All posts in Peptide News from Biotech and Pharma

Source: http://www.archtherapeutics.com/

FRAMINGHAM, MA -- (Marketwired) -- 09/08/15 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), obtained favorable data from a preclinical toxicology test for AC5™ showing that the device did not cause sensitizing reactions in animals and is considered a "non-sensitizer." The test, called the Maximization Test, is a standardized test of contact sensitization and is performed in animals as a major component of the biocompatibility test panel that a medical device must typically complete successfully prior to use in humans. Testing was conducted under the guidelines provided by the International Organization for Standardization (ISO) and the study also complied with Good Laboratory Practice (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 Food and Drug Administration (FDA). AC5 is a development-stage hemostasis product being evaluated to control bleeding, mitigate fluid loss, and create an environment permissive to normal healing in order to provide more efficient surgical and interventional care.

In this standard in vivo study, designed to provide general information on the health hazards likely to arise from acute exposure to clinically relevant quantities of AC5, AC5 was well tolerated when using standardized success criteria based upon comparison with control materials. As a result, AC5 was classified as a non-sensitizer with no evidence of causing delayed contact sensitization. Results from this biocompatibility safety study 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 sensitization to the overall biological system following application of standardized AC5 extract solutions in animals. The results of this study provide further evidence of the absence of toxicity for AC5, and represent a critical step toward demonstrating biocompatibility of this medical device.

Read more: http://www.archtherapeutics.com/news/press-releases/detail/453/arch-therapeutics-obtains-additional-positive-safety-data

Source: http://www.pharmabiz.com/

Novo Nordisk, a healthcare company, has announced that a research collaboration has been initiated with the Langer Laboratory at the Massachusetts Institute of Technology for what is hoped to be the next generation of drug delivery devices for the administration of peptides.

The aim of the research collaboration, which is conducted at both MIT in Boston, US and at Novo Nordisk's research facilities in Måløv and Hillerød, Denmark, is to develop the next generation of drug delivery devices as an alternative to parenteral or injection-based delivery of peptides.

Professor Robert Langer's laboratory is world-leading expert in creating new approaches for delivering drugs such as peptides and proteins across complex barriers in the body such as the blood-brain barrier, the intestine, the lung and the skin. Together with Dr Giovanni Traverso, a gastroenterologist and biomedical engineer at Harvard Medical School, and research affiliate of MIT, they will lead a team in the development of a platform enabling the oral delivery of peptides.

There are many challenges of developing and producing a reliable peptide delivery vehicle. They include avoiding premature degradation in the body, overcoming poor peptide transport over epithelial barriers, limiting variability of absorption (caused, for example, by interaction with food in the stomach), and producing both peptide and the delivery vehicle in sufficient scale and numbers cost-effectively. If these challenges can be overcome, as recent research suggests, drug delivery devices hold great therapeutic promise for a plethora of diseases where patients need to take frequent injections.

"Drug delivery devices hold great potential and I am looking forward to this exciting research collaboration with one of the world's leading drug delivery laboratories," says Peter Kurtzhals, senior vice president and head of global research at Novo Nordisk.

Read more: http://www.pharmabiz.com/NewsDetails.aspx?aid=90489&sid=2

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

NEW YORK, NY--(Marketwired - Sep 9, 2015) - iBio, Inc. (NYSE MKT: IBIO), a leader in plant-based biotechnology for developing and manufacturing biopharmaceutical products, announced the award of a grant to fund further development of its proprietary therapeutic product for treatment of fibrotic diseases from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) under its Small Business Technology Transfer (STTR) program. The Fast-Track award will support the work of principal investigators Carol Feghali-Bostwick, Ph.D., of The Medical University of South Carolina (MUSC) and Hal Padgett, Ph.D., of Novici Biotech LLC (Novici) and their research teams. The funded project is entitled, "Peptide Based Therapy for Lung Fibrosis." The commercial sponsor of the program is iBio, Inc.

"Our anti-fibrotic molecules were discovered and refined using phenotypic screening techniques rather than direct mechanistic targeting of a single modulator of fibrosis such as TGF-beta, giving us a high degree of confidence that these molecules can produce positive outcomes in fibrosis with broad applicability in a variety of fibrotic diseases," said Terence Ryan, Ph.D., iBio's Chief Scientific Officer. "We are encouraged by the positive reviews that led to approval of this grant application."

The NIH STTR Fast-track mechanism provides for a submission and review process whereby both Phase I and Phase II grant proposals are submitted together and reviewed as a single application, thus reducing the funding gap that may occur between phases. This grant was approved for funding as of September 1, beginning with approximately $200,000 for Phase I. Phase II funding of approximately $1.5 million may commence once the milestones for Phase I have been completed and a progress report is submitted and approved by the NHLBI. Steady progress has been made on project objectives during the grant application review period, and the principal investigators expect to submit a timely progress report.

"Our collaboration with iBio and Novici is yielding exciting progress," said Dr. Feghali-Bostwick, MUSC's SmartState® and Kitty Trask Holt Endowed Chair and Professor of Medicine. "I look forward to working with this team to translate laboratory bench discoveries into effective therapies."

Read more: http://www.marketwired.com/press-release/ibio-fibrosis-therapeutics-program-receives-nih-grant-support-nyse-mkt-ibio-2053884.htm

Source: https://www.closeconcerns.com/

Novo Nordisk announced an agreement last week to acquire Calibrium and MB2, two young private companies co-founded by the renowned Dr. Richard DiMarchi (Indiana University, Bloomington, IN) that are focused on developing protein-based products for diabetes and obesity. Closing of the agreement is expected later in 3Q15 pending approval from US regulatory authorities (where we expect zero difficulty); the companies did not disclose any financial details. For Novo Nordisk, the agreement is the latest in a series of steps aimed at expanding the company’s early-stage diabetes and obesity portfolio and its US research presence (including the investment in a major new manufacturing facility for oral semaglutide and other products in Clayton, NC announced just the other day and the establishment of an obesity research center in Seattle, WA last fall). Novo Nordisk has not historically been very active in M&A activity relative to other major pharmaceutical companies, so we see this agreement as a significant and well-deserved vote of confidence in Dr. DiMarchi and his team – from our conversation early this morning with Novo Nordisk head of R&D Dr. Peter Kurtzhals, this move may also signal a change in Novo Nordisk’s approach to partnerships. For Dr. DiMarchi, Novo Nordisk’s extensive drug development expertise will certainly be an asset and the Danish company is clearly extremely happy to be collaborating with him and his group – Dr. Kurtzhals mentioned more than once the strength of Dr. DiMarchi’s team as he has seen over his many years at Novo Nordisk. In terms of logistics, Dr. Kurtzhals indicated that the research will be conducted by a ~20-person team led by Dr. DiMarchi that is based in Indiana. Dr. DiMarchi will report directly to Dr. Kurtzhals and will have the title of Vice President of R&D. The agreement covers the majority of Dr. DiMarchi’s work at Indiana University, including assets advanced at Marcadia and Calibrium (with a few undisclosed exceptions). Novo Nordisk is also funding a discovery unit of approximately two dozen scientists focused on metabolism.

Novo Nordisk’s longstanding focus on developing peptide products for diabetes and obesity bodes well for the collaboration’s long-term success.

Read more: https://www.closeconcerns.com/knowledgebase/r/552aa02d?utm_source=Closer+Look+Subscribers+2015&utm_campaign=3b60fd3773-2015-09-03_CeQur%2C_Dexcom%2C_Zealand%2C_Frac09_03_2015&utm_medium=email&utm_term=0_c55d924bf1-3b60fd3773-411796361

Source: Esperance Pharmaceuticals, Inc. and reported by http://www.news-medical.net/

Esperance Pharmaceuticals Inc. today announced that it has entered into a strategic alliance agreement with MD Anderson Cancer Center to accelerate the clinical development of its lead anti-cancer candidate EP-100 for the treatment of ovarian cancer and to collaborate on preclinical studies of EP-100 as a treatment for breast cancer. At the 2015 ASCO Annual Meeting, the company reported positive results from a Phase II trial of EP-100 in ovarian cancer patients resistant to paclitaxel. EP-100 is a targeted membrane-disrupting peptide designed to seek and destroy cancer cells that overexpress luteinizing hormone releasing hormone (LHRH) receptors on their surfaces. LHRH receptors are over-expressed in a wide range of cancers including ovarian, breast, prostate, pancreatic and endometrial cancer.

As part of the strategic alliance, MD Anderson will conduct additional studies to help prepare for a Phase III trial of EP-100 in ovarian cancer, including more fully elucidating its mechanism of action and identifying potential biomarkers to support the selection of those patients most likely to respond to the drug. It also will collaborate with Esperance to conduct studies needed to initiate clinical trials of EP-100 in breast cancer and assess the anti-cancer potential of other drug candidates generated by Esperance's Cationic Lytic Peptide (CLYP^TM) platform technology. Further details of the agreement were not disclosed.

Read more: http://www.news-medical.net/news/20150824/Esperance-MD-Anderson-form-strategic-alliance-to-accelerate-development-of-anti-cancer-candidate-EP-100.aspx

Source: http://www.morphosys.com/

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and Immatics Biotechnologies GmbH announced today a strategic alliance to generate novel antibody-based therapeutics against multiple proprietary cancer antigens recognized by T cells. The collaboration agreement provides MorphoSys with access to several proprietary tumor-associated peptides (TUMAPs) discovered using Immatics' XPRESIDENT® platform to develop novel antibody-based therapeutics against these targets in a number of solid and hematological cancers. XPRESIDENT® enables access to novel antibody targets associated with proteins that are present inside cancer cells. In return, Immatics will be provided with MorphoSys' Ylanthia® antibodies against a number of its TUMAPs, with proprietary development rights. The companies will pay each other milestones based on their respective development progress as well as royalties on marketed products. Financial details of the agreement were not disclosed.

Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG, commented: "We are delighted to join forces with Immatics, a world leader in discovering truly novel cancer targets that would be otherwise inaccessible for antibody-based therapies. This alliance opens up the intracellular target space for us and thus complements the therapeutic approaches we use in other oncology programs. We believe this collaboration will create several unique product opportunities for us based on truly differentiated compounds."

Dr. Harpreet Singh, Chief Scientific Officer of Immatics Biotechnologies GmbH, added: "The alliance with MorphoSys marks an important strategic milestone for Immatics. We are now entering the field of antibody-based therapeutics complementing our existing cancer immunotherapy pipeline. The combination of MorphoSys' outstanding capabilities to create antibodies and the unique access to intracellular targets through our XPRESIDENT® discovery engine provides both partners the opportunity to jointly deliver the next generation of transforming antibody drugs for cancer patients with high unmet medical need."

Read more: http://www.morphosys.com/media-investors/media-center/morphosys-and-immatics-biotechnologies-enter-strategic-alliance-in

Source: http://globenewswire.com/

Bagsværd, Denmark, 24 August 2015 - Novo Nordisk today announced headline results from the second and final phase 3a trial with liraglutide as adjunct therapy to insulin for people with type 1 diabetes. ADJUNCT ONE(TM) is a randomised, double-blind, placebo-controlled trial investigating efficacy and safety of daily doses of 0.6 mg, 1.2 mg and 1.8 mg liraglutide compared with placebo as adjunct to insulin treatment. 1,398 people with type 1 diabetes were treated for 52 weeks.

From a mean baseline HbA_1c of around 8.2%, people treated with 1.2 mg and 1.8 mg liraglutide as adjunct to insulin therapy achieved the primary objective of non-inferiority in HbA_1c and showed a greater improvement in HbA_1c of around 0.5% compared with 0.3% for people treated with placebo. The primary objective of HbA_1c non-inferiority was not confirmed for the 0.6 mg dose.

Furthermore, from a mean baseline weight of around 86 kg, people treated with 1.2 mg and 1.8 mg liraglutide as adjunct to insulin therapy achieved a statistically significantly greater weight loss between 3 kg and 4 kg whereas people treated with placebo experienced a weight gain of around 1 kg.

- See more at: http://globenewswire.com/news-release/2015/08/24/762981/0/en/Novo-Nordisk-completes-second-and-final-phase-3a-trial-with-liraglutide-as-adjunct-therapy-to-insulin-for-people-with-type-1-diabetes-NN9211.html#sthash.a07qoJY9.dpuf

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

SAN DIEGO, CA--(Marketwired - Aug 27, 2015) - Aegis Therapeutics LLC announced today that it has been awarded US Patent No. 9,114,069 titled "Antibacterial Compositions for Drug Administration" providing non-toxic formulations of parathyroid hormone and related analogs, including teriparatide (PTH 1-34), suitable for injectable or metered nasal spray administration having intrinsic antimicrobial activity. The patent formulations meet the FDA's antimicrobial effectiveness test criteria set forth in USP < 51 > without the need for metacresol, an antimicrobial agent currently used in commercial formulations of teriparatide as well as certain insulins. Metacresol is irritating and/or a sensitizer to skin, eyes and mucous membranes and is classified as a possible carcinogen.

Human clinical studies have shown that formulations of teriparatide based upon Aegis' Intravail®/ProTek® technology show excellent nasal bioavailability offering the prospect of a "first in class" non-injectable PTH drug for treatment of osteoporosis. Non-injectable dosage forms of previously injectable-only drugs provide greater patient convenience and acceptance, improved compliance, and avoidance of needle-stick injury and disposal problems associated with the use of needles.

Read more: http://www.marketwired.com/press-release/aegis-therapeutics-awarded-third-patent-metered-nasal-spray-parathyroid-hormone-pth-2050686.htm

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

TEL AVIV, Israel--(BUSINESS WIRE)--BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today the initiation of a Phase 2b trial for BL-8040 as a novel consolidation treatment for acute myeloid leukemia (AML). The Phase 2b study will examine BL-8040 as part of a second stage treatment, termed consolidation therapy, to improve outcomes for AML patients who have achieved remission after the standard initial treatment regimen, known as induction therapy. The consolidation therapy is aimed at eliminating the minimal residual disease left in the bone marrow after induction therapy that can lead to relapse. This study is the first of three clinical studies in additional indications for BL-8040 which BioLineRx plans to commence during 2015, thus significantly expanding its unique BL-8040 oncology platform.

Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “The majority of high-risk AML patients achieving first complete remission relapse within one year, despite the current standard consolidation therapy. Patients with AML relapse have a poor prognosis despite further therapy, and less than 10% of these patients are cured by conventional therapy. Leukemic stem cells that are dormant in the bone marrow are presumed to be a major reason for AML relapse. Based on the pre-clinical and clinical data accumulated to date, BL-8040 is anticipated to boost the efficacy of consolidation therapy due to its dual mechanism of action. Firstly, BL-8040 induces mobilization of leukemic cells from the bone marrow, which enhances the cytotoxic effects of chemotherapy, and secondly, it possesses anti-leukemic pro-apoptotic properties that help eliminate AML cells directly. Based on positive results from our ongoing phase 2 clinical trial for BL-8040, which show substantial mobilization of AML cells from the bone marrow to the peripheral blood, as well as robust induction of AML cell apoptosis, we believe BL-8040 will be a promising addition to consolidation therapy for AML patients.”

Read more: http://www.businesswire.com/news/home/20150817005292/en/BioLineRx-Announces-Initiation-Phase-2b-Trial-AML#.VdSy9_miUQs