In its first collaboration with a major pharmaceutical company, Exopharm has signed a Master Collaborative Services Agreement (MSA) with the Astellas Institute for Regenerative Medicine (AIRM) – a subsidiary of Astellas Pharma Inc.

The aim is to validate the company’s LEAP, LOAD and EVPS technology platforms to manufacture exosomes for Astellas.

The LEAP project will commence in early 2022 at the company’s laboratories in Melbourne and will use the LEAP technology platform to purify exosomes derived from two proprietary AIRM cell lines.

A second phase of this project will involve transferring the LEAP technology to AIRM research headquarters located in Massachusetts USA.

“We believe Exopharm’s proprietary technology platforms may help us address some of the challenges involved in the development and use of extracellular vesicles for regenerative medicine,” AIRM’s director of research Dr. Jaime Chaufty said.

AIRM will pay Exopharm fees of up to US$481,000 for both projects over a period of around 15 months, starting in March 2022.


Critical step for future product collaborations

Exopharm (ASX:EX1) MD and founder Dr Ian Dixon says Astellas is keen to evaluate whether exosomes could become part of their future pipeline of innovative products.

“Our strategy is to make our proprietary technologies available under license to leading pharmaceutical companies such as Astellas,” he said.

“Exopharm has the potential to build ongoing revenue streams from such licenses through multiple alliances.

“Technical collaboration, demonstration and sharing data – as provided by this agreement – is the critical first step.”


Exomes could treat unmet medical needs

Across the pharmaceutical industry, exosomes are being recognised as a different and particularly important means for delivery of gene therapies, gene editing constructs, transcription factors, mRNA, DNA, viral vectors, targeted delivery of small molecule drugs and more.

“Regenerative medicine holds the promise of repairing or replacing the patient’s cells to restore normal function,” Dr Dixon said.

“More recently, the advantages of exosomes derived from human cells but delivered as an acellular therapy have been investigated.

“But purification of exosomes as a biomanufacturing process has blocked progress.

“Exopharm’s patented LEAP purification technology changes all that – opening up the very real prospect of exosomes as next-generation medicines to treat unmet medical needs.”

The company is confident its well-placed for partnership with pharmaceutical and biotechnology companies aspiring to use exosomes to deliver their assets inside the body.


LEAP tech granted US patent

During the December quarter the company was granted a US patent for its LEAP tech.

Exopharm says this positions them as a global leader in meeting the challenge of large-scale, commercial production of exosomes needed to enable leading-edge exosome medicines, bolstering its partnering and licencing discussions.

Plus, the company already secured a patent in Russia and is planning to pursue patents in a further 10 jurisdictions.


Developing own pipeline of products

In 2022 Exopharm’s product focus is different and it’s product strategy is clear.

Exopharm will take a small number of ‘engineered exosome’ products into clinical trials and towards registration.

The company says that developing pipeline products will require a significant investment over time and extra experts added into the company, but the potential rewards are too big to ignore.

The Pipeline Products Panel, is headed up by Dr Johannes Mühl and assisted by Dr Mike West, Dr Jennifer King, Dr Sam Keenan and Dr Ian Dixon, who are working through a field of potential products to bring into the pipeline.



This article was developed in collaboration with Exopharm Limited, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.