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Preclinical Data on PL-3994 for Heart Failure and Resistant Hypertension Presented at 2015 Heart Failure Society of America Annual Meeting

Source: Palatin Technologies, Inc. and reported by http://www.prnewswire.com/

CRANBURY, N.J., Sept. 28, 2015 /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, today announced that a poster entitled "Conditional cardiomyocyte-restricted Corin KO mice demonstrate enhanced cardiac hypertrophy and pro-fibrotic gene activation in response to TAC and PL-3994 – a novel selective GC-A receptor peptide agonist rescues the phenotype" was presented on Sunday, September 27, at the 2015 Heart Failure Society of American Annual Meeting in Washington, DC.  PL-3994 is a synthetic natriuretic peptide receptor-A agonist developed by Palatin for treatment of heart failure and other indications.

The research work was done at Temple University School of Medicine in Philadelphia under the direction of Daniel L. Dries, M.D., and investigated the role of cardiomyocytes, corin and cardiac natriuretic peptide signaling in heart failure and the potential of treatment with PL-3994. The data presented demonstrated that corin and cardiac natriuretic peptides play an important role in regulating cardiac hypertrophy and fibrosis, and that treatment with PL-3994 significantly reduced cardiac hypertrophy and pro-fibrotic and inflammatory gene activation.

Read more: http://www.prnewswire.com/news-releases/preclinical-data-on-pl-3994-for-heart-failure-and-resistant-hypertension-presented-at-2015-heart-failure-society-of-america-annual-meeting-300149516.html

PeptiDream Announces Peptide Discovery Collaboration Agreement with Teijin Pharma

Source: http://www.businesswire.com/

TOKYO--(BUSINESS WIRE)--PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”)(TOKYO:4587) today announced a multi-target discovery and optimization collaboration with Teijin Pharma Limited, Tokyo, Japan (“Teijin”)(TSE: 3401). Under the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to generate macrocyclic/constrained peptides against multiple targets of interest selected by Teijin. Teijin will have the right to develop and commercialize all therapeutic peptides resulting from the collaboration. In addition, Teijin will have the rights to use the macrocyclic/constrained peptides identified during the collaboration as starting compounds for the development of small molecules therapeutics against the collaboration targets. PeptiDream will receive an undisclosed upfront payment, research funding and will be eligible for payments associated with the achievement of certain preclinical and clinical development milestones. In addition, PeptiDream is eligible to receive royalties on sales of any products that arise from the collaboration.

We are very excited to begin collaborating with Teijin Pharma, said Kiichi Kubota, CEO of PeptiDream Inc. Our unique PDPS platform continues to prove to be one of the best hit identification platforms, especially in targeting protein-protein interactions (PPIs). No other technology can create such a chemically and structurally diverse set of functional and developable leads in such a short period of time. In collaboration with Teijin, we hope to use identified peptide leads as a starting point for small molecule drug design, an aspect of our PDPS platform that has not been overly leveraged to date, and should lead to the further expansion of alliance businesses”.

Read more: http://www.businesswire.com/news/home/20150927005119/en/PeptiDream-Announces-Peptide-Discovery-Collaboration-Agreement-Teijin#.Vgve1JeiUQs

Intarcia Announces Acquisition of Phoundry Pharmaceuticals

Source: SOURCE Intarcia Therapeutics, Inc. and reported by http://www.prnewswire.com/

BOSTON, Sept. 24, 2015 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced the acquisition of Phoundry Pharmaceuticals, Inc., a privately held biotechnology company based in Research Triangle Park, North Carolina. Founded in 2015 after six years of work as part of the Enteroendocrine Discovery Performance Unit of GlaxoSmithKline, Phoundry Pharmaceuticals has created a portfolio of optimized peptides in various therapeutic categories, most notably diabetes and obesity.

Phoundry enhances Intarcia's internal efforts to build upon the differentiated clinical success of its Phase 3 investigational therapy, ITCA 650, the first injection-free GLP-1 therapy with the potential to deliver up to a full year of treatment from a single placement.

As a result of the Phoundry acquisition and the separate Numab collaboration formed earlier this year, Intarcia will now have expanding intellectual property rights and three distinct near-term R&D programs targeting diabetes and obesity, including:

  • ITCA 650 + Optimized Peptide 1 targeting Type 2 Diabetes and/or Obesity
  • ITCA 650 + Optimized Peptide 2 targeting Type 2 Diabetes and/or Obesity
  • ITCA 650 + Single Chain Antibody Fragment targeting Type 2 Diabetes and/or Obesity

"Incredible progress with ITCA 650 and our two pipeline deals this year have transformed the strategic outlook for the company, and put us in a position to build on ITCA 650 and advance a potentially leading portfolio of disruptive once or twice yearly combo therapies in diabetes and obesity," stated Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics. "We welcome the research team from Phoundry; both companies share a common vision that combination therapies of optimized peptides have the potential to mimic and extend the metabolic benefits and weight loss potential associated with bariatric surgery, all potentially delivered in our proprietary once or twice yearly mini-pumps.

Read more: http://www.prnewswire.com/news-releases/intarcia-announces-acquisition-of-phoundry-pharmaceuticals---second-pipeline-deal-of-2015-secures-novel-peptide-therapeutics-to-combine-with-itca-650-targeting-next-gen-diabetes--obesity-therapies-300147573.html

Protagonist Therapeutics Receives SBIR Funding for Oral IL-23 Receptor Antagonists for Treatment of Inflammatory Bowel Diseases

Source: http://www.prnewswire.com/

MILPITAS, Calif., Sept. 23, 2015 /PRNewswire/ -- Protagonist Therapeutics, Inc., a company developing novel, orally stable peptide therapeutics for gastrointestinal (GI) diseases and disorders, today announced receipt of a Phase 1 Small Business Innovation Research (SBIR) Grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. This award, Number R43DK104445, will support research aimed at optimizing lead molecules in Protagonist's second pipeline program, focused on orally stable peptide antagonists of the interleukin-23 (IL-23) receptor as potential treatments for inflammatory bowel diseases (IBD).

Protagonist's research has shown that orally stable, GI-restricted drugs discovered using the company's peptide technology platform are efficacious in rodent models of colitis. This award furthers the company's efforts to translate these proof-of-concept early research findings into a potential human therapeutic that is orally delivered at high drug levels in diseased intestinal tissue with very limited drug concentrations in systemic circulation.

"We are very pleased to receive this grant, which provides further validation of the strong potential offered by our technology platform for the creation of novel, orally stable peptide drugs. Through this award, the reviewers also recognize the considerable benefit which could be provided for the treatment of inflammatory bowel disease through a first-in-class therapeutic targeting the IL-23/Th17 pathway," said David Y. Liu, Ph.D., Protagonist Chief Scientific Officer. "The SBIR program at NIH plays a vital role in helping companies develop new technology and products that serve important U.S. health care needs."

Read more: http://www.prnewswire.com/news-releases/protagonist-therapeutics-receives-sbir-funding-for-oral-il-23-receptor-antagonists-for-treatment-of-inflammatory-bowel-diseases-300147596.html

Blaze Bioscience Commences Clinical Trial of BLZ-100 in Patients with Sarcoma Undergoing Surgery

Source: http://www.businesswire.com/

SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, the Tumor Paint Company®, a biotechnology company focused on guided cancer therapy, today announced open enrollment for a clinical study of Tumor Paint BLZ-100 in soft tissue sarcoma. The study, titled “A Phase 1 study of BLZ-100 administered by intravenous injection in subjects with soft tissue sarcoma undergoing surgery,” is supported by a Small Business Innovation Research (SBIR) Phase II contract awarded to the company by the National Cancer Institute (NCI)1 following the successful completion of a Phase I SBIR contract. This is the fourth Phase 1 clinical trial under the company’s open Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). The study will be conducted at Cedars-Sinai Medical Center in Los Angeles under the direction of Principal Investigator Charles Forscher, M.D., and will enroll up to twenty-one (21) patients.

Soft tissue sarcoma is a rare disease with a high unmet need and, according to NCI, approximately 11,900 new cases of soft tissue sarcoma will be diagnosed in 2015 in the U.S. Surgery remains the principle mode of therapy for soft tissue sarcoma, and successful surgery—achieving complete resection with negative tumor margins—reduces the chance of recurrence and the need for more treatment, such as radiation or repeat surgery. “Sarcoma is an often aggressive cancer that disproportionally affects children and young adults. Improvements to treatment, including surgical intervention, are greatly needed,” said Dennis Miller, Ph.D., Blaze Bioscience’s Senior Vice President of Development and Principal Investigator on the NCI contract. “This clinical study of BLZ-100 will add to our growing understanding of the potential broad utility of BLZ-100 in cancer surgery and provide further insight to the timing of BLZ-100 dosing relative to tumor surgery.”

Read more: http://www.businesswire.com/news/home/20150922005214/en/Blaze-Bioscience-Commences-Clinical-Trial-BLZ-100-Patients#.VgTT68tViko

PeptiDream Announces Peptide Discovery Collaboration Agreement with Sanofi

Source: http://www.businesswire.com/

TOKYO--(BUSINESS WIRE)--PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”)(TOKYO:4587) today announced a multi-target discovery and optimization collaboration with Sanofi, Paris, France (“Sanofi”)(Euronext: SAN). Under the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to generate macrocyclic/constrained peptides against multiple targets of interest selected by Sanofi. Sanofi will have the right to develop and commercialize all therapeutic peptides resulting from the collaboration. PeptiDream will receive an undisclosed upfront payment, research funding and will be eligible for payments associated with the achievement of certain preclinical and clinical development milestones. In addition, PeptiDream is eligible to receive royalties on sales of any products that arise from the collaboration.

We are very excited to begin collaborating with Sanofi, said Kiichi Kubota, CEO of PeptiDream Inc. Our unique PDPS platform continues to prove to be one of the best hit identification platforms, especially in targeting protein-protein interactions (PPIs). No other technology can create such a chemically and structurally diverse set of functional and developable leads in such a short period of time”.

In the past five years, PeptiDream has established funded discovery collaborations with Amgen, AstraZeneca, Bristol-Myers-Squibb, Eli Lilly, GlaxoSmithKline, Novartis, Mitsubishi Tanabe, Daiichi Sankyo, Merck, as well as a strategic collaboration with Ipsen, all of which are actively progressing identified hits toward the clinic. In addition, PeptiDream has transferred its PDPS discovery platform for broad use to Bristol-Myers-Squibb and Novartis.

Read more: http://www.businesswire.com/news/home/20150913005124/en/PeptiDream-Announces-Peptide-Discovery-Collaboration-Agreement-Sanofi#.VgBdi5eiUQs

Sanofi’s LixiLan phase III study meets primary endpoint showing superior reduction in HbA1c vs insulin glargine alone

Source: http://www.pharmabiz.com/

Sanofi, a global healthcare leader, announced that the LixiLan-L phase III clinical trial met its primary endpoint in patients with type 2 diabetes treated with insulin glargine with or without metformin.

The fixed-ratio combination of insulin glargine 100 units/ml and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 units/ml. Overall, the fixed-ratio combination had a safety profile reflecting those of insulin glargine 100 units/ml and lixisenatide.

"This study examined an important possible use of this investigational medicine," said Richard M Bergenstal MD, executive director, International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, US.

"The result highlights that this could provide a treatment option for the roughly fifty per cent of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment."

LixiLan-L investigated the efficacy and safety of the fixed-ratio combination of insulin glargine 100 units/ml and lixisenatide versus treatment with insulin glargine 100 units/ml over a 30-week period in 736 patients whose type 2 diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study.

Read more: http://www.pharmabiz.com/NewsDetails.aspx?aid=90598&sid=2

ORYX Enrols First Patients in an Additional Phase I Trial with Therapeutic Vaccine VicOryx to Treat HPV-Associated Cancers in Combination with Standard Chemotherapy

Source: http://www.dgap.de/

Munich (Germany), September 15, 2015: ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today announced that first patients have been treated in an additional Phase I clinical trial with VicOryx, a therapeutic vaccine to treat p16INK4a overexpressing Human Papilloma Virus (HPV) positive cancer patients, in combination with standard cisplatin-based chemotherapy. The patients have undergone the first weeks of treatment and no serious side effects have been reported.

The trial is an open label study in 10 patients with HPV-associated anogenital (cervical, vulvar, vaginal, penile, and anal) tumor diseases or HPV-associated head and neck cancer who are scheduled to receive a cisplatin-based chemotherapy. The patients receive VicOryx, a synthetic p16INK4a peptide, combined with the adjuvant Montanide(R) ISA-51 VG subcutaneously plus a cisplatin based chemotherapy once a week for four weeks followed by a four week pause. Each patient will be treated in three cycles over six months or until tumor progression occurs. The primary endpoint of the trial is an immune response against the p16_37-83 peptide. Secondary endpoints include tumor response rates, progression free survival and overall survival, plus safety of the therapeutic vaccine administration.

Read more: http://www.dgap.de/dgap/News/corporate/oryx-enrols-first-patients-additional-phase-trial-with-therapeutic-vaccine-vicoryx-treat-hpvassociated-cancers-combination-with-standard-chemotherapy/?newsID=898239

Zealand presents new preclinical data on its novel GIP peptide therapeutic, ZP-I-98, at the 51st EASD Annual Meeting

Source: http://www.nasdaq.com/

COPENHAGEN, Denmark, Sept. 15, 2015 (GLOBE NEWSWIRE) -- Zealand informs that new preclinical data on its novel GIP receptor agonist, ZP-I-98, will be presented at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting, taking place on 14th - 18th September, 2015 in Stockholm, Sweden. ZP-I-98 is invented and wholly-owned by Zealand.

ZP-I-98 - A novel long-acting GIP receptor agonist

One investigational approach to enhance the efficacy of GLP-1 receptor agonists, used for the    management of Type 2 diabetes, includes combination therapy with a glucose-dependent insulinotropic peptide (GIP) receptor agonist. Recent preclinical studies conducted by Zealand with its novel GIP receptor agonist, ZP-1-98, have shown that a GIP/GLP-1 combination therapy could enhance the treatment of Type 2 diabetes by inducing both robust glycemic control as well as a greater loss of body weight than seen by a single treatment. ZP-1-98 has a long-acting profile, which indicates that it could be suitable for convenient once-weekly dosing.

Read more: http://www.nasdaq.com/press-release/zealand-presents-new-preclinical-data-on-its-novel-gip-peptide-therapeutic-zpi98-at-the-51st-easd-20150915-00264
Zealand advances its proprietary, long-acting GLP-2 analogue, ZP1848, into clinical Phase II development for the treatment of Short Bowel Syndrome

Source: http://www.nasdaq.com/

COPENHAGEN, Denmark, Sept. 17, 2015 (GLOBE NEWSWIRE) -- Zealand announces the initiation of a clinical Phase II development program for its proprietary peptide therapeutic, ZP1848, for the treatment of Short Bowel Syndrome (SBS). ZP1848 is a long-acting, stable and soluble GLP-2 receptor agonist invented and wholly owned by Zealand.

Professor, MD, Ph.D and lead study investigator, Palle Bekker Jeppesen, the Department of Medical Gastroenterology, University Hospital of Copenhagen, commented: "Short Bowel Syndrome is a very serious condition affecting a growing number of patients who have had larger parts of their intestines removed. Patients with Short Bowel Syndrome have reduced ability to absorb nutrients and to maintain adequate fluid and electrolyte balance, which makes many of them dependent on regular access to parenteral (intravenous) nutritional support through a central catheter. This is associated with shortened life span, potentially life-threatening complications including sepsis, blood clots, liver or renal damage, and severely reduced quality-of-life. GLP-2 based therapy has demonstrated the ability to improve intestinal absorption with the potential to reduce the need for parenteral support and offer patients relief and flexibility."

In preclinical studies, ZP1848 has shown efficacy on small intestine growth and demonstrated the physico-chemical properties of a long-acting, stable and soluble peptide therapeutic with the potential for convenient administration in liquid formulation. Zealand has also investigated ZP1848 in a combined single (SAD) and multiple (MAD) ascending dose Phase I trial. Results from this trial demonstrated that ZP1848 is safe and well tolerated with a supportive effect on bowel function. The attractive potential identified for ZP1848 in Short Bowel Syndrome and the opportunity for Zealand to initiate a clinical Phase II development program in this specialist care indication is an important step in line with the company's strategic focus on increasing the value of its proprietary pipeline.

Read more: http://www.nasdaq.com/press-release/zealand-advances-its-proprietary-longacting-glp2-analogue-zp1848-into-clinical-phase-ii-developmen-20150917-00025

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