CLN - Industry Playbook

Gilead Science, Second Genome Ink $38 Million Agreement

Industry Playbook: June 2020

In a 4-year agreement, Gilead Science and Second Genome have partnered to advance microbiome-based research for inflammatory diseases. Through the partnership, Second Genome will provide its Microbiome Analytics Platform to help Gilead identify biomarkers that track responses to five experimental medicines for inflammation, fibrosis, and other diseases. Additionally, both companies hope to identify new biomarkers for the treatment of inflammatory bowel disease (IBD).

“There is a growing body of evidence that the microbiome plays an important role in disease progression and treatment response in inflammatory diseases,” said William Lee, PhD, executive vice president of research at Gilead. “We look forward to working with Second Genome to investigate the microbiome’s role in inflammatory disease and particularly IBD, where patients can face significant challenges in achieving long-term remission with conventional therapies.”

According to the terms of the agreement, Second Genome will receive $38 million from Gilead, with a promise of an extra $1.5 billion if the five medicines get approved for market sale. The company will also receive up to $300 million for IBD programs. In return, Gilead will claim all rights for each drug produced from the partnership.

One Drop Buys Sano for Digital Technology Platform

The digital healthcare solutions company One Drop announced its acquisition of Sano Intelligence, a company structured around health sensing technology. One Drop will acquire all assets and intellectual property of Sano Intelligence to expand its platform in digital health. The companies plan to develop adaptive, personalized integrated health solutions for real-time patient monitoring via their mobile devices.

Through the agreement, One Drop will make use of Sano’s silicon-sensing production infrastructure to manufacture a painless stick-on device that will assist patients in better understanding and tracking their blood glucose levels. The aim is to enable patients to discover any abnormalities in their health early on to prevent progression to more severe conditions.

One Drop will increase commercialization of the sensing technology by offering end-to-end employer and payor offerings, digital-only offerings, and even retail availability. The company also plans to hire Sano employees as part of the acquisition.

Co-Diagnostics Partners With Promega for Logix Smart COVID-19 Test

Co-Diagnostics has partnered with Promega to rapidly advance production and manufacture of its Logix Smart COVID-19 test. Since Co-Diagnostics received Food and Drug Administration emergency use authorization, domestic demand for the test has increased quickly. As part of the agreement, Promega will therefore help Co-Diagnostics expand manufacturing of the test kits across the U.S. and internationally.

“Promega has shown its dedication to customer satisfaction time and again, with branches in 16 countries and over 50 global distributors. We are confident they will be instrumental in helping Co-Diagnostics meet the growing demand for our products as we connect with even more laboratories and testing centers in the United States and abroad,” said Dwight Egan, CEO of Co-Diagnostics.

The Logix Smart COVID-19 test recently acquired CE Mark approval to be sold as an in vitro diagnostic test to private and public clinical laboratories. The test, which detects RNA from the SARS-CoV-2 virus, has shown 100% sensitivity in patients who show common symptoms, according to the company.

Genetic Testing Agreement for Lysosomal Storage Disorders

To improve diagnosis of lysosomal storage disorders (LSD) in children, Axovant Gene Therapies and Invitae are collaborating in the Detect Lysosomal Storage Diseases (Detect) program, which will focus on genetic testing to advance treatment of conditions including GM1 gangliosidosis and GM2 gangliosidosis, more commonly known as Tay-Sachs/Sandhoff disease.

Studies have shown that LSDs are misdiagnosed in a majority of patients, and if not treated early, these inherited metabolic disorders have the ability to cause premature deaths. The Detect program aims to increase genetic testing and turnaround time of results to diagnose patients sooner for earlier treatment and prevention. The program will target 53 LSD-specific genes to ensure accurate diagnosis. Through the agreement, Invitae will offer testing and counseling free of charge for patients affected by LSDs.

Axovant is currently targeting GM1 gangliosidosis through its AXO-AAV-GM1 clinical program at the National Institutes of Health and is seeking clearance through the Food and Drug Administration’s investigational new drug pathway for its AXO-AAV-GM2 clinical trial.

ArcherDX and Illumina Partner for Worldwide In Vitro Diagnostics

ArcherDX has entered a multiyear agreement with Illumina in a bid to expand its companion diagnostics offerings. Through the partnership, Illumina plans to help ArcherDx commercialize its in vitro diagnostic kits in laboratories and hospitals worldwide.

The collaboration aims to place Archer FusionPlex research products globally while also increasing access to in vitro diagnostic tests performed on Illumina’s NextSeq 550Dx and MiSeqDx systems. The deal could also help ArcherDx receive Food and Drug Administration approval for its tumor Stratafide genomic companion diagnostic for monitoring cancer treatments through patient blood or tissue samples, according to the companies.

“Creating broad access to clinically relevant genomic information is core to our company’s mission, and we expect this commercial partnership with Illumina will accelerate that process,” ArcherDX CEO Jason Myers, PhD, said in a statement. “Illumina’s next-generation sequencing instruments are ubiquitous in thousands of clinical and research settings due to their accuracy, speed, and user experience.”