All posts in Peptide News from Biotech and Pharma

Source: http://www.fiercebiotech.com/
AbbVie has unveiled a clutch of pacts in fields including immuno-oncology and genomics. The deals give AbbVie access to MerTK inhibitors, a source of peptide targets and genome sequencing data on 45,000 people.

All of the deals cover early-stage research, and as such it will be years before they have a notable effect on AbbVie’s fortunes. But, collectively, the pacts hint at the areas in which AbbVie sees its future resting and how it plans to go about realizing its ambitions. Two of the alliances relate to immuno-oncology, one is in the field of immunology and the fourth sees AbbVie gain access to a source of genomic data to support its future R&D efforts.

The genomics pact is perhaps the most striking. AbbVie has teamed up with the recently founded Genomics Medicine Ireland (GMI) to sequence the genomes of 45,000 volunteers. GMI and AbbVie will enroll people with “several types of immune-mediated diseases, neurological disorders and cancer” and individuals unaffected by these conditions in the sequencing program. AbbVie plans to pair these genotypic data to phenotypic information to identify new therapeutic targets and biomarkers.

Read more: http://www.fiercebiotech.com/node/470886

Researchers have developed a new infection-blocking material made of peptide-containing nanofibers that works against antibiotic-resistant bacteria and could one day be incorporated into wound dressings (ACS Infect. Dis. 2017, DOI: 10.1021/acsinfec​dis.6b00173). The approach targets bacterial quorum sensing—a mode of chemical communication used by bacteria to detect other bacteria. When they sense that enough of their kind are present, they can mount an infectious attack. Chemist Helen E. Blackwell of the University of Wisconsin, Madison, has developed peptides to block this quorum-sensing pathway, thereby preventing cells from attacking their host. Together with David M. Lynn and other Wisconsin colleagues, Blackwell electrospun one of these peptides into poly(lactide-co-glycolide) nanofibers. The researchers tested nanofiber mats against normal and deadly antibiotic-resistant strains of Staphylococcus aureus. By using a strain of S. aureus engineered to carry fluorescent reporter genes, the scientists found that the fibers with quorum-sensing inhibitors were able to block the bacteria from successful quorum sensing for up to two weeks. Moreover, when cultured in petri dishes with red blood cells, the treated bacterial cells did not rupture the blood cells, whereas untreated cells did. The presence of ruptured cells indicates that bacteria are using quorum sensing to coordinate an infection.

A team of researchers at the College of Science at George Mason University has detected 48 antimicrobial peptides in the blood plasma of Komodo dragons (Varanus komodoensis), the largest living lizards. The discovery could lead to the development of new drugs capable of combating antibiotic-resistant bacteria.

Komodo dragons live in the lesser Sunda region of the Indonesian archipelago, including the islands of Komodo, Flores, Rinca, and Padar.

The saliva of these lizards contains more than 50 species of aerobic and anaerobic bacteria (e.g. Enterobacteriaceae, Staphylococcus sciuri, Enterococcus faecalis), which are believed to contribute to the demise of their prey.

Yet, Komodo dragons appear resistant to these bacteria, and serum from these creatures has been shown to have antibacterial activity.

“Komodo dragons are the largest living lizards and are the apex predators in their environs,” said George Mason University researcher Barney Bishop and co-authors.

“They endure numerous strains of pathogenic bacteria in their saliva and recover from wounds inflicted by other dragons, reflecting the inherent robustness of their innate immune defense.”

Substances known as cationic antimicrobial peptides (CAMPs) are produced by nearly all living creatures and are an essential part of the innate immune system.

So, Dr. Bishop and his colleagues wondered whether they could isolate CAMPs from Komodo dragon blood, as they previously had done with alligator blood to expand the library of known CAMPs for therapeutic studies.

The researchers used an approach known as bioprospecting.

They incubated Komodo dragon blood with negatively charged hydrogel particles that they developed to capture the peptides, which are positively charged.

With this method, the team identified and sequenced 48 potential CAMPs with mass spectrometry.

All but one of these was derived from histone proteins, which are known to have antimicrobial activities.

“We employed a custom bioprospecting approach combining partial de novo peptide sequencing with transcriptome assembly to identify cationic antimicrobial peptides from Komodo dragon plasma,” the authors explained.

“Through these analyses, we identified 48 novel potential cationic antimicrobial peptides. All but one of the identified peptides were derived from histone proteins.”

“The antimicrobial effectiveness of eight of these peptides was evaluated against Pseudomonas aeruginosa and Staphylococcus aureus, with seven peptides exhibiting antimicrobial activity against both microbes, and one only showing significant potency against P. aeruginosa.”

The researchers conclude that Komodo dragon blood plasma contains a host of potentially viable antimicrobial peptides that could help lead to new therapeutics.

The team’s findings were published online Feb. 6, 2017 in the Journal of Proteome Research.

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Barney M. Bishop et al. Discovery of Novel Antimicrobial Peptides from Varanus komodoensis (Komodo dragon) by Large Scale Analyses and De Novo-Assisted Sequencing using Electron Transfer Dissociation Mass Spectrometry. J. Proteome Res., published online February 6, 2017; doi: 10.1021/acs.jproteome.6b00857

Source: https://www.thestreet.com/

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the U.S. Food and Drug Administration (FDA) has approved TRULANCE ™ (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). TRULANCE is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

We are thrilled with the approval of TRULANCE because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc. “I am confident that we truly have the right team with the right strategic vision and the right launch plan to successfully bring TRULANCE into this large but underserved market.”

CIC is a complex, functional GI disorder defined by symptoms including fewer than three bowel movements a week and hard-to-pass or incomplete bowel movements, for which there is no identifiable cause. CIC affects approximately 33 million Americans and an estimated 14 percent of the global population.

Read more: https://www.thestreet.com/story/13960162/1/synergy-pharmaceuticals-trulance-plecanatide-receives-us-fda-approval-for-the-treatment-of-adults-with-chronic-idiopathic-constipation.html

Source: https://globenewswire.com/

MELBOURNE, Australia and NANTES, France, Jan. 18, 2017 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (“Telix”) is pleased to announce the completion of a product collaboration and purchase option agreement with Atlab Pharma SAS (“Atlab”). Under the terms of the agreement, Telix will finance the manufacturing and clinical development of the huJ591 monoclonal antibody (mAb) radiolabelled with 177Lu (Lutetium) and 211At (Astatine), both promising “theranostic” products for the treatment of metastatic prostate cancer. The huJ591 mAb was originally developed by Dr. Neil Bander at the Weill Cornell Graduate School of Medical Sciences (New York, NY) and targets Prostate-Specific Membrane Antigen (PSMA), a well-validated target in prostate cancer.

The parties will collaborate to manufacture clinical material and work together to execute a multi-centre Phase IIb trial for the treatment of men with metastatic prostate cancer, with and without end-stage chemotherapy (standard care). In financing development, Telix also obtains an exclusive option to acquire Atlab under pre-agreed terms. The financial terms of the option exercise are not publicly disclosed at this time.

CEO Chris Behrenbruch stated, “PSMA targeting radiopharmaceuticals have shown great promise in both the diagnostic and therapeutic setting, dramatically increasing the interest in targeted radionuclide therapy by mainstream biopharma. The 177Lu-huJ591 program is the most clinically advanced PSMA program and has extensive patient experience, including in conjunction with anti-androgens and chemotherapy. We are very pleased to be working with Atlab to add this very promising program to Telix’s development pipeline.”

Read more: https://globenewswire.com/news-release/2017/01/18/909143/0/en/Telix-Pharmaceuticals-and-Atlab-Pharma-Conclude-Therapeutic-Product-Development-Agreement-for-Prostate-Cancer.html

Source: http://phasebio.com/

Malvern, PA, January 18, 2017 — PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing biopolymer-based drugs for the treatment of orphan diseases with an initial focus on cardiopulmonary disorders, today announced the closing of $14.7 million in convertible notes (“Financing”) to advance the clinical development of its lead compound PB1046, a weekly vasoactive intestinal peptide (VIP) receptor agonist, in orphan cardiopulmonary disorders.

Participating in the Financing are existing investors New Enterprise Associates, AstraZeneca, Johnson & Johnson Innovation – JJDC, Hatteras Venture Partners, Fletcher Spaght Ventures and Syno Capital. PhaseBio has the opportunity to increase the size of the Financing by up to $2.75 million from additional investors.

The Financing will support a Phase 2 study of PB1046 for the treatment of pulmonary arterial hypertension (PAH), which is expected to initiate in the first half of 2017, as well as the continued evaluation of PB1046 in additional indications. PhaseBio also intends to use the Financing to evaluate new pipeline products based on its proprietary elastin-like polypeptide (ELP) technology platform.

Read more: http://phasebio.com/phasebio-announces-14-7-million-convertible-notes-advance-clinical-development-pb1046-orphan-cardiopulmonary-disorders/

Source: Tarix Orphan LLC & reported by http://www.prnewswire.com/

CAMBRIDGE, Mass., Jan. 18, 2017 /PRNewswire/ -- Tarix Orphan LLC today announced that the U.S. Food and Drug Administration has granted a Rare Pediatric Disease (RPD) designation for the company's drug candidate TXA127 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder. There are currently no approved therapies for RDEB and treatment is limited to supportive care.

"The RPD designation for TXA127 in RDEB supplements the Orphan Drug Designation previously granted by the FDA in this indication," said Richard Franklin, President and Chief Executive Officer of Tarix Orphan LLC. "RDEB is a devastating disease. We have been very encouraged by the preliminary animal data we have generated and are looking forward to confirming these results in an additional model through the support of DEBRA International, the European patient organization focused on epidermolysis bullosa."

The FDA defines 'Rare Pediatric Disease' as a disease that primarily affects individuals aged from birth to 18 years and affects fewer than 200,000 persons in the United States. Under the Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval for a drug or biologic for a 'rare pediatric disease' may qualify for a voucher which can be redeemed to receive a priority review of a subsequent marketing application for a different product. The Priority Review Voucher is requested at the time of the marketing application and awarded upon approval of the product. The voucher may only be used once, but may be sold or transferred an unlimited number of times.

Read more: http://www.prnewswire.com/news-releases/tarix-orphan-receives-rare-pediatric-disease-designation-for-txa127-for-recessive-dystrophic-epidermolysis-bullosa-rdeb-300392579.html

Source: https://globenewswire.com/

Paris, France - January 18th , 2017 - Sanofi announced today that the European Commission has granted marketing authorization in Europe for SuliquaTM, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. Suliqua is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

"Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "The approval of Suliqua represents the successful culmination of a concerted effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose. Sanofi has a long history of elevating care for people with diabetes, and we believe Suliqua will make it easier for patients with inadequately controlled diabetes to reach their treatment goals."

The decision to grant marketing authorization in Europe for Suliqua was based on data from two Phase 3 studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively. Suliqua demonstrated statistically superior blood sugar (HbA1c) reduction versus lixisenatide (-0.8%, p<0.0001) and insulin glargine 100 Units/mL (-0.3%, p<0.0001) in LixiLan-O, and versus insulin glargine 100 Units/mL (-0.5%, p<0.0001) in LixiLan-L. Read more: https://globenewswire.com/news-release/2017/01/17/906426/0/en/Sanofi-SuliquaTM-Approved-in-the-European-Union-for-the-Treatment-of-Adults-with-Type-2-Diabetes.html

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

MILPITAS, Calif., Jan. 17, 2017 /PRNewswire/ - Protagonist Therapeutics, Inc. (NASDAQ: PTGX) today announced that it has initiated a global Phase 2b induction study in ulcerative colitis with PTG-100, an oral peptide that targets alpha4beta7 integrin. The aim of this randomized, double-blind, placebo-controlled, adaptive design study is to evaluate the safety/tolerability and efficacy of PTG-100 in approximately 240 adult ulcerative colitis patients with moderate to severe active disease.

"We are very pleased to advance our oral, alpha4beta7 integrin-specific antagonist peptide candidate, PTG-100, into this clinical proof-of-concept and dose optimization study," said Richard Shames, M.D., Chief Medical Officer at Protagonist. "We expect to complete the study and report top-line data in second half of 2018."

Patients will be randomized to one of four dose arms (150mg/300mg/900mg PTG-100 or placebo) for 12 weeks of once-daily oral dosing, followed by four weeks of safety follow-up. An interim futility analysis is expected to be performed in the second half of 2017, and if futility criteria are not met, one or two PTG-100 optimal doses will be selected for continued randomization of the remaining patients.

Read more: http://www.prnewswire.com/news-releases/protagonist-therapeutics-initiates-phase-2b-study-of-oral-drug-candidate-ptg-100-in-ulcerative-colitis-300391589.html