All posts in Peptide News from Biotech and Pharma

Source: https://globenewswire.com/
SAN RAMON, Calif., June 10, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has granted two orphan-drug designations for Galena’s two cancer immunotherapy peptides derived from Folate Binding Protein (FBP) for the treatment (including prevention of recurrence) of ovarian cancer: one for GALE-301 (E39), and one for GALE-301 (E39) and GALE-302 (E39’). In clinical trials, GALE-301, and GALE-301/GALE-302 are combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the treatment of ovarian cancer in the adjuvant setting.

“Ovarian cancer is a very aggressive disease with almost fifty percent of women recurring within five years after their initial treatment,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “This designation supports our efforts to advance our FBP-targeted immunotherapy program consisting of GALE-301 and GALE-302 to prevent cancer recurrence in this underserved patient population.”

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives including marketing exclusivity in the U.S. for seven years after product approval3, tax credits, and exemption from the prescription drug user fee.
Read more: https://globenewswire.com/news-release/2016/06/10/847799/0/en/Galena-Biopharma-Receives-Two-Orphan-Drug-Designations-for-GALE-301-and-GALE-301-GALE-302.html

Source: Intarcia Therapeutics, Inc. & reported by http://www.prnewswire.com/
BOSTON, June 7, 2016 /PRNewswire/ -- Intarcia Therapeutics, Inc. introduced today the Medici Drug Delivery SystemTM, its innovative proprietary subcutaneous delivery system, comprised of three unique technologies: a matchstick-sized osmotic mini-pump that is placed just beneath the skin to deliver a continuous and consistent flow of medication; a placement technology designed for a simple, relatively quick and highly reliable user experience; and a stabilization technology for proteins, peptides, antibody fragments, and other high-potency small molecules. The System will be on display later this month at the American Diabetes Association's 76th Scientific Sessions in New Orleans.

"Delivering drugs via our new technology has the potential to open up a new way of delivering novel medicines just once-yearly," said Kurt Graves, Chairman, President and CEO of Intarcia. "One of the biggest problems in chronic diseases is millions of patients lack effective control of their condition due to sub-optimal effectiveness of their medication, and the fact is, the majority of patients with chronic conditions stop taking these pills and injections, after just three-to-six months. We are aiming to address these serious and costly unmet needs by introducing a new way to deliver once-yearly therapies that hold the potential for game-changing improvements in outcomes and patient adherence over time. We believe that our novel technology platform, the Medici Drug Delivery System, represents the potential for a renaissance in medicine delivery for the treatment of major chronic diseases."

Read more: http://www.prnewswire.com/news-releases/intarcia-announces-branding-of-the-medici-drug-delivery-system----a-platform-of-technologies-key-to-advancing-its-pipeline-of-once-yearly-peptide-and-antibody-fragment-based-therapeutics-in-poorly-controlled-chronic-diseases-300279739.html

Source: Cristalia & reported by http://www.prnewswire.com/
SAO PAULO, June 6, 2016 /PRNewswire/ -- The National Agency of Health Oversight (ANVISA - Agencia Nacional de Vigilancia Sanitaria) has allowed Laboratorio Cristalia to register the first biological Active Pharmaceutical Ingredient (API) based on the biodiversity of Brazil. It is called Colagenase Cristalia, an enzyme used in the production of ointments for the treatment of wounds (enzymatic debridement), burns and necrotic tissue.

"The registration of the API Colagenase Cristalia is one of our greatest achievements. We invested in research, development and innovation to arrive at a first rate medication. This is the first biotechnological API from Brazilian biodiversity that will be produced here, and will provide the opportunity to export this active ingredient," noted Dr. Ogari Pacheco, President of the Board of Cristalia.

The Biotechnology Division of Cristalia, headed up by Marcos Alegria, started production of the enzyme from a strain discovered on a farm in Espirito Santo do Pinhal, in the interior of Sao Paulo state. The productive process was registered with the Council for the Management of Genetic Assets (CGEN - Conselho de Gestao do Patrimonio Genetico) and the strain was deposited with the Brazilian Collection of Microorganisms of the Environment and Industry (CBMAI – Colecao Brasileira de Microrganismos de Ambiente e Industria), a body at Unicamp selected by CGEN as the designated depository of Brazilian biological samples.
Read more: http://www.prnewswire.com/news-releases/cristalia-obtains-registration-for-first-biotechnological-pharmaceutical-ingredient-300280459.html

Source: https://www.shire.com/
ZUG, Switzerland – May 27, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Revestive®* (teduglutide) 5 mg powder and solvent for solution for injection in paediatric patients (aged one to 17 years) with short bowel syndrome (SBS). Teduglutide is an analogue of human glucagon like peptide 2 (GLP-2) that enhances key structural and functional adaptations in the intestinal mucosa.i

The European Commission (EC) will now consider the CHMP positive opinion in its final decision of whether to extend marketing authorisation for teduglutide in paediatric patients with SBS in the European Union; a final decision from the EC is expected in August 2016.

“We are delighted that the CHMP has rendered a favorable recommendation for teduglutide in paediatric patients based on their evaluation of the data and benefit-to-risk balance,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “We await the final decision of the EMA and the potential to bring a new treatment option for children and adolescents suffering from SBS in Europe.”

Read more: https://www.shire.com/newsroom/2016/may/shire-receives-positive-chmp-opinion

Source: Novo Nordisk & reported by http://www.prnewswire.com/
ORLANDO, Fla., May 27, 2016 /PRNewswire/ -- Findings from a phase 3a clinical trial for semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue, demonstrated that treatment with semaglutide, administered once-weekly, significantly improved glycemic control compared to insulin glargine U100 in adults with type 2 diabetes. Results from the SUSTAIN 4 trial were presented today at the American Association of Clinical Endocrinologists 25th Annual Scientific and Clinical Congress (AACE) in Orlando, Fla.

The 30-week SUSTAIN 4 trial showed that, from a mean baseline HbA1c of 8.2%, adults with type 2 diabetes receiving metformin with or without sulfonylurea, achieved statistically significant and superior improvements in HbA1c reductions of 1.2% and 1.6% when treated with 0.5 mg and 1.0 mg semaglutide, respectively, vs a 0.8% reduction with insulin glargine U100 (p<0.0001 for both).1 End of trial mean dose of insulin glargine U100 was 29 IU/day. "Type 2 diabetes is a complex disease and many patients on insulin are still uncontrolled," said Vanita Aroda, SUSTAIN 4 investigator and physician investigator at the MedStar Health Research Institute, Hyattsville, Md. "The results of SUSTAIN 4 are encouraging, as once-weekly semaglutide demonstrated superior glycemic control compared to insulin glargine U100 in people that generally had a relatively long duration of type 2 diabetes." Read more: http://www.prnewswire.com/news-releases/semaglutide-demonstrated-superior-glycemic-control-vs-insulin-glargine-u100-in-adults-with-type-2-diabetes-300276365.html

Source: http://www.businesswire.com/
SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, Inc., the Tumor Paint Company®, a biotechnology company focused on guided cancer therapy, announced today that the company’s Senior Vice President of Development, Dennis Miller, Ph.D., will present at the American Society of Surgical Oncology (ASCO) 2016 Annual Meeting, taking place in Chicago, IL on June 3-7, 2016.
The poster presentation, titled “Phase 1 Dose Escalation and Expansion Safety Study of BLZ-100 in Pediatric Subjects with Primary Central Nervous System Tumors,” will highlight the company’s first study in the pediatric population.
About BLZ-100

BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide) and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, potentially enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types. BLZ-100 is an investigational agent currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumors, including brain, breast, lung, prostate, and colorectal cancer. More details about on-going trials are available at www.blazebioscience.com or www.clinicaltrials.gov.

Read more: http://www.businesswire.com/news/home/20160531005190/en/Blaze-Bioscience-Announces-Trial-Progress-Presentation-ASCO

Source: Targovax ASA & reported by https://globenewswire.com/
OSLO, Norway, June 2, 2016 (GLOBE NEWSWIRE) -- Targovax receives approval to conduct a study with TG02 and pembrolizumab, a checkpoint inhibitor, in patients with locally recurrent RAS mutated rectal cancer.

TGO2 is a cancer vaccine containing a mixture of 8 synthetic peptides representing fragments of the most common RAS mutations seen in colorectal cancer disease.

Mutations in RAS, a protein regulating cell growth, is seen in about 50% of patients with colorectal cancer and 20-30% of all cancers. It is associated with a lack of response to chemotherapy and poor prognosis. Previous and ongoing clinical studies have shown that TG peptides are able to induce RAS mutation specific immune responses. Targovax is the only research organization with RAS mutated specific vaccines at clinical development stage. This will be the first study with TG02 in humans and 20 patients will be included at Australian sites.

The study will assess safety and immune activation, both at lesional level and in peripheral blood. One cohort will only receive TG02 and another cohort will receive TG02 in combination with pembrolizumab, a PD-1 receptor inhibitor.

"We have already shown in other indications that TG peptides can induce specific immune responses and that these are associated with clinical benefits. However, this study will take us one step further in assessing immune activation at tumor level. It will also give us an indication on how our immune therapy may be enhanced when combining with a check point inhibitor" says Magnus Jaderberg, CMO at Targovax.
Read more: https://globenewswire.com/news-release/2016/06/02/845453/10163212/en/Targovax-receives-approval-in-Australia-to-conduct-a-clinical-trial-with-TG02-an-immunotheraphy-treatment-targeting-RAS-mutations.html

Source: Intarcia Therapeutics, Inc. & reported by http://www.prnewswire.com/
BOSTON and WÄDENSWIL, Switzerland, June 2, 2016 /PRNewswire/ -- Intarcia Therapeutics, Inc., and Numab AG, today announced the achievement of several key milestones in the development of a multi-specific antibody targeting inflammatory / autoimmune diseases. This is an important step towards realizing the potential of combining Numab's antibody-based therapeutics with Intarcia's unique delivery and formulation technologies.

Numab applied its novel discovery and optimization platform to identify two highly potent, highly selective antibody fragment based leads. The chemical and biological profiles of the lead molecules have met or exceeded all of the success criteria that were established upon the initiation of the licensing collaboration early last year.

David Urech Ph.D., CSO and co-CEO of Numab AG, commented: "Achievement of this milestone for Intarcia further confirms the power of Numab's discovery platform to produce next-generation antibody-based therapeutics, as well as our commitment to exceed expectations with our strategic partners."

In addition, Intarcia has successfully formulated multiple lead molecules produced by Numab. Results confirm the robust stability of the Numab molecules, demonstrate the versatility of the Intarcia formulation technology, and are a testimony to the powerful synergies of the companies' respective technology platforms.

Read more: http://www.prnewswire.com/news-releases/intarcia-and-numab-announce-achievement-of-key-research-and-development-milestones-300278468.html#continue-jump

Source: http://www.prnewswire.com/

CRANBURY, N.J., May 26, 2016 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/514,472 (the '472 application). The allowed composition of matter claims are to a broad family of melanocortin receptor-1 (MC1r) peptides with potential application in inflammatory disease-related and autoimmune indications.

Carl Spana, Ph.D., President and CEO of Palatin, commented, "Our MC1r peptide drug candidates, which are covered by the allowed patent, are highly specific, with substantially greater binding and efficacy at MC1r than at other melanocortin receptors. Our MC1r program has the potential to treat a number of diseases, including inflammatory bowel disease, nephritis (inflammation of the kidneys), rheumatoid arthritis, ocular indications such as uveitis and dry eye, and dermatologic indications. We are pleased with this important extension of our patent portfolio."

Read more: http://www.prnewswire.com/news-releases/palatin-technologies-receives-patent-strengthening-its-melanocortin-peptide-intellectual-property-300275359.html

Source: http://www.businesswire.com/
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ImmusanT, Inc., a clinical-stage company developing Nexvax2®, a therapeutic vaccine intended to protect against the effects of gluten exposure in HLA-DQ2.5+ patients with celiac disease, today announced the results of two Phase 1 studies of Nexvax2® in patients with celiac disease. The studies were presented in an oral presentation and two poster presentations at Digestive Disease Week (DDW) 2016 in San Diego, California.

Celiac disease is an immune-mediated gastrointestinal disease caused by dietary gluten predominantly in individuals who carry the HLA-DQ2.5 immune recognition gene, and shares key pathogenic and genetic features with organ-specific autoimmune (AI) diseases. ImmusanT is developing Nexvax2®, an epitope-specific immuno-therapy (ESIT) that consists of an injectable formulation of 3 peptides with epitopes recognized by gluten-reactive CD4+ T cells to target and render these cells unresponsive to gluten.

One poster, titled “A Single Intradermal (ID) Injection of Nexvax2®, a Peptide Composition with Dominant Epitopes for Gluten-Reactive CD4+ T Cells, Activates T Cells and Triggers Acute Gastrointestinal Symptoms in HLA-DQ2.5+ People with Celiac Disease (CeD),” included data from two Phase 1b clinical trials investigating the safety, tolerability, pharmacokinetics, and mechanism of action of Nexvax2 in 82 HLA-DQ2.5+ subjects with celiac disease on a gluten-free diet. In these studies, subjects received intra-dermal administration of Nexvax2 or placebo, and cytokine and chemokine serum levels were evaluated six hours post-dose. The results demonstrated that Nexvax2 peptides were detectable in plasma shortly after administration until up to four hours post-dose and confirmed T-cell engagement within 2 hours of administration. This suggests that gluten-specific memory CD4+ T cells were activated by Nexvax2 and could be related to the clinical effects observed following gluten ingestion in patients with celiac disease.

Read more: http://www.businesswire.com/news/home/20160524006174/en/ImmusanT-Reports-Nexvax2-Phase-1-Data-Patients