All posts in Peptide News from Biotech and Pharma

Source: http://www.streetinsider.com/
Galena Biopharma, Inc. (Nasdaq: GALE) announced that preclinical data from the Company’s NeuVax (nelipepimut-S) program is being presented today at the Progress in Vaccination Against Cancer (PIVAC) Conference in Winchester, UK. NeuVax contains the immunodominant peptide derived from the extracellular region of the HER2 protein, which is expressed in ovarian and pancreatic cancers as well as in breast cancer.

The poster, entitled, “Preclinical study on the efficacy of NeuVax peptide vaccine against human Her2+/ HLA-A2.1+ ovarian and pancreatic cancer,” demonstrated the results of HLA-A2 transgenic mice that were immunized with NeuVax (E75) mixed with recombinant mouse GM-CSF (NeuVax mice). As control, a group of mice received GM-CSF alone (control mice). CD8+ T cells purified from the spleens of HLA-A2 transgenic immunized mice were adoptively transferred to NSG (NOD/SCID/IL2Rγnull) mice bearing human ovarian or pancreatic tumors which were HER2+, HLA-A2+.

Administration of the NeuVax vaccination resulted in a specific, delayed-type hypersensitivity (DTH) reaction and in the induction of E75 specific CD8+ T cells that express PD-1 (programmed T-cell death protein). Both ovarian and pancreatic tumor growth rate was significantly reduced in NSG mice that received the CD8+ T cells from NeuVax-immunized mice compared to those receiving CD8+ T cells from control mice. Additionally, PD-1 was identified on activated CD8+ T cells.

Read more: http://www.streetinsider.com/Corporate+News/Galena+Biopharma+(GALE)+Announces+Presentation+of+Significant+NeuVax+Preclinical+Data+at+PIVAC+Conference/12026975.html

Source: Novo Nordisk & reported by http://www.prnewswire.co.uk/
MUNICH, September 13, 2016 /PRNewswire/ -- Novo Nordisk today announced that semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, significantly improved glycaemic control compared to placebo, as add-on to basal insulin alone or in combination with metformin, in adults with a mean type 2 diabetes duration of 13 years. Results from SUSTAIN 5 were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.

The 30-week trial showed that, from a mean baseline HbA1c of 8.4%, adults treated with 0.5 mg and 1.0 mg semaglutide achieved statistically significant and superior HbA1c reductions of 1.4% and 1.8%, respectively, vs 0.1% reduction with placebo. In addition, more adults treated with 0.5 mg and 1.0 mg semaglutide achieved HbA1c targets compared with placebo: HbA1c <7% (61% and 79% vs 11%) and ≤6.5% (41% and 61% vs 5%). Adults with type 2 diabetes treated with 0.5 mg and 1.0 mg semaglutide achieved superior weight loss vs placebo (3.7 kg and 6.4 kg vs 1.4 kg) from a mean baseline body weight of 91.7 kg. Read more: http://www.prnewswire.co.uk/news-releases/semaglutide-demonstrated-superior-hba1c-reduction-vs-placebo-as-add-on-to-basal-insulin-alone-or-with-metformin-in-adults-with-type-2-diabetes-593219281.html

Source: Stealth BioTherapeutics & reported by http://www.prnewswire.com/
BOSTON, Sept. 12, 2016 /PRNewswire/ -- Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of a longitudinal extension trial for evaluating elamipretide in primary mitochondrial disease. The study, MMPOWER-2, will be limited to patients who completed the initial MMPOWER Phase 2 study. Positive data from MMPOWER were announced in June 2016 showing statistically significant improvement in distance walked in six minutes.

"Patients with rare primary mitochondrial diseases have no FDA-approved treatment options to address their needs," said Stealth Chief Executive Officer Reenie McCarthy. "We're committed to helping fill these significant gaps in care through our study of elamipretide. Following the promising results from our Phase 2 MMPOWER study, we're happy to announce the initiation of MMPOWER-2, which will help us better understand the effects of longer treatment with elamipretide for these patients, who often face severe challenges completing even simple daily activities."

MMPOWER-2 is a randomized, double-blind, placebo-controlled crossover study to evaluate the safety, tolerability and efficacy of four weeks' treatment with once-daily subcutaneous injections of elamipretide in patients with genetically confirmed mitochondrial disease. All patients in this study have previously completed the MMPOWER study.
Read more: http://www.prnewswire.com/news-releases/stealth-biotherapeutics-initiates-phase-2-study-of-elamipretide-in-primary-mitochondrial-disease-300325810.html

Source: http://www.businesswire.com/
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Circle Pharma, Inc., today announced that it will apply its computational design and synthetic chemistry platform to design and create a physical screening library of novel macrocyclic peptides. Once completed, the library is initially expected to comprise several hundred macrocycles that will be designed to potentially disrupt bioactive conformations commonly found in protein-protein interactions known to drive disease processes, and will deploy backbone scaffolds screened in silico for intrinsic cell permeability characteristics. In addition, the design of the library will permit the simple creation of derivative libraries tailored to specific features of a therapeutic target class.

Pfizer Inc. (NYSE:PFE) has entered into an agreement with Circle under which Pfizer will provide support for the library build, and Circle has granted Pfizer non-exclusive rights to screen the library against certain targets. The rights granted to Pfizer exclude specified targets for which Circle has reserved exclusive rights to screen the library.

“This physical library will complement Circle’s target-specific computational design toolkit,” said David J. Earp, J.D., Ph.D., Circle’s President and CEO. “We expect to use the library for our internal pipeline discovery work, and we will make it available to all of our collaboration partners in drug discovery.”

Read more: http://www.businesswire.com/news/home/20160912005024/en/

Source: http://www.alz-pharma.com/
Lyon, France, September 12, 2016: Alizé Pharma III SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, today announces it will present preclinical results from its I-HBD1 program in osteoporosis during the Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Atlanta on September 16-19, 2016.

Alizé’s I-HBD1 program focuses on a new peptide derived from a physiological protein, IGFBP-2 (Insulin-like Growth Factor Binding Protein-2), as a new bone anabolic agent. Scientific work led by Dr David Clemmons from the University of North Carolina at Chapel Hill (USA) and Dr Clifford Rosen from the University of Maine (USA) has established that IGFBP2 plays a key physiological role in the differentiation of osteoblasts, the cells responsible for bone formation. I-HBD1, a short peptide fragment derived from IGFBP-2, replicates the anabolic effects of IGFBP-2 on bone. It is intended to be developed as a new therapeutic approach for osteoporosis and some rare metabolic diseases associated with impaired bone formation.

Alizé Pharma III is conducting the I-HBD1 project in collaboration with New Paradigm Therapeutics, a spin-off company from the University of North Carolina at Chapel Hill founded by Dr. David Clemmons.

Read more: http://www.alz-pharma.com/actualite/alize-pharma-iii-presents-preclinical-results-from-its-i-hbd1-program-at-the-annual-meeting-of-the-american-society-for-bone-and-mineral-research

Source: Avelas Bioscienes, Inc. & reported by http://www.prnewswire.com/
SAN DIEGO, Sept. 8, 2016 /PRNewswire/ -- Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced the completion of patient enrollment in its Phase 1b clinical trial for AVB-620, a surgical marker, in women with primary, non-recurrent breast cancer undergoing surgery. Avelas will announce data from the trial at a future medical meeting.

"I'm pleased to announce that we have completed enrollment in our Phase 1b trial of AVB-620 in women with primary, non-recurrent breast cancer undergoing surgery," said Carmine N. Stengone, president and chief executive officer of Avelas Biosciences. "I believe that AVB-620 could contribute materially and positively to the diagnosis and treatment of this highly prevalent disease and look forward to sharing the results from this program in the coming months."

AVB-620 Phase 1b Clinical Program: Fifteen patients were enrolled in the initial dose-escalation portion of the Phase 1b trial, the purpose of which was to evaluate safety and pharmacokinetics and to determine the dose for additional imaging analysis in the second stage of the study. Interim analysis showed no toxicity issues and identified a preferred dose to take forward into the expansion phase of the trial. A total of 12 additional patients have been enrolled in the dose-expansion stage of the trial, where the focus remains on safety, pharmacokinetics, and the timing of imaging after AVB-620 administration. The company expects to announce data from its completed Phase 1b trial later this year.

Read more: http://www.prnewswire.com/news-releases/avelas-biosciences-completes-patient-enrollment-for-avb-620-phase-1b-clinical-trial-300324345.html

Source: http://www.businesswire.com/
SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today reported positive results from its Phase 1 study of LJPC-401 in patients at risk of iron overload.
The Phase 1 study is a multi-center, open-label, dose-escalation study evaluating the safety, tolerability, and effect on serum iron of a single dose of LJPC-401 in patients at risk of iron overload due to conditions such as hereditary hemochromatosis (HH), thalassemia, and sickle cell disease (SCD). Fifteen patients were dosed at escalating dose levels ranging from 1 mg to 20 mg.

LJPC-401 was well tolerated, and there were no dose-limiting toxicities observed. Injection-site reactions were the most commonly reported adverse event. These were all mild or moderate in severity, self-limiting, and fully resolved. There were no significant changes in serum chemistries or hematology other than serum iron parameters.

A dose-dependent, statistically significant reduction in serum iron was observed (p=0.008 for dose response; not adjusted for multiple comparisons). At the 20 mg dose level, LJPC-401 reduced serum iron by an average of 58.1% from baseline to hour 8 (p=0.001; not adjusted for potential regression to the mean effect), and serum iron had not returned to baseline through day 7 (21.2% reduction from baseline to the end of day 7).

Read more: http://www.businesswire.com/news/home/20160907006780/en/La-Jolla-Pharmaceutical-Company-Reports-Positive-Results

Source: BioMarin Pharmaceutical Inc. & reported by http://www.nasdaq.com/press-release/

SAN RAFAEL, Calif., Sept. 06, 2016 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced a program update for cerliponase alfa, a recombinant human tripeptidyl peptidase 1 (rhTPP1) to treat children with CLN2 disease, a form of Batten disease. CLN2 disease is a rapidly progressing, fatal neurodegenerative disease with no approved treatments, where the majority of affected children lose their ability to walk and talk by approximately six years of age. After 81 weeks, patients treated with cerliponase alfa continue to have motor-language (ML) scores representing substantial attenuation of disease progression compared to natural history. These data are consistent with the data at 48 weeks submitted with the original Biologics License Application (BLA), and demonstrate durable and consistent treatment response. During their initial review of the BLA, the U.S. Food and Drug Administration (FDA) requested an updated efficacy data cut from the ongoing extension study, which the company provided. The FDA designated this submission as a major amendment to the application, thus extending the PDUFA action date by three months to April 27, 2017.

Read more: http://www.nasdaq.com/press-release/biomarin-announces-update-to-brineura-cerliponase-alfa-program--for-treatment-of-cln2-disease-a-20160906-01176#ixzz4KXHZUbGD

Source: Soligenix, Inc. & reported by http://www.prnewswire.com/
Princeton, N. J., Sept. 6, 2016 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the United States (US) Patent Office granted the patent entitled "Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity." The newly issued patent claims composition of matter of analogs of dusquetide (research name: SGX94), the Company's lead development compound. Dusquetide recently demonstrated positive preliminary results in a Phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer patients. The recently issued patent broadens the protection around dusquetide and provides further protection for the underlying innate defense regulator (IDR) technology platform. Similar claims have been granted and/or are being pursued in jurisdictions worldwide.

IDRs are first-in-class small peptides with a novel mechanism of action. IDRs function by modulating the response of the innate immune system at a key convergence point in the intracellular signaling pathways. The innate immune system is a non-specific system which responds to a variety of insults, including infections and tissue damage. Because IDRs act by modulating the response of the innate immune system, they are agnostic as to either the cause of tissue damage (e.g., chemotherapy, radiation or trauma) or infection (e.g., antibiotic sensitive or antibiotic resistant infections). A summary of the IDR technology can be found in the following audio presentation entitled, "Dusquetide: Innate Defense Regulation as a Novel Approach to Antibiotic-Resistant Infection": https://www.youtube.com/watch?v=ef0-wQod-2E&feature=youtu.be

Read more: http://www.prnewswire.com/news-releases/soligenix-announces-issuance-of-new-composition-of-matter-patent-for-dusquetide-analogs-300321894.html

Source: Dipexium Pharmaceuticals, Inc. & reported by http://www.prnewswire.com/
NEW YORK, Sept. 7, 2016 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad-spectrum, topical antimicrobial peptide, today announced that the European Patent Office has issued a new Locilex patent in the European Union (EU). The patent claims are directed to a novel formulation of Locilex, a topical antimicrobial peptide formulated as a topical cream, and the use of Locilex as a method of treating skin or wound infections. The issued patent has an expiry date in June 2033.

"This constitutes the first patent granted by the European Union, the second largest pharmaceuticals market in the world," stated David P. Luci, President & Chief Executive Officer of Dipexium, "this is an important building block for our commercialization strategy for Locilex in Europe." Mr. Luci continued, "Dipexium now has issued patents for Locilex in the US, EU, and Japan, the three largest pharmaceuticals markets in the world, as well as Australia and New Zealand. In addition, Dipexium has obtained notice of allowance for patents in Hong Kong and Korea. We anticipate the issuance of additional patents for Locilex in other major international markets throughout 2016 and 2017."

Read more: http://www.prnewswire.com/news-releases/dipexium-pharmaceuticals-announces-issuance-of-locilex-patent-by-european-union-300323725.html