All posts in Peptide News from Biotech and Pharma

Source: SELLAS Life Sciences Group & reported by http://www.prnewswire.com/
ZUG, Switzerland and NEW YORK, May 24, 2016 /PRNewswire/ -- SELLAS™ Life Sciences Group (SELLAS™), a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancer, today announced that results from a Phase 2 trial of the Company's WT1 cancer vaccine, galinpepimut-S, in patients with acute myeloid leukemia (AML) will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, IL, June 3-7, 2016. SELLAS™ also will present a poster detailing Phase 2 results of its WT1 cancer vaccine for the treatment of patients with malignant pleural mesothelioma (MPM). In addition, SELLAS™ announced today that ZELTHERVA has been formally accepted by the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research as the proprietary name for SELLAS™'s cancer vaccine. SELLAS™'s WT1 vaccine is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including AML, MPM, multiple myeloma, ovarian cancer, and multiple other cancers. Based on the results of its mid-stage clinical program, SELLAS™ expects to begin a pivotal Phase 3 trial of its WT1 vaccine in AML patients and a pivotal Phase 2b/3 trial of its WT1 vaccine in patients with MPM later this year.
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About the Phase 1 and 2 Trials in AML: Phase 1 and Phase 2 trials studied the WT1 analog peptide vaccine in combination with Montanide-adjuvant + GM-CSF in patients with AML who were in first complete response and completed any planned post-remission therapy. Altogether, 31 patients were enrolled in the two studies at Memorial Sloan Kettering Cancer Center. The WT1 vaccine was also provided to the Moffitt Cancer Center for an independent Phase 2 study in AML and myelodysplastic syndrome (MDS) patients (N=10) in second remission (CR2).

Read more: http://www.prnewswire.com/news-releases/sellas-life-sciences-announces-upcoming-presentation-of-phase-2-clinical-results-for-wt1-cancer-vaccine-at-the-2016-asco-annual-meeting-300273378.html

Source: Protagonist Therapeutics, Inc. & reported by http://www.prnewswire.com/
MILPITAS, Calif., May 17, 2016 /PRNewswire/ -- Protagonist Therapeutics, Inc. today announced that the company will present new preclinical data on the company's oral peptide drug candidates for inflammatory bowel disease (IBD), PTG-100 and PTG-200, at Digestive Disease Week 2016 (DDW). PTG-200, a first-in-class, IL-23 oral peptide receptor antagonist, will be the subject of an oral presentation, and PTG-100, an alpha-4-beta-7 integrin-specific oral peptide antagonist, will be the subject of a poster presentation.
About PTG-100 and PTG 200

PTG-100 is an oral, GI-restricted, alpha-4-beta-7 integrin-specific antagonist peptide currently in Phase 1 clinical trial in normal healthy volunteers, and is being developed initially for potential treatment of moderate-to-severe ulcerative colitis (UC). The integrin pathway is considered to be one of the most specific biological mechanisms for IBD.

PTG-200 is a first-in-class oral, GI-restricted, Interleukin 23 receptor (IL-23R) antagonist peptide that is being developed initially for potential treatment of moderate-to-severe CD. PTG-200 is currently in Investigational New Drug (IND) enabling studies.

PTG-100 and PTG-200 are derived from Protagonist's proprietary peptide technology platform, and they have the potential of offering oral targeted therapy treatment option for IBD. Protagonist believes PTG-100 and PTG-200 have the potential to transform the existing IBD treatment paradigm because of improved convenience and patient compliance, and potentially improved tolerability compared to injectable antibody drugs.
Read more: http://www.prnewswire.com/news-releases/protagonist-therapeutics-to-present-new-data-for-ptg-100-and-ptg-200-at-digestive-disease-week-2016-300269736.html

Source: Eiger BioPharmaceuticals, Inc. & reported by http://www.prnewswire.com/
PALO ALTO, Calif., May 10, 2016 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today that the first patient has been dosed in a Phase 2 study to evaluate subcutaneously administered exendin (9-39) in patients who experience dangerously low blood glucose levels (hypoglycemia) after undergoing gastric bypass surgery. Exendin (9-39) is a 31-amino acid peptide, which selectively targets and blocks glucagon like peptide-1 (GLP-1) receptors, normalizing insulin secretion by the pancreas, and thereby reducing hypoglycemia.

Stanford researchers have already demonstrated in proof-of-concept exploratory clinical studies with exendin (9-39) that pharmacologic blockade of GLP-1 prevents hypoglycemia in post-bariatric surgical patients and may represent the first targeted medical treatment for patients with post-gastric bypass hypoglycemia.

"Increasing numbers of obese patients are turning to gastric bypass surgery as an effective means to rapidly and sustainably reduce weight and as a critical healthcare intervention," said David Cory, President and CEO of Eiger. "Unfortunately, some of these bypass surgery patients develop a chronic condition leading to severe hypoglycemia after meals which cannot be managed by dietary modification or resolved by existing pharmacologic agents. A significant unmet medical need exists and there is no approved therapy."
Read more: http://www.prnewswire.com/news-releases/eiger-announces-first-patient-dosed-in-phase-2-multiple-ascending-dose-study-of-subcutaneous-exendin-9-39-in-patients-with-hypoglycemia-post-gastric-bypass-surgery-300265682.html

Source: http://www.archtherapeutics.com/
FRAMINGHAM, MA - (Marketwired) - 05/10/16 - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ (AC5™) for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, received a notice of allowance from the U.S. Patent Office for a broad composition of matter and method of use patent that covers solid forms of the Company's self-assembling technology.

The invention describes, among other things, a mesh that includes dehydrated or dried fibers of self-assembling peptides. The mesh may further incorporate additional therapeutic, prophylactic and/or diagnostic agents. The mesh can be used for controlling the movement of bodily substances including, for instance, blood, in order to provide hemostasis.

Many clinical scenarios can lead to undesirable loss of bodily fluids as a result of injury, disease or surgery. This invention would enable Arch to use a solid form of its self-assembling peptide technology to provide mechanical support and provide a barrier to bodily fluids.
Read more: http://www.archtherapeutics.com/news/press-releases/detail/473/arch-therapeutics-receives-notice-of-allowance-for

Source: http://www.eurekalert.org/
GALVESTON, TX, May 2, 2016. Chrysalis BioTherapeutics, Inc. today announced receipt of a $3 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to continue development of TP508 as a nuclear medical countermeasure. The drug is intended to be used in the event of a nuclear accident or the intentional detonation of a nuclear device to prevent radiation sickness and increase both survival and quality-of-life for those who survive.

Chrysalis BioTherapeutics has been developing TP508 as a medical countermeasure that could be quickly administered to thousands of people under emergency field conditions. In controlled preclinical studies, TP508 has significantly increased survival and delayed mortality when injected up to 24 hours after lethal radiation exposure.

"A single injection of TP508 protects endothelial cells lining blood vessels and stimulates stem cells to replace radiation-damaged cells," explained CEO of Chrysalis, Dr. Darrell Carney. "Administering TP508 after radiation exposure counteracts the effects of radiation on microvascular endothelial cells and stem cells in bone marrow, gastrointestinal crypts, skin, and even those in the brain."
Read more: http://www.eurekalert.org/pub_releases/2016-05/cbi-cbr050916.php

Source: http://www.businesswire.com/
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Merganser Biotech Inc. today announced the issuance of U.S. patent number 9,315,545 that includes a composition of matter claim for M012,  Merganser’s clinical stage hepcidin mimetic peptide. M012 is currently under evaluation in a Phase 1 clinical program as a potentially transformative therapy for a number of rare hematological and iron overload diseases including beta thalassemia, low risk myelodysplasia (MDS), polycythemia vera and sickle cell disease. This patent is expected to provide exclusivity until at least 2035 and builds on the patent estate for hepcidin mimetic peptides that has been licensed by Merganser from the University of California.
“We are delighted to have been granted patent coverage on M012,” said Brian MacDonald, CEO of Merganser Biotech. “Hepcidin mimetic peptides such as M012 represent a potential new therapeutic approach to control ineffective or dysregulated erythropoiesis in a wide range of hematological diseases. The long period of exclusivity created by this patent supports continued clinical development and commercialization of this promising technology.”
Read more: http://www.businesswire.com/news/home/20160509006012/en/Merganser-Biotech-Announces-Issuance-U.S.-Patent-9315545

Source: https://www.imvaccine.com/
Halifax, Nova Scotia; May 5, 2016 – Immunovaccine Inc. (“Immunovaccine” or the “company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced the launch of its DPX-NEO program to develop neoepitope immunotherapies to further expand the immuno-oncology applications for its DepoVax™-based vaccines. As its first official partnership for this program, Immunovaccine will collaborate with experts in this field at UConn Health on a preclinical study to evaluate the immunologic and anti-tumor activity of patient-specific neoepitopes.

Epitopes are the part of the biological molecule that is the target of an immune response. Neoepitopes are the mutated proteins produced by a patient's own tumors. Neoepitope vaccines target these patient-specific proteins and were recently dubbed ‘the next immunotherapy frontier.

“Neoepitopes are emerging as a very strong option to advance personalized cancer medicine, as they have tremendous potential to effect cancer treatments that provide truly individualized immunotherapies,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “Our novel DepoVax™ platform, with its unique mechanism of action and cost-effective, scaleable manufacturing capabilities, is ideally positioned to become an enabling technology in this exciting field.”
Read more: https://www.imvaccine.com/releases.php?releases_id=390

Source: Juniper Pharmaceuticals, Inc. & reported by http://www.prnewswire.com/
BOSTON, May 5, 2016 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today announced that the Journal of Controlled Release has published the results of the first proof of concept study to explore the ability of Juniper's intravaginal ring ("IVR") to successfully deliver larger molecules, including peptides and proteins. The article reports that the unique technology of Juniper's IVR differs from all of the five commercially available transvaginal rings. The abstract is available online at http://www.ncbi.nlm.nih.gov/pubmed/27130696. The Journal of Controlled Release has a current impact factor of 7.633, making it one of the most influential journals in the pharmaceutics, biomaterials, and drug delivery fields.

"Therapies based on peptides are notoriously difficult to deliver and typically cannot be taken orally," said principal investigator Alexa B. Kimball, MD, MPH, Massachusetts General Hospital and Harvard Medical School. "This study demonstrates the potential of a new delivery route for peptide therapeutics for women. To further explore transvaginal absorption capabilities, future studies will need to examine larger molecules and the administration of these molecules for longer periods of time and in larger numbers of women."
Read more: http://www.prnewswire.com/news-releases/juniper-pharmaceuticals-announces-publication-of-phase-1-study-demonstrating-ability-of-its-proprietary-intravaginal-ring-to-deliver-large-molecules-300263764.html

Source: Alizé Pharma & reported by http://www.medicalnewstoday.com/releases/309615.php
Alizé Pharma SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, announces today the top-line results of a Phase II clinical trial of AZP-531, its unacylated ghrelin analog, in patients with Prader-Willi Syndrome (PWS).

This randomized, double-blind, placebo-controlled, European multicenter study was aimed at evaluating the safety, tolerability and efficacy of AZP-531 administered daily subcutaneously for 14 days on food-related behavior, versus placebo. The trial was conducted across seven centers in France, Spain and Italy. It enrolled a total of 47 patients with genetically diagnosed PWS and evidence of hyperphagia, with a mean age of 27 years (range 13-46) and mean BMI of 38 kg/m2 (range 21-67).

The results showed a significant improvement in food-related behavior in patients treated with AZP-531 (p<0.05 versus placebo), as assessed by the Hyperphagia Questionnaire (HQ), the most widely used tool for assessing efficacy in clinical trials in PWS. The results showed a particular improvement in the Hyperphagic Severity domain score of the HQ (p<0.05 versus placebo). These findings were supported by a reduction in appetite following breakfast for patients treated with AZP-531, as assessed by a newly developed patient-reported outcome scale (p<0.001 versus baseline; not significant versus baseline for the placebo group). Read more: http://www.medicalnewstoday.com/releases/309615.php

Source: http://www.archtherapeutics.com/
FRAMINGHAM, MA -- (Marketwired) -- 04/25/16 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ (AC5™) for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, received a notice of allowance from the U.S. Patent Office for a broad method-of-use patent that covers systemically administering the Company's self-assembling technology for treating damaged extracellular matrix and leaky tight junctions.

Many disorders are associated with leakage around blood vessels and within the tight junctions between cells. Such leakage can lead to fluid invading the tissues, causing a loss in blood pressure, organ dysfunction or failure, and death. Some examples include inflammatory bowel disease, sepsis and ischemic stroke.

Dr. Terrence W. Norchi, President and CEO of Arch Therapeutics, said, "This important patent lends additional support to Arch's planned products. It is another example of Arch's inventiveness in exploring better ways to address a range of areas of unmet or poorly met medical needs with our self-assembling peptide technology."

Read more: http://www.archtherapeutics.com/news/press-releases/detail/471/arch-therapeutics-receives-notice-of-allowance-for-patent