BioNTech to Present New Clinical Data from First-in-Class CAR-T Program BNT211 in Late-breaking Session at 36th SITC Annual Meeting

Rhea-AI Summary

BioNTech SE (Nasdaq: BNTX) announced the presentation of new clinical data from its Phase 1/2 trial for BNT211, a CAR-T cell therapy targeting Claudin 6, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) from November 10-14, 2021. This first-in-human study aims to evaluate the safety and efficacy of BNT211 as a monotherapy and in combination with an mRNA-based vaccine. The late-breaking abstract presentation highlights BioNTech's commitment to advancing novel cancer treatments.

Positive

• Presentation of Phase 1/2 trial data for BNT211 at SITC enhances visibility among immuno-oncology experts.
• BNT211 targets Claudin 6, a novel approach for treating solid tumors, potentially improving treatment options.

Negative

• None.

MAINZ, Germany, November 1, 2021 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, today announced that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company’s novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation. The presentation is scheduled for the late-breaking abstract poster session at the 36^th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held both in person and virtually from November 10 - 14, 2021. 

“Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments,” said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology.”

BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company’s clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial (NCT04503278) to evaluate safety and preliminary efficacy in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Poster Details:

Program: BNT211
Poster Title: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors
Abstract Number: 958
Presenter: Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany
Date & Time: Friday, November 12, 2021; 12.25 – 12.40 pm ET

About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company 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 T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and 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 pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.

For more information, please visit www.BioNTech.de 

Investor Relations
Sylke Maas, Ph.D.
VP Investor Relations & Strategy
Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de 

Media Relations
Jasmina Alatovic
Director Global External Communications
Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385
E-mail: Media@biontech.de

FAQ

What is the purpose of the BNT211 Phase 1/2 trial?

The trial aims to evaluate the safety and preliminary efficacy of BNT211, a CAR-T therapy targeting Claudin 6 in patients with advanced solid tumors.

When will BioNTech present data from the BNT211 trial?

BioNTech will present data at the late-breaking abstract session during the SITC meeting on November 12, 2021.

What is Claudin 6 and why is it significant for CAR-T therapy?

Claudin 6 is an oncofetal antigen identified as a suitable target for CAR-T therapy, offering a new avenue for treating solid tumors.

What are the next steps for BioNTech after the trial presentation?

Following the presentation, BioNTech will continue to analyze trial results and explore further development opportunities for BNT211.

What is the stock symbol for BioNTech?

The stock symbol for BioNTech is BNTX, traded on the Nasdaq.