Siemens Healthcare Diagnostics announced two new companion diagnostics partnerships with pharmaceutical companies ViiV Healthcare and Tocagen, marking a major step for Siemens into this important and fast-growing segment of the IVD market. Both partnerships intend to leverage the clinical trial and commercialization options within Siemens’ CLIA laboratory, as well as Siemens’ established IVD clinical and regulatory expertise.
Siemens’ partnership with ViiV Healthcare will focus on clinical trials related to Celsentri/Selzentry (maraviroc), ViiV Healthcare’s CCR5 co-receptor antagonist for the treatment of CCR5-tropic HIV, followed by potential commercialization of a diagnostics test to assist in patient selection prior to physician treatment decisions, subject to FDA approval.
The Siemens-Tocagen relationship will begin with diagnostic tests to support clinical trials related to Tocagen’s viral gene therapy (Toca 511 & Toca FC) under investigation for the treatment of primary brain cancer, followed by potential commercialization of diagnostic tests for therapy monitoring, subject to FDA approval.
Complementing a move into next-generation sequencing, Siemens’ companion diagnostics business will establish relationships with pharmaceutical companies to offer clinical trial expertise as well as diagnostic test development and commercialization. The company’s CLIA-certified clinical lab in Berkeley, CA is capable of offering a broad range of nucleic acids and immunoassay tests, as well as developing new test approaches as required.
“Siemens’ presence in the emerging companion diagnostics market enables us to leverage our innovation capabilities and deep clinical knowledge to help improve pharmaceutical drug safety and effectiveness,” said Michael Reitermann, CEO, Siemens Healthcare Diagnostics. “More so, it helps align Siemens with new classes of therapies tailored to the individual that hold the promise of improving patient care and delivering on the goal of personalized medicine.”
ViiV Healthcare previously announced the start of the Phase III MODERN Study [Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen], also known as A4001095, comparing its CCR5-inhibitor, Celsentri/Selzentry (maraviroc), to emtricitabine/tenofovir (Truvada), both in combination with darunavir/ritonavir. The 96-week trial will evaluate a two-drug versus three-drug once-daily regimen for the treatment of antiretroviral-naive patients infected with CCR5-tropic HIV-1.
In addition, MODERN is the first large Phase III trial that will compare the performance of a genotypic test with a phenotypic test in identifying patients appropriate for use of Celsentri/Selzentry. Patients will be randomized to undergo screening with either the genotypic or phenotypic test. Genotypic tropism testing in the MODERN study is provided by Siemens Healthcare Diagnostics as part of this partnership and phenotypic testing (Trofile) by Monogram Biosciences. Subject to FDA approval, Siemens Healthcare Diagnostics may commercialize their genotypic tropism diagnostic test.
“Our partnership with Siemens Healthcare Diagnostics is a valuable part of our commitment to addressing patient needs through developing innovative treatment approaches,” said Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. “Celsentri/Selzentry is an important treatment option for people living with CCR5-tropic HIV, and we continue to support the evolution of tropism testing to provide physicians with accurate, accessible and affordable companion diagnostics.”
Tocagen is enrolling patients in its clinical trials of Toca 511 (vocimagene amiretrorepvec), for injection & Toca FC (flucytosine), extended-release tablets. These multicenter, open-label studies are in patients with recurrent high-grade glioma, such as those with glioblastoma multiforme (GBM, Grade 4), who have had prior surgery and chemoradiation. Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a cytosine deaminase (CD) gene selectively to cancer cells. After allowing time for the administered Toca 511 to spread through the tumor, those cancer cells expressing the CD gene may convert the antibiotic flucytosine into the anti-cancer drug 5-fluorouracil (5-FU). In these studies, patients receive multiple cycles of oral Toca FC. Tocagen plans to work with Siemens Healthcare Diagnostics on the assays used during these clinical studies. Subject to FDA approval, Siemens may commercialize diagnostic tests capable of monitoring patient levels of Toca 511 and Toca FC.
“We believe that developing the necessary diagnostic tests with the right diagnostic partner is an important component for the successful commercialization of Toca 511 & Toca FC,” said Harry E. Gruber, CEO, Tocagen. “Siemens’ capabilities in developing commercial viral assays in addition to their market presence in the diagnostics space make them an excellent complement to Tocagen’s focus on the development and commercialization of viral gene transfer products to treat advanced cancer.”