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Merck Serono bets on precision medicine

pharmafile | March 11, 2015 | News story | Sales and Marketing AstraZeneca, Diagnostics, FDA, Illumina, Merck Serono, opexa, personalised 

Merck Serono is looking to expand further into personalised medicine as the company enters into an agreement with Illumina to develop a new diagnostic, and boosts its personalised MS treatment deal with Opexa.

The German biopharma division of Merck’s deal with Illumina will see the two companies expanding the development of a ‘next-generation’ oncology diagnostic for clinical trials of cancer therapies.

Under the terms of the agreement Merck Serono and Illumina will together develop assays that detect and measure multiple genetic variants in a single tumour. The collaboration will include development of the diagnostic, any regulatory approvals and commercialisation.

“Illumina’s successful regulatory track record was an important consideration in the collaboration,” Merck Serono says in its statement, “as next-generation sequencing platforms cleared by a regulatory agency could accelerate the development of an assay and facilitate the registration of a companion diagnostic.”

Richard Klausner, Illumina’s chief medical officer, adds: “This agreement is another step forward in realising the promise of precision medicine. There is a clear need to expand genetically-based clinical trials as a key approach for developing better treatments for cancer.”

Last year Illumina also entered into an agreement with AstraZeneca to develop a similar diagnostic.

More money for Opexa

Meanwhile Merck has made an extra payment to another US biotech Opexa, to support its personalised MS immunotherapy Tcelna (imilecleucel-T).

The two companies originally entered into an agreement in February 2013, with Opexa receiving an upfront payment of $5 million for granting Merck an option for the exclusive license of Tcelna, which treats secondary progressive multiple sclerosis.

Merck has now given Opexa a further $3 million to support the ongoing Phase IIb Abili-T study for the drug. “We are very pleased with this show of support by Merck Serono towards Opexa’s potential personalized immunotherapy,” says Neil Warma, Opexa’s president and chief executive.

“Our relationship with Merck Serono over the last two years has been productive and we are pleased to strengthen this relationship and expand our development efforts with them in the critical work we are doing in the field of multiple sclerosis.”

Tcelna has received fast track designation from the FDA. Top-line data from the Abili-T study is expected in the second half of 2016.

George Underwood

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