All posts in Peptide News from Biotech and Pharma

Source: Protagonist Therapeutics, Inc. & reported by http://www.prnewswire.com/
MILPITAS, Calif., July 28, 2016 /PRNewswire/ -- Protagonist Therapeutics, Inc. today announced receipt of a Phase 1 Small Business Innovation Research (SBIR) Grant from the National Institute of Heart and Lung Diseases of the National Institutes of Health. The award, Number HL132702-01A1, supports preclinical research aimed at discovering and optimizing lead molecules as novel peptide mimetics of the natural hepcidin hormone. Protagonist aims to develop these mimetics as potential injectable treatments for iron overload disorders, such as beta-thalassemia and hereditary hemochromatosis.

Protagonist's research has shown that hepcidin mimetics discovered using the company's peptide technology platform can lower serum iron when administered subcutaneously in animal studies. This award will help further the company's efforts to translate these preclinical proof-of-concept findings into a potential human therapeutic for patients characterized by anemia and organ iron overload.

"This new SBIR grant will support our efforts to use our technology platform to create novel peptide drugs," said David Y. Liu, Ph.D., Protagonist Chief Scientific Officer. "Through this award, the reviewers also recognize the considerable benefit which could be provided for the treatment of iron overload disorders through therapeutic targeting of the hepcidin-ferroportin pathway, which is the master regulator of iron homeostasis."

Read more: http://www.prnewswire.com/news-releases/protagonist-therapeutics-receives-sbir-funding-for-the-development-of-injectable-hepcidin-mimetics-for-treatment-of-iron-overload-disorders-300305384.html

Source: Profil Institute for Clinical Research, Inc. & reported by http://www.prnewswire.com/
SAN DIEGO and SHENZHEN, China, July 28, 2016 /PRNewswire/ -- Profil Institute for Clinical Research, Inc., a science-driven clinical research organization (CRO) focused exclusively on metabolic diseases, announced today a strategic master services agreement with Shenzhen HighTide Biopharmaceutical Ltd., a subsidiary of Shenzhen Hepalink Pharmaceutical Co., Ltd.
Under the terms of the agreement, Profil Institute will provide clinical research and development services, from IND readiness through the completion of early phase development, including regulatory and scientific support services, for HighTide's portfolio of drug candidates that address the therapeutic areas of diabetes and NAFLD/NASH.
HighTide is a US-China joint venture founded in 2011 by Dr. Liping Liu and Hepalink Pharmaceutical to progress a promising portfolio of novel therapeutic candidates from discovery to clinical development for the treatment of diabetes and NAFLD/NASH.
Profil Institute is a leading early phase CRO focused exclusively on metabolic diseases. Its experience encompasses a wide range of investigational and marketed drugs for diabetes, obesity and NAFLD/NASH, with more than 280 clinical research projects completed.
Read more: http://www.prnewswire.com/news-releases/profil-institute-and-hightide-biopharmaceutical-announce-a-strategic-partnership-focused-on-the-development-of-new-therapies-for-diabetes-and-nafldnash-300305293.html

Source: Sanofi & reported by http://www.prnewswire.com/
PARIS, July 27, 2016 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin™ (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.
"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled."
The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA's request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting.
Read more: http://www.prnewswire.com/news-releases/sanofi-receives-fda-approval-of-adlyxintm-for-treatment-of-adults-with-type-2-diabetes-300305253.html

Source: CSL Behring & reported by http://www.prnewswire.com/
ORLANDO, Fla., July 26, 2016 /PRNewswire/ -- CSL Behring today announced new data from its Phase III PROLONG-9FP clinical development program evaluating IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], the company's novel, long-acting recombinant albumin fusion protein for treating hemophilia B. The data, from a Phase III study and an ongoing extension study, assessed the long-term efficacy and safety of IDELVION for routine prophylaxis in previously treated children and adults with hemophilia B. The results showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption. The findings were presented at the XXXII International Congress of the World Federation of Hemophilia (WFH) in Orlando, Fla., July 24 – 28, 2016. Separately, an abstract reporting efficacy and safety results of IDELVION in hemophilia B patients undergoing surgery was also presented.

"These new data corroborate findings from the pivotal Phase III trials from PROLONG-9FP and demonstrate that IDELVION prophylaxis maintains robust efficacy and safety over time in pediatric and adult patients living with hemophilia B," said Elena Santagostino, M.D., Ph.D., Professor in the Medical School of Clinical and Experimental Hematology at the University of Milan/IRCCS Maggiore Hospital, and lead investigator of the PROLONG-9FP clinical development program. "Interim results from the extension study are promising and suggest that extended treatment intervals of up to 10 and 14 days are achievable in children less than 12 years of age with hemophilia B, and even more prolonged treatment intervals of up to 21 days are conceivable for older patients."

Read more: http://www.prnewswire.com/news-releases/csl-behring-presents-phase-iii-data-for-idelvion-for-hemophilia-b-at-the-world-federation-of-hemophilia-2016-world-congress-300303994.html

Source: Halozyme Therapeutics, Inc. & reported by http://www.prnewswire.com/

SAN DIEGO, July 25, 2016 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that it has resumed the enrollment and dosing of patients in its ongoing Phase 1b trial evaluating its investigational new drug, PEGPH20, in combination with KEYTRUDA (pembrolizumab) in patients with advanced non-small cell lung and gastric cancers under a revised clinical protocol.

The revised protocol has been submitted to all institutional review boards (IRB) and is pending feedback from the FDA. The majority of IRBs have completed their review and approved the revised protocol allowing the study to resume.

The Phase 1b study will enroll up to approximately 80 patients at a number of leading sites in the United States. For more information, go to www.clinicaltrials.gov and reference NCT02563548.

Read more: http://www.prnewswire.com/news-releases/halozyme-resumes-patient-enrollment-and-dosing-in-pegph20-clinical-trial-with-keytruda-300303044.html

Source: https://globenewswire.com/
BOTHELL, Wash., July 25, 2016 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced top-line 24-week data demonstrating persistent migraine prevention in a Phase 2b clinical trial evaluating ALD403 in patients with chronic migraine. ALD403 is Alder’s proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide (CGRP). In March 2016, Alder reported that the Phase 2b study met both the primary efficacy endpoint, a 75% reduction in migraine days over 12 weeks, and the secondary efficacy endpoint of mean reduction in migraine days from baseline.
“The 24-week data confirm and extend our previously reported 12-week data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group. These data will help us finalize the dose selection and design of PROMISE 2, our second planned pivotal trial on track to start later this year,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “Additionally, the data validate the dose selection for the ongoing PROMISE 1 study and further demonstrate ALD403’s best-in-class potential as evidenced by prolonged migraine prevention after a single injection. Reinforced by these positive results, we will continue to advance our development plan and, assuming regulatory approval, commercialize ALD403 in the U.S. to meet the needs of the approximate 13 million Americans who are candidates for a migraine preventative therapy.”
Read more: https://globenewswire.com/news-release/2016/07/25/858569/0/en/Alder-Reports-Positive-Top-Line-24-Week-Data-Demonstrating-Persistent-Migraine-Prevention-in-Phase-2b-Study-of-ALD403-in-Patients-with-Chronic-Migraine.html

Source: Mylan N.V. & reported by http://www.prnewswire.com/
BENGALURU, India, HERTFORDSHIRE, England and PITTSBURGH, July 21, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines Agency (EMA) has accepted for review, Mylan's Marketing Authorization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Mylan and Biocon, who have co-developed the proposed biosimilar, received EMA's acceptance of the submission for review. In addition to analytical, functional and pre-clinical data, the application includes clinical data from pivotal Pharmacokinetic / Pharmacodynamic (PK / PD) and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016. The results from the studies are expected to be presented at the prestigious European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen in Oct. 2016.

Read more: http://www.prnewswire.com/news-releases/mylan-and-biocon-announce-regulatory-submission-for-proposed-biosimilar-pegfilgrastim-accepted-for-review-by-european-medicines-agency-300302009.html

Source: http://www.businesswire.com/
TOKYO--(BUSINESS WIRE)--PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”)(TOKYO:4587) announced today that it has entered into a Technology License Agreement with U.S.-based Genentech, a member of the Roche Group, to nonexclusively license PeptiDream’s proprietary Peptide Discovery Platform System (PDPS) technology. Under the terms of the agreement, PeptiDream will receive an undisclosed upfront payment, annual technology access payments, and is eligible to receive payments based on achievement of certain predetermined development milestones. In addition, PeptiDream is eligible to receive royalties on sales of certain products that arise from use of the PDPS technology.

PeptiDream will continue to work with Genentech to identify macrocyclic/constrained peptides against multiple targets of interest selected by Genentech, and to optimize hit peptides into therapeutic peptides or small molecule products using PeptiDream’s PDPS technology, under the original agreement in December 2015.

In the past six years, PeptiDream has established funded discovery collaborations with 15 of the leading pharmaceutical companies; Amgen, AstraZeneca, Bristol-Myers-Squibb, Lilly, GlaxoSmithKline, Novartis, Mitsubishi Tanabe, Daiichi Sankyo, Merck, Sanofi, Teijin, Kyorin, Ipsen, Genentech, Shionogi, and Asahi Kasei, all of which are active and ongoing. In addition, PeptiDream has transferred its PDPS discovery platform for broad use to Bristol-Myers-Squibb, Novartis, and Lilly.
Read more: http://www.businesswire.com/news/home/20160720005494/en/PeptiDream-Announces-License-PDPS-Technology-Genentech

Source: https://www.a-star.edu.sg/
Singapore – Singapore’s Agency for Science, Technology and Research (A*STAR) and MSD (known as Merck & Co., Inc., in U.S.A. and Canada) have formed a two-year collaboration aimed at improving cellular delivery of macrocyclic peptides, a class of molecules that can potentially access therapeutic strategies that have been refractory to traditional approaches.

Macrocyclic peptides are a diverse family of molecules with a stabilizing ring architecture. What distinguishes these molecules from traditional classes of therapeutics is their capacity to disrupt intracellular protein-protein interactions drug targets. Importantly, these targets have traditionally been cast as ‘undruggable’1 due to their lack of obvious binding sites for small molecules and their residence inside cells, a location that shields them from antibody based therapies. Accordingly, the promise of macrocyclic peptides opens up new opportunities to address a range of human diseases such as cancer, cardiovascular and metabolic diseases. Indeed, given their medical potential, peptide therapeutics are on the rise. Globally, the market for peptide therapeutics is expected to grow to US$23.7 billion by 2020.[1]

While macrocyclic peptides offer therapeutic advantages over traditional approaches, their medical potential is currently limited by their marginal ability to penetrate into cells to reach their respective biological drug targets. Accordingly, this collaboration, which involves scientists from MSD as well as A*STAR’s Bioinformatics Institute (BII), Institute of Chemical and Engineering Sciences (ICES), Institute of Molecular and Cell Biology (IMCB) and the p53 Lab, aims to uncover the chemical and biophysical properties that influence peptide penetration into cells, as well as to explore the use of smart delivery systems that leverage natural cell entry mechanisms. The collaboration will combine MSD’s experience and expertise in drug discovery including medicinal chemistry, pharmacology, pharmacokinetics, and molecular modelling with A*STAR’s research capabilities in multiple areas such as protein peptide interactions, bioinformatics, chemistry and membrane trafficking to establish compound design principles that will help unlock the full therapeutic potential of macrocyclic peptides.

Read more: https://www.a-star.edu.sg/Media/News/Press-Releases/ID/4819/ASTAR-and-MSD-establish-a-new-research-collaboration-to-advance-peptide-therapeutics.aspx

Source: https://globenewswire.com/
AUSTIN, Texas, July 18, 2016 (GLOBE NEWSWIRE) - Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE) a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare diseases and cancer, today provided a regulatory and clinical update for its AEB1102 program. AEB1102, the company’s lead investigational molecule, is a recombinant human enzyme designed to degrade the amino acid arginine and is being developed to treat two extremes of arginine metabolism.

“We have developed a clinical program for AEB1102 with three ongoing clinical trials. The momentum for this program continues to build with AEB1102 receiving Fast Track designation from the FDA for hyperargininaemia in May and also receiving a positive opinion for Orphan Drug Designation from the European Medicines Agency this month,” said David G. Lowe, Ph.D., co-founder, president and chief executive officer at Aeglea. “We believe this molecule has great potential for patients with rare diseases and cancer, and we look forward to gathering critical data as we continue to advance our programs.”
Read more: https://globenewswire.com/news-release/2016/07/18/856717/0/en/Aeglea-BioTherapeutics-Provides-Update-on-AEB1102-Clinical-Program-in-Rare-Diseases-and-Cancer.html