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Here is a rundown of all 15 FDA-approved companion diagnostics, a pair of CDx submissions for FDA review, and 35 recent announcements of CDx collaborations between developers of diagnostics and drugs. [© adimas - Fotolia.com]
Life Technologies (being acquired by Thermo Fisher Scientific) and Bristol-Myers SquibbAgreement announced September 17, 2012Master Development Agreement Collaboration—the second between the companies—covers an initial oncology project, and a long-term partnership “across a potentially broad range of Life instrument platforms and a wide range of therapeutic areas.” Specific drugs and cancer indications undisclosed. In oncology, “hundreds of agents are currently in clinical trials, and we see strong market opportunity in the robust expansion this will mean for the companion diagnostics space," Ronnie Andrews, president of medical sciences at Life Technologies, said in a statement.Financial terms not disclosed.
PrimeraDx and Eli LillyAgreement announced June 26, 2012“Multi-year” collaboration to develop diagnostic that will apply Primera Dx’s ICEPlex System assay-development platform to identify multiple DNA and RNA biomarkers: “Our early focus will be in oncology,” Andrew Schade, M.D., Ph.D., senior director, Clinical Diagnostics Laboratory at Lilly, said in a statement, adding that what is learned would be applied later “across therapeutic areas.” Drugs and specific cancer indications undisclosed.Financial terms not disclosed.
Genomic Health and OncoMed PharmaceuticalsAgreement announced May 2, 2012Collaboration to discover biomarkers designed to help identify subsets of patients that will more likely respond to cancer therapeutics, targeting the Notch, Wnt, and other pathways critical to the spread of cancer stem cells. OncoMed providing Genomic Health with breast, prostate, colon, and lung tumor samples, some of which will include OncoMed's proprietary xenograft models derived from freshly resected human cancers.Financial terms not disclosed.
Roche (Ventana Medical Systems) and Seattle Genetics and Takeda Pharmaceutical (Millennium: The Takeda Oncology Company)Agreement announced April 12, 2012Ventana to develop, manufacture, and commercialize diagnostic for use alongside Adcetris (brentuximab vedotin), jointly developed by Seattle Genetics and Millennium. Diagnostic will be designed to detect CD30 expression levels in tissue specimens, and thus identify additional patients who might benefit from Adcetris. The antibody-drug conjugate was approved by FDA in 2011 for relapsed Hodgkin lymphoma and systemic anaplastic large call lymphoma.Financial terms not disclosed.
HTG Molecular Diagnostics and SanofiAgreement announced March 30, 2012Collaborative program to identify biomarkers that may lead to the development of a companion diagnostic to help identify patients most likely to respond to a new Sanofi investigational cancer drug. Drug and specific cancer indications not disclosed. Diagnostic will apply HTG Molecular Diagnostics’ qNPA technology measures mRNA and/or miRNA expression in formalin-fixed paraffin embedded tumor samples, allowing clinicians to verify the presence of certain biomarkers relevant to patient selection and therapy.Financial terms not disclosed.
Myriad Genetics and Teva Pharmaceutical (Cephalon)Agreement announced March 28, 2012Collaboration to test for BRCA1 and BRCA2 mutation via Myriad’s lead product, BRACAnalysis® on patients before their enrollment in a Phase I/II clinical study for a drug candidate. Drug and specific cancer indication not disclosed.Financial terms not disclosed.
Abbott (Abbott Molecular) and Merck & Co.Agreement announced March 6, 2012Collaboration to evaluate the use of a FISH-based companion diagnostic for use alongside a Merck investigational cancer therapy. Drug and specific cancer indication not disclosed. Abbott agreed to develop a test based on its FISH technology, intended to identify deletions of the TP53 gene in cancer patients. Abbott FISH will be evaluated in clinical trials to help identify patients more likely to respond favorably to the Merck investigational cancer drug.Financial terms not disclosed.
Biodesix and KadmonAgreement announced February 27, 2012Collaboration to apply Biodesix’ VeriStrat® in a Phase III NSCLC study of Kadmon’s KD019, a reversible TKI targeting EGFR, Her2, VEGFR2 & 3, and SRC. Trial designed to evaluate KD019 compared to erlotinib in patients with stage IIIB/IV NSCLC who have progressed after first- or second-line chemotherapy.Financial terms not disclosed.
Agilent Technologies (Dako) and AmgenAgreement announced February 20, 2012Collaboration agreement to develop a diagnostic for “an Amgen cancer drug candidate in clinical development” that is also “a rare but deadly cancer.” Drug and specific indication not disclosed.Financial terms not disclosed.
Siemens Healthcare Diagnostics and ViiV HealthcareAgreement announced February 7, 2012Collaboration to develop a diagnostic for use alongside ViiV’s Celsentri/Selzentry® (maraviroc), an experimental CCR5 co-receptor antagonist for CCR5-tropic HIV, in the Phase III MODERN trial [Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen], also known as A4001095. The 96-week trial is designed to comparing its CCR5-inhibitor, Celsentri/Selzentry® (maraviroc), to emtricitabine/tenofovir (Truvada®), both in combination with darunavir/ritonavir. Also being compared in the trial is the performance of a genotypic test with a phenotypic test in identifying randomized patients appropriate for use of Celsentri/Selzentry®. Genotypic tropism testing in the MODERN study is provided by Siemens Healthcare Diagnostics; phenotypic testing (Trofile®), by Monogram Biosciences.Financial terms not disclosed.
Siemens Healthcare Diagnostics and TocagenAgreement announced February 7, 2012Collaboration to develop diagnostics to support clinical trials related to Tocagen's viral gene therapy (Toca 511 & Toca FC) for primary brain cancer, followed by potential commercialization of the diagnostic tests for therapy monitoring. Tocagen is enrolling patients in clinical trials of Toca 511 (vocimagene amiretrorepvec), for injection & Toca FC (flucytosine), extended-release tablets. Study designed for 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 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 anticancer drug 5-fluorouracil (5-FU).Financial terms not disclosed.
Roche (Ventana Medical Systems) and Bayer HealthCareAgreement announced January 17, 2012Strategic collaboration to develop a molecular companion diagnostic test intended to identify patients most likely to benefit from a Bayer antibody-drug conjugate (ADC). Diagnostic will apply Ventana’s diagnostic immunohistochemistry platform, designed to analyze the expression level of certain tumor targets serving as biomarkers in clinical studies for patient selection. Ventana agreed to initially develop, manufacture and commercialize a companion diagnostic test for one of Bayer’s ADCs. Over five years, however, both parties may launch further projects to develop molecular diagnostic tests in support of additional targeted cancer therapy drugs.Financial terms not disclosed.
Foundation Medicine and SanofiAgreement announced January 10, 2012Foundation Medicine agreed to use next-gen genomic sequencing and analytic capabilities to identify genetic biomarkers and potential companion diagnostics for select Sanofi oncology drug candidates. Drug candidates and specific cancer indications not disclosed. Collaboration will apply Foundation Medicine’s comprehensive cancer genomic test to analyze routine clinical specimens for molecular alterations in approximately 200 cancer-related genes.Financial terms not disclosed.
Agilent Technologies (Dako) and AmgenAgreement announced January 10, 2012Development and collaboration agreement to develop a diagnostic for “an Amgen cancer drug candidate targeted for a rare and deadly cancer” that is also “a low-incidence cancer.” Drug and specific indication undisclosed.Financial terms not disclosed.
Roche (Ventana Medical Systems), Pfizer, and Cell Signaling Technology (CST)Agreement announced January 9, 2012Collaboration to develop diagnostic for use alongside Pfizer drug Xalkori. Ventana agreed to develop the first fully automated and standardized immunohistochemistry companion diagnostic for ALK gene rearrangements. Diagnostic will apply CST’s D5F3 antibody and Ventana’s Optiview DAB detection platforms to measure the associated protein product when an ALK gene rearrangement is present. The diagnostic will be designed to identify NSCLC patients with ALK gene rearrangements who may benefit from the Pfizer drug.Financial terms not disclosed.
Xenon Pharmaceuticals and Roche (Genentech)Agreement announced January 9, 2012Strategic alliance designed to discover and develop companion diagnostics and compounds for pain. Genentech awarded an exclusive license to compounds and a nonexclusive license to diagnostics from Xenon for development and commercialization of products.Financial terms: Xenon received an undisclosed up-front payment, plus research funding and eligibility for payments tied to undisclosed research, development and commercialization milestones, all totaling $646 million for multiple products and indications. Xenon will receive royalties on sales of products from the collaboration.
Roche (Ventana Medical Systems) and Aeterna ZentarisAgreement announced January 5, 2012Companies to develop a companion diagnostic for use alongside Aeterna Zentaris’ doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound AEZS-108 against cancer. Announcement cites positive final Phase I results in LHRH-receptor expressing endometrial and ovarian cancer, while raising the possibility of additional indications by adding that LHRH receptors are “are expressed in a significant proportion of endometrial, ovarian, breast, bladder, prostate, and pancreatic tumors.”Financial terms not disclosed.
Roche (Ventana Medical Systems) and Syndax PharmaceuticalsAgreement announced January 5, 2012Companies agreed to develop a companion diagnostic for use alongside erlotinib and Syndax' lead drug candidate entinostat. Diagnostic to apply Ventana’s in vitro diagnostic kit to measure levels of E-cadherin in epithelial tissues, to identify patients likely to benefit from combination therapy of erlotinib plus entinostat.Financial terms not disclosed.
Metamark Genetics and Johnson & Johnson (Janssen Biotech)Agreement announced December 19, 2011Research, collaboration, and license agreement applying Metamark’s discovery platform to identify and characterize specific cancer targets demonstrated to play a causal role in promoting tumor progression and spread. Upon selection of targets, Janssen will receive a limited exclusive license and take responsibility for discovery, development, and commercialization of therapeutic inhibitors for the cancer targets.Financial terms: Metamark received an undisclosed initial up-front payment from Janssen, and is eligible for near-term milestone payments following initial target validation. Metamark may be eligible to receive up to $365 million in milestone payments across multiple targets, tied to specified but undisclosed development, regulatory, and commercialization goals. Metamark will also be entitled to royalties on worldwide net sales of therapeutics and any associated companion diagnostics upon commercialization.
MDx Health and CelldexAgreement announced December 2, 2011Companies agreed to use MDxHealth’s epigenetic MGMT test during recruitment of patients for Phase III global clinical study of Celldex’ immunotherapeutic vaccine rindopepimut in newly diagnosed GBM. Diagnostic will be used to determine the methylation status of the MGMT promotor gene in patients enrolled in the rindopepimut study.Financial terms not disclosed.
Abbott (Abbott Molecular) and GlaxoSmithKlineAgreement expanded November 28, 2011 and March 3, 2010; originally announced July 13, 2009Collaboration to develop diagnostic to support GSK's cancer immunotherapy research program by identifying specific DNA sequences to guide physicians in determining patient benefit from specific drugs. Expanded agreement entails development of a PCR test for use on the Abbott m2000rtTM instrument to screen NSCLC tumors for the expression of the PRAME antigen of melanoma, expressed in most NSCLC cases as well as other cancer types, including melanoma, breast, ovarian, and bladder cancer. Earlier agreements focused on the development of PCR tests to screen NSCLC and melanoma tumors for expression of the MAGE-A3 antigen, in a large variety of cancers, including melanoma, NSCLC, head and neck, and bladder cancer.Financial terms not disclosed.
Agilent Technologies (Dako) and Bristol-Myers SquibbAgreement announced November 9, 2011, by BMS and Dako, acquired last year by AgilentBroad Framework Agreement to develop diagnostics intended to identify patients more likely to benefit from treatment with investigational drug candidates under development by BMS. Drugs and indications not disclosed. Expansion of a collaboration launched in 2008.Financial terms not disclosed.
Life Technologies (being acquired by Thermo Fisher Scientific) and GlaxoSmithKlineAgreement announced October 25, 2011Collaboration designed to develop a companion diagnostic to a GSK candidate cancer immunotherapy. Life will apply its Taqman® Array Card technology to develop a qPCR-based diagnostic assay for GSK's MAGE-A3 cancer immunotherapy candidate, designed to identify patients likely to benefit from the experimental drug, now in Phase II development for melanoma and NSCLC, and Phase I for bladder cancer.Financial terms not disclosed.
Foundation Medicine and Johnson & JohnsonAgreement announced October 25, 2011Collaboration designed to apply Foundation Medicine’s clinical cancer genomic test to identify potential biomarkers to support J&J Pharmaceutical Research and Development oncology clinical development programs. Drug candidates and specific cancer indications not disclosed. Diagnostic uses next-generation sequencing to analyze routine clinical specimens for molecular alterations in more than 200 cancer-related genes.Financial terms not disclosed.
Qiagen and Eli LillyAgreement announced September 6, 2011Partnership to develop diagnostic for use alongside Eli Lilly’s JAK2 inhibitor blood cancers candidate, which targets the Janus kinase 2, or JAK2, gene associated with myeloproliferative neoplasms. The PCR-based diagnostic will apply Qiagen’s Rotor-Gene Q platform to qualitatively and quantitatively test for JAK2 V617F mutation, in order to identify patients most likely to benefit from the pathway inhibitor. Qiagen initially licensed the JAK2 inhibitor from Ipogen before acquiring the French company later in 2011.Financial terms not disclosed.
Skyline Diagnostics and Clavis PharmaAgreement announced September 6, 2011Research agreement, under which Skyline agreed to investigate gene expression biomarkers for selection of individual acute myeloid leukemia (AML) patients that may benefit from an experimental drug then being developed by Clavis. All development of elacytarabine was halted April 1 after the elaidic acid derivative of cytarabine failed the CLAVELA Phase III study, showing no significant improvement in overall survival among patients with relapsed/refractory AML randomized to either the drug candidate or a treatment of the investigator’s choice.Financial terms not disclosed.
Qiagen and PfizerAgreement announced August 16, 2011Partnership to develop diagnostic for use alongside investigational compound dacomitinib (PF-00299804), an oral Her1, Her2, and Her4 TKI now in Phase III clinical trials for NSCLC. As of April 22, ARCHER 1050 trial was recruiting participants, while the Phase III ARCHER 109 trial was active but not recruiting as of April 9, according to ClinicalTrials.gov. Pfizer is co-developing the drug with The SFJ Pharmaceuticals Group. Diagnostic will apply Qiagen’s KRAS assay technology to identify patients with wild-type KRAS who are generally most likely to respond to EGFR inhibitor therapy.Financial terms not disclosed.
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