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Merck Serono, Compugen Form Joint Venture to Develop Genomic Tests for Drug-Induced Toxicity

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Originally published July 2.

Neviah Genomics, a newly established startup, has received initial funding from Merck Serono and will collaborate with therapeutics discovery firm Compugen to develop toxicogenomic tests that can help pharmaceutical firms prioritize therapeutic candidates in their pipelines.

"Neviah is a joint venture in which both Merck Serono and Compugen have made a decision to discover and develop biomarkers for drug-induced toxicity," Compugen CEO Anat Cohen-Dayag told PGx Reporter this week. "In this capacity, Compugen is going to utilize its [proprietary technologies] in order to discover these biomarkers and Neviah Genomics, through its funding from Merck, will validate and develop these biomarkers into a diagnostic test."

Merck Serono, a biopharmaceutical division of Merck KGaA, will provide the initial funding for Neviah Genomics through its Israel Bioincubator Fund, which was launched last year. The startup will be located in Merck Serono's 600-square meter Inter-Lab facilities in Israel.

Compugen, a Tel Aviv-based firm focused on discovering monoclonal antibodies and therapeutic proteins in immunology and oncology, will have equity ownership in Neviah Genomics and has a right to royalties from potential future sales. The companies did not disclose additional financial details of the transaction.

The newly established company is focused on advancing tests that will help drug developers anticipate the potential adverse events that their drugs can cause in patients harboring certain genomic markers. Neviah will validate biomarker leads generated via Compugen's proprietary LEADS and MED computational biology discovery platforms.

According to Cohen-Dayag, Compugen will apply in silico computational approaches to predict toxicity markers by "crunching together" genomic and proteomic information, as well as other data sources.

Compugen's LEADS platform allows researchers to analyze the human transcriptome, proteome, and peptidome and identify novel genes, transcripts, and proteins. The MED platform comprises results from more than 70,000 public and proprietary microarray experiments, which are categorized into 1,400 conditions for which there are therapeutic targets. Researchers can use this database to "predict the expression of different types of gene products in various pathological and healthy conditions," Cohen-Dayag said.

The Neviah Genomics joint venture is an extension of a partnership Merck Serono and Compugen inked in 2009 for the discovery of biomarker signatures for drug-induced toxicity. The partners believe that their investment in Neviah Genomics will pay off as there is a great need among pharmas to gain earlier insights into the safety profiles of investigational drugs and reduce risk of late-stage drug failures due to unforeseen toxicities.

"The more information they can get at this stage on the predictive toxicity of their potential drug, it will help them decide about investments and it may save development time and money on drugs that may be toxic," Cohen-Dayag noted.

She added that any diagnostics that Neviah Genomics develops "are not just for Merck Serono's pipeline."

According to a report released by the UK's Center for Medicines Research, 50 percent of drug candidates in Phase III development fail to reach commercialization. For drug candidates in Phase II development, the success rate is only 18 percent, according to CMR, which examined drug trials conducted by 16 pharmas from 2008 to 2009.

As drug developers increase their investment in genomically guided personalized treatments, they are working to employ pharmacogenomic strategies early in development programs in order to identify patient populations that are most likely to benefit from their investigational agents. The diagnostics-focused non-profit DxInsights reported recently that companion diagnostics that guide treatments to best responders can save as much as $15 billion.

However, once a company such as Neviah identifies a genomically defined drug toxicity profile for a particular therapeutic candidate, it won't necessarily lead to the advancement of a pharmacogenomic drug. Naturally, the decision as to whether to advance a personalized treatment with a companion genomic test or just nix development plans for the candidate altogether will depend on the drug developer's assessment of the financial risks and benefits of each strategy.

With regard to Neviah Genomics' aims, the specific business model the company will pursue to advance diagnostics for predicting drug-induced toxicity is still to be determined. According to Cohen-Dayag, there are a number of possible options. "It may well be that Neviah Genomics develops the tests and commercializes them," she said. "It may well be that Neviah commercializes the tests through a diagnostics tools company or it may be that Neviah gets into an arrangement with a pharma company for the use of its test for internal R&D [purposes]."

Due to confidentiality agreements, Cohen-Dayag could not reveal any near-term projects that Compugen and Neviah Genomics are working on.

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