BioNTech & Crescendo Biologics Announce Global Collaboration to Develop Multi-Specific Precision Immunotherapies

BioNTech SE and Crescendo Biologics Ltd. recently announced they have entered a multi-target discovery collaboration to develop novel immunotherapies for the treatment of patients with cancer and other diseases. The initial term of the discovery collaboration is three years.

Crescendo will contribute its unique, proprietary, transgenic platform to deliver fully human heavy-chain antibody domains (Humabody V_H) against targets nominated by BioNTech. Humabodies represent a novel class of therapeutics that retain the high-affinity binding and specificity of conventional therapeutic antibodies while providing additional advantages such as small size, enhanced tissue and tumor penetration, stability and molecular simplicity due to the lack of a light chain. In particular, the modular nature of Humabodies make them ideally suited for the development of multi-target immunotherapies.

“Crescendo’s platform provides excellent properties for exploiting novel targets and target combinations which we believe has great potential for the development of multi-specific mRNA and engineered cell-based therapies in a variety of disease areas,” said Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We are excited to begin working with Crescendo to further strengthen and expand our multimodal immunotherapy portfolio and deliver breakthrough precision medicines for patients.”

“To collaborate with BioNTech and their world-class team is a transformational opportunity for Crescendo. We are looking forward to further leveraging our clinically validated Humabody V_H platform within mRNA therapeutics to develop better treatment options for patients,” said Theodora Harold, Chief Executive Officer at Crescendo Biologics.

Under the terms of the agreement, Crescendo will receive $40 million upfront, including a cash payment and an equity investment from BioNTech, as well as research funding for the period of the collaboration. BioNTech will be responsible for global development and hold exclusive worldwide commercialization rights on any products arising from the collaboration. Crescendo will be eligible to receive development, regulatory and commercial milestones up to a total of more than $750 million, in addition to tiered royalties on global net sales.

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, bi-specific 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, visit www.BioNTech.de.

Crescendo Biologics is a private, clinical stage immuno-oncology company developing novel, targeted T cell enhancing Humabody therapeutics. Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel half-life extended CD137 x PSMA Humabody for the selective activation of tumour-specific T cells exclusively within the tumour microenvironment. CB307 is designed to achieve a longer lasting anti-cancer effect whilst avoiding systemic toxicity, and the clinical programme for CB307 is underway in patients with PSMA positive solid tumors. The company’s ability to develop multi-functional Humabody therapeutics is based on its unique, patent protected, transgenic mouse platform generating fully human V_H domain building blocks (Humabody V_H). These robust molecules can be configured to engage therapeutic targets in such a way that they deliver novel pharmacology and superior bio-distribution. This can lead to larger therapeutic windows compared to conventional IgG approaches. Humabody-based formats can also be applied across a range of non-cancer indications.

Beyond Crescendo’s proprietary pipeline, the company has a global, multi-target discovery and development collaboration with Takeda; a clinical development partnership for CB213 (a PD-1xLAG-3 multi-specific Humabody) with Cancer Research UK; and an exclusive, worldwide licensing agreement with Zai Lab for ZL-1102 (formerly CB001, an anti-IL-17A targeting Humabody), which has recently successfully completed a Phase 1 clinical trial.

Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital and Astellas. For more information, visit www.crescendobiologics.com.