profit from COVID-19 vaccine sales in Pfizer Inc.’s (“Pfizer”) territory; and anticipated revenues from a pandemic preparedness contract with the German government. Current and potential further developments in law, global public policy, international trade, and public sentiment as they continue to evolve could further impact the anticipated COVID-19 vaccine revenues and expenses. The revenue guidance also includes anticipated revenues from collaborations, and from the BioNTech Group service businesses. Planned 2025 Financial Year Expenses and Capex: FY Guidance March 2025 FY Guidance November 2025 R&D expenses €2,600 - €2,800 million €2,000 - €2,200 million SG&A expenses €650 - €750 million €550 - €650 million Capital expenditures for operating activities €250 - €350 million €200 - €250 million BioNTech has lowered expense guidance ranges for R&D, SG&A and capital expenditures for operating activities for the 2025 financial year. The Company expects to continuously focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to be a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and creating future value. The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended September 30, 2025, filed today with the United States Securities and Exchange Commission (“SEC”) and available at www.sec.gov. Endnotes1 An overview of target abbreviations is compiled in a directory at the end of this press release.2 All numbers in this press release have been rounded.3 Calculated applying the average foreign exchange rate for the three months ended September 30, 2025, as published by the German Central Bank (Deutsche Bundesbank).4 As of September 30, 2025. 5 Financial guidance excludes external risks that are not yet known and/or quantifiable, including, but not limited to, the effects of ongoing and/or future legal disputes and related activities, as well as certain potential one-time effects and charges related to portfolio prioritization. It includes effects identified from licensing arrangements, collaborations and M&A transactions to the extent disclosed and completed and may be subject to update. It excludes the effect of the announced transaction to acquire CureVac, which is ongoing. The Company does not expect to report a positive net income figure for the 2025 financial year. The Company’s approach to revenue recognition, including the amount and timing of revenues, is based on the facts and circumstances known to the Company and various other judgments, estimates, and assumptions that the Company believes to be reasonable under the circumstances. More information can be found in BioNTech’s Report on Form 6-K for the three and nine months ended September 30, 2025, filed today, and in BioNTech’s Report on Form 20-F for the year ended December 31, 2024 filed on March 10, 2025, both of which are available at www.sec.gov. Operational Review for the Third Quarter 2025, Key Post Period-End Events and OutlookVariant-adapted COVID-19 Vaccine In the third quarter of 2025, BioNTech and Pfizer executed the commercial launch of their variant-adapted COVID-19 vaccine for the 2025/2026 vaccination season. In July, BioNTech and Pfizer’s LP.8.1-adapted monovalent COVID-19 vaccine was approved by the European Commission following recommendation for marketing authorization by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). The companies began shipments of the vaccine to EU member states that ordered this formulation. In August, the U.S. Food and Drug Administration (“FDA”) approved the companies’ LP.8.1-adapted COVID-19 vaccine. Shipping of the vaccine began immediately to ensure timely availability of this season’s vaccine in pharmacies, hospitals, and clinics across the United States. Select Oncology Pipeline Updates Next-Generation Immunomodulators and Combinations Pumitamig (BNT327/BMS986545) is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with BMS. In September 2025, interim data from a global Phase 2 clinical trial (NCT06449209) evaluating pumitamig in combination with chemotherapy in patients with untreated extensive-stage small-cell lung cancer (“ES-SCLC”) were presented at the IASLC 2025 World Conference on Lung Cancer (“WCLC”). The data showed encouraging anti-tumor responses, with a positive trend in the secondary endpoint, progression free survival (“PFS”) and a manageable safety profile with no new safety signals and a low discontinuation rate. The clinical trial is fully enrolled and treatment is ongoing, including further cohorts evaluating pumitamig in combination with chemotherapy in patients with SCLC whose disease has progressed on first- or second-line treatment. A global Phase 3 clinical trial (ROSETTA Lung-01; NCT06712355) is being conducted to evaluate pumitamig as a first-line treatment in combination with chemotherapy compared to atezolizumab in combination with chemotherapy in patients with untreated ES-SCLC.A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is being conducted to evaluate pumitamig in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line non-small cell lung cancer (“NSCLC”). The Phase 2 part of the seamless Phase 2/3 trial achieved full enrollment and the Phase 3 portion is recruiting. A global Phase 2 clinical trial (NCT06449222) is being conducted to evaluate pumitamig in combination with chemotherapy as a first- and second-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (“TNBC”). Interim data from this clinical trial are planned to be presented at the San Antonio Breast Cancer Symposium (“SABCS”) in December. A global Phase 3 clinical trial in patients with first-line TNBC (ROSETTA Breast-01; NCT07173751) is planned to start by the end of 2025.Additional pivotal Phase 2/3 clinical trials for pumitamig in first-line microsatellite stable colorectal cancer (“CRC”) (ROSETTA CRC-203; NCT07221357) and first-line gastric cancer (ROSETTA GI-204; NCT07221149) are planned. In the last quarter, BioNTech initiated several signal-seeking clinical trials to evaluate pumitamig with the Company’s proprietary assets: In August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07079631) to evaluate BioNTech and Genmab AS’s (“Genmab”) bispecific antibody candidate BNT314/GEN1059 in combination with pumitamig and chemotherapy in patients with advanced CRC.Also in August, the first patient was dosed in a Phase 1/2 clinical trial (NCT07070232) to evaluate pumitamig in combination with BioNTech and MediLink Therapeutics’ (“MediLink”) HER3 ADC candidate BNT326/YL202 and BNT326/YL202 as monotherapy in advanced solid tumors. In September, the first patient was dosed in a Phase 1/2 clinical trial (NCT07147348) to evaluate BNT3212, a novel bispecific ADC candidate targeting EGFR and HER3, as monotherapy and in combination with pumitamig in patients with advanced solid tumors.In October, the first patient was dosed in a Phase 1/2 clinical trial (NCT07111520) to evaluate BioNTech and MediLink’s BNT326/YL202 in combination with pumitamig in advanced NSCLC. Antibody-Drug Conjugates Trastuzumab pamirtecan (BNT323/DB-1303) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd.’s (“DualityBio”). A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate trastuzumab pamirtecan in patients with advanced HER2-expressing tumors. A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with recurrent endometrial cancer is ongoing. Data are expected to be shared at a medical conference in 2026. BioNTech and DualityBio continue discussions with the FDA and now plan to file a biologics license application (“BLA”) in 2026, subject to regulatory feedback. In September, the first patient was dosed in a global Phase 3 clinical trial (NCT06340568) to evaluate trastuzumab pamirtecan in patients with advanced endometrial cancer.Also in September, BioNTech and DualityBio announced that the pivotal Phase 3 clinical trial (NCT06265428) which DualityBio is conducting in China to evaluate trastuzumab pamirtecan versus trastuzumab emtansine (“T-DM1”) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy met its primary endpoint of PFS at a pre-specified interim analysis. A global Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337) for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer is ongoing. Data are expected in 2026. BNT325/DB-1305 is a TROP2-targeted ADC candidate that is being developed in collaboration with DualityBio. A Phase 1/2 clinical trial (NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing. In October, data from this trial in patients with pretreated TNBC were presented at the European Society For Medical Oncology (“ESMO”) Congress 2025. Data showed encouraging anti-tumor activity and a manageable safety profile. mRNA Cancer Immunotherapies Autogene cevumeran (BNT122/RO7198457) is an mRNA cancer immunotherapy candidate for individualized neoantigen-specific immunotherapy (“iNeST”) that is being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group (“Roche”). In October, data from a randomized Phase 2 clinical trial (IMCODE001; NCT03815058) evaluating the efficacy and safety of autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone as a potential first-line treatment for patients with previously untreated advanced melanoma were presented at the 2025 ESMO Congress. While, as previously disclosed, the trial did not meet its primary efficacy endpoint of statically significant improvement of PFS in this advanced and aggressive tumor type, a numerical trend favoring the combination arm in overall survival (“OS”) and PFS was observed, with the breadth of immune response correlating with a prolonged PFS in the combination arm. Autogene cevumeran induced and expanded high-magnitude and durable immune responses against the encoded neoantigens that persisted for up to 1.5 years after treatment completion. The combination of autogene cevumeran with PD-L1 checkpoint blockade was well tolerated and adverse events were consistent with the known safety profiles of the individual trial treatments, with no new safety signals observed. BNT111 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and encodes four melanoma-associated antigens. In October, data from a randomized Phase 2 clinical trial (BNT111-01; NCT04526899) conducted in collaboration with Regeneron Pharmaceuticals Inc. (“Regeneron”) to evaluate BNT111 in combination with cemiplimab in patients with anti-PD-(L)1 refractory/relapsed, unresectable Stage III or IV melanoma were presented at the 2025 ESMO Congress. As previously disclosed, the trial met its primary endpoint demonstrating statistically significant improvement in objective response rate (“ORR”) in patients treated with BNT111 in combination with cemiplimab, as compared to an historical control. The data showed that the combination of BNT111 and cemiplimab induced anti-tumor responses that were deep and durable and a manageable safety profile for BNT111 as a single agent and in combination. BNT116 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and is designed to elicit an immune response to six tumor-associated antigens that were identified to be frequently expressed in NSCLC. A Phase 1 clinical trial (LuCa-MERIT-1; NCT05142189) is being conducted to evaluate BNT116 as monotherapy and in several treatment combinations, including with chemotherapy, cemiplimab, and BioNTech’s proprietary assets across various treatment lines and clinical settings in patients with NSCLC. In September, data were presented at the IASLC 2025 WCLC from a cohort evaluating BNT116 in combination with cemiplimab as consolidation treatment in patients with NSCLC after receiving concurrent chemoradiotherapy. BNT116 in combination with cemiplimab demonstrated encouraging event-free and overall survival rates and a manageable safety profile. Corporate Update for the Third Quarter 2025 In October, BioNTech and InstaDeep Ltd. (“InstaDeep”), its artificial intelligence (“AI”) subsidiary, hosted their second AI Day live event in London, United Kingdom, as part of their Innovation Series. BioNTech showcased its AI strategy, capabilities as well as scaling and deployment across its pipeline with a focus on personalized cancer immunotherapies and precision medicines Upcoming Investor and Analyst Events Innovation Series R&D Day: November 11, 2025, in New York City, United States, with the option to join via webcast.Fourth Quarter and Full Year 2025 Financial Results and Corporate Update: March 10, 2026 Conference Call and Webcast Information BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, November 3, 2025, at 8:00 a.m. EST (2:00 p.m. CET) to report its financial results and provide a corporate update for the third quarter of 2025. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided. The slide presentation and audio of the webcast will be available via this link. Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor section of the Company’s website at www.BioNTech.com. A replay of the webcast will be made available shortly after the closing of the call and archived on the Company’s website for 30 days following the call. About BioNTechBiopharmaceutical 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 Bristol Myers Squibb, 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. Forward-Looking StatementsThis 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: BioNTech’s expected revenues and net profit/(loss) related to sales of BioNTech’s COVID-19 vaccine in territories controlled by BioNTech’s collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech’s partners; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine and, if approved, BioNTech’s investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs, including BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or clinical trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements, including BioNTech’s partnership with Bristol Myers Squibb; BioNTech’s planned acquisition of CureVac; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech’s preclinical and clinical operations; BioNTech’s expectations with respect to developments in law, public policy, and international trade; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; BioNTech’s expectations regarding upcoming payments relating to litigation settlements; BioNTech’s expectations for upcoming scientific and investor presentations; and BioNTech’s expectations of net profit/(loss). 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; BioNTech’s pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or annual booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; 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; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; 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 BioNTech’s COVID-19 vaccine and, if approved, its product candidates; 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 September 30, 2025 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 Investor RelationsDouglas Maffei, PhDInvestors@biontech.de Media RelationsJasmina AlatovicMedia@biontech.de Target Overview B7-H3Also known as CD276, cluster of differentiation 276EpCAMEpithelial cell adhesion moleculeHER2 (or HER3)Human epidermal growth factor receptor 2 (or 3)HRHormone ReceptorPD-(L)1Programmed cell death protein (death-ligand) 1TROP2Trophoblast cell-surface antigen 2VEGF-AVascular endothelial growth factor A Interim Condensed Consolidated Statements of Profit or Loss
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024(in millions €, except per share data) (unaudited) (unaudited) (unaudited) (unaudited)Revenues 1,518.9 1,244.8 1,962.5 1,561.1Cost of sales (148.3) (178.9) (308.5) (297.8)Research and development expenses (564.8) (550.3) (1,599.5) (1,642.4)Sales and marketing expenses (27.3) (18.1) (60.7) (46.6)General and administrative expenses (121.2) (132.4) (345.8) (420.3)Other operating expenses (729.5) (410.9) (884.7) (719.9)Other operating income 25.3 56.3 154.6 103.0Operating profit / (loss) (46.9) 10.5 (1,082.1) (1,462.9)Finance income 96.8 156.2 324.8 498.8Finance expenses (25.2) (8.0) (66.1) (14.8)Profit / (Loss) before tax 24.7 158.7 (823.4) (978.9)Income taxes (53.4) 39.4 (7.7) 54.1Net profit / (loss) (28.7) 198.1 (831.1) (924.8)Earnings / (Loss) per share
Basic earnings / (loss) per share (0.12) 0.82 (3.45) (3.83)Diluted earnings / (loss) per share (0.12) 0.81 (3.45) (3.83) Interim Condensed Consolidated Statements of Financial Position
September 30, December 31, (in millions €) 2025 2024Assets (unaudited) Non-current assets
Goodwill 357.7 380.6Other intangible assets 1,389.8 790.4Property, plant and equipment 1,039.7 935.3Right-of-use assets 201.0 248.1Contract assets 3.9 9.8Other financial assets 2,476.0 1,254.0Other non-financial assets 24.6 26.3Deferred tax assets 17.7 81.7Total non-current assets 5,510.4 3,726.2Current assets
Inventories 225.7 283.3Trade and other receivables 690.8 1,463.9Contract assets 8.9 10.0Other financial assets 4,434.7 7,021.7Other non-financial assets 292.9 212.7Income tax assets 84.8 50.0Cash and cash equivalents 10,092.9 9,761.9Total current assets 15,830.7 18,803.5Total assets 21,341.1 22,529.7
Equity and liabilities
Equity
Share capital 248.6 248.6Capital reserve 1,453.2 1,398.6Treasury shares (8.1) (8.6)Retained earnings 18,266.9 19,098.0Other reserves (1,483.3) (1,325.5)Total equity 18,477.3 19,411.1Non-current liabilities
Lease liabilities, loans and borrowings 192.0 214.7Other financial liabilities 96.4 46.9Provisions 24.2 20.9Contract liabilities 219.0 183.0Other non-financial liabilities 85.5 87.5Deferred tax liabilities 24.2 42.4Total non-current liabilities 641.3 595.4Current liabilities
Lease liabilities, loans and borrowings 53.4 39.5Trade payables and other payables 399.8 426.7Other financial liabilities 597.4 1,443.4Income tax liabilities 6.3 4.5Provisions 211.5 144.8Contract liabilities 796.1 294.9Other non-financial liabilities 158.0 169.4Total current liabilities 2,222.5 2,523.2Total liabilities 2,863.8 3,118.6Total equity and liabilities 21,341.1 22,529.7 Interim Condensed Consolidated Statements of Cash Flows
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024(in millions €) (unaudited) (unaudited) (unaudited) (unaudited)Operating activities
Net profit / (loss) (28.7) 198.1 (831.1) (924.8)Income taxes 53.4 (39.4) 7.7 (54.1)Profit / (Loss) before tax 24.7 158.7 (823.4) (978.9)Adjustments to reconcile loss before tax to net cash flows:
Depreciation, amortization and impairment of property, plant, equipment, intangible assets and right-of-use assets 124.2 44.4 218.0 132.6Share-based payment expenses 27.9 40.9 82.1 77.4Net foreign exchange differences (24.1) (35.5) 36.4 (77.4)(Gain) / Loss on disposal of property, plant and equipment (1.3) — (1.7) (0.2)Finance income excluding foreign exchange differences (96.8) (156.2) (324.8) (498.8)Finance expense excluding foreign exchange differences 2.6 5.3 17.1 14.8Government grants (10.5) (14.6) (43.5) (26.8)Other non-cash (income) / loss — — (15.0) —Unrealized (gain) / loss on derivative instruments at fair value through profit or loss 15.7 (6.0) (12.9) 0.7Working capital adjustments:
Decrease / (Increase) in trade and other receivables, contract assets and other assets 881.7 (830.2) 1,002.7 1,267.6Decrease in inventories 5.1 37.0 61.7 54.6(Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions (242.8) 117.9 (299.2) 590.7Interest received and realized gains from cash and cash equivalents 83.5 73.1 275.2 353.3Interest paid and realized losses from cash and cash equivalents (2.4) (1.6) (8.2) (6.9)Income tax received / (paid), net (9.6) 1.6 (36.7) (190.8)Share-based payments (4.2) (134.4) (19.3) (143.6)Government grants received 7.0 60.7 38.0 102.7Net cash flows from / (used in) operating activities 780.7 (638.9) 146.5 671.0Investing activities
Purchase of property, plant and equipment (35.9) (72.8) (111.9) (219.9)Proceeds from sale of property, plant and equipment 2.9 0.3 3.9 0.5Purchase of intangible assets (2.7) (10.2) (575.0) (141.3)Acquisition of subsidiaries and businesses, net of cash acquired — — (78.5) —Investment in other financial assets (2,869.0) (2,958.2) (7,046.7) (10,301.5)Proceeds from maturity of other financial assets 1,979.4 2,898.8 8,065.3 7,974.3Net cash flows from / (used in) investing activities (925.3) (142.1) 257.1 (2,687.9)Financing activities
Repayment of loans and borrowings (1.2) — (9.4) (2.3)Payments related to lease liabilities (10.3) (7.9) (29.2) (36.3)Net cash flows used in financing activities (11.5) (7.9) (38.6) (38.6)Net increase / (decrease) in cash and cash equivalents (156.1) (788.9) 365.0 (2,055.5)Change in cash and cash equivalents resulting from exchange rate differences (21.5) (2.3) (28.4) 1.2Change in cash and cash equivalents resulting from other valuation effects 1.0 39.1 (5.6) 15.2Cash and cash equivalents at the beginning of the period 10,269.5 10,376.7 9,761.9 11,663.7Cash and cash equivalents as of September 30 10,092.9 9,624.6 10,092.9 9,624.6
Phase 2VaccinePhase 3Financial StatementClinical Result
100 Deals associated with Pumitamig
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Adenocarcinoma of Esophagus | Phase 3 | United States | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | United States | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | China | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | China | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | Japan | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | Japan | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | Argentina | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | Argentina | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | Australia | 09 Mar 2026 | |
| Adenocarcinoma of Esophagus | Phase 3 | Australia | 09 Mar 2026 |
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Clinical Result
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1/2 | Advanced breast cancer HER2-expressing | HER2-null | HR+ or - | 320 | xoykbrvupj(ktltprfhay) = rhihbhrnbf ncuzueyhpc (yyninuhfir ) | Positive | 17 Oct 2025 | ||
NCT06449209 (WCLC2025) Manual  | Phase 2 | Extensive stage Small Cell Lung Cancer First line | 43 | Total | uewcldtdgt(vtqmiuvfse) = cehumznadv ojvkdnmbin (amadyptked ) View more | Positive | 09 Sep 2025 |
uewcldtdgt(vtqmiuvfse) = swcygznuun ojvkdnmbin (amadyptked ) View more | |||||||
Phase 2 | Extensive stage Small Cell Lung Cancer First line | 43 | hftzrzjvcx(fzyyogbuxx) = ewbjwmtmiz fdkwyttyfn (iisgfukire ) View more | Positive | 08 Sep 2025 | ||
(Pumitamig 20 mg/kg) | hftzrzjvcx(fzyyogbuxx) = kdianogjos fdkwyttyfn (iisgfukire ) View more | ||||||
NCT05918107 (ASCO2025) Manual | Phase 2 | Mesothelioma, Malignant First line | 31 | BNT327 + Chemotherapy (unresectable malignant mesothelioma) | cfzsfujaya(vpqjqzqvnp) = jymrybeiwk icgqlxkuyg (mgtlvtwoqm ) View more | Positive | 30 May 2025 |
BNT327 + Chemotherapy (unresectable malignant mesothelioma + epithelioid histology) | cfzsfujaya(vpqjqzqvnp) = cydwtuboru icgqlxkuyg (mgtlvtwoqm ) View more | ||||||
NCT05438329 (AACR2025) Manual | Phase 1/2 | 8 | hojqklvoyd(dvsrbeuahu) = Stomatitis was reported in 6/8 patients (Grade 3 in 2 patients), which led to a dose reduction of BNT325 in 3 patients dbnfvsckxn (oohtulsvgj ) View more | Positive | 27 Apr 2025 | ||
Phase 2 | Extensive stage Small Cell Lung Cancer First line | 50 | BNT327 30 mg/kg + Platinum-Etoposide | mpctcewelr(drqgmzsjel) = rkcotplbfj zmmnvhwpkb (ukpqrquwmp ) View more | Positive | 26 Mar 2025 | |
Phase 2 | 70 | BNT327 + Paclitaxel | dneiacoxsj(vjlhzyscxb) = oknwtxcxkk ljabbpwjax (qhnvmepaxx, 29.4 - 54.4) View more | Positive | 26 Mar 2025 | ||
NCT05918133 (SABCS2024) Manual | Phase 1/2 | Triple Negative Breast Cancer First line | 42 | zrrazdqomi(llanrazgqg) = istqdijrrz tclqnmdquh (kaszbrdifw ) View more | Positive | 10 Dec 2024 | |
Phase 1/2 | 42 | lwecsbnrfb(tghnraglin) = ksqpnlxlsb bqcdutzsam (kxxlqmdjcw, 63.2 - 89.7) View more | Positive | 16 Sep 2024 | |||
NCT05918445 (ESMO2024) Manual | Phase 1/2 | Advanced Renal Cell Carcinoma Second line | 53 | PM8002/BNT-327 | ngfylmtviv(cagtsowtse) = ffglxcwuiy pzjzsjfxuj (fishkdtnar ) View more | Positive | 15 Sep 2024 |
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