Company News: BioNTech AG Enters into Licensing Agreement with CELLSCRIPT, LLC as it Advances Development of Messenger RNA Encoding Bispecific Antibodies and other Therapeutic Proteins

BioNTech AG, a fully integrated biotechnology company pioneering individualized cancer immunotherapy, today announced that it has entered into a broad and comprehensive non-exclusive patent licensing agreement with CELLSCRIPT, LLC covering nucleoside-modified messenger RNA (mRNA) for use in all in vivo applications, including therapeutic and non-therapeutic applications in humans and animals.

Modified mRNAs covered by these technologies exhibit reduced innate immunogenicity, thereby allowing repeated dosing of mRNA therapeutics for the treatment of cancer and other diseases such as protein-deficient rare diseases. The modified mRNA technology is complementary to, but separate from, BioNTech’s other mRNA technologies used in its clinical-stage cancer vaccines for the treatment of cancer. Financial details of the agreement were not disclosed.

The patents for CELLSCRIPT’s nucleoside-modified RNA technologies are the result of research conducted by Prof. Katalin Karikó, Ph.D. and Drew Weissman, M.D., Ph.D. at the University of Pennsylvania Medical School. Prof. Karikó, one of the world’s leading experts in mRNA biochemistry, with more than 30 years of experience, joined BioNTech in 2013. She has published more than 70 peer-reviewed papers and conducted groundbreaking research into the discovery that incorporation of modified nucleosides suppresses immunogenicity of RNA, consequently demonstrating the feasibility of using nucleoside-modified mRNA for protein replacement in vivo. She is co-inventor of therapeutic mRNA-related patents, including the patents for RNA containing modified nucleosides.

BioNTech recently reported preclinical animal data in Nature Medicine demonstrating that in vivo delivery of mRNA encoding T cell-engaging bispecific antibodies eliminated aggressive large tumors in mice. Administering an mRNA encoding a bispecific antibody and thereby enabling the patient’s body to act as a factory, synthesizing the active therapeutic antibody itself, may profoundly reduce complexity and decrease drug development times compared to protein-based approaches.

“Our recently published data on bispecific antibodies reinforces the significant potential of this new therapeutic approach,” said Prof. Ugur Sahin, founder and CEO of BioNTech. “CELLSCRIPT’s technology will play an important role in our efforts to develop first-in-class mRNA-encoded antibodies and other therapies for the treatment of cancer and other diseases.”

BioNTech’s modified mRNA program complements the company’s larger portfolio of clinical-stage individualized RNA cancer vaccines. While modified mRNA is designed to be immunologically silent, BioNTech’s mRNA cancer vaccine treatments are optimized for appropriate immune stimulation and translation in immune cells.