Exosomes are extracellular vesicles (EVs) of endosomal origin that range in size between 30 and 150 nanometers. Exosomes are secreted by a wide range of cells, with virtually all living cells utilize exosome-mediated communication. Today, exosomes are being explored across a diverse range of therapeutic and diagnostic applications, with particular attention being given by the pharmaceutical industry to drug-loaded exosomes.
Already, three pharmaceutical companies—Jazz Pharmaceuticals, Roche, and Boehringer Ingelheim—have signed partnership deals with exosome companies with royalties and milestone payments structured to deliver at or around $1 billion dollars.
The following is the list of strategic partnerships executed between exosome companies and their biotech and pharmaceutical partners.
Exosome Industry Partnerships
The partnerships described below demonstrate surging demand for exosome technologies, as well as the high price tags industry partners are willing to pay in order to secure access. The partnerships are listed in chronological order, from most recent to least recent.
Evotec SE, Sartorius, and Curexsys GmbH
On December 09, 2020, Evotec SE and Sartorius signed a partnership with Curexsys GmbH, a start-up company specializing in the emerging field of therapeutic exosomes. Curexsys has developed a proprietary isolation technology for exosomes based on a traceless immune-affinity process. Under the terms of the agreement, Evotec and Curexsys will collaborate for the production of MSCs, which serve as a source for exosomes. Curexsys aims to develop targeted approaches for a variety of diseases, initially focusing on Sicca Syndrome, commonly known as “dry eye”, an inflammatory condition.
This collaboration combines Evotec’s iPSCs platform with Curexsys’ proprietary technology to selectively isolate exosomes. Sartorius will support Curexsys to set up a GMP-compliant and scalable manufacturing platform. Furthermore, Evotec and Sartorius have formed a consortium to jointly invest in Curexsys’ $9.9 million (€ 8.2 million) seed financing round, with Evotec acquiring an equity stake of 37% in Curexsys and Sartorius of approximately 21%.
Sarepta Therapeutics and Codiak BioSciences
On June 22, 2020, Sarepta Therapeutics and Codiak BioSciences signed a global research and option agreement to design and develop engineered exosome therapeutics to deliver gene therapy, gene editing and RNA technologies for neuromuscular diseases. The engineered exosome approach offers the potential to effectively deliver genetic therapeutics without triggering the adaptive immune response.
The two-year agreement includes up to five neuromuscular targets. Codiak is eligible to receive up to $72.5 million in upfront and near-term license payments plus research funding.
Evox Therapeutics and Takeda Pharmaceutical Company
On March 30, 2020, Evox and Takeda signed a partnership agreement under which Evox will puruse development of up to five exosome therapeutics targeted for the treatment of rare diseases. The deal involves Evox’s Exosome Technology to load exosomes with drugs enabling targeted delivery of proteins and RNA to the central nervous system (CNS).
Under the terms of the deal, Evox is eligible to receive up to $44 million in upfront payments and near-term milestones. This represents a small percentage of the total deal value, as Evox is eligible to receive up to $882 million in upfront, development, and commercial milestone payments from Takeda over time. Evox can also receive tiered royalties on the net sales of each product.
In exchange for payment, Takeda has gained access to five novel protein replacement and mRNA therapies. Evox is responsible for research and development until an IND is submitted, as well as manufacturing and associated program costs up to and including Phase I trials.
Jazz Pharmaceuticals and Codiak BioSciences
On January 03, 2019, Jazz Pharmaceuticals and Codiak BioSciences signed a strategic collaboration agreement focused on the research, development and commercialization of exosome therapeutics to treat cancer. Codiak granted Jazz an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize therapeutic candidates directed at five targets to be developed using Codiak’s engEx precision engineering platform for exosome therapeutics.
The targets focus on oncogenes that have been well validated in hematological malignancies and solid tumors but have been undruggable with current modalities, including NRAS and STAT3. Codiak received a $56 million upfront payment.
Codiak could also receive up to $200 million in milestones for each of five targets ($1 billion total), as well as additional preclinical development milestones of up to $20 million, a co-commercialization option on two products, and royalties on future net sales.
PureTech Health and Roche
On July 20, 2018, the U.S. biotech PureTech Health signed a potential billion-dollar deal with Roche, based around its exosome technology that allows for oral administration of complex payloads, specifically antisense oligonucleotides developed by Roche. PureTech has developed a milk-derived exosome, which can travel through the lymphatic system. It could enable the targeting of immune cells in novel ways.
Under this agreement, PureTech Health received approximately $36 million, including upfront payments, research support, and early preclinical milestones. PureTech Health could potentially receive development milestone payments of over $1 billion and additional sales milestones and royalties for an undisclosed number of products.
Exosome Diagnostics and Intezyne, Inc.
On March 14, 2018, Exosome Diagnostics signed a collaboration agreement with Intezyne, Inc., to design and validate a highly sensitive exosomal RNA based assay for use in Intezyne’s Phase I/II clinical trials of IT-139. IT-139 is a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric, and other cancers in combination with existing anti-cancer therapies.
The assay leverages Exosome Diagnostics’ ExoLution isolation kit, a cGMP-grade exosome RNA isolation platform, and is intended for the stratification and long-term monitoring of patients.
Evox Therapeutics and Boehringer Ingelheim
On December 20, 2017, Evox Therapeutics Ltd. signed research collaboration with Boehringer Ingelheim to investigate exosome-mediated delivery of RNAs with high medical relevance to targets for specific disease areas of focus to Boehringer Ingelheim. Under the terms of the agreement, Evox and Boehringer Ingelheim will perform comprehensive in vitro and in vivo research with Evox’s exosome technology in return for undisclosed financial considerations.
This research may help to pave the way for approaching therapeutic concepts in diseases with high medical need that are currently not amenable to therapeutic intervention. Upon completion of these studies, Boehringer Ingelheim will have the option to negotiate a license agreement to further develop RNA drug candidates using Evox’s exosome-mediated delivery technology.
The Future of Exosome Industry Partnerships
Clearly, market demand for exosome technologies is accelerating, with deals within the sector repeatedly being structured to include payments and incentives of $1 billion or more.
Exosome-related technologies have been developing rapidly over the past few years and substantial growth is expected for the market as they get integrated into the fields of liquid biopsy, precision medicine and regenerative medicine.