14 July 2021 - - US-based biotechnology company Ionis Pharmaceuticals (NASDAQ: IONS) has exercised its option and entered into an exclusive worldwide license and collaboration agreement with UK-based biotechnology company Bicycle Therapeutics plc (NASDAQ: BCYC) for tissue-targeted delivery of oligonucleotide therapeutics using Bicycles with high affinity to the transferrin receptor, Bicycle said.

Ionis had an option for an exclusive license under the terms of a December 2020 evaluation and option agreement.

The agreement granted Ionis the right to evaluate tissue-targeting TfR1 binding Bicycles as vehicles to deliver oligonucleotide therapeutics to specific organ systems and an option to obtain an exclusive license at the end of the evaluation period.

Bicycle receives a total of USD 45m upfront, which includes a license fee, an option fee, and an USD 11m equity investment.

Bicycle is also eligible to receive development, regulatory and commercial milestone payments and royalties for each program developed under the collaboration.

Bicycle has identified binders that it believes to be the first small molecules to target TfR1 with high specificity without modifying TfR1's natural function.

These binders present broad conjugation potential across multiple payloads, thereby resulting in the potential to treat diseases in multiple therapeutic areas, including those of the skeletal and cardiac muscles and of the central nervous system.

Bicycle is currently also collaborating with the Dementia Discovery Fund to advance potential TfR1 Bicycles for treating dementia.

Under the terms of the license and collaboration agreement, Ionis and Bicycle will collaborate to develop a pipeline of oligonucleotide therapeutic product candidates delivered using the tissue-targeting TfR1 Bicycle technology, while Bicycle retains the rights to use TfR1 Bicycles for all non-oligonucleotide therapeutic purposes, including within its existing collaboration with DDF targeting dementia.

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. 

Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry.

This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development.

Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate targeting EphA2, and BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen, in company-sponsored Phase I/II trials.

In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Centre for Drug Development of Cancer Research UK.

Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA.