HTG Molecular Diagnostics is expanding its year-old collaboration with Merck KGaA beyond companion diagnostics with a complementary focus on translational programs, the companies said.
The value of the expanded collaboration was not disclosed.
The companies’ new Master Collaboration Agreement includes a statement of work with EMD Serono, Merck KGaA’s biopharmaceutical business in the U.S. and Canada. Under the companies’ first program statement, HTG plans to develop and manufacture a custom profiling assay designed to support biomarker research for six undisclosed indications within Merck KGaA’s drug development pipeline.
The profiling assay is expected to be designed for use on HTG EdgeSeq instruments to be acquired by Merck KGaA and/or their contract research organization partners, the companies said.
EdgeSeq technology—which combines HTG Edge chemistry and automation with next-generation sequencing (NGS) technology—is designed to automate highly multiplexed molecular profiling of small samples for NGS.
HTG launched EdgeSeq in 2014, the year it received its first patent for the technology. In 2017, HTG introduced to market a new direct-target sequencing chemistry for DNA analysis, offered in the company’s VERI/O services laboratory.
“We are pleased to expand our relationship with Merck KGaA, Darmstadt, Germany, into earlier research stages of their programs, and have already begun work on an initial custom assay development program,” HTG President and CEO TJ Johnson said in a statement. “They are terrific partners, and we appreciate the confidence their teams have placed in us and our HTG EdgeSeq technology.”
HTG is eligible for up to $9.9 million in upfront and milestone payments under the initial master CDx agreement inked with Merck KGaA in October 2016. The initial focus of that collaboration was the development of a test designed to be used with Merck KGaA’s Bruton's tyrosine kinase (BTK) inhibitor candidate M7583. The test is to be based on HTG's EdgeSeq Diffuse Large B-Cell Lymphoma (DLBCL) Cell of Origin Assay.
The project has three stages, all aligned with timelines and outcomes of M7583 development. During stages 1 and 2, HTG has agreed to perform specified DLBCL Assay development activities and sell DLBCL Assay kits and/or perform sample processing services upon request of, and as instructed by, Merck KGaA. In stage 3, HTG has agreed to pursue regulatory approvals on the DLBCL Assay and introduce it commercially in the U.S. and other unspecified jurisdictions.
Stages 2 and 3 each have upfront payments, and all stages have milestone-based payments, HTG disclosed in its Form 10-K for 2016.
During the second quarter of 2017, HTG earned its first milestone-based payment under the master CDx agreement, receiving $25,000 in service revenue for the completion of research and development services, the company disclosed in a Form 10-Q filing. That money was a fraction of the $5,281,483 in total service revenue recorded by HTG for the first nine months of 2017.
Merck is one of two biopharma giants with which HTG launched collaborations in 2016; the other is Bristol-Myers Squibb (BMS). The collaborations were two of 36 such projects with 16 biopharmas using HTG technology in their clinical research and drug development programs as of December 31, 2016. The number of HTG’s partner biopharmas grew in 2017, in part through a master services agreement with Daiichi Sankyo and a research agreement with France’s Centre Léon Bérard, both covering separate projects to develop targeted therapies.