Roche will work to enable oral administration of its antisense oligonucleotide platform using PureTech Health’s milk-derived exosome technology, through a collaboration that PureTech said today could generate for it more than $1 billion.

Under the multi-year collaboration, Roche will study applying PureTech’s milk exosomes technology, which is designed to facilitate oral delivery of macromolecules such as nucleic acids and peptides, as well as complex small molecules.

PureTech reasons that the exosomes, which are believed to traffic via lymphatic circulation, could potentially enable new treatments through novel ways of targeting immune cells. Since the exosomes are mammalian-derived, according to the company, their natural composition will likely provide superior tolerability over current synthetic polymers.

The challenge, according to PureTech, is that most sources of mammalian exosomes are not suitable or viable for use in oral administration of drugs due to their lack of stability under the harsh physiologic conditions associated with transit through the stomach and small intestine.

The milk-derived exosomes–which have generated what the company calls compelling preclinical data—are based on research conducted by the company and its academic collaborators, including Ramesh Gupta, Ph.D., Agnes Brown Duggan Chair in oncological research at the James Graham Brown Cancer Center, and professor in the department of pharmacology and toxicology at University of Louisville.

Roche has agreed to pay PureTech up to $36 million in combined upfront, research support, and early preclinical milestone payments—as well as more than $1 billion in payments tied to achieving development milestones, and additional unspecified sales milestone payments and royalties for an undisclosed number of products.

“The expertise and resources that Roche is bringing to the collaboration will help us to potentially address one of the biggest challenges in oligonucleotide-based therapeutic development: oral administration of nucleic acids,” PureTech co-founder and CEO Daphne Zohar said in a statement. “We are excited to accelerate the development of this promising technology from our internal lymphatic and immune cell trafficking programs.”

The milk-derived exosomes are to be developed by PureTech’s Internal division, while the company has consolidated into a separate Ariya division its internal pipeline programs, R&D projects that focus on the Brain-Immune-Gut (BIG) Axis, with an emphasis on lymphatics, and immune cell trafficking to modulate immunity in a tissue-specific manner.

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