Regenerative medicine company Exopharm (ASX: EX1) has received amiable results from a BioMAP testing program operated by Eurofins with respect to its exosome products.
Results showed that Exopharm’s exosome platform is safe in its mechanism of action and that has “different and distinct activities” compared to 4,500 other drugs.
Strong lab results raise the chances of Exopharm’s world-leading exosome products of becoming fully-fledged medicines although further testing is required.
The news is expected to have a positive impact across Exopharm’s business and will be of interest to potential customers, according to the company’s chief executive officer Dr Ian Dixon.
The company said the results “confirm this therapeutic approach is a distinct and potentially new class of medicine”.
However, Exopharm did temper its positivity by admitting that BioMAP testing results may not translate to future testing in non-clinical or clinical trials and said that unforeseen product safety issues may arise at later stages of testing.
Eurofins’ BioMAP phenotypic profiling and screening service provides an objective, target agnostic and data-driven approach to understanding a medicine’s impact on human disease models and translational biomarkers.
Validated with clinically approved drugs and known test agents, the BioMAP platform is powered by human primary cell-based disease systems, a reference database of more than 4,500 compounds, data analytics, and expert interpretation to provide clients with actionable insights.
Headline BioMAP results indicated that Exopharm’s Plexaris product was safe in both relative and absolute terms and had “notable biological activity” in tissue remodelling, immunomodulatory and inflammatory-related activities.
Exosomes are natural particles produced by cells, delivering what’s known as “therapeutic cargoes” to other cells to reduce inflammation and promote regeneration.
According to researchers, exosomes are plentiful in young individuals but decline with age.
Recent research has indicated that exosomes can be used as a way of extending the number of healthy functional years – extending life quality and span.
Moreover, exosomes secreted by stem cells could be used as a substitute for stem-cell therapy with equal or greater benefit while avoiding various problems associated with stem-cell therapy.
Exopharm said exosome could even be used to deliver targeted novel drugs and serve a diagnostic function within various applications.
Сompare and contrast
In parallel to Plexaris, Exopharm’s Cevaris product was compared with 4,500 experimental and sold medicines across a panel of 12 human primary cell-based systems.
Cevaris was found to be safe and had notable biological activity in the same areas as Plexaris.
Importantly, neither was shown to be cytotoxic, and neither caused antiproliferative effects at the concentrations tested.
Another key finding was that comparing the screening profiles of both Plexaris and Cevaris against the database of 4,500 medicines did not produce a significant match, thereby suggesting that both Plexaris and Cevaris have different and distinct activities in comparison to existing drugs.
“This is a valuable finding, pointing to exosomes as a unique and potentially new class of medicine, with potential application unmet by existing medicines,” the company said.
“These are very positive results from a detailed external test of two of our experimental exosome products,” said Dr Ian Dixon.
“The testing showed that both Plexaris and Cevaris had different and distinct activities to comparison drugs. This confirms our belief that exosomes are a distinct and potentially new class of medicine, different from existing medicines.”
“The results of the BioMAP testing will help Exopharm plan its next studies with additional insights and confidence. After that, further human clinical trials are the next step,” said Dr Dixon.
Moving forward, Exopharm said the results indicate several potential mechanisms of action and biological pathways for Plexaris and Cevaris, that will be verified in planned upcoming non-clinical studies.