Fulfilling a promise it made when it acquired TherImmune Research nearly one year ago, Gene Logic has combined its gene expression-based toxicogenomics database with TherImmune’s experience as an early-stage contract research organization to create a novel drug-development offering
The program, called ToxPlus, enables pharmaceutical companies to use a single vendor to help them shepherd candidate compounds from the pre-clinic into the clinic. Specifically, the program calls for Gene Logic to inject rats with the candidate, collect tissue samples, develop a gene-expression profile on those samples based on information in its ToxExpress database, and determine how — or whether — the drug should proceed to the clinic.
Gene Logic is betting ToxPlus will help drug makers decide “how to subtly change a pre-clinical study design so that you’re capturing more relevant evidence in support of an IND,” said Pat Morgan, the company’s director for toxicogenomics product marketing.
The offer is unique because, traditionally, most small and medium-sized drug companies would have to perform pre-clinical toxicology studies either in-house or with a CRO, and perform gene-expression research with a different division or through a vendor such as Gene Logic.
But will drug makers buy into it?
The ToxPlus program was developed to provide drug makers with three pieces of data: It tells them whether their compound is likely to be toxic; what types of pathology it is likely to induce; and if its profile has an analog in the ToxExpress database.
For example, results of a ToxPlus study may tell pharma companies that their compound “looks like it’s going to be toxic in humans, [and that] it has a pathology that is similar to an inducer-enlarger,” Morgan told SNPtech Pharmacogenomics Reporter. “Next, let’s say that the compound matches [the profile of the barbiturate] … Phenobarbital. What’s really interesting about Phenobarbital is that is can cause rat-specific thyroid tumors, and it has absolutely no indication of that at all in humans.
“So what would you do different?” she said. “You’ve looked at this compound prior to your pre-clinical safety assessment; one of the things that is apparent here is that you would add additional clinical-chemistry parameters to look for thyroid hormones. It’s not something that people normally do.”
According to Gene Logic, ToxPlus can save drug makers’ money by saving them time, as it’s more expensive — and likely more damaging — to stumble upon a drug’s toxicity in the clinic. However, there is no accurate way to determine how much money a drug maker can save if it employs the ToxPlus program to nab a toxic candidate.
“We would say, in general, that if the program were to be implemented at the point of candidate nomination, or right before clinical development, and it’s followed through, it is easy to imagine that pharma companies can save a minimum of about $10 million per successful [new chemical entity],” said Morgan. “But it can go way beyond that.”
Morgan said that all of Gene Logic’s existing ToxExpress customers can integrate the TherImmune component into their drug-development processes. She added that the company is “on the verge of signing” two service contracts with a pair of pharma companies.
Robert Burrows, a spokesman for Gene Logic, added that drug makers these days “are looking to compress things in terms of steps in the overall process, but also the vendors on whom they are reliant for these kinds of services.”
Some toxicologists believe drug makers will appreciate that both services fall under the umbrella of a single company. “Intellectually, it makes sense,” said Kenneth Ramos, a professor of toxicology at the University of Louisville Department of Biochemistry and Molecular Biology, and a researcher in the school’s Center for Genetics and Molecular Medicine. “Oftentimes, through the interface [of two or more labs] you lose connectivity, and presumably consolidation would offer some protection against that.”
Gene Logic set in motion the wheels of this program when it decided to acquire TherImmune in February 2003. For one thing, TherImmune was an established CRO that concentrated on pre-clinical safety assessments — which Gene Logic brass believed would make a nice fit with their own toxicogenomics platform.
Specifically, TherImmune’s CRO chops enable Gene Logic to help pharma customers determine a candidate’s developmental and reproductive toxicity, necropsy, neurotoxicity, and other toxicological endpoints. TherImmune’s programs cover two to three years worth of studies “that are required” by the US Food and Drug Administration, said Morgan.
Essentially, Gene Logic’s ToxPlus program would begin looking at the toxicological profile of a candidate one step before the traditional hepatotoxicity or nephrotoxicity studies are begun, said Morgan. ToxPlus “does, very clearly, give you the ability to predict hepatotoxicity before any overt injury” and “hone in” on an organ of interest, she added.
The acquisition, which closed in April 2003 for around $52 million in cash and stock, had an immediate financial effect on Gene Logic by buoying its fourth-quarter top line. Total revenue for the three months ended Dec. 31 increased to $19.7 million from $14.8 million one year ago — largely on the shoulders of the $5.8 million generated by TherImmune Research.
Without the acquisition, Gene Logic’s revenue for the fourth quarter 2003 would have fallen by nearly $1 million to $13.9 million.
Elsewhere in the company’s fourth-quarter balance sheet, R&D costs decreased to $500,000 from $800,000 during the same quarter a year ago, while net loss decreased to $4.9 million, or $.16 per share, from $5.2 million, or $.19 per share, during the fourth quarter a year ago.
As of Dec. 31, Gene Logic had approximately $111.8 million in cash, cash equivalents and marketable securities available for sale. This included $48.7 million in cash and cash equivalents.