Summary: A top Pharmaceutical company in Sorrento Valley is now hiring! Multiple openings for both Analytical and Method development Chemists of varying experience. Please e-mail your resume if you are interested in hearing more!
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Morphotek To Present Preclinical Data On Antibody-Drug Conjugate MORAb-202 At The Upcoming 8th Annual World ADC In San Diego
EXTON, Pa., Sept. 19, 2017 /PRNewswire/ — Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it will present preclinical data on its investigational antibody-drug conjugate (ADC) MORAb-202 at the 8th Annual World ADC being held September 20-22 at the Sheraton San Diego Marina in San Diego, CA. The presentation will take place on Thursday, September 21 at 1:30 p.m. PT during the “Practical Lessons Learned from Preclinical ADC Development” session.
MORAb-202 is a novel ADC that uses a cathepsin-cleavable linker to combine investigational farletuzumab with a microtubule inhibitor payload, eribulin*. Farletuzumab is a humanized antibody targeting human folate receptor alpha (FRA) and has been studied in clinical trials for FRA-expressing tumors. FRA expression is observed in a large number of cancers, including endometrial, gastric, non-small cell lung, ovarian and triple-negative breast, but is largely absent from normal tissue. Eribulin mesylate (Halaven®) is approved in the U.S. for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.
*Any ADC employing eribulin as a payload is investigational and has not been approved by regulatory authorities. For more information on Halaven® (eribulin mesylate), please see www.halaven.com or contact Eisai’s Medical Information toll-free number 1.888.274.2378.
“We are pleased to have this opportunity to present MORAb-202 at the upcoming 8th Annual World ADC,” said Nicholas Nicolaides, President and CEO of Morphotek. “Based on the preclinical data to be presented, we are excited to begin transitioning MORAb-202 into the clinical development stage later this year.”
Morphotek will also present three posters on Wednesday, September 20:
- MORAb-202, a novel antibody-drug conjugate comprised of farletuzumab conjugated with eribulin, exhibits long-lasting targeted antitumor activity and payload-mediated bystander effects on the tumor microenvironment (Poster #29);
- Eribulin, a novel microtubule-targeting payload for antibody-drug conjugate development (Poster #28); and
- Site-specific conjugation to native & engineered lysines in IgG by transglutaminase (Poster #5).
In April 2017, Morphotek launched an ADC Services business that leverages its proprietary REsidue-SPEcific Conjugation Technology (RESPECT™) and eribulin-linker platform to assist clients with development of a site-specific bioconjugate-ready monoclonal antibody and ADC through in vivo safety and efficacy validation. Additional services include manufacture of GMP clinical trial material, conducting GLP toxicology studies and development of IHC companion diagnostics for patient screening. For more information on Morphotek’s ADC Services business and RESPECT platform, please visit us at Booth #2 at the 8th Annual World ADC or contact email@example.com.
Morphotek®, Inc., a subsidiary of Eisai Inc., is a clinical-stage biotechnology company focused on developing novel classes of biological-based products to treat cancer, inflammatory and infectious diseases. Our mission is to develop novel targeted therapies that attack underlying disease pathways, and in oncology indications, that can overcome the immunosuppressive effects by tumors on immune-mediated experimental therapies. Our diverse pipeline includes clinical-stage monoclonal antibodies to lead targets folate receptor alpha, mesothelin and endosialin, as well as antibody-drug conjugates and bispecific antibodies to undisclosed targets in preclinical development. Our mission is supported by proprietary cutting-edge technologies in antibody engineering, manufacturing and screening optimization platforms, along with our expertise in developing diagnostics to support patient selection and therapeutic strategy. For more information, please visit www.morphotek.com.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thought to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
About Halaven® (eribulin mesylate) Injection
Halaven® (eribulin mesylate) is a microtubule dynamics inhibitor indicated for the treatment of patients with:
- Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
- Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
The antibody drug conjugate (ADC) employing eribulin as a payload is investigational and has not been approved by regulatory authorities.
Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, Halaven is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells.
Important Safety Information for Halaven (eribulin mesylate) Injection
Warnings and Precautions
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.
Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman.
Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.
QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
In patients with mBC receiving HALAVEN (eribulin mesylate) Injection, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).
In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).
Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.
Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.
For more information about HALAVEN, click here for the full Prescribing Information.
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SOURCE Morphotek, Inc.
Ultra-Rapid, Highly Accurate Platform for Secondary Analysis of Genomic Data Available to New Sequencing Instrument Customers Under Illumina’s Unlimited Data Plan
SAN DIEGO, Sept. 19, 2017 /PRNewswire/ — Edico Genome today announced the availability of its DRAGENTM Bio-IT Platform on Illumina’s BaseSpace® Sequence Hub, enabling users to now run DRAGEN instances to enhance the accuracy and speed of their secondary analysis of next-generation sequencing data.
Powered by Amazon Web Services’ (AWS) new reconfigurable Field Programmable Gate Array (FPGA) enabled F1 instances, Edico Genome’s ultra-rapid DRAGEN Genome Pipeline features optimized algorithms for mapping, aligning, sorting, duplicate marking, variant calling and more. As an alternative to traditional CPU-based systems, FPGAs are able to process genomic data at much quicker speeds, enabling customers to keep pace with high throughput demands. By implementing algorithms as logic circuits, DRAGEN offers unprecedented speeds. To date, DRAGEN customers have processed more than 17 petabytes of data.
“Our collaboration with Illumina is founded on a joint mission – to provide researchers with new and innovative ways to enhance their work in the genomics space,” said Pieter van Rooyen, Ph.D., chief executive officer at Edico Genome. “With the availability of DRAGEN’s Genome Pipeline on BaseSpace Sequence Hub, scientists can more efficiently and seamlessly conduct secondary analysis of genomic data through the online portal, reducing time spent waiting on data and enabling more focus on producing breakthrough results.”
BaseSpace Sequence Hub is a cloud-based platform that is an extension of Illumina instruments for the acquisition and analysis of genomic data, and manages sequencing runs and Illumina sequencing platforms to optimize operations. In June 2017, Illumina announced BaseSpace Sequence Hub’s unlimited data plan, designed to provide customers with a choice between fixed cost, or pay as you go billing, and help organizations mitigate budgeting uncertainties when scaling their operations. Under this arrangement, new BaseSpace Sequence Hub customers have access to unlimited data storage and can harness the full power of the online app platform for the first year of use. Illumina’s fast and comprehensive Whole Genome Sequencing v6.0 app is also available as part of the unlimited plan.
“Our new unlimited storage and compute plan makes it easier to onboard a new sequencing instrument, particularly our powerful and scalable NovaSeq™ Series, enabling customers to confidently construct and maintain budgets to keep their organizations on-track,” said Ilya Chorny, Ph.D., associate director, product marketing at Illumina. “Our goal is to empower our customers to choose the analysis option that best suits their needs by providing a choice between the DRAGEN Genome Pipeline or Illumina’s Whole Genome Sequencing v6.0 App.”
Edico Genome will launch several additional pipelines on BaseSpace Sequence Hub in 2017. These pipelines will also be made available as part of the unlimited plan offered to new BaseSpace Sequence Hub customers. To learn more about DRAGEN on BaseSpace, visit www.edicogenome.com/basespace.
About Edico Genome
The use of next-generation sequencing is growing at an unprecedented pace, creating a need for easy to implement infrastructure that enables rapid, accurate, and cost-effective processing and storage of this big data. Edico Genome has created a patented end-to-end platform solution for analysis of next-generation sequencing data, DRAGEN™, which speeds whole genome data analysis from hours to minutes while maintaining high accuracy and reducing costs. Top clinicians and researchers are utilizing the platform to achieve faster diagnoses for critically ill newborns, cancer patients and expecting parents waiting on prenatal tests, and faster results for scientists and drug developers. For more information, visit www.EdicoGenome.com or follow @EdicoGenome.
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SOURCE Edico Genome
Sorrento Therapeutics, Inc. To Present At Cantor Global Healthcare Conference (09/25/17 – 2:25 PM ET)
SAN DIEGO, Sept. 19, 2017 /PRNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”), announced today that it will participate in the Cantor Global Healthcare Conference, taking place in New York City (Intercontinental NY Barclay Hotel).
Dr Henry Ji, Chairman and CEO will be presenting on Monday September 25th at 2:25PM ET (Rockefeller Track 6).
Interested parties will be able to ask questions following the presentation, and an update of the materials presented will be made available on Sorrento’s website following the event at www.sorrentotherapeutics.com
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Sephrevir®”).
Sorrento’s commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido. Resiniferatoxin is completing a phase IB trial in terminal cancer patients. ZTlido is in regulatory review following NDA re-submission.
For more information visit www.sorrentotherapeutics.com
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the expectations for Sorrento’s and its subsidiaries’ technologies and product candidates. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento’s and its subsidiaries’ technologies and prospects; risks related to seeking regulatory approvals and conducting clinical trials; and other risks that are described in Sorrento’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2015, as amended, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ZTlido™ and G-MAB™ are trademarks owned by Scilex Pharmaceuticals, Inc. and Sorrento, respectively.
Seprehvir®, is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.
All other trademarks are the property of their respective owners.
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved.
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SOURCE Sorrento Therapeutics, Inc.
SAN FRANCISCO, Sept. 19, 2017 /PRNewswire/ — ValGenesis Inc., the global leader in Enterprise Validation Lifecycle Management Solutions (VLMS) is pleased to announce the strategic partnership with VTI Life Sciences (VTI). This partnership enables VTI to provide clients with validation services using the latest technology available in the ValGenesis VLMS system. As a partner, VTI will provide clients with efficient and cost-effective validation services using ValGenesis VLMS. VTI will also be a marketing partner for the ValGenesis VLMS system.
The partnership between ValGenesis and VTI creates a fully comprehensive and innovative approach towards providing validation services using an integrated paperless validation lifecycle management platform. Life science companies will benefit greatly from VTI’s validation expertise and their knowledge of the ValGenesis VLMS platform.
“We are pleased to be a strategic technology partner with VTI and look forward to enhanced efficiency, enabled compliance and reduced costs of Validation lifecycle processes through ValGenesis VLMS,” said Siva Samy, CEO of ValGenesis “We share the same vision, which is providing customers with validation services through VLMS so as to satisfy their every need.”
President of VTI, Herb Matheson, adds: “VTI looks forward to the partnership with ValGenesis and the team of technology experts that ValGenesis represents. Together, VTI and ValGenesis look to providing industry leading, turn-key VLMS integration and support to our customers. We look forward to better serving our clients through this partnership.”
ValGenesis is a comprehensive leading paperless validation lifecycle management solution in the life science industry that allows customers to fully automate the validation process, eliminate inefficiencies found in paper based manual processes, while also reducing costs and validation cycle times. The ValGenesis Validation Lifecycle Management System (VLMS) effectively manages all types of validation activities such as equipment, instruments, computer systems, cleaning, analytical methods, and process validation. ValGenesis’ VLMS covers the entire validation lifecycle thereby delivering technology solutions that are validated, fully configurable and rapidly deployable through onsite or by way of a validated secured cloud environment.
VTI Life Sciences, an ISO 9001:2008 Certified Global Company, strives to maintain and inspire professional excellence by providing Validation, Commissioning, and Qualification (C&Q) Services to Pharmaceuticals, Biotechnology, Biologics, Medical Devices and FDA/Internationally regulated industries. VTI has the experience, expertise, and demonstrated leadership that provides premier validation and compliance consulting services to life science clients.
ValGenesis, Inc. is the creator of an innovative software platform serving as the foundation for managing compliance-based validation activities in Life Sciences companies. ValGenesis, Inc. provides the first enterprise application to manage the corporate validation lifecycle process. As the only system for managing validation execution and approval 100% electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award. The solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. For more information, visit ValGenesis’ website at http://www.valgenesis.com.
About VTI Life Sciences
VTI Life Sciences provides superior service and expertise required to meet life science industry validation needs. Founded in 1996, VTI offers a full range of validation and quality system services for a cGMP/GLP facility. VTI validation professionals have hands-on experience and subject matter expertise in Facility Design and Construction, Utility Systems, Process Equipment, Process Qualification and Computerized Systems Validation.
VTI offers a full spectrum of services such as computer validation, cleaning validation, process validation, clean room certification, temperature mapping, process equipment, facility qualification, and much more. Dedication to quality, personalized support and the success of client projects are at the foundation of the company.
As a leading worldwide consulting firm, the basis of VTI’s business is founded on dedication to quality, personalized support, and the success of projects. VTI offices are located in San Diego, San Francisco, Boston, and China.
510 445 0505
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SOURCE ValGenesis Inc
SOUTH SAN FRANCISCO, Calif., Sept. 19, 2017 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that Raul Rodriguez, the company’s president and chief executive officer, is scheduled to present a company overview at the Cantor Fitzgerald Global Healthcare Conference in New York City on Tuesday, September 26, 2017 at 2:15pm EDT.
To access the live webcast of the presentation or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematological disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current clinical programs include clinical trials of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in a number of indications. Rigel has submitted an NDA to the FDA for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics.
Contact: Raul Rodriguez
Media Contact: Jessica Daitch
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SOURCE Rigel Pharmaceuticals, Inc.
Agena Bioscience Announces Molecular Health As The First Interpretation Software Provider For MassARRAY Insights(TM)
MassARRAY Insights providers will aid in results interpretation
SAN DIEGO, Sept. 19, 2017 /PRNewswire/ — Agena Bioscience, a global provider of molecular genetic solutions and Molecular Health, a leader in cloud-based decision support technology for precision medicine, have entered into a strategic partnership, whereby Molecular Health Guide® (MH Guide) analysis platform will aid interpretation of raw data generated by Agena’s MassARRAY® System. The agreement conceives a framework by which the two parties will cooperate and collaborate with their respective customer bases.
The relationship is part of Agena Bioscience’s MassARRAY Insights reporting network, a collaboration program between Agena Bioscience and preeminent molecular analysis platform providers. It serves to connect the unique capabilities of the MassARRAY mass spectrometer with the power of high quality analysis software, to aid in interpretation.
“Agena Bioscience is focused on enabling labs to generate relevant genomic data. Many of our customers with laboratory developed tests have been interested in additional resources for result interpretation. We believe that Molecular Health’s data interpretation applications based on its Dataome® knowledge platform can greatly streamline the data analysis and interpretation workflow for these customers, and we are happy to have an experienced partner like Molecular Health,” said Pete Dansky, Chief Executive Officer at Agena Bioscience.
“This partnership will enable Agena’s users with the highest quality clinical interpretations to improve the value of Agena’s MassARRAY for their customers.” said Friedrich von Bohlen, PhD, Chief Executive Officer at Molecular Health. He added, “We look forward to coupling Agena Bioscience’s highly scalable MassARRAY System and Molecular Health’s comprehensive molecular data annotation and interpretation applications in order to offer the market at large the value-add of a workflow-centric solution and ultimately informing impactful decisions.”
Information regarding Agena’s MassARRAY Insights reporting network can be found on http://www.agenabio.com/services/insights/
About Agena Bioscience
Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research. For more information about Agena, visit www.agenabio.com.
About Molecular Health
Molecular Health is a computational biomedicine company focused on big-data curation, integration and analytics to enable precision medicine. The company has developed Dataome®, a top quality-curated, interoperable technology system comprising a large set of databases and analytics that allow the integration and referencing of clinico-molecular drug and disease data to generate novel and actionable insights on drug outcomes for stakeholders across the healthcare ecosystem. These include physicians, hospitals, research networks, commercial labs, regulators and Pharma companies. Molecular Health GmbH is ISO 13485 certified for the design, development, and manufacture of software systems for the integrated analysis of clinical and genomic patient data to support treatment decisions and provision of related services (Certificate No: MD 609736). Molecular Health is CAP/CLIA accredited for its bioinformatics offering. In addition, the MH Guide software was the first of its kind to be registered as in-vitro diagnostic medical device (IVD) in Europe, and is CE-marked in compliance with the European regulations. Molecular Health’s scientific and commercial teams are based in Heidelberg, Germany and Boston, MA, USA.
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SOURCE Agena Bioscience
Dr. Andres Gutierrez, Oncolytics’ Chief Medical Officer, to present on the clinical progress and robust safety findings of using reovirus as an immuno-oncology viral agent to treat cancer
CALGARY and SAN DIEGO, Sept. 19, 2017 /PRNewswire/ – Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN®, a first-in-class, intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems, today announced that it will present at the Phacilitate Immuno-Oncology Frontiers Conference. Dr. Andres Gutierrez, Oncolytics’ Chief Medical Officer, will present at 4:00 pm CEST on September 21, 2017 at the Maritim Proarte Hotel. The conference takes place on September 20th and 21st in Berlin, Germany.
Dr. Gutierrez will highlight the role of REOLYSIN in the activation of the immune system and the induction of an inflamed tumor phenotype in the tumor microenvironment. His presentation will also review certain historical clinical programs, highlight the positive survival data from the IND 213 study in metastatic breast cancer (mBC) and the pooled safety database – the largest of any oncolytic virus.
“We want to share our extensive experience with REOLYSIN in the clinic to illustrate the specific expertise and efforts required to develop an oncolytic virus for intravenous administration and systemic exposure in oncology,” said Dr. Gutierrez. “This experience helped us define a clear regulatory pathway for registration in metastatic breast cancer. With an overall agreement with the FDA on the phase 3 study design, details of the pivotal registration study will be made available following evaluation and completion of discussions with clinical advisors and potentially partners, as well as European regulators.”
The Phacilitate Immuno-Oncology Frontiers conference hosts over 300 industry decision-makers and key external stakeholders to come together discuss and define a strategic roadmap to success for immuno-oncology developers, ensuring European patients gain access to the game-changing biotherapeutics of tomorrow. Immuno-Oncology frontiers Berlin is the only European event that offers extensive coverage of the latest emerging science whilst placing it in its wider strategic context as the basis of tomorrow’s successful business and commercialisation models.
REOLYSIN® is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing REOLYSIN, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers. Oncolytics’ clinical development program emphasizes three pillars: chemotherapy combinations to trigger selective tumor lysis; immuno-therapy combinations to produce adaptive immune responses; and immune modulator (IMiD) combinations to facilitate innate immune responses. Oncolytics is currently planning its first registration study in metastatic breast cancer, as well as studies in combination with checkpoint inhibitors as well as targeted and IMiD therapies in solid and hematological malignancies. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company’s belief as to the potential of REOLYSIN® as a cancer therapeutic; the Company’s expectations as to the success of its research and development programs in 2017 and beyond, the Company’s planned operations, the value of the additional patents and intellectual property; the Company’s expectations related to the applications of the patented technology; the Company’s expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company’s business and technologies involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.
SOURCE Oncolytics Biotech Inc.
SAN DIEGO, Sept. 19, 2017 /PRNewswire/ — Pfenex Inc. (NYSE MKT: PFNX) announced today that it will be presenting at the Cantor Fitzgerald Global Healthcare Conference on September 27th, 2017 at 4:00 pm ET. The conference will be held at the Intercontinental New York Barclay Hotel, New York. The presentation will be webcast and available for replay in the Investor Section of Pfenex’s website www.pfenex.com.
Pfenex investors and others should note that we announce material information to the public about the Company through a variety of means, including our website (http://www.pfenex.com/), our investor relations website (http://pfenex.investorroom.com/), press releases, SEC filings, public conference calls, corporate Twitter account (https://twitter.com/pfenex), Facebook page (https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/), and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.
About Pfenex Inc.
Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The company’s lead product candidates are PF708, a therapeutic equivalent candidate to Forteo (teriparatide) for the treatment of osteoporosis, and PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, therapeutic equivalents to reference listed drug products, and next generation biologics.
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SOURCE Pfenex Inc.