BioNTech SE is at the forefront of immunotherapy, focusing on harnessing the immune system to combat cancer and infectious diseases. The company employs a variety of innovative technologies, including mRNA-based therapies, engineered cell therapies, and protein-based therapeutics. Their mRNA platforms are particularly noteworthy, as they utilize optimized uridine mRNA (uRNA) to deliver genetic information that instructs cells to produce proteins for therapeutic effects. This approach is central to their cancer vaccine platforms, such as FixVac, which targets specific tumor antigens to activate the immune response against cancer cells. Additionally, BioNTech's individualized mRNA cancer vaccines (iNeST) are designed to tailor treatments to the unique mutations present in a patient's tumor, further enhancing the precision of their therapies.

In the realm of infectious diseases, BioNTech's mRNA vaccine technology has gained significant attention, especially following the success of their COVID-19 vaccine. Their platform is designed to train the immune system to recognize and respond to pathogens effectively, utilizing nucleoside-modified mRNA (modRNA) to improve stability and reduce unwanted immune reactions. Beyond COVID-19, BioNTech aims to apply this technology to other infectious diseases, including malaria and tuberculosis. The company is also exploring bispecific antibodies and cytokine therapies through their RiboMab and RiboCytokine platforms, respectively, which aim to enhance the immune response against both cancer and infectious diseases. Overall, BioNTech's diverse technological portfolio positions it as a leader in the development of next-generation immunotherapies.

Germany

BioNTech is a global next generation immunotherapy company aspiring to translate science into survival. Around 6.100 pioneers currently work with us, employing a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Our 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 our deep expertise in mRNA vaccine development and in-house manufacturing capabilities, we are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. 

To learn more about us, please visit www.BioNTech.com. 

Our privacy statement can be found here:  https://www.biontech.com/int/en/home/data-privacy-statement.html 

Our imprint can be found:
https://www.biontech.com/int/en/home/imprint.html

Cancer

Immune System Diseases

Infectious Diseases

Lung Diseases

Skin Diseases

Urogenital Diseases

BioNTech SE

COVID-19

Infectious disease

BNT162b2, encodes the SARS-CoV-2 full-length spike, &nbsp;modified by two proline mutations to lock it in the prefusion &nbsp;conformation9 and more closely mimic the intact virus with which the &nbsp;elicited virus-neutralizing antibodies must interact.10 
<a href="https://www.nejm.org/doi/10.1056/NEJMoa2027906">SOURCE&nbsp;</a>

COMIRNATY (BNT162b2)

Breast cancer

BNT323 (DB-1303) is a third-generation, topoisomerase-1 inhibitor-based antibody-drug conjugate directed against Human Epidermal Growth Factor Receptor 2 (“HER2”). HER2 is often overexpressed in various tumors, contributing to aggressive growth, and spreading of cancer cells. BNT323 (DB-1303) exhibited potent antitumor activity in both HER2 positive and HER2 low tumor models with a favorable safety profile and a potentially expanded therapeutic window. The DB-1303 program received the Fast Track designation from the U.S. Food and Drug Administration (“FDA”) and is currently in a Phase 2 clinical trial for HER2-expressing advanced solid tumors.

BNT323/DB-1303

Influenza

Combined modified mRNA vaccine (Influenza A/B + COVID-19)

Endometrial cancer

HER2-expressing cancers

BNT323/DB-1303 is an ADC candidate targeting Human Epidermal Growth Factor 2 (“HER2”) that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”). The program has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors.
 
A potentially registrational cohort is enrolling HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with advanced/recurrent endometrial carcinoma and aims to recruit 140 patients. A confirmatory Phase 3 trial (NCT06340568) in this patient population is planned to start in 2024.

Melanoma

BNT111 is the most advanced of five clinical stage FixVac product &nbsp;candidates within BioNTech’s broader development pipeline. It is an mRNA &nbsp;cancer immunotherapy targeting four antigens frequently expressed in &nbsp;the tumors of patients with melanoma – NY-ESO-1, MAGE-A3, tyrosinase, &nbsp;and TPTE. BNT111 has demonstrated clinical anti-tumor activity as a &nbsp;monotherapy and in combination with checkpoint inhibitors in an ongoing &nbsp;Phase 1 trial in patients with advanced melanoma after prior checkpoint &nbsp;blockade.&nbsp;
<a href="https://investors.biontech.de/news-releases/news-release-details/biontech-announces-strategic-collaboration-regeneron-advance">Source</a>

BNT111 w/ LIBTAYO (cemiplimab).

Pancreatic cancer

Solid tumor/s

BNT122 induces CD8+ T cells in CPI-sensitive and CPI-insensitive tumor types and CD8+ T cells &nbsp;infiltrate tumors

Autogene cevumeran (BNT122) (w/ with atezolizumab and chemotherapy)

Bladder cancer

Non-small cell lung carcinoma

Autogene Cevumeran (BNT122) (w/ pembrolizumab)

Colorectal cancer

Autogene cevumeran (BNT122) (RO7198457)

Head and neck cancer

Human papillomavirus

BNT113 is designed to elicit an immune response against the &nbsp;well-characterized HPV16-derived oncoproteins E6 and E7, which are &nbsp;strongly immunogenic, viral neoantigens that are found in HPV16-positive &nbsp;solid cancers such as head and neck squamous cell carcinoma.
<a href="https://biontech.de/science/pipeline">Source</a>

BNT113

Lung cancer

BNT316 (ONC-392) is a next-generation monoclonal antibody candidate targeting the immune checkpoint receptor CTLA-4 expressed on the surface of immunosuppressive regulatory T cells (“Treg”) that inhibit T cell activity. Blocking CTLA-4 prevents inhibition of T cell activity and therefore enhances anti-tumor effects. BNT316 (ONC-392) is designed to preserve CTLA-4 recycling, thereby enabling deletion of Tregs in the tumor microenvironment while sparing them in healthy tissues. This aims to give rise to a positive safety profile that can offer a more effective dosing regimen in the clinic and more successful tumor killing. BNT316 (ONC-392) is currently being evaluated in an ongoing Phase 2 trial, PRESERVE-004, as combination therapy with pembrolizumab, a PD-1 inhibitor, in platinum-resistant ovarian cancer.

BNT316 (ONC-392)

BNT116 +/- cemiplimab

BNT311/GEN1046 +/- pembrolizumab

Cervical cancer

Platinum-resistant ovarian cancer

BNT327/PM8002 

BNT211 comprises two drug products, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac) based on BioNTech’s proprietary mRNA-lipoplex technology to improve persistence and functionality of the CAR-T cells. The therapy aims to induce a powerful immune response against various CLDN6+ solid tumors, such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. It is a potential first-in-class therapeutic approach and the most advanced CAR-T product candidate in BioNTech’s clinical development. BNT211 is currently being investigated alone or in combination with CARVac in a Phase 1/2 trial in patients with CLDN6+ relapsed or refractory advanced solid tumors. First preliminary results demonstrated a encouraging safety profile and early signs of anti-tumor efficacy at the first evaluated dose levels of BNT211.

BNT211

Tuberculosis

Vaccine

BNT164

Shingles

BNT167

BNT325 (DB-1305)

BNT116 +/- cemiplimab 

Non-engineered neoantigen-specific T cell product BNT221

BNT221

BNT324/DB-1311 is a next-generation topoisomerase-I-inhibitor-based ADC candidate targeting the immune checkpoint protein B7-H3. The transmembrane glycoprotein B7-H3 plays a critical role in the anti-tumor immune response and the shaping of the tumor microenvironment. It is overexpressed in a range of solid tumors, with limited expression in healthy tissues, and has been associated with disease progression and very poor prognosis.5 Preclinical studies have shown that BNT324/DB-1311 exhibits antitumor activity in various solid tumor models.2 Preliminary data from the ongoing Phase 1/2 trial has demonstrated antitumor activity and a manageable safety profile for BNT324/DB-1311 in patients with advanced solid tumors.1 BNT324/DB-1311 is currently being evaluated in a Phase 1/2 clinical trial (<a href="https://www.globenewswire.com/Tracker?data=nOrFBWHDEKFyluVu_4WOfW69eW-Yv4VNO4InBDyovWyP1fO1gLsPZl_zir-4haAsoGlz7TTjlVP-nIkAGOKkKkN9tfWOuRlT-rrkDoaZ1RhJM_ILQ20JNKqHKNGhxIiY" rel="nofollow" target="_blank">NCT05914116</a>) in patients with advanced or metastatic solid tumors.

BNT324/DB-1311

BNT326/YL202

BNT312/GEN1042 is a bispecific antibody candidate based on Genmab A/S (“Genmab”)'s DuoBody technology and designed to induce conditional immune activation by crosslinking CD40 and 4-1BB positive cells.

BNT312/GEN1042

Smallpox

BNT166

BNT327/PM8002

BNT323/DB-1303 is an ADC candidate targeting Human Epidermal Growth Factor 2 (“HER2”) that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”). The program has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors.
 
BNT323/DB-1303 is being evaluated in a Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent or metastatic HER2-expressing solid tumors.&nbsp;

BioNTech SE

Company Details