ReachBio, a stem cell assay services company based in Seattle, Wash., this week announced the official launch of its operations.
The company provides contract assay services using in vitro and in vivo stem cell and progenitor cell assays. In particular, ReachBio offers services for evaluating the toxic, inhibitory, or stimulatory effects of compounds on hematopoietic and non-hematopoietic cells.
The founding members of ReachBio are all former managers, scientists, and executives of Vancouver, BC-based StemCell Technologies. Emer Clarke, ReachBio’s chief scientific officer, was the founding scientific director for contract assay services at StemCell Technologies and the head of its education division. Robert Chaney, chief operations officer, was the founding business director for contract assay services and manager of international sales at SCT, which provides products and contract assay services to the stem cell research market.
“Through our collective experience, we were exposed to some of the other aspects of the stem cell market, such as the interest in outsourcing that biotech and pharma companies have, and the pivotal role that cell-based assays, particularly progenitor and stem cells assays, are playing in drug discovery,” Chaney told CBA News this week.
ReachBio offers clients multiparametric high-content assays to evaluate bone marrow toxicity, including hematotoxicity, myelotoxicity, lymphatotoxicity, and neutropenia. In addition, the firm offers stem cell engraftment kinetics, maximum tolerated dose studies, and colony-forming cell content in clinical samples. The company also offers assay design and validation services.
ReachBio is entirely founder-funded, Chaney said. According to him, the founders’ short term plans are to keep the company privately funded. However, angel funding may be in ReachBio’s future as its strategy for growth develops.
Chaney, Clarke, and Eric Atkinson are currently the only staff members at ReachBio. Atkinson, president of BroadReach Biosystems, was formerly director of corporate development and head of marketing at StemCell Technologies. He serves as ReachBio’s management consultant and strategic advisor.
The company plans to increase its head count to about five or six by the end of the year by hiring technologists and scientists.
“Over the longer term, we are looking at assay system development,” Chaney said. “We are looking to develop products either on our own or through partnerships with other companies or research institutes, although they will be based on functional cell-based assay systems.”
The founders’ decision to break away from StemCell Technologies was fueled in part by that company’s Canadian location, said Clarke. She explained that many clinical trials occur in the US and investigators running the trials were very skeptical about sending samples across the border to Canada, because they were afraid it could affect the quality of the samples. The concerns of the investigators made a move across the border to Seattle a logical choice, Clarke said.
In addition, the US Food and Drug Administration recently began to require bone marrow toxicity data be obtained for many types of compounds, whereas previously such testing was mostly required for chemotherapy reagents, said Clarke. This requirement arose from concern that other types of drugs inadvertently affect red and white blood cell precursors.
As a result of these new FDA requirements, more and more pharma companies will be requiring, and likely outsourcing, bone marrow toxicity testing.
Some overlap exists between the assays and services offered by ReachBio and those offered by commercial companies such as cell culture media providers for stem cell assays, Chaney said. In addition, many non-profit laboratories such as transplantation centers perform colony forming cell assays to determine stem cell progenitor content in a tissue sample such as bone marrow, but relatively few organizations offer this as a service to the drug development community.
“ReachBio is different in that we offer a wide range of assays as a service coupled with contract research, consulting, client ‘on-site’ contract work, and educational opportunities such as workshops and seminars,” Chaney said.
For the toxicity assay, “we place the cells in a semisolid matrix with lots of cytokines,” Clarke said. Cells are provided with all of the necessary nutrients and the researchers determine whether the test compounds have a deleterious effect on either the number or size of the colony.
These assays are very versatile, Clarke said. “The other thing that one can do is set up the cells in the matrix, put in erythropoietin as a standard control, and the test compound, and see if the test compound simulates erythropoietin. Is its effect comparable to erythropoietin’s effect?”
“I think a lot of companies see the validity of this type of test.”
Clarke said these assays are applicable for the red blood cell lineage using erythropoietin, for the white blood cell lineage using granulocyte-colony stimulating factor, which is also called neupogen, or for the platelet lineage by looking at molecules that are similar to thrombopoietin.
Clarke said that the company sees a particular market opportunity for its services in the area of erythropoietin mimetic development because erythropoietin is nearing the end of its patent protection.
The use of progenitor and stem cells for toxicity testing is a growing trend in the drug discovery arena, according to Clarke. “I think a lot of companies see the validity of this type of test,” she said.
“Many believe that a primary cell will give you a better readout of how a compound will affect the cells in the body, compared to a cell line that has been transformed and may or may not respond,” she said, “so assays that use primary cells are considered to be high-content assays that provide more pertinent information about how the body would respond to drugs.”
While these assays were originally developed in the ‘60s for the transplantation field, their use in screening has been overlooked until the last few years, Clarke said. “It is only recently that the drug development industry has understood the value of these assays to test compounds to ensure that they do not inadvertently knock out white blood cell and red blood cell precursors,” Clarke said.
Chaney agreed. “Based on our experience working with small companies, virtual companies, or even larger companies, they definitely have an interest in looking at higher-content assays. Basically, they want to get a ‘bigger bang for their buck,’ so to speak.”
Chaney noted that bone marrow is relatively unique among tissues or organs in that the stem cells and progenitor cells can easily be accessed and ex vivo studies performed.
He also cited a recent study from the European Center for the Validation of Alternative Methods — an organization that studies in vitro assays with the goal of reducing the need for animal testing — that looked at the use of colony forming unit for granulocyte macrophages assays and found that it was able to develop an effective model system using a combination of in vitro assays and mouse in vivo data.
“In effect, by using these in vitro assays, you improve data quality in terms of predicting potential toxicity of compounds in phase 1 trials,” said Chaney. He said the stem cell and progenitor assays are among the few cell-based assays that are used for this purpose.
“Consequently, one of the issues that we discuss with clients is the use of these in vitro assays not just for doing toxicity studies early on, but also in the late preclinical phase and phase 1, where they need to look at the compound’s effect on human cells, not just on animal cells, because these are robust assays,” Chaney said.