All posts in Peptide News from Biotech and Pharma

Source: http://www.cantabio.com/
PALO ALTO, Calif., April 12, 2016 (GLOBE NEWSWIRE) -- Cantabio Pharmaceuticals Inc. (OTCQB:CTBO) announced today a new preclinical therapeutic program for Alzheimer’s Disease which it is pursuing through its drug discovery partnership with NovAliX. This program is aimed at the development of small molecule chaperones that stabilize the Abeta peptide, the aggregation of which is considered to be a key element in the onset and progression of Alzheimer’s disease.

This new program, which is the result of collaborative work between Cantabio and NovAliX, is based on the discovery of novel small molecules that interact with the Abeta peptide, which were identified using NovAliX’s high throughput chemical microarray based surface plasmon resonance (SPR-WORM) screen, a unique high throughput biophysics based binding assay platform.

Cantabio aims to develop a novel therapy for the treatment of Alzheimer's disease, which impacts an estimated 5.4 million Americans, including 200,000 individuals below the age of 65. Alzheimer’s is the 6th leading cause of death in the United States, with 700,000 seniors expected to die in 2016 with the disease. The annual number of new cases of Alzheimer's is projected to double by 2050, with a public cost of direct care currently at $236 billion. There is currently no disease modifying treatment available for this growing problem.

Read more: http://www.cantabio.com/news-media/press-releases/detail/8/cantabio-pharmaceuticals-announces-the-development-of-small

Source: http://www.prnewswire.com/
PASADENA, Calif., April 18, 2016 /PRNewswire/ -- Meditope Biosciences, Inc., a preclinical biotechnology company developing novel antibody-based products using its proprietary technology, today announced the presentation of data demonstrating the ability of its SnAP technology platform to facilitate cell surface receptor crosslinking and enhance antibody internalization. The data were presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2016, April 16-20 in New Orleans.

"These data highlight additional commercial applications for our unique SnAP technology, showing that meditope-enabled antibodies using SnAP are a site selective way to attach molecules to antibodies, without interfering with normal antigen binding. Further, SnAP-induced crosslinking can promote enhanced internalization, facilitating antibody mediated cell death and cell signaling modulation," said Elisabeth Gardiner, Meditope Biosciences' Chief Scientific Officer and an author of the abstract. "We are highly encouraged by these results as we seek to advance our first antibody drug conjugate (ADC) product candidate into the clinic."

SnAP technology (Site-specific novel Antibody Platform) enables antibodies to bind to specific peptides called "meditopes," an ability that can be used to facilitate receptor crosslinking when meditope-enabled antibodies are bound to cell surface receptors. The poster presented at AACR, titled "Utilization of Meditope Biosciences SnAP Technology to Enhance Antibody Internalization" (Abstract #598) summarized an internalization experiment demonstrating how meditope-enabled antibody-to-antibody crosslinking leads to enhanced internalization.

Read more: http://www.prnewswire.com/news-releases/meditope-biosciences-announces-data-at-aacr-annual-meeting-demonstrating-further-capabilities-of-its-snap-technology-300252728.html

Source: http://www.prnewswire.com/
TORONTO, April 18, 2016 /PRNewswire/ - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) today announced that it has received notification that Eli Lilly and Co. ("Lilly") will not elect to advance diabetes drug candidate, TT401 into Phase 3 development. Under the companies' collaboration agreement, all TT401 development and commercialization rights will be transferred to Transition. Transition is unencumbered to advance TT401 on its own or with a third party.

TT401 is a once-weekly administered oxyntomodulin analog, with dual agonist activity on the GLP1 and Glucagon receptors. TT401 is the most clinically advanced drug candidate among the new class of GLP1-glucagon receptor dual agonists. The product profile for this class of diabetes drug candidates is to provide type 2 diabetes individuals with blood-glucose control and greater weight loss than GLP1 single agonists.

In the recently completed Phase 2 study of 420 type 2 diabetes individuals, the highest dose of TT401 once-weekly administered peptide demonstrated significantly superior weight loss to currently approved extended release exenatide and placebo after 12 and 24 weeks of treatment. TT401 also provided similar HbA1c reduction as exenatide at weeks 12 and 24. The study demonstrated that TT401 had an acceptable safety and tolerability profile consistent with GLP-1 single agonists.

Read more: http://www.prnewswire.com/news-releases/transition-therapeutics-provides-update-on-type-2-diabetes-drug-candidate-tt401-576035781.html

Source: http://www.biospace.com/
TORONTO – Eli Lilly (LLY) has opted to not advance a diabetes drug into a Phase III clinical trial it was developing in coordination with Canada-based Transition Therapeutics Inc. (TTH.TO), the companies announced today.

News of Eli Lilly’s withdrawal of support for Transition’s drug sent that company’s stock plummeting nearly 20 percent. The stock is currently trading at $1 per share, down from its closing price of $1.24 per share on Friday.

Development and possible commercialization of the experimental drug, TT401, will now rest solely with Transition Therapeutics. Lilly chose not to continue in the advancement of TT401 because the experimental drug did not demonstrate a significant advantage in lowering HbA1c, glycated hemoglobin, Seeking Alpha noted.

TT401 is a once-weekly administered oxyntomodulin analog, with dual agonist activity on the GLP1 and Glucagon receptors. The product profile for this class of diabetes drug candidates is to provide type 2 diabetes individuals with blood-glucose control and greater weight loss than GLP1 single agonists.

Read more: http://www.biospace.com/News/eli-lilly-abandons-development-of-transition/415814/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

Source: http://www.biospace.com/
Leiden, The Netherlands, April 19, 2016 – ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced it has been granted a US patent on its AMPLIVANT® technology and compounds (patent no. 9,314,521). The patent ensures market protection in the United States until 2032 and covers the compounds, either as a stand-alone substance or in combination with antigenic peptides, nucleic acids or antibodies. The patent also covers the process for preparing the compounds.

ISA’s AMPLIVANT® technology provides an adjuvant that has been demonstrated to improve the immunostimulatory potency of SLP® immunotherapeutics 100- to 1000-fold. It comprises a synthetic small molecule toll-like receptor 1/2 (TLR1/2) ligand with enhanced immunostimulatory activity that can be used as a stand-alone additive or chemically coupled to immunotherapeutic compounds like synthetic peptides during the SLP® manufacturing process. SLP®-AMPLIVANT® conjugate compounds allow for lower doses at higher efficacy through better dendritic cell antigen processing and presentation as well as enhanced T cell priming. At present, clinical researchers at Leiden University Medical Center are evaluating the safety and immunogenicity of two SLP®-AMPLIVANT® conjugates in patients affected by HPV16+ disease (HESPECTA trial).
Read more: http://www.biospace.com/News/isa-pharmaceuticals-obtains-broad-patent/416134

Source: http://www.eucodis.com/

Novel Enzymatic, 1-Step Site-Specific Protein Conjugation Technology for ADC Production

Berlin, Germany, and Vienna, Austria, April 19th: ProBioGen, a leading specialist for contract development and manufacturing of complex glycoproteins and Eucodis Bioscience, an expert in enzyme engineering, today jointly announced the signature of an exclusive license agreement on C-LiNK (CTAT), an innovative, site-specific ADC conjugation technology. Under the agreement ProBioGen gains exclusive rights to commercialize Eucodis’ enzymatic C-terminal linking technology, and to offer it, together with its antibody development services, royalty-free to ADC-developing parties.

ProBioGen’s CEO, Dr. Wieland Wolf, commented: “This agreement is an excellent match between Eucodis’ enzyme engineering expertise and ProBioGen’s therapeutic protein-optimizing technologies and we look much forward to position C-LiNK and our contract manufacturing services right in the middle of the hot ADC field”.

Dr. Karl Hübler, CEO of Eucodis explained: “We see a huge potential for C-LiNK in Biopharma, especially in ADC development, but our expertise is engineering enzymes. Therefore, by teaming up with ProBioGen, our ADC conjugation technology will certainly get a much wider and quicker access to the community of therapeutic protein developing companies and we are convinced that our agreement with ProBioGen will result in fruitful collaborations within the industry.”

Read more: http://www.eucodis.com/index.php/news/news/94-probiogen-and-eucodis-sign-agreement-to-commercialize-c-link-a-novel-antibody-drug-conjugation-technology

Source: http://seekingalpha.com/

Read more: http://seekingalpha.com/article/3966204-novo-nordisk-holy-grail-diabetes-pill-big-advantages

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

NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced the U.S. Food and Drug Administration (FDA) has determined that the company’s New Drug Application (NDA) for plecanatide, its first uroguanylin analog, for the treatment of chronic idiopathic constipation (CIC) is sufficiently complete to permit a substantive review. The FDA Prescription Drug User Fee Act (PDUFA) target action date is January 29, 2017.

"This is a transformative milestone for our company and reflects our relentless commitment to bringing meaningful treatment options to patients suffering from GI diseases,” said Gary S. Jacob, Chairman and Chief Executive Officer of Synergy Pharmaceuticals. “If approved, we believe plecanatide will become an important new treatment option that will benefit patients with CIC. I want to thank the Synergy employees and outside consultants working on the CIC NDA for their hard work and dedication which contributed to this important milestone.” ........

About Plecanatide

Plecanatide is our first uroguanylin analog currently being evaluated for use as a once-daily tablet for the treatment of two functional GI disorders, CIC and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino acid peptide that is structurally similar to uroguanylin with the exception of a single amino acid change. Plecanatide is designed to replicate the function of uroguanylin, a naturally occurring GI peptide, by working locally in the upper GI tract to stimulate digestive fluid movement and support regular bowel function. In 2015, we announced positive phase 3 data with plecanatide in two pivotal CIC clinical trials and on January 29, 2016 the company filed its first NDA for plecanatide in CIC. We presently have two ongoing phase 3 clinical trials with plecanatide in IBS-C and intend to file our second NDA in IBS-C by the end of this year. We expect top-line data results from both pivotal IBS-C trials in the third quarter of this year.

Read more: http://www.businesswire.com/news/home/20160419005404/en/

Source: https://globenewswire.com/

SAN RAMON, Calif., April 19, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced that data from the booster phase of the Company’s GALE-301/GALE-302 Phase 1/2a clinical trial was presented at the American Association for Cancer Research (AACR) Annual Meeting.

The poster, entitled, “Comparing an attenuated booster (E39’) vs. E39 booster to potentiate the clinical benefit of the folate binding protein (FBP)-derived vaccine (E39 + GM-CSF) in a phase I/IIa trial to prevent recurrence in endometrial (EC) and ovarian cancer (OC) patients,” was presented today by Dr. Doreen Jackson from the San Antonio Military Medical Center.  In the Phase 2a portion of the trial, patients were randomized to two different boosters: E39 (GALE-301), versus E39’ (GALE-302). The purpose of the study was to evaluate the immune responses and determine which booster, if either, would provide a sustained immune response and potentially longer disease free survival (DFS) rates.

The use of the wildtype peptide (GALE-301/E39) demonstrated the same tolerable safety profile as the attenuated peptide (GALE-302/E39’) with only Grade 1 local reactions and minimal Grade 2 toxicities.  Importantly, the percentage of patients who received two booster inoculations and remained disease free was significantly better in the drug treatment arm, versus the control arm (p=0.02), regardless of which booster was used. At median follow up of 16 months, the boosters demonstrated equivalent efficacy after two booster inoculations with an estimated, two-year DFS rate of 66.7% (GALE-301 n=7, GALE-302 n=7) in each booster arm versus 36% (n=22) in the control arm.

Read more: https://globenewswire.com/news-release/2016/04/19/830247/0/en/Galena-Biopharma-Presents-GALE-301-GALE-302-Clinical-Booster-Data-at-the-American-Association-for-Cancer-Research-AACR-Annual-Meeting.html

Source: http://www.marketwired.com/

FRAMINGHAM, MA--(Marketwired - Mar 22, 2016) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), reports favorable data from a 21-day repeat exposure skin test to evaluate the irritation potential of AC5 to human skin. This represents the first safety data obtained for AC5 from human testing.

The study was a Cumulative Irritation Evaluation test designed to determine the skin irritation potential of AC5 and controls after each was applied daily for 21 sequential days to the skin of a total of 41 healthy male and female human subjects. Results were obtained by evaluating and comparing the subject's skin in areas where AC5 and the controls were repeatedly applied. Based upon the results, AC5 was not considered an irritant.

Arch Therapeutics President and CEO Terrence Norchi, MD, stated, "The results of this study represent an important step toward demonstrating clinical safety of AC5, and we remain pleased with the safety data generated to date. This irritation test adds to the portfolio of solid results and should enhance the profile of AC5 for hemostasis and other wound care applications."

Read more: http://www.marketwired.com/press-release/arch-therapeutics-obtains-favorable-safety-data-ac5-surgical-hemostatic-device-skin-otcqb-arth-2107937.htm