MAINZ, Germany, May 21, 2024 -- https://www.globenewswire.com/Tracker?data=2RJKVw6dBE-JXX0Malj7sDXW2qKdh494LX_TyRywMNGHfcQXX0qL--tgSCCredlFGyZOiQIg5FFvL_ZaHkc57gLeAXGefNHJXwfcq2lk3h4= 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:

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-- 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 (
https://classic.clinicaltrials.gov/ct2/show/NCT05117242 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 (
https://clinicaltrials.gov/study/NCT04813627?cond=NCT04813627&rank=1
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 (
https://classic.clinicaltrials.gov/ct2/show/NCT04486378 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 https://www.globenewswire.com/Tracker?data=QyGPVIkW00e0rr1xv-fzoOqlVQ-QX4dXBPdNoj85EKP5v0kj00cVwYQoaGkcdbiXB8VrY_-qntiWisxjENYbw43VpDBGuoYuUliGIyJreAZhhnGMaf3sjVqE20Fch2ESHyBUu4DzUjX1yU3US2aZ-X7aNN5vFMPe3-smnWXpZXpWl2W7Y6gyI-sAJfcrd8pcxe2D-T2SpJjizZuNeL0O7MjVrtWzDi947vuwwOdmkbiiqEZwefXy0znP_n6tCBcqez8APUumMcN_NSlXJFU6ublWYSXAlX0BAhnS2EgZOvS5SlCfLCtti8duvXWGfXgtaTHnzwDztaHSd29Szj8A7RNTH1jMsKiNFoYN-FBrepUJOF_jKAPNRrRICDYrfAV4T8P0BobLl8q2xQ7ojvcDFNQmxW8oliV6PijVb2nUdpLh7rd6Y7aPIe0jS7C6twOo3lhGPmOF0U_XgXx51oKfM79nLTN-Jqu9RyybuSQafZDlzx6TprP6eXvsMe4wYkjwHOOXQklDIJaskwsyjpLmxEegtvnjdDeYzeEA0zLiG1U86_c7-uuCMOYqB5wxjU1S ASCO Annual Meeting website. Click https://www.globenewswire.com/Tracker?data=KpQ14WiiqieF4-5w0rvG21WTSNCN5aqOaR7Kkjoeuvn2pAEpSZXbz27YKfPpfkhNxWxRc0f8NQE4bkDZDuZMfhgGv54zDzz-eNmVrpYCJnBAVkPBg4Ypigd7W9Nv-T2EPCymWhIXsX244nfS5pgfog== 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

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