corporate presentation biontech

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We are a global immunotherapy powerhouse aspiring to translate science into survival

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Our mission

We are committed to improving the health of people worldwide with our fundamental research and development of immunotherapies. We believe in scientific rigor, innovation and passion as driving force. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. 

Therapeutic Areas

We at BioNTech believe that the immune system is the fundamental driver for therapeutic success in cancer, and infectious diseases and other serious diseases. As immune engineers we have a deep understanding of the underlying mechanisms that enable the immune system to effectively recognize both external threats like infectious diseases and internal threats like cancer. Our goal is to translate this expertise into therapies and vaccines that can make a difference for individuals as well as humankind. 

Cancer is a devastating disease and remains a tremendous burden worldwide. As every cancer type is unique, we believe that immunology and immunotherapy should be able to address each cancer indication in a different way. Therefore, we have established a range of technology platforms and tools with the aim to develop the optimal treatment options for each tumor indication. 

Infectious Diseases

We believe the technology behind our COVID-19 vaccine has potential against a range of other infectious diseases. Our COVID-19 vaccine efforts have demonstrated several advantages over the traditional vaccine development that we aim to translate into new mRNA vaccine programs targeting diseases with a massive health burden such as malaria, tuberculosis and HIV.

Drug Classes

Our goal is clear: we want to provide better medicines for patients worldwide. Our toolbox includes a broad range of drug classes and platform technologies including mRNA-based therapies, cell therapies, small molecules as well as antibodies and other protein-based therapies. They can be utilized for specific purposes and have the potential to be combined with each other or with approved therapies in a synergistic manner. With this diversified approach, we aim to provide the optimal treatment for each patient.

mRNA Therapies

We use mRNA to deliver genetic information to cells, where it translates this genetic information into proteins for therapeutic effect. We are developing a portfolio of immunotherapies that use four mRNA formats and explore new formulations to develop innovative vaccines for the treatment of cancer and/or prevention of infectious diseases.

Engineered Cell Therapies

We are developing a range of novel cell therapies in which the patient’s T cells are modified to target cancer-specific antigens. These include two platforms for the treatment of solid tumors: chimeric antigen receptor (CAR) T cell therapies and T cell receptor (TCR) programs. We are also combining our mRNA FixVac platform with our first CAR T product candidates to enhance the persistence of CAR-T cells  in vivo .

Protein-based Therapeutics

We develop next-generation protein-based therapeutics across different formats, including mono- and bispecific antibodies and antibody-drug conjugates, with which we aim to address a range of tumor types through different mode of actions. We are also applying synthetic lysins as a potential new class of precision antibacterials that could be effective where established antibiotics have failed and could improve the standard of care across many types of bacterial infections.

Small Molecule Immunomodulators

We use small molecules to augment the activity of other drug classes by inducing specific and discrete patterns of immunomodulation. We are developing a small molecule toll-like receptor 7 (TLR7) immunomodulator for the treatment of solid tumors.

Clinical Trials

We strive to exploit the full potential of the body’s immune system by combining powerful new therapeutic mechanisms and a diverse array of biological targets to successfully help address cancer, infectious diseases and other serious diseases. As part of this mission, we are conducting clinical trials to translate science into survival.

Ongoing Trials

How trials work.

We have built a unique pipeline of investigational immunotherapies and vaccines based on multiple drug classes with the aim to achieve medical breakthroughs in oncology and infectious diseases. 

Careers at BioNTech

Our mission is clear: translating science into survival to improve the health of people worldwide. We are always on the lookout for dedicated and curious new talents supporting our team of visionaries, entrepreneurs, scientists, engineers and business professionals. Join us and be part of our unique pioneering spirit.

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Questions about our products, services or clinical trials? Find the right contact person at our Service Center.

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BioNTech SE An der Goldgrube 12 55131 Mainz, Germany

T: +49 6131 9084-0 F: +49 6131 9084-2121 M:  service@biontech.de

© 2024  BioNTech SE.  All rights reserved

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BioNTech gets $145 mln funding for African vaccine plants

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Jen reports on health issues affecting people around the world, from malaria to malnutrition. Part of the Health & Pharma team, recent notable pieces include an investigation into healthcare for young transgender people in the UK as well as stories on the rise in measles after COVID hit routine vaccination, as well as efforts to prevent the next pandemic. She previously worked at the Telegraph newspaper and Channel 4 News in the UK, as well as freelance in Myanmar and the Czech Republic.

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Reiterating Buy on BioNTech Amid Strategic Growth and Upcoming Catalysts

Robert Burns , an analyst from H.C. Wainwright, reiterated the Buy rating on BioNTech SE ( BNTX – Research Report ). The associated price target remains the same with $113.00.

Robert Burns has given his Buy rating due to a combination of factors including BioNTech’s recent strategic developments and the anticipation of upcoming catalysts. Despite the emergence of new COVID-19 variants, Burns does not foresee a significant increase in vaccination rates. This assessment is informed by the scheduled termination of the CDC’s Bridge Access Program, which will affect the availability of free vaccines to uninsured individuals, and the decreasing transparency in infection rates as hospitals ceased reporting confirmed COVID-19 cases as of April. Furthermore, the analyst considers the potential impact of the new variants on public health to be limited and thus does not expect a resurgence in vaccine demand to drive the company’s growth in the near term.

Additionally, BioNTech’s recent licensing agreement with MediLink Therapeutic to utilize the TMALIN antibody-drug conjugate (ADC) platform is seen as a positive strategic move. This deal, which includes significant potential milestone payments and royalties, expands BioNTech’s pipeline with several novel targets. Moreover, Burns highlights several near-term catalysts such as data presentations at upcoming conferences and results from various clinical trials that are expected to generate investor interest and potentially drive the stock’s performance. Based on these considerations, Burns reiterates a Buy rating with a 12-month price target of $113 per share, reflecting a positive outlook on BioNTech SE’s stock.

In another report released on May 24, Bank of America Securities also assigned a Buy rating to the stock with a $146.00 price target.

Based on the recent corporate insider activity of 7 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of BNTX in relation to earlier this year.

TipRanks tracks over 100,000 company insiders, identifying the select few who excel in timing their transactions. By upgrading to TipRanks Premium, you will gain access to this exclusive data and discover crucial insights to guide your investment decisions. Begin your TipRanks Premium journey today.

BioNTech SE (BNTX) Company Description:

BioNTech SE is a Germany-based biotechnology company that develops and manufactures immunotherapies for cancer, infectious diseases, allergies and autoimmune disorders.

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Covid vaccine maker BioNTech gets $145 mn funding for plant in Africa

A future african network could produce affordable vaccines to fight malaria, mpox, tuberculosis or other health threats, they added.

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Astrazeneca admits its covishield vaccine may lead to rare side effect, astrazeneca admits covishield has rare side effect: is concern warranted, world malaria day 2024: 10 signs and symptoms of malaria one should know, world malaria day 2024: history, significance, theme and more, serum institute of india to apply for licence of jn.1 covid variant vaccine, after encouraging q4, outlook positive for public sector insurer lic, dr lal pathlabs looks to go deeper in tier-3 towns; eyes m&a in south, trial to triumph: adani group firms echo message in latest annual reports, rbi imposes rs 36.38 lakh penalty on hsbc for violating fema regulations, varanasi, detroit, venice to host toyota's $9 mn sustainability initiative.

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First Published: May 29 2024 | 9:12 PM IST

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BioNTech SE

Us09075v1026, biotechnology & medical research.

• BioNTech : Corporate Presentation

This slide presentation includes forward-looking statements

Forward-Looking Statements

Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, includingthe Company's views with respect to the potential for mRNA therapeutics; the planned next steps in BioNTech's pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech's product candidates and expectations for data announcements with respect to BioNTech's product candidates; the development of commercial capabilities and the transition of BioNTech to a fully integrated biopharmaceutical company; its expectations with respect to interactions with regulatory authorities such as FDA and EMA, including the potential approval of BioNTech's or its collaborators' current or future drug candidates; expected royalty and milestone payments in connection with BioNTech's collaborations; BioNTech's anticipated cash usage for fiscal year 2020 and beyond; the creation of long-term value for BioNTech shareholders; the ability of BioNTech to successfully develop and commercialize a vaccine for COVID-19 in partnership with Pfizer and Fosun Pharma; the timing for any potential emergency use authorizations or approvals for BNT162; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including its production estimates for 2020 and 2021 and the impact of COVID-19 on our clinical trials and business operations, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "expects," "plans," "potential," "target," "continue" and variations of these words or similar expressions are intended to identify forward-looking statements. Such statements are based on the current beliefs and assumptions of the management team of BioNTech and on the information currently available to the management team of BioNTech, and are subject to change. The Company will not necessarily inform you of such changes. These forward looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause the Company's actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the Company's ability to discover and develop its novel product candidates and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates; actions of the Company's collaborators regarding continued product development and product commercialization; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical trials or the ability of the Company to obtain marketing authorization for its product candidates; the Company's ability to obtain, maintain and protect its intellectual property; the Company's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; competition from others using technology similar to the Company's and others developing products for similar uses; the Company's ability to manage operating expenses; the Company's ability to obtain additional funding to support its business activities and establish and maintain its existing and future collaborations and new business initiatives; the Company's dependence on collaborators and other third parties for development, manufacture, marketing, sales and distribution of products; the outcome of litigation; and unexpected expenditures. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements. The mRNA vaccines and other product candidates discussed in this slide presentation are investigational products being developed by BioNTech and its collaborators and are not currently approved by the FDA, EMA or any other regulatory authority.

Broad suite of novel technology platforms Immunotherapies for cancer and infectious diseases Fully integrated with in-house GMP manufacturing Industry-leading global collaborations

We collaborate with global leaders in our industry

University of Pennsylvania

1 50:50 Cost & Profit share refers to terms of Pfizer collaboration only (world-wide ex-China)

Broad progress in executing our multi-platform IO strategy

Engineered Cytokines

• First Phase 1/2 data from intratumoral mRNA in 2H 2020

• Ribocytokines to enter the clinic. in 2021

Potential for multiple blockbuster opportunities with powerful combinations

Compelling data generated from innovative immunotherapy approaches

 FixVac Melanoma (BNT111): Induces objective responses in CPI-experienced patients

Approved PD1-/PD-L1

mRNA Cancer

 iNeST (BNT122): Currently in Phase 2 in combination with CPI in 1L Melanoma. 2 adjuvant trials planned in 2020

 Ribocytokine IL-2 (BNT151): Amplification of vaccine induced T cell response in pre-clinical studies

Cell Therapies

 BNT211: Novel CLDN-6 CAR-T approach utilizing C AR-T A mplifying R NA Vac cine ( CARVac )

 Significant amplification of CAR-T cells in preclinical studies (published in Science, 2020)

A technology agnostic approach targets a broader addressable market

1 Tumor microenvironment

12 product candidates in 13 ongoing clinical trials

Data update phase 1 (BNT162b2) in Q3 2020

We intend to initiate up to five Phase 2 trials in 2020

1 BNT113 and BNT115 are currently being studied in investigator-initiated phase 1 trials; 2 Checkpoint Inhibitor; 3 Update on the ongoing study including patient enrollment number, efficacy and safety data for an interim update expected in the second half of 2021; 4 BNT122 (iNeST) is also being investigated in arm 2 (N=15) of the 3 arm TNBC-MERIT trial, with BNT114 as an optional treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC-MERIT trial (total patients in study: N=42); 5 As the trial is sponsored and conducted by Sanofi, the timing of data updates is not under our control, and is subject to change by Sanofi; 6 Small Molecule Immunomodulators

We plan to initiate FIH 1 trials for our preclinical product candidates across all platforms

CellTherapies

1 FIH = First in Human; 2 PRT = Protein Replacement Therapy; 3 We are eligible to receive worldwide licenses

Outlook for 2H 2020

HPV16+ H&N cancer triple negative breast cancer 1L melanoma with CPI NSCLC (adjuvant) CRC (adjuvant)

RO7198457 (BNT122) Start Phase 2 in 2H 2020

Start Phase 2 in 2H 2020

Intratumoral Immunotherapy

CAR-T Cells

Neoantigen-based T cell therapy

Next-Gen CP Immunomodulators

Infectious Diseases

Solid tumors

(IL-12sc, IL-15sushi, GM-CSF, IFN α )

multiple solid tumors (CLDN6) multiple solid tumors multiple solid tumors (PD-L1x4-1BB) COVID-19

Data update Phase 1/2 in 2H 2020 2

Start Phase 1/2 in 2H 2020

Expected newsflow / milestones:

• Phase 1 data for BNT162b2 COVID-19 vaccine and update from Phase 2b/3 trial as early as October 2020

• Data updates for 3 oncology trials (BNT114, 131, and 311)

• To initiate up to 4 randomized phase 2 trials for FixVac and iNeST

• To initiate up to 2 first-in-human phase 1 trials for our Engineered Cell Therapy product candidates

1 We expect this update to include an update on the ongoing study, including patient enrollment numbers, with full efficacyand safetydata for an interim update expectedin the second half of 2021; 2 As the trial is sponsored and conducted bySanofi, the timing of data updates is not under our control, and is subject to change bySanofi. 3 Our expectations for timingof milestones beyond 2020 are premisedon and subject to the achievement of earlier milestones on their expected timelines. Press releases will be issued once first patient has beendosed; 4 BNT122 (iNeST) is also being investigated in arm 2 (N=15) of the 3 arm TNBC-MERIT trial, with BNT114 as an optional treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC-MERIT trial (total patients in study: N=42);

Building a next generation immunotherapy company

Rapid progress in key pipeline programs in both oncology and infectious diseases

Multiple data read-outs & late-stage trial starts anticipated in 2H 2020

Expanded transatlantic operations with newly established R&D hub in Cambridge, U.S.

Strong momentum toward our vision of building a global immunotherapy company

Overview and business outlook

Deeper dive on our key programs

COVID- 19 vaccine program (project " Lightspeed ")

mRNA vaccines - FixVac and iNeST

Small Molecule Immunomodulators

CARVac platform - CLDN6 CAR-T

RiboCytokines

mRNA pharmaceuticals as pandemic vaccines

• Synthetic variants of naturally occuring genetic molecules

• Biochemically defined biopharmaceuticals

• High purity and free of animal product

• Inherent immune-activating qualities with no need for additional adjuvant

• Stimulates both antibody and T-cell immune response at low doses

• More than 400 patients dosed in cancer setting since 2013 (observing both safety and efficacy data)

• Highly scalable production with potential to manufacture hundreds of millions of doses

Genetic Information

Clinical Testing

Note : All future dates represented in graphic reflect anticipated timelines and are subject to clinical, technical, regulatory and manufacturing success

Status of COVID-19 vaccine program

SARS-CoV -2 Genetic Sequence Made public January 12, 2020

Initiated Project " Lightspeed "

Candidate selection

Animal Studies Toxicology Studies GMP manufacturing

Phase 1/2 Trials ongoing in Europe, U.S. and in China (started later in July) 4 vaccine candidates in the clinic > 500 subjects

Approximately 6 months to initiate Pivotal Trial

BNT162b2 selected as lead candidate for Phase 2b/3

1 Wrapp et al., Science, 2020

Receptor Binding Domain (RBD)

Spike Protein 3D Structure 1

Received Fast Track designation

Global BNT162 clinical development program Phase 1/2 ongoing

Phase 1/2 trials ongoing in Europe and US

• Evaluating safety, efficacy and optimal dose of 4 vaccine candidates

• Europe: Dose escalation part up to 200 healthy subjects aged 18 to 55

• US: Seamless study design with several thousand subjects; Initial dose-finding part up to 360 healthy subjects aged 18-85

• Dose range

• Single-dose and 2-dose regimens to be tested in initial trial

Between May 4, 2020 and June 19, 2020; 45 participants randomized and vaccinated in US study

Between April 23, 2020 and May 22, 2020; 60 participants randomized and vaccinated in German study

BNT162 Global collaborations

• Co-development and Co-commercialization worldwide (ex China) if approved

• Combined upfront payment and equity investment of $185 million to BioNTech received in April

• Capital expenditures to be funded by each party independently

• Companies to share development expenses and gross profits on a 50:50 basis

• BioNTech eligible to receive further development & sales milestones up to $563 million

• Co-development with Fosun Pharma to hold exclusive marketing rights in China if approved

• Combined upfront payment and equity investment of $51 million to BioNTech received in April

• Fosun Pharma to fund development expenses in China

• BioNTech and Fosun to share gross profits on the sale of the vaccine in China

• BioNTech eligible to receive further China development & sales milestones up to $84 million

Our mRNA vaccine platforms: FixVac and iNeST

• Off-the-shelf mRNA immunotherapy

• Fully individualized mRNA immunotherapy

• Targeting a fixed combination of shared antigens

 Non-mutated antigens shared among patients with a specific cancer type

 Applicable for almost all types of tumor antigens

• Targeting 20 neo-antigens unique to each patient  Vast majority of neo-antigens are unique to individual patients  Applicable across solid tumor types

• Proprietary RNA-LPX formulation for systemic dendritic cell targeting

• Strong immunogenicity observed in vivo via TLR7-driven adjuvant effect

• Potent induction of strong ex vivo CD4+ and CD8+ T cell responses

Kranz et al., Nature 2016

Our RNA-LPX vaccine approach

1 T cell responses analyzed by ex vivo multimer staining analysis in blood

BNT111 FixVac Melanoma: Planning to initiate randomized phase 2 trial

• Phase 1 trial data in CPI-experienced patients in monotherapy and in combination with anti-PD1

previously reported in July 2020 and published in Nature

• All patients showed tumor associated antigen (TAA) specific T cell responses with In vitro stimulation, and > 75% of patients showed immune responses against ≥ 1 TAA on an ex vivo basis

T cells responses ramped up over 4-8 weeks and increased or remained stable up to over one year with monthly maintenance therapy

• Reported durable clinical responses in monotherapy and in combination with anti-PD1 accompanied by high magnitude CD4+ and CD8+ response

• Signed strategic collaboration to jointly conduct randomized Phase 2 trial with BNT111 and Libtayo® (cemiplimab anti-PD-1 therapy)

• Targeting patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma

• Companies to share development costs equally and keep full commercial rights to own programs

• Plan to initiate potentially registrational Phase 2 trial by the end of 2020 - more details on anticipated trial design to be released in Q3

FixVac: BNT111 Interim clinical activity data in advanced melanoma

• Advanced melanoma patients (stage III, IV); dose range: 14µg -100µg

• Out of 74 patients with available follow-up radiological imaging 42 patients were assessed for preliminary analysis as of July 29, 2019

• of 25 patients with metastatic melanoma who received BNT111 m onotherapy following progression on CPI* and in some cases other therapies

 3 patients with partial response (PR)

 1 patient with metabolic complete response 1

 7 patients with stable disease (SD)

 14 progressive disease (PD)

• of 17 patients with metastatic melanoma who received BNT111 in com bination with CPI after progression on CPI monotherapy

 6 patients with partial response (PR)

 2 patients with stable disease (SD)

 9 progressive disease (PD)

• Adjuvant cohort of 32 patients still in study

*CPI: Checkpoint inhibitor; 1 based on 18 F-FDG-PET/CT analysis

Cumulative patient coverage of FixVac melanoma targets is over 90%

FixVac: BNT112 in Prostate Cancer

Antigen 1 PSA

Ph1/2: first patient enrolled in December 2019

• Multipronged vaccine: Targeted antigens of BNT112 are 5 prostate cancer specific antigens (PAP, PSA and 3 undisclosed antigens)

• RNA-LPX vaccine format validated by our FixVac Melanoma program

FixVac: a flexible format designed to be rapidly adapted for different tumors

Product candidate Preclinical Phase 1

Phase 2 with registrational potential start in 2H 2020

Individualized Neoantigen Specific Immunotherapy (iNeST)

Preclinical

• Targeting multiple neoantigens

• Intended to be a universal approach applicable for the majority of cancers

• 50:50 profit/loss share with Genentech

BNT121 (i.n.)

Data update

Trial progress update

BNT121: Interim clinical activity data

RNA vaccination

New Metastases

Stable Disease

Relapse free disease control

Sahin et. al. Nature 2017

Metastatic melanoma (N=13)

• First-in-human Phase 1 with 13 patients with melanoma stage IIIB, IIIC, and IV; intranodal delivery

• Immune responses against at least one neoantigen in all patients

• Cumulative rate of metastatic events significantly reduced, resulting in a sustained PFS

• 3 out of 5 pts with melanoma relapses developed treatment-related objective clinical responses

• One complete response (CR), relapse-free 26 mon

• One immunotherapy-related partial response (PR)

• One CR in combination with anti-PD1

• 8 patients (no detectable lesions at start) relapse free and recurrence-free for the whole follow-up (12 to 23 months)

iNeST: BNT122 recent AACR data update

• Data from ongoing Phase 1 trial in heavily pre-treated, PD-1 low patients across multiple tumor types

• Demonstrated ability to elicit significant T cell responses of both effector and memory phenotype as monotherapy and in combination (multiple patients with > 5% T cell response per neoepitope)

• Treatment-related adverse events were primarily transient systemic reactions, manifesting as low grade CRS, IRR or flu-like symptoms

• Initial signals of clinical activity observed in monotherapy dose-escalation cohort (1 CR, 12 SD)

Evaluation of BNT122 safety & feasibility with/without Tecentriq in > 10 indications

BNT122 induces CD8+ T cells in CPI-sensitive and CPI-insensitive tumor types BNT122 induces CD8+ T cell

Infiltrates in tumors

iNeST: BNT122 recent AACR data update, Phase 2 adjuvant trials planned

Phase 1a dose escalation: Monotherapy in locally advanced or metastatic solid tumors

Phase 1b combination with atezolizumab demonstrated clinical activity in heavily pretreated patients

• 31 patients enrolled, cohorts with doses ranging from 25-100ug

• Most common tumor types were HR+/HER2+ breast, prostate, and ovarian cancer

• Median of 5 lines of prior therapies (range 1-17)

• Most patients enrolled had low level of PD-L1 expression in tumor

• Neoantigen-specific T cell responses observed in peripheral blood in 86% of patients, significant T cell expansion and both naïve and memory activated phenotype

• Of 26 patients with at least one tumor assessment,

• 1 patient with gastric cancer and metastatic liver lesions had confirmed CR (ongoing for 10 months)

• 12 patients had SD

• Demonstrates ability to elicit significant T cell responses of both effector and memory phenotype as monotherapy and in combination

• Successfully manufacturing patient-specific oncology vaccines

• 132 patients enrolled, cohorts with doses ranging from 15- 50μg

• Heavily pre-treated patient population

• Both CPI experienced and inexperienced

• Most patients with low PD-1

• Clinical responses associated with T cell response, correlating immune profiling of patients' T cells to cancer -specific response

• Of 108 patients with at least one tumor assessment

• 1 patient had CR as best response (0.9%),

• 8 patients had PR (7.4%), and

• 53 patients had SD (49.1%)

Patient With TNBC (CPI experienced) Treated With RO7198457 (38 µg) +

Atezolizumab 1200 mg IV q3w

BV421 Multimer BV605 Multimer Post Treatment

Note: Patients in both cohorts received personalized product manufactured on per patient basis with up to 20 patient-specific neoantigens, in both cohorts majority of AEs were Grad 1 or Grade 2

BNT122 iNeST randomized Phase 2 trials ongoing and planned

First-Line Advanced

A Phase 2, open-label, multicenter randomized trial of the efficacy and safety of BNT122 in combination with pembrolizumab vs. pembrolizumab in patients with previously untreated Advanced Melanoma

• Evaluate added benefit of 1L BNT122 in an advanced CPI-sensitive tumor (PFS, ORR)

• Success ungates 1L use of iNeST in CPI-sensitive advanced cancers for combination therapy

Adjuvant Non-Small Cell

Lung Cancer

A Phase 2, open-label, multicenter, randomized trial of the efficacy and safety of BNT122 in combination with atezolizumab vs. atezolizumab alone following adjuvant platinum-doublet chemotherapy in patients who are ctDNA positive after surgical resection of Stage II-III NSCLC

• Evaluate added benefit of BNT122 in a micrometastatic CPI-sensitive tumor (RFS)

• Success ungates adjuvant use of iNeST in CPI-sensitive ctDNA+ cancer types

A Phase 2, open-label, multicenter randomized trial to compare the efficacy of BNT122 versus watchful waiting in patients with ctDNA positive, surgically resected Stage 2/3 rectal cancer, or Stage 2 high risk/stage 3 colon cancer

• Evaluate added benefit of BNT122 in a micrometastatic CPI-insensitive tumor (RFS)

• Success ungates adjuvant use of iNeST for CPI-insensitive ctDNA+ cancer types

Digitization and automation for neo-antigen vaccine manufacturing

Paperless documentation

Semi-automatic manufacturing

• 2 mRNA GMP production facilities: Idar-Oberstein (GMP since 2011) and Mainz (GMP since 2018)

• Construction and GMP licensure of new Mainz facility for iNeST expected in 2022/2023

• Partnered with Siemens to develop automated production processes

Bispecific Next-Gen CP immunomodulators and targeted cancer antibodies

BNT321: Ab targeting Cancer Associated Carbohydrate sLe a

• Potential "first -in- class" bispecific antibodies

• Conditional activation of immuno-stimulatory checkpoint activity

• 50:50 profit/loss share

• Both programs are now in the clinic

Product Candidate

BNT311 (GEN1046)

BNT312 (GEN1042)

Preliminary data

• 6 patients evaluated in combo with chemotherapy ― 4 / 6 met the criteria for PR and 2 / 6 met the criteria for SD ― BNT321 was generally well tolerated by all 6 patients

PET/CT imaging study with MVT-2163 (PET conjugated Ab version; 89 Zr-DFO-HuMab-5B1)

BNT321 (MVT-5873)

1 Engle et al, Science 2019: The glycan CA19-9 promotes pancreatitis and pancreatic cancer in mice CP:checkpoint;PR:partialresponse;SD:stabledisease

Next-Gen checkpoint immunomodulator: GEN1046 (BNT311)

Characteristics

• Bispecific antibody combining constitutive CPI blockade and conditional co-stimulatory activity

• Enhanced proliferation of antigen specific activated T cells in the presence of PD-L1+ cells

Mode of Action

PDL1 Blockade

41BB Agonism

T c e ll a c t iv a t io n

( f o ld in c r e a s e )

A n t i b o d y c o n c e n t r a t io n (  g /m L ) P D - L 1 x 4 - 1 B B

A n t i- P D - L 1 ( p a r e n t a l) T c e ll a c t iv a t io n

A n t ib o d y c o n c e n t r a t io n ( µ g /m L )

P D - L 1 x 4 - 1 B B

P D - L 1 x C o n tr o l

C o n t r o l x 4 - 1 B B A n ti-P D -L 1

Is o t y p e c o n t r o l

Preclinical antitumor activity beyond PDL1 blockade

Constitutive PD-L1 blockade & conditional 4-1BB agonism

*SITC 2018, Altintas et al

Increased tumor infiltrating lymphocyte (TIL) expansion in human tumor tissue cultures ex vivo

Induced tumor regression of murine tumors superior to pure PD-L1 blockage and is associated with an increase in tumor-specific CD8 T-cells

Bispecific antibody GEN1046 (BNT311): Phase 1/2a in solid tumors

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 (PD-L1x4-1BB) in subjects with malignant solid tumors

Intervention:

• GEN1046 (BNT311) is a PD-L1x4-1BB bispecific antibody that induces conditional activation of T cells through 4-1BB stimulation which is dependent on simultaneous binding to PD-L1

• GEN1046 (BNT311) IV once every 21 days

• Dose levels determined by the starting dose and the escalation steps taken in the trial

Description:

• Open-label safety trial

• Two parts, a dose escalation (phase 1, first-in-human) and an expansion part (phase 2a)

Key Primary endpoints:

• Dose limiting toxicity

• Adverse events

• Safety laboratory parameters

BNT411: initiated FIH Phase 1 trial for our TLR7 agonist in July 2020

• BNT411 is an intravenously administered small molecule TLR7 (toll-like receptor 7) agonist

• Engineered for high potency and high TLR7 receptor-selectivity at the therapeutically active dose range

• Activation of both adaptive and innate immune system has been observed, in particular in combination with cytotoxic therapies and CPIs

• Type 1 interferon-dominated release of cytokines and chemokines and potent stimulation of antigen-specific CD8+ T cells, B cells and innate immune cells such as NK cells and macrophages

• Expected to have therapeutic potential across various solid tumor indications

• Phase 1/2a clinical trial as a mono and combination therapy initiated in July 2020

Study design :

• Phase 1/2a, first-in-human, open-label, dose-escalation trial

• Evaluation of safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT411 as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC)

• Enrollment: ~60 participants

BNT211: Next generation CAR- T targeting CLDN6 with CARVac "primer"

CAR-T cell therapy + RNA Vaccine to amplify CAR-T cell in vivo

CLDN6 is not present in healthy tissues

CLDN6 is expressed in multiple cancers

Ovarian cancer Testicular tumor

Lung cancer

t o t a l f lu x [ p / s ]

R N A ( L I P ) v a c c in a t io n

C L D N 6 R N A (L IP )

c trl R N A (L IP )

d a y s p o s t A C T

Applicability shown for CLDN6, CLD18.2, CD19 CAR-T cells

RNA-lipoplex vaccine shown to enhance expansion & persistence of CAR-T

1 Reinhard et al, Science 2020: An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors

RiboCytokines: a novel therapeutic platform

The Concept

 Cytokines encoded by mRNA and produced in the patient

 Improved PK properties to improve tolerability and activity

 Cytokine design to improve immunological properties and tolerability

Therapeutic Goals

 Overcome resistance mechanisms by therapeutic synergy

 Improve activity of mRNA Vaccines

Worldwide rights; wholly owned

Pharmacokinetic Profile

Recombinant cytokine

RiboCytokine

RiboCytokines boosted activity of vaccination and PD-L1 blockade in mouse model

Vaccine + aPD-L1 (5mm 2 )

Vaccine + aPD-L1 (60mm 2 )

Percent survival

CT26 tumor model, vaccine antigen: gp70

Vaccine + aPD-L1 +

Dr. Sylke Maas

Vice President Investor Relations & Business Strategy

An der Goldgrube 12

55131 Mainz Germany

T: +49 6131 9084-1074

M: [email protected]

This is an excerpt of the original content. To continue reading it, access the original document here .

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BioNTech SE published this content on 12 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 September 2020 12:34:04 UTC

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BioNTech gains antibody drug conjugate platform license from Chinese biotech

• BioNTech ( NASDAQ: BNTX ) has inked a deal with China-based biotech MediLink Therapeutics to gain a license to the latter's antibody drug conjugate platform TMALIN.
• BioNTech will apply TMALIN to several novel targets of its choosing.
• Terms call for the German biotech to pay $25M upfront. MediLink is also eligible for additional milestone payments of up to $1.8B, as well as tiered royalties on potential sales.
• MediLink also has the right of first negotiation for future collaboration of these ADC product candidates if BioNTech licenses or assigns rights to ADC products in Mainland China or Hong Kong, Macau or Taiwan region.
• BioNTech ( BNTX ) and MediLink are not strangers. In October 2023, the German biotech paid $1.1B for global rights for the latter's HER3 antibody drug conjugate candidate BNT326/YL202.

More on BioNTech

• BioNTech: Undecided Between A One Trick Pony And A Full-Fledged Pharma Company
• New COVID FLiRT variants spike as FDA delays key vaccine meeting
• Moderna, BioNTech close with double-digit percentage gains amid bird flu fears
• BioNTech SE 2024 Q1 - Results - Earnings Call Presentation
• BioNTech SE (BNTX) Q1 2024 Earnings Call Transcript

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Biontech to present clinical data updates for next-generation immunotherapy candidates at the asco annual meeting 2024.

MAINZ, Germany, May 21, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected programs from the Company’s diversified immuno-oncology pipeline at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, Illinois, from May 31 to June 4, 2024. Moreover, in support of the Company’s ongoing CAR-T cell and individualized mRNA programs, BioNTech will also present epidemiological and real-world data from two observational studies in patient populations for which product candidates are being developed in the Company’s respective clinical programs.

“Our aim is to develop innovative treatment options across the continuum of cancer disease and establish new treatment paradigms that have the potential to address the fundamental challenges of treating cancer to drive meaningful improvements in the long-term survival rates for patients,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “The data from the interventional and observational studies that we will present at this year’s ASCO are of relevance for progress towards our goal as they will contribute to informing the direction of further development of several of our priority product candidates as well as the design of planned pivotal and later-stage clinical trials across all three key pillars of our diversified oncology pipeline, including novel immunomodulators, targeted therapies such as cell therapies and ADCs, and mRNA-based therapeutic cancer vaccines.”

Highlights of BioNTech’s updates to be presented at the ASCO Annual Meeting 2024:

Updates on several Phase 1b/2a trials investigating BNT327/PM8002 as a monotherapy in patients with solid tumors will be presented. BNT327/PM8002 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization to create a cycle of vascular normalization and immunostimulation in the microenvironment of the tumor. Two posters will provide clinical data updates for cohorts with advanced cervical cancer, platinum-resistant recurrent ovarian cancer and advanced non-small cell lung cancer (“NSCLC”). The product candidate is being developed in collaboration with Biotheus Inc. (“Biotheus”).

Initial results from the randomized, open-label, Phase 2 trial ( NCT05117242 ) with the bispecific antibody candidate BNT311/GEN1046 (acasunlimab) alone or in combination with pembrolizumab in patients with previously treated metastatic NSCLC (“mNSCLC”) will be presented. BNT311/GEN1046 combines PD-L1 checkpoint inhibition with 4-1BB costimulatory activation. The product candidate is being developed in collaboration with Genmab S/A (“Genmab”).

BioNTech will present preliminary data of an epidemiological study ( NCT04813627 ) that correlates post-operative circulating tumor DNA (“ctDNA”), a cancer biomarker for minimal residual disease, with disease-free survival in patients with colorectal cancer (“CRC”). This observational study provides supportive epidemiological and prognostic data for the ongoing interventional Phase 2 trial ( NCT04486378 ) with the individualized neoantigen-specific immunotherapy (“iNeST”) candidate autogene cevumeran (BNT122, RO7198457) in ctDNA-positive, high-risk stage II/stage III adjuvant CRC. Autogene cevumeran is jointly being developed by BioNTech and Genentech Inc. (“Genentech”), a member of the Roche Group.

BioNTech will present an analysis of real-world data that investigated the overall survival, treatment patterns and prognostic variables of patients with testicular germ cell tumors receiving palliative chemotherapy. This analysis will inform the design of BioNTech’s planned pivotal trial with the Company’s CAR-T cell therapy candidate BNT211 in patients with germ cell tumors. BNT211 combines an autologous CAR-T cell therapy candidate targeting the oncofetal antigen Claudin-6 (“CLDN6”) and an investigational CLDN6-encoding CAR-T cell amplifying RNA vaccine (“CARVac”).

BioNTech has established a diversified clinical oncology pipeline based on its modular multi-platform approach. The Company is advancing more than 20 clinical programs in unmet medical need solid tumor indications, including mRNA-based immunotherapies, targeted therapies entailing cell therapies and antibody-drug conjugates (ADCs), and novel immunomodulators. These candidates are currently being evaluated in more than 30 clinical studies, including nine programs in advanced Phase 2 trials and two candidates in pivotal Phase 3 trials. BioNTech is advancing key programs into late-stage development with the aim to have ten or more potentially registrational trials in its oncology pipeline by the end of 2024. The Company aims to launch its first cancer immunotherapy in 2026. By 2030, BioNTech plans to obtain approvals for a total of ten cancer indications across various drug classes.

The full abstracts will be available on the ASCO Annual Meeting website . Click here for further information on BioNTech’s pipeline candidates.

Full poster details:

Candidate : BNT327/PM8002 Session title : Lung Cancer—Non-Small Cell Metastatic Abstract Title : A Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients with advanced NSCLC Location: Hall A, Poster Board 397 Abstract Number : 8533 Date: Monday, June 3, 2024 Time: 1.30 PM-4.30 PM CDT

Candidate : BNT327/PM8002 Session title: Gynecologic Cancer Abstract Title : Efficacy and Safety of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients with Solid Tumors: Clinical Data from Advanced Cervical Cancer and Platinum-resistant Recurrent Ovarian Cancer Cohorts Location: Hall A, Poster Board 395 Abstract Number : 5524 Date: Monday, June 3, 2024 Time: 9.00 AM-12.00 PM CDT

Candidate : BNT326/YL202 Session title : Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Abstract Title : YL202/BNT326, a HER3-targeted ADC, in patients with locally advanced or metastatic non-small cell lung cancer and breast cancer: Preliminary results from a first-in human phase I trial Location: Hall A, Poster Board 179 Abstract Number : 3034 Date: Saturday, June 1, 2024 Time: 09:00 AM – 12:00 PM CDT

Candidate : BNT311/GEN1046 (acasunlimab) Session Title: Developmental Therapeutics—Immunotherapy Abstract Title : Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in combination with pembrolizumab (pembro) in patients (pts) with previously treated metastatic non-small cell lung cancer (mNSCLC): initial results of a randomized, open-label, phase 2 trial Location: Hall A, Poster Board 12 Abstract Number: 2533 Date: Saturday, June 1, 2024 Time: 9.00 AM-12.00 PM CDT

Candidate : Autogene cevumeran (BNT122, RO7198457) Session Title: Gastrointestinal Cancer—Colorectal and Anal Abstract Title : Preliminary results correlating post-operative ctDNA status with disease-free survival in Stage II (high risk) / III Colorectal Cancer Patients in the BNT000-001 epidemiology study Location: Hall A, Poster board 189 Abstract Number : 3526 Date: Saturday, June 1, 2024 Time: 1.30 PM-4.30 PM CDT

Candidate : BNT211 Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile Abstract Title : Real-world evidence of overall survival (OS) and treatment patterns of patients (pts) with testicular germ cell tumors (DCT) receiving palliative chemotherapy in the United States Location: Poster board 356 Abstract Number : 5038 Date: Sunday, June 2, 2024 Time: 9.00 AM – 12.00 PM CDT

About BioNTech Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are 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 Biotheus, DualityBio, 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 be 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 current and future preclinical studies and clinical trials in oncology, including the bispecific antibody candidates BNT311/GEN1046 (acasunlimab) in patients with mNSCLC and BNT327/PM8002 in patients with advanced cervical cancer, platinum-resistant recurrent ovarian cancer and advanced NSCLC, iNeST candidate autogene cevumeran (BNT122, RO7198457) in patients with colorectal cancer, the CAR-T cell candidate BNT211 in multiple solid tumor types, and the ADC candidate BNT326/YL202 in patients with locally advanced or metastatic NSCLC and breast cancer; 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; BioNTech’s ability to effectively scale BioNTech’s production capabilities and manufacture BioNTech’s products and BioNTech’s 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, 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 Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 [email protected]

Investor Relations Victoria Meissner, M.D. +1 617 528 8293 [email protected]

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BioNTech and CEPI expand deal to boost Africa’s vaccine capabilities

The initiative bolsters Africa's preparedness for future epidemic and pandemic threats.

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BioNTech and the Coalition for Epidemic Preparedness Innovations (CEPI) have announced an expansion of their strategic partnership, aiming to strengthen the mRNA vaccine ecosystem in Africa.

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CEPI will offer $145m to support BioNTech’s efforts in developing research and development, clinical and commercial-scale manufacturing capabilities for mRNA vaccines at the company’s facility in Kigali, Rwanda.

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This initiative bolsters Africa’s preparedness for future epidemic and pandemic threats.

BioNTech’s Kigali facility, inaugurated in December 2023, is based on the company’s BioNTainers – modular manufacturing units capable of producing various mRNA-based vaccines.

The Kigali manufacturing site is set to become the first commercial mRNA vaccine facility in Africa. It aligns with the African Union and Africa’s Centres for Disease Control and Prevention (CDC)’s ambitious goal to locally produce 60% of the vaccines required on the continent by 2040.

Under the expanded partnership, BioNTech will offer affordable access to its prophylactic vaccines produced in the Kigali unit, including potential vaccines against mpox, malaria and tuberculosis to low and middle-income countries.

It will also prioritise vaccine supply to African nations upon successful development and authorisation.

The deal also includes a commitment to jointly respond to outbreaks in Africa caused by known viral threats or new pathogens with epidemic or pandemic potential.

The collaboration supports BioNTech’s ongoing initiatives in three critical areas: commercial-scale production, clinical-scale manufacturing of new vaccine candidates, and bolstering the research and development ecosystem for mRNA-based vaccines in Africa.

BioNTech and CEPI initially signed a strategic partnership in September 2023.

BioNTech CEO and co-founder Professor Ugur Sahin said: “Our partnership with CEPI is an important next step in our comprehensive strategy towards sustainable mRNA vaccine manufacturing in Africa. Our joint efforts are strengthening the implementation of a local mRNA vaccine ecosystem – covering the entire spectrum from research and clinical trials to commercial production.

“This, along with our continued efforts to develop mRNA vaccines against diseases like tuberculosis, malaria, HIV and mpox is aimed at bringing lasting health benefits to millions of people in Africa.”

mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena)  is supported by Trilink . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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