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June 15, 2017 (Vol. 37, No. 12)

Insights

  • Industry Watch: With New Lab, Corporate HQ, Selexis Eyes Expanded Workforce

    Selexis says the new laboratory and corporate headquarters it recently dedicated in Switzerland will help the company expand its workforce as well as production capacity.

    Located at the Geneva suburb of Plan les Ouates, the new facility will serve as headquarters for Selexis’ corporate and scientific leadership teams. During a grand opening and ribbon-cutting event, Selexis CEO Igor Fisch, Ph.D., said the new facility was a tremendous accomplishment for the privately held company. Selexis consisted of an office in Geneva and a lab based at the University of Lausanne when the company was established in 2001 with a single scientist and a seed investment of CHF 100,000 ($102,000), he recalled.

    “Since July 2005, Selexis has added 31 jobs, with eight new positions created in the past year alone. The company plans to add more than 15 additional positions in the next four years,” Dr. Fisch told GEN.

    He said the new laboratory will triple the company’s cell line development capacity, including space for bioreactors for non-GPM batches of protein. The company doubled its cell-line development laboratory space in February 2011.

    Selexis specializes in mammalian (suspension-adapted CHO-K1) cell-line generation. The company works with a variety of cell lines, including CHO, BHK, HEK-293, B-cell, and C2C12 cell lines. Most recently, Selexis launched a novel metabolic selection method based on the co-expression of a vitamin B5 transporter.

    The new facility also houses the company’s proprietary SUREtechnology™ platform, which is designed to facilitate rapid, stable, and cost-effective generation of cell lines producing virtually any recombinant protein. Selexis says the platform provides seamless integration of bioproduction phases from discovery to commercialization. The first monoclonal antibody therapeutic developed through the platform was approved in January 2015.

    Earlier this year, Selexis announced that it was applying SUREtechnology to cell lines for three Sanofi biotherapeutics: a “naked” antibody, a bispecific antibody, and a complex recombinant vaccine.

    Selexis’ expansion was driven, Dr. Fisch explained, by both current partnership activities and anticipated company growth. Selexis’ roster of partners has expanded to 95—and includes biopharma giants Amgen and Baxter International, as well as biotechs such as Jounce Therapeutics, Merrimack Pharmaceuticals, Pieris Pharmaceuticals, and Zymeworks.

  • Discovery & Development: Sangamo Collaborates with Pfizer for Hemophilia A Gene Therapy

    Sangamo Therapeutics and Pfizer signed an exclusive, global collaboration and license agreement for the development and commercialization of gene therapy programs for Hemophilia A, including SB-525, one of Sangamo’s four lead product candidates, which Sangamo expects will enter the clinic this quarter.

    “Sangamo brings deep scientific and technical expertise across multiple genomic platforms, and we look forward to working together to advance this potentially transformative treatment for patients living with Hemophilia A,” said Mikael Dolsten, M.D., Ph.D., president of worldwide R&D at Pfizer.

    “Pfizer has made significant investments in gene therapy over the last few years and we are building an industry-leading expertise in recombinant adeno-associated virus (rAAV) vector design and manufacturing. We believe SB-525 has the potential to be a best-in-class therapy that may provide patients with stable and durable levels of Factor VIII protein with a single administration treatment.”

    Sandy Macrae, Ph.D., Sangamo’s CEO, called Pfizer an ideal partner for its Hemophilia A program.

    “We believe Pfizer’s end-to-end gene therapy capabilities will enable comprehensive development and commercialization of SB-525, which could potentially benefit Hemophilia A patients around the world,” noted Dr. Macrae.

    Sangamo will receive a $70 million upfront payment from Pfizer and will be responsible for conducting the SB-525 Phase 1/2 clinical study and certain manufacturing activities.

    Pfizer will be operationally and financially responsible for subsequent R&D, manufacturing, and commercialization activities for SB-525 and additional products, if any.

    Sangamo is eligible to receive potential milestone payments of up to $475 million, including up to $300 million for the development and commercialization of SB-525 and up to $175 million for additional Hemophilia A gene therapy product candidates that may be developed under the collaboration.

    Sangamo will also receive tiered double-digit royalties on net sales. Additionally, Sangamo will be collaborating with Pfizer on manufacturing and technical operations utilizing viral delivery vectors.

  • Genomics & Proteomics: Rady Children’s Institute and Alexion Partner to Tackle Rare Genetic Disease Diagnosis

    Alexion Pharmaceuticals and The Rady Children’s Institute for Genomic Medicine (RCIGM) have recently agreed to a partnership for accelerating the diagnosis of critically-ill newborns with rare genetic disorders. There is an unmet need for employing new molecular diagnostic technology in medicine since as many as 15 percent of babies born in the United States are admitted to neonatal or pediatric intensive care units—with almost one-third affected by genetic diseases or congenital anomalies. This new collaboration combines RCIGM’s genomic research expertise with Alexion data science and bioinformatics capabilities to advance precision medicine for infants in an intensive care setting.

    “Diagnosing acutely ill babies is a race against the clock, so it’s essential for physicians to have access to solutions that will provide answers faster and help set the course of treatment,” explained President and CEO of RCIGM Stephen Kingsmore, M.D., D.Sc. “Winning this race will require a collaborative effort, which is why we are delighted to work with the people at Alexion who share our vision for unraveling the mysteries of genetic disease and giving hope to families with critically sick newborns.”

    In the new venture, Alexion will share research, and further refine the SmartPanel, a platform developed by Alexion that personalizes and prioritizes suspected rare-disease genes from a patient’s next-generation sequenced genome and specific clinical presentation. RCIGM is evaluating the SmartPanel in research to establish positive predictive value, enable electronic medical record integration for rapid phenotypic extraction, and assess overall patient outcomes via earlier diagnosis.

    Rapid diagnosis through genome sequencing can provide definitive answers, allowing physicians to provide timely, targeted treatment that can help prevent a needless diagnostic odyssey and improve medical outcomes. The rapidly falling cost of whole-genome sequencing increases the feasibility of clinical testing for rare genetic diseases.

    “In rare diseases, rapid diagnosis is made all the more challenging by the significant amount of genomic and phenotypic data a clinician must sift through to reach a diagnosis,” stated John Reynders, Ph.D., vice president of Data Sciences, Genomics, and Bioinformatics at Alexion. “This collaboration will help accelerate an accurate diagnosis for patients with genetic diseases, clarify available paths of intervention and provide hope to families.”

  • Bioprocessing: India’s First GE FlexFactory to Be Installed at Dr. Reddy’s

    GE Healthcare announced today that it will install India’s first FlexFactory™ in Hyderabad, at Dr. Reddy’s Laboratories’ biologics production facility.

    With this expansion, Dr. Reddy’s will be able to increase its manufacturing capacity for its portfolio of biosimilars within 9 to 12 months. Most significantly, the new FlexFactory will allow the facility to make the transition from stainless-steel to single-use technologies, with an estimated change-over-time reduction of 50%.

    “We are delighted to be working with GE Healthcare to expand our biologics manufacturing footprint. We strongly believe that the FlexFactory platform from GE will enable us to rapidly ramp-up capacity and serve more patients in both emerging markets and highly regulated markets,” said Cartikeya Reddy, head of biologics at Dr. Reddy’s.

    “We are pleased to partner with Dr. Reddy’s in their efforts to increase the availability and affordability of biopharmaceuticals globally by bringing single-use, flexible manufacturing capacity to its facility in Hyderabad,” said Milind Palsule, country manager, South Asia, GE Healthcare Life Sciences. “India today has one of the fastest growing biopharma sectors in the world and we are keen to support this development and the production capability of Indian pharma players with the latest biopharma technology and know-how.”

  • Molecular Diagnostics: MDxHealth to Develop New Cancer Assays with GROW

    MDxHealth and the School for Oncology and Developmental Biology (GROW) at the Maastricht University Medical Centre (MUMC), The Netherlands, said they will focus on developing next-generation sample in-, result out-based assays that provide insight into the diagnosis, staging, and treatment of cancer.

    MDxHealth said its partnership with GROW is designed to develop technology that can also be applied to its own existing and future liquid biopsy tests, including its urine-based SelectMDx™ for Prostate Cancer biomarker assay.

    The multiyear R&D partnership—whose only use for people and animals—represents an expansion of an existing research collaboration focused on developing epigenetic cancer diagnostics.

    “The development of next-generation liquid biopsy diagnostics for oncology will be game-changing and help physicians manage their patients faster and more effectively,” MDxHealth CEO Jan Groen, Ph.D., said in a statement. “GROW and Maastricht University are true visionaries and we are fortunate to have such a long-standing and collaborative relationship.”

    MDx Health develops tests based on proprietary genetic, epigenetic (methylation), and other molecular technologies, with the aim of providing actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer.

    The company’s tests are designed to assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy.GROW, which is sited at the MUMC, emphasizes translation of basic knowledge into innovative approaches for individualizing prevention, patient diagnostics, and treatment of cancer. GROW also focuses on epigenetic research and teaching, as well as microenvironmental factors underlying normal and abnormal development.

    GROW, which is sited at the MUMC, emphasizes translation of basic knowledge into innovative approaches for individualizing prevention, patient diagnostics, and treatment of cancer. GROW also focuses on epigenetic research and teaching, as well as microenvironmental factors underlying normal and abnormal development.