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HemoGenix Will Use HALO Tech to Evaluate ImmuneRegen BioSciences Rx Candidate

Contract research-service lab HemoGenix this week said it will use its internally developed and validated in vitro assays to help development-stage biotech shop ImmuneRegen BioSciences test its therapeutic candidate Homspera.
A derivative of substance P, a peptide immunomodulator and homeostatic compound that improves pulmonary function and stimulates the immune system, Homspera is designed to be used as a countermeasure against bioterrorist threats, the manufacturer said.
ImmuneRegen was “intrigued” by HemoGenix’ assay, in which it takes a traditional stem cell-classification and -activity assay — the colony-forming cell assay — “and basically makes it quantitative,” said Hal Siegel, vice president and CSO at ImmuneRegen.
According to Siegel, HemoGenix’ platform, called Hematopoietic/Hemotoxicity Assays via Luminescence Output, or HALO, gives ImmuneRegen two advantages over traditional colony-forming cell assays.
“It gives the company, in terms of reproducibility, an assay that it can use repeatedly to assess and compare different preparations and cell types,” Siegel told CBA News this week. “It also gives ImmuneRegen the ability, as it talks to potential partners and regulatory agencies, to have an assay that may be a cellular activity assay, but that can also be validated because it is quantitative and reproducible.”
ImmuneRegen, based in Scottsdale, Ariz., works with companies in the stem-cell space, and HemoGenix offers the ability to quantify the well-recognized colony-forming assay for stem-cell activation, said Siegel.
The company will test Homspera next week, and expects the results approximately two weeks after that, Ivan Rich, founder and CEO of HemoGenix, told CBA News this week.
HemoGenix’ IP portfolio is currently built exclusively around Homspera, said Siegel. “Its activity in stem cells is something that the company is extremely interested in pursuing, because it underlies a lot of the research activity that it sees in terms of protection from radiation and immune stimulation, protection from anthrax, protection from avian flu, as well as potential wound-healing and vaccine adjuvant capabilities.”
According to Siegel, ImmuneRegen has been communicating with the US government for a number of years about Homspera’s progress, because of the compound’s potential as a countermeasure against bioterrorist attacks.
HALO “is an assay that ImmuneRegen thinks will help it in those discussions, both with the government and with commercial entities that may be potential partners,” said Siegel.
Terms of the current deal call for ImmuneRegen to pay HemoGenix milestone payments. According to Rich, “usually it’s a sum upfront, another sum after the draft report has been sent, and then a final amount after the final report has been sent.”
Teaching Old Tech New Tricks
The basis of HemoGenix’ technology goes back to 1966 when groups in Australia and Israel developed an assay called the colony-forming cell assay, said Rich. He said this assay has not changed in the last 40 years in terms of its protocol and how it is run.
HemoGenix was founded in 2000 in Colorado Springs, Colo., on the “basis … that a niche existed in the biopharma industry that allowed the company to develop specific assays that overcame the drawbacks to the colony-forming cell assay and had, up until that time, not been available,” Rich said.
He said that the colony-forming cell assay had its drawbacks, including the fact that it is a manual assay; it is subjective; it cannot be standardized; and it is very difficult, if not impossible, to validate.
The HALO platform, which is an ATP-based bioluminescence proliferation assay, avoids those drawbacks.
According to Rich, HALO, which was introduced as a contract service in March 2002, is non-subjective, completely standardized, and can be validated against the original colony-forming assay and against IC50 assays. “As a matter of fact, the assay has been validated against the Registry of Cytotoxicity Prediction Model that was published in NIH Publication No.: 01-4500.”

HALO “gives ImmuneRegen the ability, as it talks to potential partners and regulatory agencies, to have an assay that may be a cellular activity assay, but that can also be validated because it is quantitative and reproducible.”

The assay has matured over the years from one originally based on the colony-forming cell assay into a highly refined, 384-well, high-throughput assay, said Rich, who said it can be used in virtually any stage of drug discovery and development, from screening to patient monitoring.
In December 2003, HemoGenix introduced the HALO assay kit product line. The company now offers four HALO kits: HALO-96 MeC, a 96-well assay which uses methyl cellulose; HALO-96 SEC (Suspension Expansion Culture); HALO-384, a high-throughout assay that uses SEC technology; and HALO-96 PQR, a stem cell-potency quality-release assay that can be used by cord blood banks and stem cell-transplantation centers to determine if a stem cell product is suitable for transplantation (see CBA News, 6/23/06).
While HALO is specific for hematopoietic stem cells, Rich said HemoGenix offers a platform called Lumenesc that is specific to the mesenchymal stem cell system. Lumenesc detects and quantifies the four cellular parameters indicated by changes in ATP concentration: proliferation/cytotoxicity, viability, cellular integrity/mitochondrial activity, and apoptosis. 
It sells another platform, called LumiSTEM, which he described as “a general assay that can be used for multiple cell types from multiple cell systems.” For example, he said, it can be used to look at embryonic stem cells from different species and from different organs. LumiSTEM quantifies the proliferative/cytotoxic status of non-hematopoietic stem cells and other proliferating cell types under varying conditions of the investigator’s choosing.
These three platforms are ATP-based, bioluminescent proliferation assays, so they all have the same readout, Rich said. “When all three platforms are put together, they form a platform that HemoGenix calls ComparaTOX, which detects the effects of agents on more than 50 different cell types from 14 cell systems simultaneously, if necessary.” 
The effects of compounds on multiple cell types can be evaluated, and the compounds can then be ranked in order of their potential toxicity, said Rich.
“All of these assays were originally developed for fresh, primary human cells,” Rich said. “Over the years, however, they were developed for different species, including nonhuman primate, dog, rat, mouse, and even sheep.”
Sell Proliferation
HemoGenix primarily serves three market areas — biopharma, academic and government basic research labs, and quality control for stem cell-transplantation and cord blood storage-processing laboratories.
The company currently employs five people, and Rich said that it is not planning any more hires in the immediate future. “The company has just hired two people. Someone else will be joining us at the end of February,” he said.
However, over the next two to three years, it plans to put a greater emphasis on sales and marketing. The “emphasis in the future will be on dramatically expanding its market share,” Rich said.
To that end, HemoGenix has recently hired a sales and marketing representative for the East coast and plans to hire another such rep for the West coast later this year.
The company would also like to establish a footprint in the veterinary market, Rich said. “HemoGenix has assays that are available for a number of species, and until now, those species have been defined by those actually used in drug development for preclinical animal studies,” he said. “The company would like to adapt its present assays to use for horses, pigs, and various other species.”
The veterinary market is a very specific market, said Rich. The company will need to first develop its assays so that they can be used in the vet space. “It’s not a difficult thing to do,” Rich said. “HemoGenix just needs to find the time to do it.”

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