Eleven Biotherapeutics Presents Clinical Data on EBI-005; Aduro Biotech's STING-Targeted CDN Immuno-Oncology Platform Print E-mail
By William Kent   
Thursday, 07 May 2015 18:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 7, 2015. 
Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the presentation of clinical data for EBI-005, its novel, protein therapeutic which is in late-stage clinical development for dry eye disease and allergic conjunctivitis, at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting. Clinical data on Eleven's lead drug candidate, EBI-005, the first IL-1 (Interleukin-1) receptor inhibitor designed for topical ocular administration, demonstrated a clinically relevant effect in dry eye disease and clinically relevant, statistically significant improvements in ocular itching, ocular tearing and nasal symptoms associated with the late phase allergen response utilizing a modified direct conjunctival allergen model in patients with allergic conjunctivitis.
"We are pleased with these data, which further support the important role of interleukin-1 as a key target for ocular surface inflammation, offering a potential new therapy for the treatment of dry eye disease and allergic conjunctivitis," said Abbie Celniker, PhD, President and Chief Executive Officer of Eleven Biotherapeutics. "We are looking forward to reporting top-line pivotal Phase 3 results for EBI-005 in dry eye disease later this quarter and
initiating a Phase 3 study with EBI-005 in allergic conjunctivitis in the second half of this year."
In an oral presentation entitled, "Comparison of Two Clinical Repeat Allergen Challenge Models to Evaluate EBI-005 in the Late Phase Inflammatory Response in Allergic Conjunctivitis," Michael H. Goldstein, MD, Chief Medical Officer of Eleven Biotherapeutics presented data from a Phase 2 study in subjects with moderate to severe allergic conjunctivitis in which EBI-005 was evaluated in two different clinical models adapted for the late phase inflammatory response, an area of high unmet need and

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the allergic conjunctivitis patient population for which EBI-005 is being developed. Based on these data, EBI-005 will be evaluated utilizing a natural environment model in a planned Phase 3 allergic conjunctivitis study of EBI-005 in the second half of this year. Highlights of the presentation include:
EBI-005 demonstrated clinically relevant, statistically significant improvement in multiple symptoms associated with late phase allergen response in a modified direct conjunctival allergen model
Clinically relevant improvements in ocular itching compared with vehicle in a modified direct conjunctival allergen model at the final two efficacy time points
In a poster presentation entitled, "Clinical Development of EBI-005, a Novel Interleukin-1 Receptor Inhibitor, for Patients with Ocular Surface Inflammation," Eleven Biotherapeutics researchers describe how data related to dosing, disease severity, patient selection, and endpoint selection from previously completed clinical studies shaped the design of pivotal, Phase 3 studies for EBI-005 in dry eye disease.
 
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Aduro Biotech, Inc. (Nasdaq:ADRO) announced two publications in prestigious peer-reviewed journals highlighting the anti-tumor activity of its synthetic cyclic dinucleotide (CDN) molecules when used to treat aggressive metastatic cancers in preclinical models. The journal articles in Cell Reports and
in Science and Translational Medicine showcase the ability of Aduro's CDN molecules to specifically target the human STING pathway, which when activated, have been shown to initiate broad innate immune responses that lead to effective and specific adaptive immune responses.
"Having our data peer-reviewed and featured in these major journals is a tremendous validation of our CDN technology and approach to activating the novel STING receptor," said Thomas W. Dubensky, Jr., Ph.D., chief scientific officer for Aduro. "In preclinical animal models, our synthetic CDN molecules potently activate immune stimulating cells including dendritic cells through this central pathway, altering the tumor microenvironment which leads to induction of tumor-specific T cells, durable immune-mediated tumor shrinkage and immune protection when re-challenged with the same tumor cells. In addition, we have shown that our synthetic CDN molecules activate all known variants of human STING receptors. Our ultimate goal with ADU-S100 and other novel CDN candidates is to design compounds that offer an off-the-shelf therapeutic approach to stimulate personalized responses to fight each patient's specific cancer."
 
 
Also Thursday:
 
ACETO Corporation (Nasdaq:ACET), a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, announced today financial results for the third quarter of fiscal 2015 ended March 31, 2015.
Alder BioPharmaceuticals, Inc. ("Alder") (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, Cushing's disease and autoimmune and inflammatory diseases, today provided recent corporate highlights and reported its financial results for the first quarter ended March 31, 2015.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its ArcelisĀ® technology platform, today announced that the Company's first quarter 2015 financial results will be released after market close on Thursday, May 14, 2015. 
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a biopharmaceutical company with a focus on developing innovative therapies for patients with debilitating diseases, today reported financial results for the first quarter ended March 31, 2015.
BG Medicine, Inc. (Nasdaq:BGMD) today announced that the company will host a conference call and webcast on Thursday, May 14, 2015 at 8:30 a.m. Eastern Time to discuss its Q1 2015 financial results before the market opens.
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today its financial results for the first quarter ended March 31, 2015.

Codexis, Inc. (Nasdaq:CDXS), a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, announces financial results for the quarter ended March 31, 2015.

CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders and pre-implantation genetic screening (PGS) services, today reported financial results for the first quarter ended March 31, 2015. 

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced financial results for the first quarter ended March 31, 2015, and provided updates on its initial registration pathway and clinical development programs.

Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced unaudited financial results from operations for both the second fiscal quarter and the six months ended March 31, 2015.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today reported financial results for the quarter ended March 31, 2015, as well as recent highlights.
Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter ended March 31, 2015.

Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today reported its financial results for the three months ended March 31, 2015.

Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, today announced its financial results for the first quarter ended March 31, 2015, and recent corporate and clinical highlights.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX) (Five Prime), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, will report its first quarter financial results on Wednesday, May 13, 2015, after the U.S. financial markets close.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the first quarter ended March 31, 2015.

Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today reported its financial results for the quarter ended March 31, 2015 and provided a business update.
INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to Phase IV contract research organization, today announced that Chief Financial Officer Greg Rush is scheduled to present during the Bank of America Merrill Lynch 2015 Health Care Conference on Tuesday, May 12, 2015, at 10:00 a.m. PDT at the Encore Wynn in Las Vegas.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today reported financial results for the first quarter of 2015, and provided an update on recent accomplishments.
MannKind Corporation (Nasdaq:MNKD) today reported financial results for the first quarter ended March 31, 2015.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced results for the first quarter of 2015.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the quarter ended March 31, 2015.
Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today reported financial results for the quarter ended March 31, 2015. 
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the first quarter of 2015.
Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator, for the prevention of oral mucositis. 
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) today reported its consolidated financial results for the first quarter ended March 31, 2015.
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced that it will report its 2015 first quarter financial and operating results after the close of U.S. financial markets on Tuesday, May 12, 2015. 
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced recent achievements and financial results for the first quarter ended March 31, 2015.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced financial results for the first quarter ended March 31, 2015, and provided an update on the company's recent activities.



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