BioNTech SE, the largest privately held biopharmaceutical company in Europe, recently announced initiation of first-in-human study of DuoBody-PD-L1x4-1BB for the treatment of solid tumors, cite sources.

For the record, BioNTech SE is a clinical-stage biotechnology company that focuses on development of precision immunotherapies for prevention of infectious diseases & treatment of cancer. The company’s innovative technologies range from individualized mRNA-based products to T-cell receptor-based compounds to novel checkpoint immunomodulators, chimeric antigen receptors and small molecules.

Antibody Duobody PD-L1x4-1BB is a bispecific antibody, that has been jointly developed by Genmab A/S and BioNTech SE, and the drug has been studied in patients with unresectable or metastatic malignant solid tumors. Signed in 2015 and expanded in 2016, the objective of the collaboration is to include additional targets & technologies, to develop & commercialize multiple innovated bispecific antibodies with superior efficacy, that activates immune system against cancer cells.

Prof. Ugur Sahin, CEO, BioNTech was reportedly quoted saying that- in highly productive partnership with Genmab, the company has initiated Phase I/IIa clinical trial of a product that has been developed jointly, only in four years. DuoBody-PD-L1x4-1BB has pan-cancer, dual-immuno-stimulatory properties which contributes to an extra layer of treatment options. The drug serves BioNTech’s strategy of exploiting new targets & mechanisms to utilize full potential of the immune system for cancer immunotherapy.

Antibody Duobody PD-L1x4-1BB, is a unique antibody that combines barrier block of the inhibitory PD-1: PD-L1 signaling axis along with conditional simulation of T-cells, by the activation of receptor (4-1BB) and enhances production of activated T-cells to efficiently target cancer cells. The original concept for the approach, which combines acceleration properties (4-1BB) and immune-brake removing (PD-L1) to resist cancer, is based on research conducted at BioNTech.

Reportedly, the open-label safety trial of DuoBody-PD-L1x4-1BB consists of 2 parts- Phase I(first-in-human), a dose escalation part and Phase IIa, an expansion part. The multi-center trial will assess safety including dose limiting toxicity and AE (adverse events).

Source credits: https://biontech.de/2019/06/17/biontech-and-genmab-initiate-first-in-human-phase-i-iia-trial-of-bispecific-antibody-duobody-pd-l1x4-1bb-in-solid-tumors/