All posts in Peptide News from Biotech and Pharma

Source: http://www.marketwired.com/

TORONTO, CANADA--(Marketwired - March 8, 2016) - Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to peptide SOR-C13 for the treatment of ovarian cancer.

Orphan drug status is granted following review of the rarity and severity of the medical condition, as well as the potential benefit of the product treating this condition. Orphan drug status qualifies Soricimed for various development incentives, including tax credits and reduced filing fees for clinical trials undertaken in the U.S. If approved for commercialization by the FDA, SOR-C13 may qualify for seven years of marketing exclusivity in the United States.

According to the American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system, with an incidence rate of 11.9 per 100,000 and a death rate of 7.7 per 100,000. In some cases, orphan drugs can be made available to patients before marketing approval on a compassionate use basis.

"Receiving orphan drug status is significant", stated Paul Gunn, President and CEO at Soricimed. "It is an important regulatory milestone, offering special incentives to Soricimed through the development stage of SOR-C13."

Soricimed announced that it had reached its target enrollment and treatment duration in its Phase 1 trial of SOR-C13 in patients with solid tumor cancers who had failed other treatments. Topline results were released last month.

Read more: http://www.marketwired.com/press-release/soricimed-granted-orphan-drug-designation-from-us-fda-treatment-ovarian-cancer-2103744.htm

Source: http://www.thepharmaletter.com/

French drugmaker Ipsen (Euronext: IPN) and new startup PeptiMimesis have announced a new partnership to develop a novel generation of therapeutic peptides targeting membrane receptors which are overexpressed in a large number of cancers.

Only last month PeptiMimesis formally launched its activities to develop the new therapeutic peptides using a breakthrough technology from the University of Strasbourg and INSERM (the French Institute of Health and Medical Research).

Now it has agreed a research deal with Ipsen and a licensing option allowing the company to develop and market new drug candidates which come from the partnership.

The deal seeks to combine Ipsen’s expertise in peptide design and development with PeptiMimesis’ knowledge in identifying transmembrane peptides and intracellular signalling.

The target receptor is involved in various phases of cancer development, including angiogenesis, immune tolerance and proliferation.

Read more: http://www.thepharmaletter.com/article/ipsen-and-new-biotech-startup-announce-oncology-partnership

Source: http://www.globenewswire.com/

OSLO, Norway, March 10, 2016 (GLOBE NEWSWIRE) -- Targovax has conducted a predetermined interim analysis of the TG01 Phase I/II trial, indicating promising 1-year overall survival data when combining TG01 with gemcitabine (chemotherapy) as supplementary treatment of patients with pancreatic cancer.

Of the 19 patients included in the study, 15 patients provided consent to be followed up for survival and four patients did not provide consent to be followed up. 1-year survival data showed that 14 out of these 15 patient were alive and one passed away due to pneumonia assessed by the investigator as unrelated to the patients underlying cancer.

The regimen was generally well tolerated and RAS specific T-cell immune responses were induced and enhanced when TG01/GM-CSF was administered in combination with gemcitabine.

"One must be careful when drawing conclusions from small survival trials, but this result is an encouraging signal of efficacy and we look forward to the two year survival data which is expected during the first half year of next year", says Gunnar Gårdemyr, CEO of Targovax.

The study is a single arm study of TG01 in combination with standard of care gemcitabine as adjuvant treatment of patients with operable pancreatic cancer. The interim analysis covered 1-year survival of the first cohort of 19 patients.

Read more: http://www.globenewswire.com/news-release/2016/03/10/818498/10160922/en/Targovax-announces-encouraging-interim-results-with-RAS-specific-peptide-vaccine-in-resected-pancreatic-cancer.html

Source: Sanofi & reported by http://www.prnewswire.com/

PARIS, Feb. 22, 2016 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational 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.

Following the redemption of a Priority Review Voucher with the submission, an FDA decision is anticipated in August 2016.

"The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio," said Pascale Witz, Executive Vice President, Global Diabetes & Cardiovascular, Sanofi. "Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed. We look forward to working with the FDA during the review process with a view toward bringing this investigational medicine to adults with type 2 diabetes in the U.S."

This NDA submission is based on data from two Phase 3 studies, which enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints and will be presented at a medical congress in 2016.

Read more: http://www.prnewswire.com/news-releases/fda-accepts-sanofi-new-drug-application-for-once-daily-fixed-ratio-combination-of-insulin-glargine-and-lixisenatide-300223605.html

Source: SELLAS Life Sciences Group & reported by http://www.prnewswire.com/

ZUG, Switzerland and NEW YORK, Feb. 29, 2016 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on innovative products to treat cancers and central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for the Company's WT1 cancer vaccine for the treatment of patients with Malignant Pleural Mesothelioma (MPM). SELLAS recently reported positive results of a Phase 2 trial of its WT1 vaccine in MPM patients, showing that overall survival improved and progression-free survival doubled. Based on these findings, SELLAS intends to initiate a pivotal Phase 2b/3 trial of its product candidate in patients with MPM by the third quarter of 2016.

"We are thrilled with the progress of our WT1 vaccine program, which has received two orphan designations in the last two months and is advancing into pivotal studies in AML and in MPM patients in 2016, as well as further Phase 2 studies including in multiple myeloma, ovarian cancer, glioblastoma multiforme, and a series of genetically defined cancers in a basket-trial design," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS.

Miltiadis Sougioultzoglou, M.D., SELLAS's Executive Vice President, commented, "MPM is a difficult-to-treat and aggressive cancer, and fewer than five percent of patients survive beyond five years. There is a significant need for new treatment options, and we look forward to the commencement of the pivotal Phase 2b/3 trial."

Read more: http://www.prnewswire.com/news-releases/sellas-life-sciences-announces-fda-orphan-drug-designation-for-wt1-cancer-vaccine-in-patients-with-malignant-pleural-mesothelioma-300227450.html

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

CRANBURY, N.J., Feb. 8, 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 today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/313,258 (the '258 application).  The allowed claims are for methods of treating female sexual dysfunction using the formulation and dose used in Palatin's ongoing Phase 3 clinical trials and commercialization upon FDA approval.

Carl Spana, Ph.D., President and CEO of Palatin, commented, "The allowed patent is significant because it applies specifically to methods of treatment of female sexual dysfunction consistent with our projected approved product. Securing strong patent protection is a key component of our development program."

Once issued, the patent is expected to expire no earlier than November 2033, and will further enhance Palatin's key bremelanotide patent family, which includes U.S. Patent Nos. 6,579,968 and 6,794,489, which expire in June 2020 before patent term extensions.  Each of these patents contain composition and method of use claims covering bremelanotide.

Read more: http://www.prnewswire.com/news-releases/palatin-technologies-strengthens-intellectual-property-surrounding-use-of-bremelanotide-for-female-sexual-dysfunction-300216182.html

Source: TapImmune Inc. & reported by http://www.prnewswire.com/

TapImmune, Inc. (TPIV), a clinical-stage immuno-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 the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.

The FDA has designated the investigation of multiple-epitope Folate Receptor Alpha Peptide Vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard of care chemotherapy, as a Fast Track Development Program.

Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product.

Read more: http://www.prnewswire.com/news-releases/tapimmune-granted-fast-track-designation-by-us-food--drug-administration-for-its-lead-vaccine-tpiv-200-in-the-treatment-of-ovarian-cancer-567496381.html

Source: Dipexium Pharmaceuticals, Inc. and reported by http://www.prnewswire.com/

NEW YORK, Feb. 1, 2016 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide, today announced that the governments of Australia and New Zealand have issued new Locilex patents. The patents' claims are directed to a novel formulation of Locilex, an antibiotic peptide formulated as a topical cream, and the use of Locilex as a method of treating skin or wound infections. Both issued patents have expiry dates in June 2033.

"These patents in Australia and New Zealand are some of the first issued patents from our 2013 Patent Cooperation Treaty (PCT) filing in jurisdictions outside the United States," stated David P. Luci, President & Chief Executive Officer of Dipexium, "We anticipate the issuance of additional Locilex patents in other major international markets which will allow us to continue to establish commercial viability of Locilex throughout the world."

Read more: http://www.prnewswire.com/news-releases/dipexium-pharmaceuticals-announces-issuance-of-locilex-patents-in-australia-and-new-zealand-300212116.html

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

NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the company has filed with the U.S. Food and Drug Administration (FDA) its first new drug application (NDA) for plecanatide in chronic idiopathic constipation (CIC).

“The submission of the plecanatide NDA for CIC marks a major milestone for Synergy as we move the product candidate another step closer to potential approval early next year,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals. “I want to thank the Synergy team, our many advisors and my board of directors for their relentless efforts, enthusiasm and commitment in bringing plecanatide, a drug candidate which we invented in-house and developed entirely on our own, to this important milestone. We remain completely focused on flawless execution in 2016, with the ultimate goal of potentially providing patients and their healthcare providers a new treatment option for this very debilitating disease.” The plecanatide NDA for CIC is supported by positive results from two phase 3 clinical trials which Synergy completed in 2015. If approved, Synergy plans to launch plecanatide with the CIC indication in the first quarter of 2017.

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About Plecanatide

Synergy has pioneered discovery, research and development efforts involving uroguanylin analogs for the treatment of functional gastrointestinal (GI) disorders and inflammatory bowel disease. Uroguanylin is a naturally occurring human GI peptide and activator of the intestinal guanylate cyclase-C (GC-C) receptor, a known target for stimulating a variety of beneficial physiological responses. Plecanatide is a 16-amino acid peptide that is structurally identical to uroguanylin with the exception of a single amino acid change. This key amino acid substitution provides improved stability and an 8-fold higher binding constant to the GC-C receptor.

Read more: http://www.businesswire.com/news/home/20160129005757/en/Synergy-Pharmaceuticals-Files-Drug-Application-Plecanatide-Chronic

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

HIGH POINT, N.C.--(BUSINESS WIRE)--vTv Therapeutics Inc. (Nasdaq:VTVT), a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, today announced the enrollment of the first patients in the Company’s Phase 2 LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273. TTP273 is an oral, small molecule GLP-1R agonist with best-in-class potential.

he previous Phase 1b trial of TTP273 demonstrated robust effects on postprandial and fasting glucose. All doses of TTP273 were safe and well tolerated with no serious adverse events or evidence of gastrointestinal side effects compared to placebo.

“Earlier studies of this compound showed that TTP273 has the potential to provide enhanced glycemic control and weight loss without the burden of injections or gastrointestinal side effects seen with GLP-1 biologic agents,” said Steve Holcombe, President and CEO of vTv. “TTP273 is just one of two diabetes treatments in our pipeline reading out this year with our best-in-class orally administered Glucokinase Activator, TTP399, expected to report Phase 2 results in mid-2016.”

Read more: http://www.businesswire.com/news/home/20160121005208/en/vTv-Therapeutics-Initiates-Phase-2-Trial-Evaluating