All posts in Peptide News from Biotech and Pharma

Source: http://www.streetinsider.com/

Agenus Inc. (NASDAQ: AGEN) announced that it has acquired privately-held PhosImmune Inc., a company that has discovered an entirely new portfolio of cancer neoantigens. The acquisition provides Agenus the ability to accelerate the development of new cancer vaccines and other single agent immuno-oncology approaches, as well as combination therapies.

“PhosImmune’s groundbreaking neoantigen assets significantly expand Agenus’ current efforts, and present exciting near-term opportunities for new products and partnerships,” said Dr. Garo H. Armen, Chairman and Chief Executive Officer of Agenus. “This acquisition expands our immuno-oncology pipeline and strengthens our neoantigen capabilities to enable the development of best-in-class cancer vaccines and other novel therapies.”

Novel Neoantigens

PhosImmune’s neoantigens have unique advantages in cancer immunotherapy. The company’s phosphopeptide tumor targets (PTTs) are fragments of proteins expressed in cancer cells. These fragments are phosphorylated due to signal dysregulation involved in the development of cancers and, as a result, appear as foreign to the immune system. The approach is synergistic with Agenus’ AutoSynVax™ vaccine program for targeting patient-specific tumor neoantigens. PTTs can expand AutoSynVax and other immunotherapeutic approaches to include patients with lower levels of mutations that may not have enough neoantigens to activate the immune system effectively. PTTs can also be shared by patients with specific cancers, providing the potential for “off-the-shelf” vaccines.

PhosImmune’s scientific founders, Donald Hunt, Ph.D. and Vic Engelhard, Ph.D., both of University of Virginia, and Mark Cobbold, M.D., Ph.D., of Massachusetts General Hospital, have identified a large number of proprietary, tumor-specific PTTs. These PTTs are found on a wide variety of cancer types.

Read more: http://www.streetinsider.com/Corporate+News/Agenus+(AGEN)+to+Acquire+PhosImmune+in+~$45M+Deal/11175886.html

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 US-based Genentech Inc., (“Genentech”), a member of the Roche Group. PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology 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. Genentech will have the right to develop and commercialize all molecules resulting from the collaboration. Under the terms of the agreement, PeptiDream will receive an undisclosed upfront payment, research funding and is 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. The Roche Group retains an option to nonexclusively license the PDPS technology at a future date.

“We are very excited to be collaborating with the Genentech, said Kiichi Kubota, CEO of PeptiDream Inc. This deal further validates the potential of PeptiDream’s unique PDPS platform and matches PeptiDream’s growing capabilities in turning PDPS identified hits into clinical candidates with Genentech’s expertise in drug discovery and development”.

Read more: http://www.businesswire.com/news/home/20151221005370/en/PeptiDream-Announces-Peptide-Discovery-Collaboration-Agreement-Genentech

Source: http://www.vancouversun.com/

B.C. biotech Primary Peptides has signed a $40-million development agreement for a new stroke treatment with a Chinese pharmaceutical giant, but co-founder Max Cynader says it may be just the first of a dozen such agreements.

The new compound is intended to block the “toxic cascade” of reactions that lead to cell death in the hours immediately after a stroke and is the first candidate drug for commercialization produced by the fledgling firm.

Just 18 months after launching the company with Yu Tian Wang and William Jia — both fellow professors at the University of B.C. — Primary Peptides has a contractually guaranteed source of income in the form of progress payments from its deal with Beijing’s Yabao Pharmaceutical.

“With young companies, you are always hanging on by your fingernails, but this is a pretty special moment for us,” said Cynader, who recently retired from his administrative duties as director of the Brain Research Centre to join Primary Peptides and another start-up, Wavemakers Research.

Read More: http://www.vancouversun.com/health/stroke+drug+breakthrough+could+first+many+biotech+primary+peptides/11600198/story.html?__lsa=3cab-e0a5

Source: http://globenewswire.com/

Bagsværd, Denmark, 17 December 2015 - Novo Nordisk today announced the headline results from the fourth phase 3a trial for semaglutide, SUSTAIN2. Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly. The double-blinded trial investigated the efficacy and safety of 0.5 mg and 1.0 mg semaglutide compared with 100 mg sitagliptin, a once-daily DPP-IV inhibitor, after 56 weeks of treatment in 1,231 people with type 2 diabetes, where both drugs were added on to metformin, thiazolidinedione (TZD) or a combination of metformin/TZD.

The trial successfully achieved its objective by demonstrating that from a mean baseline HbA_1c of 8.1%, people treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA_1c of 1.3% and 1.6% respectively, compared to an improvement in HbA_1c of 0.5% with 100 mg sitagliptin.

69% of the people treated with 0.5 mg semaglutide and 78% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) treatment target of HbA_1c below 7% compared with 36% of the people treated with 100 mg sitagliptin.

Furthermore, from a mean baseline body weight of 89 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 4.3 kg and 6.1 kg respectively, compared with a weight loss of 1.9 kg for people treated with 100 mg sitagliptin.

Read more: http://globenewswire.com/news-release/2015/12/17/796325/0/en/Novo-Nordisk-successfully-completes-fourth-phase-3a-trial-with-semaglutide-in-people-with-type-2-diabetes.html

Source: http://www.marketwired.com/

MONCTON, NEW BRUNSWICK--(Marketwired - Dec. 15, 2015) - Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, today announced that it has reached its target enrollment and treatment duration in its Phase 1 trial. The Phase 1 is designed to evaluate the safety and tolerability of SOR-C13 in patients with solid tumor cancers who have failed other treatments. The Phase 1 was conducted at two sites in Canada and at the University of Texas MD Anderson Cancer Center under regulatory submissions filed by Soricimed with both the US Food and Drug Administration and Health Canada. The Company has initiated the compilation of the formal Clinical Study Report and expects to have top-line results from the trial early in Q1 of 2016.

SOR-C13 is a first-in-class peptide in development for the treatment of cancer. SOR-C13 binds with high selectivity and affinity to TRPV6, a calcium channel that is over-represented in solid-tumor cancers. By binding to this channel, SOR-C13 starves cancer cells of calcium that is needed for cell growth and division. As demonstrated in animal models the result is an inhibition of tumor growth. Due to the high specificity of SOR-C13 for its target and its unique mechanism of action this drug candidate may result in fewer and less severe side effects compared to standard cancer chemotherapy. SOR-C13 is the first drug candidate targeting TRPV6 to have entered clinical development anywhere in the world.

Read more: http://www.marketwired.com/press-release/soricimed-completes-phase-1-trial-of-sor-c13-in-advanced-solid-tumour-cancers-2081983.htm

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

ZUG, Switzerland, Dec. 11, 2015 /PRNewswire/ -- Cardiorentis AG, a privately held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to Ularitide, an investigational therapy for the treatment of acute decompensated heart failure (ADHF). The FDA's Fast Track process is intended to facilitate the development and expedite the review of drugs for the treatment of serious conditions addressing an unmet medical need. Cardiorentis anticipates top-line results from the TRUE-AHF Phase III trial in Spring 2016 and expects to file a U.S New Drug Application (NDA) and European Marketing Authorization Application (MAA) in the second half of 2016.

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"We are pleased that the FDA continues to acknowledge the current high unmet need for patients with ADHF by granting Fast Track status for Ularitide," said Johannes Holzmeister, M.D., CEO of Cardiorentis. "We look forward to working closely with the FDA on an expedited review process for Ularitide, as we are eager to provide a potential new treatment option for patients suffering from ADHF."

Ularitide is a natriuretic peptide in Phase III development for the treatment of ADHF. The trial has fully enrolled 2,157 patients in over 200 centers across the U.S., Europe, Canada and Latin America. TRUE-AHF is a randomized, double-blind, placebo-controlled event driven trial with two co-primary endpoints. The first is a composite endpoint for ADHF, which assesses a patient's symptoms and persistent or worsening heart failure within the first 48 hours after initiation of treatment. The second co-primary endpoint is cardiovascular mortality.

Read more: http://www.prnewswire.com/news-releases/cardiorentis-ularitide-receives-fda-fast-track-designation-for-the-treatment-of-acute-decompensated-heart-failure-300191703.html

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

CRANBURY, N.J., Dec. 10, 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 needs and commercial potential, today announced it has achieved its patient enrollment target in its two pivotal phase 3 clinical studies of bremelanotide for the treatment of female sexual dysfunction (FSD).

"We are pleased to achieve this major milestone in the development of bremelanotide," stated Carl Spana, Ph.D., President and CEO of Palatin.  "We are grateful for the enthusiastic response from our clinical investigators and strong interest from patients to participate in our Phase 3 reconnect study program." Dr. Spana further stated that, "This puts us on target to release top-line data results in the third quarter of calendar year 2016."

Each North American (primarily U.S.)  reconnect study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. The clinical trials are designed to randomize approximately 1100 women (~550 each trial) to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) as an on-demand, as-needed treatment.

Read more: http://www.prnewswire.com/news-releases/palatin-technologies-achieves-target-patient-enrollment-in-pivotal-phase-3-studies-for-bremelanotide-for-female-sexual-dysfunction-300191004.html

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

JACKSONVILLE, Florida, December 9, 2015 /PRNewswire/ -- TapImmune, Inc. (TPIV), a clinical-stage immunology-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, announced today that it has received Orphan Drug Designation from the U.S. Food & Drug Administration's Office of Orphan Products Development (OOPD) for its cancer vaccine TPIV 200 in the treatment of ovarian cancer. The TPIV 200 ovarian cancer clinical program will now receive benefits including tax credits on clinical research and 7-year market exclusivity upon receiving marketing approval.

TPIV 200 is a multi-epitope peptide vaccine that targets Folate Receptor Alpha which is overexpressed in multiple cancers including over 90% of ovarian cancer cells.  In Phase I clinical studies conducted at the Mayo Clinic in patients with breast and ovarian cancer this vaccine was shown to be safe and well tolerated and to give robust cellular immune responses in 20 out of 21 evaluable patients.  Further, the data showed that 16 out of 16 patients in the observation stage still showed immune responses. Data from the Phase I studies were published in the Journal of Clinical Oncology covering the American Society of Clinical Oncology meeting in May 2015.   Multiple Phase II studies will examine the efficacy of this vaccine in ovarian and triple negative breast cancer.

Read more: http://www.prnewswire.com/news-releases/us-food--drug-administration-grants-orphan-drug-designation-to-tapimmunes-tpiv-200-in-the-treatment-of-ovarian-cancer-561310051.html

Source: http://globenewswire.com/

Copenhagen, 9 December 2015 – Zealand informs that its acting Senior Vice President of Research, Keld Fosgerau presented at the New York Academy of Sciences’ (NYAS) GLP-1 Treatment for Diabetes and Beyond meeting yesterday in New York.

The New York Academy of Sciences is one of the oldest and most prestigious scientific membership organizations in the US, with over 20,000 members from around the world. The GLP-1 Treatment for Diabetes and Beyond meeting highlighted innovative scientific approaches to GLP-1 based new therapies in the preclinical and clinical arena with a focus on human genetics, novel cellular and molecular mechanisms for insulin secretion and weight loss, new indications and new opportunities for drug development.

In his presentation, Keld Fosgerau discussed various approaches applied by Zealand in the creation of second generation GLP-1 based therapies, and how these can help address unmet medical needs in the field of Type 2 diabetes and obesity. He showcased the company’s leading expertise in the synthesis of novel dual acting peptides and in developing those peptides to create compelling new medicines. The Zealand peptides that were presented include ZP2929, a glucagon/GLP-1 dual agonist in clinical Phase I development for improved weight management in diabetes, a preclinical GIP/GLP-1 dual agonist for greater therapeutic index with reduced risk of hypoglycemia, and a preclinical gastrin/GLP-1 dual agonist for the prevention of beta cell decline.

Read more: http://globenewswire.com/news-release/2015/12/09/794000/0/en/Zealand-presented-on-its-dual-acting-peptides-at-the-New-York-Academy-of-Sciences-meeting-GLP-1-Treatment-for-Diabetes-and-Beyond.html

Source: http://globenewswire.com/

BASKING RIDGE, N.J., Dec. 01, 2015 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (“Caladrius” or the “Company”) (NASDAQ:CLBS), a cell therapy company combining an industry-leading external development and manufacturing provider with a development pipeline in immunotherapy, announces today the publication of two-year results from a Phase 1 clinical study of an autologous Regulatory T cell (Treg) immunotherapy for type 1 diabetes (T1D). The study investigated a product that is the forerunner of the Company’s CLBS03 product candidate for recent-onset T1D.

The publication, entitled “Type 1 diabetes immunotherapy using polyclonal regulatory T cells,” was published in Science Translational Medicine and authored by a team led by Jeffrey A. Bluestone, PhD, Professor at the Diabetes Center, University of California San Francisco, and a member of the Company’s Type 1 Diabetes Scientific Advisory Board.

The Phase 1 open-label, uncontrolled dose-escalating study was conducted at the University of California, San Francisco and Yale University and provided evidence for safety and tolerability of autologous expanded polyclonal Treg cell therapy in fourteen adults with recent-onset T1D. In the Phase 1 trial, subjects received ex vivo-expanded Tregs, ranging in dose from 5 million to 2.6 billion cells. The study found that autologous Tregs can be expanded and were well tolerated in patients with recent-onset T1D. Additionally, the Tregs retained their T cell receptor diversity and demonstrated enhanced functional activity.

Read more: http://globenewswire.com/news-release/2015/12/01/791891/0/en/Caladrius-Announces-Publication-of-Two-Year-Results-From-Phase-1-Trial-of-Type-1-Diabetes-Product-Candidate-in-Science-Translational-Medicine.html