BioNTech and Genmab Initiate First-In-Human Phase I/IIa Trial of Bispecific Antibody DuoBody®-PD-L1x4-1BB in Solid Tumors

MAINZ, Germany–(BUSINESS WIRE)–BioNTech SE, a clinical-stage biotechnology company focused on
patient-specific immunotherapies for the treatment of cancer and other
serious diseases, announced today that the first-in-human Phase I/IIa
study with DuoBody-PD-L1x4-1BB has been initiated. DuoBody-PD-L1x4-1BB
is a bispecific antibody in joint development with Genmab A/S, which is
being studied in patients with metastatic or unresectable malignant
solid tumors, who are not candidates for standard therapy.
DuoBody-PD-L1x4-1BB is the first product candidate from the companies’
worldwide 50% cost-sharing 50% profit-sharing collaboration to enter the
clinic. The objective of the collaboration, signed in 2015 and expanded
in 2016 to include additional targets and technologies, is to develop
and commercialize multiple novel bispecific antibodies with superior in
vivo efficacy that specifically activate the immune system against
cancer cells.

“The achievement of starting a Phase I/IIa clinical trial with a product
candidate developed in only four years is a validation of our highly
productive partnership with Genmab,” said Prof. Ugur Sahin,
CEO of BioNTech. “DuoBody-PD-L1x4-1BB’s pan-cancer,
dual-immuno-stimulatory mode of action contributes an additional layer
of treatment options to our overall cancer pipeline. It also serves
BioNTech’s strategy of exploiting novel targets and mechanisms to
harness the full potential of the immune system for cancer
immunotherapy.”

DuoBody-PD-L1x4-1BB is a novel bispecific antibody that combines
checkpoint blockade of the inhibitory PD-1:PD-L1 signaling axis with
conditional stimulation of T cells by activation of the 4-1BB receptor,
thereby enhancing the proliferation of activated T cells to efficiently
target cancer cells. The original idea and concept for this approach to
combine immune-brake removing (PD-L1) and acceleration properties
(4-1BB) to combat cancer are based on research conducted at BioNTech.
The open-label safety trial of DuoBody-PD-L1x4-1BB (ClinicalTrials.gov
Identifier NCT03917381)
consists of two parts: a dose escalation part (Phase I, first-in-human)
and an expansion part (Phase IIa). As primary endpoint, the multi-center
trial will foremost assess safety including dose limiting toxicity and
adverse events.

About BioNTech

BioNTech SE is Europe’s largest privately held biopharmaceutical company
pioneering the development of precision immunotherapies for
individualized treatment of cancer and prevention of infectious
diseases. The company combines all building blocks for more precise and
individualized immunotherapies under one roof – from diagnostics and
drug development to manufacturing. Its cutting-edge technologies range
from individualized mRNA-based product candidates through innovative
chimeric antigen receptors and T-cell receptor-based compounds to novel
checkpoint immunomodulators and small molecules. BioNTech’s product
development approach has been validated by seven corporate partnerships
with, in chronological order, Genmab, Eli Lilly and Company, Sanofi,
Bayer Animal Health, Genentech, a member of the Roche Group, Genevant
and Pfizer, and its scientific approach through over 60 peer-reviewed
scientific publications. Founded in 2008, BioNTech’s financial
shareholders include the Struengmann Family Office as its majority
shareholder, Fidelity Management & Research Company, Invus, Janus
Henderson Investors, MIG Fonds, Redmile Group, Salvia and several
European family offices. For more information, please see: www.biontech.de.

DuoBody^® is a registered trademark of Genmab A/S.

Contacts

For more information, please contact:
BioNTech SE
Michael
Boehler, MD, Head of Global External Communications
Tel: +49
(0)6131 9084 1640
Email: [email protected]

BioNTech
media inquiries:
Trophic Communications
Gretchen
Schweitzer / Stephanie May, PhD
Tel: +49 (0)89 23 88 77 30 or +49
171 185 5682
Email: [email protected]