Clinical OMICS

JUL-AUG 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com July/August 2017 Clinical OMICs 19 With $8 million in new financing, Ser- Immune plans to expand its immune– mapping technology platform and antibody repertoire database, as well as expand its staff and build strategic partnerships. SerImmune's Immune Information Technology (ImmuneIT) platform is designed to reveal the antigens that determine functional immune reper- toires. It does this by mapping circulat- ing antibodies to their diverse antigens using molecular libraries composed of billions of antigen decoys and applying big data informatics tools. Antibodies within a repertoire can be mapped to antigens from infections, allergens, microbiome organisms, autoimmune diseases, and cancers. The platform presents new oppor- tunities for therapeutic as well as diagnostics development, SerImmune CEO Patrick Daugherty, Ph.D., said. "Prior immune repertoire focused companies have focused almost exclu- sively on sequencing the genes that encode B- and T-cell receptors. While this information is clearly useful, it doesn't tell us which antigens these receptors bind. Another problem is that receptors can exhibit widely vary- ing sequences, yet very similar anti- gen specificity," Dr. Daugherty said. "SerImmune is constructing the map to identify which of the many diverse antigens are targeted by the humoral immune response." SerImmune's platform can analyze for an effectively unlimited number of antibody species, in parallel, to provide a detailed picture of immune responses at the epitope level. It employs a diverse peptide library capable of rep- resenting many antigens to probe the repertoire within a specimen. Dr. Daugherty said SerImmune plans to grow its staff to between 16 and 20 people over the next year using proceeds from the financing. Investors included Illumina Ventures, a venture firm funded mostly by Illumina, and Merck & Co., with which SerImmune has launched an R&D; collaboration. The company will apply its immune repertoire characterization platform to clinical and preclinical specimens pro- vided by Merck, which will lead pre- clinical and clinical development and commercialize candidates identified from the collaboration. SerImmune is eligible for payments from Merck tied to achieving development and regu- latory milestones, plus tiered royal- ties on sales of any products resulting from the collaboration. Dr. Daugherty said future SerIm- mune alliances will focus on thera- peutic areas where partners have "a clear and compelling need," adding: "Longer term, we may pursue wholly owned therapeutic programs." "We will partner to discover dis- ease-associated antigens for therapeu- tic antibody development, vaccines, early disease detection, and to develop companion diagnostics in areas where defining the immune repertoire can identify patients likely to respond," Dr. Daugherty said. "SerImmune is also partnering with organizations that have a need to identify environ- mental factors associated with disease for global health and epidemiology." —Alex Philippidis SerImmune to Expand Mapping Platform, Partnerships with $8M Financing Agilent Wins Expanded Use in Europe for Opdivo Diagnostic in Urothelial Cancer Agilent Technologies was granted ex- panded CE marking for its Dako PD-L1 IHC 28-8 pharmDx test in Europe for an addi- tional oncology indication, urothelial can- cer, in patients who are most likely to ben- efit from treatment with the Bristol-Myers Squibb (BMS) cancer immunotherapy Op- divo (nivolumab). PD-L1 IHC 28-8 pharmDx is a qualita- tive immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28- 8. The test is designed to detect PD-L1 (programmed death-ligand 1) protein in formalin-fixed paraffin-embedded (FFPE) tissues of tumor cells for specific cancers. Opdivo indications include treatment of previously treated locally advanced unre- sectable or metastatic urothelial cancer in adults after failure of prior platinum-con- taining therapy regardless of PD-L1 sta- tus. The test received earlier CE marking for use in patients with non-squamous, non-small cell lung cancer (NSCLC), mel- anoma, and, as of last month, squamous cell carcinoma of head and neck (SCCHN). Europe's approval came after PD-L1 IHC 28-8 pharmDx was approved for use with SCCHN patients in Japan. With the expanded CE marking, Agi- lent said, Europe becomes the first region in the world to approve a test designed to assess which patients with urotheli- al cancer are most likely to benefit from Opdivo. n Eraxion / Getty Images

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