All posts in Peptide News from Biotech and Pharma

Source: http://www.marketwired.com/

TORONTO, ON and REHOVOT, ISRAEL--(Marketwired - March 31, 2016) - VAXIL BIO LTD.(TSX VENTURE: VXL), an Israeli biotechnology company specializing in cancer immunotherapy, is very pleased to report that it has received a Notice of Allowance from the Canadian Intellectual Property Office (CIPO) for Canadian Patent Application No. 2,665,816 entitled "Antigen Specific Multi Epitope Vaccines." The patent would make Vaxil the Canadian leader in regard to utilizing MUC1 signal peptide domains as cancer immunotherapy treatments.

As opposed to many other cancer vaccines targeting entire cancer antigens, Vaxil has developed its proprietary immunotherapy platform for producing cancer vaccines relevant to specific signal peptide domains within the cancer antigen. This patent allowance protects Vaxil's ownership of all signal peptides of the MUC1 cancer target. MUC1 is known to be a highly important cancer target, given its therapeutic function, immunogencitiy, and wide presence in many cancer types. Vaxil will now be protected in Canada for the development of any signal peptide domain of the MUC1 cancer antigen. Vaxil's lead product, the Immucin™ cancer vaccine, represents one such promising variation of MUC1's signal peptide: the 21-mer peptide domain.

ImMucin™, is an immunotherapeutic treatment which educates a cancer patient's immune system, particularly T-cells and antibodies, to attack cancer cells via a specific domain, termed signal peptide, of the MUC1 cancer antigen. In a Phase-I/II trial which included 15 multiple myeloma patients, 100% of patients demonstrated robust immune responses, including both T-Cells and B-Cells.This signal peptide domain of the MUC1 cancer target, bears significant advantages as an immunotherapeutic agent, including its presence on approximately 90% of all cancer types.

Read more: http://www.marketwired.com/press-release/vaxil-receives-canadian-notice-patent-allowance-its-lead-immunotherapy-platform-including-tsx-venture-vxl-2110683.htm

Source: http://www.nasdaq.com/

(RTTNews.com) - Alder BioPharmaceuticals, Inc. (ALDER) announced positive top-line data from two clinical trials evaluating ALD403, Alder's proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide or CGRP. Positive top-line data from a Phase 2b study of patients with chronic migraine demonstrated that ALD403 acted rapidly and prevented migraine over the entire 12 week study period, meeting both primary and secondary efficacy endpoints.

Additionally, positive Phase 1 study data demonstrated that the pharmacokinetics and pharmacodynamics by intravenous (IV), subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.

The Phase 2b clinical trial is a double-blind, placebo-controlled, randomized, single intravenous infusion, dose ranging study in patients with chronic migraine. Patients were randomized to receive a single intravenous infusion of 10 mg, 30 mg, 100 mg or 300 mg of ALD403 or placebo (approximately 120 patients per group). The primary efficacy endpoint of the study is the change in migraine days between ALD403 and placebo as determined by the 75% responder rates over a 12-week period. Endpoints will also be evaluated at week 24 (expected Q3 2016) and at week 48 (end of study).

Read more: http://www.nasdaq.com/article/alder-reports-phase-2b-trial-of-ald403-meets-primary-and-secondary-endpoints-20160328-00122

Source: http://www.prnewswire.com/

NEW YORK, March 28, 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 antimicrobial peptide, today announced that the government of Japan has issued a Locilex patent. The patent claims are directed to a novel formulation of Locilex, an antimicrobial peptide formulated as a topical cream. The issued patent has an expiry date in June 2033.

"We are delighted to receive a Locilex patent in Japan, the third largest pharmaceuticals market in the world," 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-patent-in-japan-300241111.html

Source: http://www.firstwordpharma.com/

TOKYO, JAPAN – March 28, 2016 – PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”)(TSE First Section:4587) announced today that it has entered into a multi-target discovery and development collaboration with Tokyo-based Asahi Kasei Pharma Corp.(“Asahi Kasei Pharma”), a division of Asahi Kasei Corp. (TSE First Section: 3407). PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to identify macrocylic/constrained peptides against multiple targets of interest selected by Asahi Kasei Pharma, and to optimize hit peptides into therapeutic peptides. Asahi Kasei Pharma 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.

Read more: http://www.firstwordpharma.com/node/1370310?tsid=28&region_id=4#axzz44RvqhWDx

Source: http://globenewswire.com/

MENLO PARK, Calif., March 29, 2016 (GLOBE NEWSWIRE) -- Corium International, Inc.  (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the publication of a paper in the Early Edition of the Proceedings of the National Academy of Sciences (PNAS), titled “Long-acting Potent GLP-1 Analog Delivered in Microstructure-based Transdermal Patch”.  The results demonstrate that the combination of MicroCor transdermal system with E6, a new GLP-1R agonist, resulted in improved peptide effectiveness by increasing plasma stability and providing sustained glucose control in a preclinical proof-of-concept study.

The research was conducted in partnership with the California Institute for Biomedical Research (Calibr) and the Scripps Research Institute (TSRI).  In the study, E6, which was developed using a novel peptide engineering strategy, was formulated in Corium’s dissolving microstructure transdermal delivery system.  A single five-minute application of the MicroCor system resulted in bioavailability comparable to subcutaneous injection, with corresponding improvements in glucose tolerance sustained for up to four days.

The MicroCor transdermal delivery approach has the potential to offer a safe, effective, convenient and needle-free alternative to currently marketed GLP-1 injectables for the treatment of diabetes and obesity.  The MicroCor system has been clinically validated with parathyroid hormone, and the results published today with GLP-1 continue to support broader applications, including other therapeutic peptides and proteins, and vaccines. 

Read more: http://globenewswire.com/news-release/2016/03/29/823807/0/en/Corium-Announces-Positive-Preclinical-Results-with-Long-acting-Potent-GLP-1-Analog-Delivered-in-MicroCor-Transdermal-Patch.html?f=22&fvtc=7

Source: http://www.b3cnewswire.com/

Geneva, Switzerland, and Ingelheim, Germany, March 30, 2016 / B3C newswire / -- Amal Therapeutics (Amal) completes CHF 3 million (EUR 2.75 million) Series A financing round with Boehringer Ingelheim Venture Fund (BIVF) as cornerstone investors. VI Partners and High-Tech Gründerfonds also participated in the round which will help progress Amal’s cancer vaccines.

Amal Therapeutics is a Swiss biotech company developing and progressing therapeutic cancer vaccines. The company will use the funds to progress the preclinical development of its lead vaccine (ATP124) for colorectal cancer and to further develop its KISIMA technology platform for therapeutic tumor vaccination. This novel technology is able to generate potent long lasting anti-tumor immunity and avoid tumor immune escape.

Dr. Frank Kalkbrenner from the Boehringer Ingelheim Venture Fund and Dr. Frank Hensel from the High-Tech Gruenderfonds will join the Board as Board Observers. Dr. Diego Braguglia from VI Partners will also become a member of Amal’s Supervisory Board.

Read more: http://www.b3cnewswire.com/201603301360/amal-therapeutics-raises-chf-3-million-in-a-series-a-financing-round-led-by-boehringer-ingelheim-venture-fund.html

Source: Vaxon Biotech & reported by http://www.clinicalleader.com/

Vaxon Biotech, a biopharmaceutical company developing therapeutic cancer vaccines based on optimized cryptic peptides, recently announces the completion of enrollment for its phase 2b trial of Vx-001 in non-small-cell lung cancer (NSCLC). Vx-001 is a therapeutic cancer vaccine based on proprietary antigens known as optimized cryptic tumor peptides.

A total of 220 patients with metastatic NSCLC have now been enrolled in this phase 2b trial across 70 European trial centers. The primary endpoint is to assess the benefit of Vx-001 versus placebo on overall survival. Final trial results are expected in the fourth quarter of 2016.

An average of one in six patients were selected after meeting three criteria: expression of HLA-A2, TERT-expressing tumors and non-progression of cancer after first line chemotherapy. Over four months, participants received six doses of the Vx-001 vaccine or the placebo, then one dose every three months.

Vx-001 is the first vaccine to use optimized cryptic peptides and is the only such vaccine in development. Optimized cryptic peptides are universal tumor peptides that, while normally undetected by the immune system, have been modified to optimize their presentation to the immune system so as to induce a powerful anti-tumor immune response.

Read more: http://www.clinicalleader.com/doc/vaxon-biotech-completes-optimized-peptides-0001

Source: Arch Therapeutics & reported by http://www.marketwired.com/

FRAMINGHAM, MA--(Marketwired - Mar 14, 2016) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), has obtained favorable results from a broad panel of preclinical biocompatibility tests that were performed on AC5, which is required prior to the planned filing of a CE Mark application and commercialization of AC5 in Europe. Results from these biocompatibility safety studies indicate that AC5's peptide structure and mechanism of action, which is based on the formation of a local physical-mechanical barrier at the wound site, does not promote toxicity to the overall biological system following exposure to AC5.

Arch Therapeutics President and CEO Terrence Norchi, MD, stated, "This testing of AC5, performed under International Organization for Standardization (ISO) and Good Laboratory Practice (GLP) protocols, represents another step in our progress toward commercialization. Outcomes of the biocompatibility tests can be meaningful predictors of human safety, which enhances our confidence as we continue with our first human trial. Further, they are an important component of a CE Mark application, which we expect to file this summer -- and obtaining a CE Mark is a required critical step for commercialization."

The standardized studies included tests to assess cytotoxicity, implantation, irritation, pyrogenicity, sensitization and systemic toxicity. The testing was conducted on AC5 samples that were produced and sterilized under the same Good Manufacturing Practice (GMP) protocols as used for the product being tested in the Company's human trial that is underway in Western Europe. Testing was conducted under the guidelines provided by the ISO. The studies also complied with GLP, a Federal regulation (21 CFR part 58) governing the conduct of nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the United States Food and Drug Administration (FDA).

Read more: http://www.marketwired.com/press-release/arch-therapeutics-reports-favorable-results-ac5-surgical-hemostatic-device-biocompatibility-otcqb-arth-2105447.htm

Source: http://www.insideindianabusiness.com/

TOKYO - Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has entered into a technology license agreement with a Japanese biopharmaceutical company. The agreement with PeptiDream Inc. concerns products developed through the use of the company's Peptide Discovery Platform System technology.

The drugmaker says PeptiDream will receive upfront and annual technology access payments, as well as potential royalties based on future sales of products that arise through the use of its technology. The Japanese company will continue to work with Lilly on drug development.

PeptiDream says it has established discovery collaborations with many other pharmaceutical giants, including AstraZeneca, Ipsen, GlaxoSmithKline and Bristol-Myers-Squibb.

Read more: http://www.insideindianabusiness.com/story/31468766/lilly-inks-tech-agreement-with-japanese-company

Source: https://globenewswire.com/

Copenhagen, 2 March 2016 – Zealand announces top-line results from its clinical Phase II Proof-of-Concept trial with danegaptide for the protection against cardiac reperfusion injuries in patients with an acute myocardial infarction (blood clot in the heart). Results show no effect of danegaptide on the primary endpoint of saving cardiac tissue from ischemic reperfusion injuries as measured on the Myocardial Salvage Index (MSI).

Danegaptide is a Zealand invented peptide and the first in a new class of gap junction modifiers. The compound has demonstrated cell protective and anti-arrhythmic properties and shown significant effect in established preclinical models of cardiac ischemic reperfusion injuries. Despite substantial improvements in the treatment of patients with ST-elevation myocardial infarction (STEMI), significant unmet medical needs remain in the field, primarily associated with reperfusion injuries.

Britt Meelby Jensen, President and CEO of Zealand, said: “We had obviously hoped with this study to demonstrate a therapeutic benefit of danegaptide to patients. Cardiac damage remains a serious challenge following a heart attack, so in this sense, we are disappointed. Based also on the strong results seen with danegaptide in preclinical studies, we still think this was a relevant opportunity for us to explore despite the fact that this is a notoriously difficult therapeutic area, where many other drug candidates have failed. On behalf of Zealand, I would like to thank all patients and the study investigators at Rigshospitalet’s Cardiac Center for their participation in this very well-conducted trial.

Read more: https://globenewswire.com/news-release/2016/03/02/816290/0/en/Zealand-announces-results-of-a-Phase-II-Proof-of-Concept-trial-with-danegaptide-for-cardiac-reperfusion-injuries.html