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Lonza's New Investments in Exosome Technologies Reflect Growing Industry Interest


NEW YORK (GenomeWeb) – The recent addition of exosome technologies to the portfolio of Swiss multinational life sciences company Lonza reflects a growing belief in industry and academia that the cell-derived vesicles could be the biomarker of choice for non-invasive tests and new therapies. 

Lonza, headquartered in Basel, Switzerland, announced in mid-May that it had acquired HansaBioMed Life Sciences, a Tallinn, Estonia-based supplier of technology and services for exosome research, for an undisclosed sum, while simultaneously investing in Exosomics, a Siena, Italy-based firm developing next-generation sequencing-based cancer tests.

Behzad Mahdavi, Lonza's vice president of strategic innovation and alliances, said that the deals represent Lonza's first foray into the nascent arena of exosome-based diagnostics and therapeutics, though one it sees as complementary to its existing expertise and target markets.

"Exosomes are considered to have potential as therapeutic agents, vehicles for drug delivery, diagnostic biomarkers, and active agents in consumer care products, making them compatible with current Lonza markets," said Mahdavi.

"With Lonza's capabilities in large scale cell-culture manufacturing, we are well suited to develop the processes needed for the commercial scale production for exosome applications, an additional logical step in the advancement of this field," he said.

Founded in 1897 in the Swiss Alps, Lonza initially focused on chemical production, before branching out into cell culture manufacturing and producing substances for pharmaceutical and agrochemical companies. Over the past decade, the company has undergone a significant transformation, moulding itself into a leading supplier of active pharmaceutical ingredients, biopharmaceuticals, and research products through multiple acquisitions. It now employs 10,000 worldwide, and had global sales of CHF4.13 billion ($4.24 billion) in 2016. In 2013, Lonza reorganized itself into two segments: Pharma & Biotech, serving the custom manufacturing and bioscience sectors; and Specialty Ingredients, serving the life science ingredients sector.

HansaBioMed LS, Lonza's new acquisition, will come under its Pharma & Biotech segment. Established in 2007, HansaBioMed promotes itself as one of the oldest companies focused on isolating and analyzing exosomes. It maintains an extensive menu of products and services for exosome research, including exosomes from various cell lines, exosome-binding antibodies, and kits for the enrichment of specific exosome subpopulations.

One of its best-known products is its ExoTest platform, a double sandwich enzyme-linked immunosorbent assay for the quantitative and qualitative analysis of exosomes, including those released by cancer cells in the plasma and urine of tumor patients. The company also offers next-generation sequencing-based nucleic acid profiling services on Thermo Fisher Scientific's Ion Torrent and SOLiD instruments.

By acquiring HansaBioMed LS, Lonza gains a "knowledgeable team" with experience in exosomes that will support its efforts to enter the field, Mahdavi said. He said that the Estonian company, which has six employees, will work with Lonza to develop new exosome-based applications going forward.

"It is important to continue to serve the exosome research market and help promote the development of new, more regulated potential applications to fully leverage our asset and expertise," Mahdavi said. He noted that by working together, Lonza and HansaBioMed have the potential to develop a "new class of therapies" for patients.

Meanwhile, Exosomics is a 2011 spinout of HansaBioMed, and both firms have been led by CEO Antonio Chiesi. The company, which will remain independent following the Lonza investment, is engaged in the development of immunometric multiplex assays for non-invasive cancer diagnostics, as well as cancer screening and monitoring assays. According to its website, it also has developed microarrays for use as companion diagnostics in collaboration with pharmaceutical clients.

Moreover, Exosomics employs HansaBioMed's ExoTest platform to capture tumor exosomes that can then be further analyzed using sequencing, and has a number of cancer-focused tests in development, including assays focused on colorectal cancer, prostate cancer, and solid tumors. Mahdavi did not discuss plans for making these available commercially.

However, he said that for Lonza the "common denominator" of Exosomics' test pipeline is that it is focused on tumor exosomes, which he called "true surrogates of tumor tissue, which are carriers of the informative biomarkers load." He reiterated that Exosomics' technology is based on the selective immune-capture of exosomes of interest for a specific application, which Lonza believes should support "timely and non-invasive" molecular tests on a sequencing platform.

"The combination of extracellular vesicle-based enrichment with an NGS-based platform to improve the overall signal-to-noise ratio of panels of actionable mutations make this technology and approach unique and suitable for true liquid biopsy service," he said.

By "true liquid biopsy," Mahdavi indicated that Exosomics' approach could have advantages over other non-invasive cancer tests either on the market or in development that rely on different sources of tumor markers, such as cell-free DNA or circulating tumor cells. "The extracellular vesicles in some ways may unify the best of both worlds," said Mahdavi, as they carry a variety of biomarkers, rather than just DNA, and allow the enrichment of clinically relevant tumor markers versus the "overall low accessible amount of tumor derived cell-free DNA."

In addition, because exosomes are secreted by the cell, and are responsible for cell-to-cell communication and modulating cellular immunity, Lonza sees an avenue to developing HansaBioMed and Exosomics' technology for use in therapeutic agents, as vehicles for drug delivery, and as active agents in consumer care products.

"The exosome field is complementary to our expertise," said Mahdavi, adding that the acquisition and investment allow Lonza to "leverage our assets and expertise, and, over time, potentially open new markets." 

An industry trend?

The past six months have been eventful for companies and academic groups developing exosome-based tests. In March, for instance, Weill Cornell Medicine was awarded $600,000 to develop exosome-based tests for cancer recurrence in children and adults. The same month, the Atlantic Cancer Research Institute licensed extracellular vesicle isolation technology to BioVendor – Laboratorní Medicína, a Czech biotech developing tests and research-use-only immunoassays. The prior month, Peregrine Pharmaceuticals provided an update on exosome-based technology it licensed from the University of Texas Southwestern Medical Center last year, referencing a recent study that demonstrated the use of the technology to distinguish between healthy subjects and patients with ovarian tumors based on the levels of exosomes containing phosphatidylserine in their plasma.

Cambridge, Massachusetts-based Exosome Diagnostics has been among the higher profile companies to attempt to bring this "true liquid biopsy" approach to the clinic. The company has released or is developing four different ExoDx tests for prostate and lung cancer, and at the end of last year launched a label-free, automated instrument called Shahky for detection of exosomal proteins directly from blood or other body fluids. In February, Exosome Diagnostics announced a deal with Merck, to use Shahky and other expertise in profiling exosomes in Merck's oncology-related drug development programs.

Experts in academia are not surprised by this uptick in exosome-related activity. Simona Cocó, an investigator at University Hospital San Martino in Genoa, Italy, and a co-author on a recent review of exosome-based tests in lung cancer, said that a number of aspects should be considered when trying to understand the growing interest in exosome-based testing.

First, there are limitations to using circulating tumor cells or cell-free DNA as the basis of a molecular test, she noted. "It should be underlined that the free circulating genetic materials, particularly RNA, can be degraded by ribonuclease and/or extreme pH present in the blood and that only a fraction of the whole circulating free DNA is tumor-derived," said Cocó. "This may lead to failure of molecular biology workflows or result in false negative data of the diagnostic test," she said.

In contrast, she said that molecules transferred by exosomes are both protected from degradation by bi-layered lipids and can be enriched and characterized from bodily fluids using various methodologies, such as Exosomics' approach. "For these reasons exosomes can actually be considered as ideal biomarkers in cancer diagnosis and to monitor treatment efficacy," said Cocó. "This is particularly true in lung cancer, where the possibility to obtain suitable tumor tissue for diagnosis remains challenging."

Another factor attracting interest is the use of exosomes as bio-delivery vectors in therapeutics, meaning that they could be applied in new cancer treatments. Cocó stressed, however, that further research is needed to make best use of exosomes in new molecular diagnostics and therapeutics.

"In the expectation that these findings may turn into a clinical reality, extensive studies should be addressed to better elucidate their role [in cancer] in order to reduce the risk of off-target effects or therapeutic failures in the perspective of their translation into the clinical setting," she said.

Lucio Barile, a research scientist at Cardiocentro Ticino in Switzerland, and a co-author on a new review in Pharmacology & Therapeutics entitled, "Exosomes: Therapy delivery tools and biomarkers of diseases," holds a similar view.

According to Barile, the recent interest in exosomes is a "typical example of science repeating itself," noting that exosomes had been studied already in the early 1980s because of their role in intercellular communication.

Barile noted though that because of the immediate potential, companies such as Lonza or Exosome Diagnostics have focused on the shorter-term goal of bringing exosome-based diagnostics to market.

"While traditional tissue biopsies are removed from the body organs to check for diseased protein — an approach that requires a complex invasive surgery — circulating exosomes can be tested for this marker  starting from a less-invasive blood sampling," he noted, "greatly benefitting patients."

However, Barile cautioned that therapeutic approaches, such as those currently envisioned by Lonza, could require "many years of basic research studies and investments" to be fully realized.

"It will take long because the therapeutic approach needs to be carefully validated in large animal models before it goes to the patient," Barile said. He noted that initial enthusiasm for stem cell-based therapies has been downplayed by results in patients that have not always been consistent with those obtained in small animals. "For this reason it's important to carefully evaluate in all aspects the use of therapeutic exosomes."