All posts in Peptide News from Biotech and Pharma

Source: http://www.prnewswire.com/
BOSTON, June 27, 2016 /PRNewswire/ -- Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of two Phase 2 studies evaluating elamipretide in heart failure: PROGRESS-HF in patients with heart failure with reduced ejection fraction and RESTORE-HF in those with preserved ejection fraction. Top-line data from each are expected in the second half of 2017.

"The heart's reduced ability to relax and contract during heart failure may be linked to mitochondrial dysfunction and a resulting lack of energy in heart muscle," said Stealth Vice President of Clinical Development Jim Carr. "Since muscle is required for both pumping and re-filling the heart, we believe elamipretide could address this lack of energy in the heart muscle in the two major forms of heart failure by improving mitochondrial function."

PROGRESS-HF and RESTORE-HF are randomized, double-blind, placebo-controlled trials to evaluate the effects of four weeks' treatment with daily subcutaneous injections of elamipretide on left ventricular function in patients with stable heart failure with reduced ejection fraction (PROGRESS-HF) or preserved ejection fraction (RESTORE-HF).

Read more: http://www.prnewswire.com/news-releases/stealth-biotherapeutics-initiates-two-phase-2-trials-evaluating-elamipretide-for-the-treatment-of-heart-failure-300290044.html

Source: http://www.prnewswire.com/
CAMBRIDGE, Mass., June 27, 2016 /PRNewswire/ -- Tarix Orphan LLC today announced that the company's lead compound, TXA127, has shown positive preclinical results in the C7-hypomorphic mouse model of recessive dystrophic epidermolysis bullosa (DEB), a rare and often severe genetic skin disorder.

Researchers in the laboratory of Dr. Leena Bruckner-Tuderman at the University of Freiburg, Germany showed that four weeks of daily subcutaneous administration of TXA127, a pharmaceutical formulation of the natural Angiotensin (1‐7) peptide, substantially reduced the fusion of digits, a symptom analogous to mitten deformity common in patients with DEB. In addition, immunohistology showed that TXA127 significantly reduced tenascin c, a marker of dermal fibrosis.

"These are very interesting results from two perspectives," said Richard Franklin, President and Chief Executive Officer of Tarix Orphan LLC. "First, DEB is a devastating disease with no currently approved therapies and treatment limited to supportive care. These results suggest that TXA127 may be able to affect the progression of the disease.

"The second important conclusion from this work," he continued, "is that it supports a mechanism of action for our compound that is involved in other serious orphan diseases. TXA127 interferes with the TGF beta pathway, which is involved in the pathophysiology of DEB, Marfan Syndrome, and muscular dystrophy."

Read more: http://www.prnewswire.com/news-releases/tarix-orphan-announces-positive-results-with-txa127-in-animal-model-of-dystrophic-epidermolysis-bullosa-deb-300290265.html

Source: Roche & reported by http://www.prnewswire.com/
INDIANAPOLIS, June 23, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. With this clearance, Roche is the first IVD company in the U.S to provide a fully integrated solution for sepsis risk assessment and management.

PCT is a sepsis-specific biomarker associated with bacterial infection and PCT levels in blood can aid clinicians in assessing the risk of sepsis as well as managing the disease when present. The Elecsys BRAHMS PCT assay can aid in assessing the risk of critically ill patients to progress from severe sepsis to septic shock; and help determine the 28 day mortality risk in sepsis patients.

"Given the prevalence of sepsis in the U.S. – more than 1.6 million annual hospitalizations – this clearance is an important advancement in its assessment and management," said Dr. Alan Wright, chief medical officer, Roche Diagnostics North America. "With such compelling clinical utilities and the automation advantages associated with Roche lab instrumentation, the Elecsys BRAHMS PCT test can provide healthcare professionals the confidence they need to manage this deadly disease."

Read more: http://www.prnewswire.com/news-releases/roche-receives-fda-clearance-for-its-procalcitonin-pct-assay-to-help-clinicians-effectively-assess-sepsis-risk-and-manage-sepsis-patients-300289386.html

Source: http://www.proactiveinvestors.com/
ImmunoVaccine Inc (CVE:IMV), a clinical stage vaccine and immunotherapy company, has been awarded a sub-contract by Leidos, a health, national security, and infrastructure solutions company.
The contract is to evaluate ImmunoVaccine's DepoVax platform for the development of peptide based malaria vaccine targets.
Leidos and ImmunoVaccine will work together to identify adjuvant and antigen combinations that can be used to protect against malaria and, with the DepoVax delivery system, formulate promising vaccine candidates for potential clinical testing.
"The flexibility and rapid immune response of Immunovaccine's DepoVax platform allows us to broaden application beyond immuno-oncology and collaborate with Leidos and other companies that are developing vaccines against diseases that cause widespread public health issues," said Frederic Ors, chief executive officer of ImmunoVaccine.
Ream more: http://www.proactiveinvestors.com/companies/news/127443/immunovaccine-inc-awarded-a-contract-for-malaria-vaccine-evaluation-127443.html

Source: http://angiochem.com/
MONTREAL, QC-- (Marketwired - June 23, 2016) - Angiochem, a biotechnology company developing proprietary peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, today announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for ANG1005. As a result, the company is in final preparation stages to commence its Phase 3 trial to support a New Drug Application (NDA) for ANG1005 in patients with leptomeningeal carcinomatosis (LC) from breast cancer.

“We are very pleased with our recent positive interaction with the FDA” said John Huss, Executive Chairman of Angiochem. “Based on the constructive guidance received from our discussions with the FDA, we believe our clinical development and registration strategy for ANG1005 will support an NDA submission. We are excited to start Phase 3, and bring ANG1005 treatment to an expanded number of patients with few alternative treatment options.”

The trial design for the single pivotal study is a randomized two-arm superiority trial in breast cancer patients with recurrent brain metastases (BCBM patients) and LC. The primary efficacy endpoint of the study is a significant improvement in overall survival with ANG1005 compared to treatment with Physicians’ Best Choice.

ANG1005 demonstrated clinical benefit, both intracranially and extracranially in pretreated BCBM patients with LC in the company’s Phase 2 trial.

ANG1005 is a peptide-drug conjugate containing paclitaxel covalently linked to a peptide (Angiopep-2) designed to cross the blood-brain barrier (BBB) and blood cerebrospinal fluid barrier (BCB) via the LRP-1 transport system.
Read more: http://angiochem.com/angiochem-announces-successful-end-phase-2-meeting-fda-ang1005

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

TOKYO--(BUSINESS WIRE)--PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”) (TOKYO:4587) announced today that it has earned a milestone for the dosing of a first patient in a clinical trial by its alliance partner, Bristol-Myers Squibb Company (BMS). This is the first program to enter clinical testing out of the discovery collaboration between the two companies. The molecule being advanced in clinical testing was discovered by Bristol-Myers Squibb starting from an active lead macrocyclic compound identified by Peptidream using its PDPS technology and provided to BMS for further optimization.

Under the terms of the original Discovery and Development Agreement, which was initiated on October 15, 2010 and extended on October 15, 2012, PeptiDream will receive a milestone payment for this event and is eligible to receive additional milestone payments upon the continuation of successful clinical development by BMS. In addition, Peptidream is eligible to receive tiered royalties on net sales of any product that results from the collaboration. Further financial terms have not been disclosed.

Read more: http://www.businesswire.com/news/home/20160615005627/en/PeptiDream-Achieves-Milestone-Initiation-Clinical-Development-Bristol-Myers

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

TORONTO, ON and REHOVOT, ISRAEL--(Marketwired - June 16, 2016) - VAXIL BIO LTD. (TSX VENTURE: VXL), an Israeli biotech specializing in immuno-oncology, reports that it has successfully received a Notice of Allowance to Grant a Patent from the European Patent Office for Patent Application No. 07827143.4 entitled "Antigen Specific Multi Epitope Vaccines".
"This is a major patent for Vaxil and our team has been working towards this for a long time. Vaxil is very excited about having broad IP protection in the European Union, covering the VaxHit™ platform and all immunotherapy products derived from it. This of course includes Vaxil's lead, Orphan Drug Designated immunotherapy ImMucin™. Perhaps even more importantly, however, is the protection this patent affords VaxHit™ as a platform with potential to generate additional immunotherapies targeting a range of cancer antigens in the uniquely advantageous manner through which ImMucin™ has targeted MUC1," commented Vaxil Founder Dr. Lior Carmon.
Vaxil's VaxHit™ platform technology combines proprietary algorithms which enable in-silico identification of signal peptides domains and their subsequent use as immunotherapeutic products. The VaxHit™ platform is essentially a launchpad for novel and uniquely targeted immunotherapy products. In the case of MUC1, a renowned yet still unsuccessfully targeted cancer antigen, Vaxil utilized its VaxHit™ platform in order to isolate a 21-mer lead product now known as ImMucin™. A Phase-I/II clinical trial with 15 myeloma cancer patients served to validate strong immunotherapeutic potential. The trial also served to endorse VaxHit™'s potential as a platform for generating products with the ability to target renowned cancer antigens in an altogether novel and effective way.

Read more: http://www.marketwired.com/press-release/vaxil-receives-positive-response-from-european-patent-office-allowance-immunotherapy-tsx-venture-vxl-2134984.htm

Source: http://www.businesswire.com/
PITTSBURGH--(BUSINESS WIRE)--Noveome Biotherapeutics, Inc., a clinical-stage company focused on the biology of paracrine signaling, today announced the initiation of a phase 2 clinical trial of its novel secretome, ST266, to treat patients with moderate to severe periodontitis, a severe inflammatory condition that leads to damage of the soft tissue and destruction of the bone that supports the tooth. The company is the leading innovator in paracrine signaling for the clinical development of novel biotherapeutic products that work safely and effectively in complex biologic processes.
“ST266 provides essential ‘tools’ at critical stages of the healing process to restore homeostasis within the periodontal microenvironment,” said Kenneth J. Mandell, M.D., Ph.D., Chief Medical Officer of Noveome. “The biological attributes of ST266, including the capacity to modulate inflammation, accelerate impaired wound healing, prevent bone loss and support bone regrowth, suggest that ST266 has the potential to become an important new treatment for those suffering with periodontitis.”
The phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled study of ST266 to evaluate the safety, efficacy, and treatment regimen of topical ST266 in patients with moderate to severe periodontitis. The primary efficacy endpoint of this study is the change from baseline in pocket depth evaluated after 3 months of treatment. Subjects will be followed for 9 months for safety and secondary efficacy endpoints. For additional information on this clinical trial, please visit www.clinicaltrials.gov, Identifier NCT02761993.
Read more: http://www.businesswire.com/news/home/20160615005334/en/Noveome-Initiates-Phase-2-Clinical-Trial-ST266

Source: PharmaMar & reported by http://www.prnewswire.com/
MADRID, June 14, 2016 /PRNewswire/ -- PharmaMar (MCE:PHM) today announced the start of a multicenter, prospective, pivotal study to analyze the efficacy of the antitumoral compound of marine origin, plitidepsin in patients with relapsed and refractory angioimmunoblastic T-cell lymphoma. As this is classified as a rare disease, and in consultation with the US Food and Drug Administration (FDA), the study has been designed with only one study arm.

The primary objective is to analyze the efficacy of plitidepsin in terms of overall response rate, to be evaluated by an independent committee following the Lugano classification response criteria. The secondary endpoint will be to evaluate other efficacy parameters such as duration of response, progression free survival and overall survival; the pharmacokinetic characteristics, the safety profile of plitidepsina and the identification of possible biomarkers that help to identify the predictive activity of the compound.

Read more: http://www.prnewswire.com/news-releases/pharmamar-announces-the-start-of-a-pivotal-study-with-plitidepsin-in-angioimmunoblastic-t-cell-lymphoma-582932041.html

Source: http://www.businesswire.com/
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from two Phase 3 studies evaluating MK-1293, Merck’s investigational, follow-on biologic* insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes. In both studies, MK-1293 achieved its primary endpoint by demonstrating non-inferiority in change from baseline A1C (a measure of average blood glucose) and similar safety to Lantus® (insulin glargine)** after 24 weeks in patients with type 1 and type 2 diabetes. Furthermore, in both studies, MK-1293 met its pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, a measure used to show that an investigational treatment is similar, within an acceptable range, to a current therapy.

It is encouraging to see that the investigational agent MK-1293 met its primary and secondary endpoints,” said Philip Home, D.M., D.Phil, professor of diabetes medicine, Newcastle University, United Kingdom. “These data, together with other clinical studies of its time-action profile, suggest that Merck’s insulin glargine, if approved, could help provide glycemic control in appropriate patients with type 1 and type 2 diabetes.”

MK-1293 has the same amino acid sequence as Lantus, the originator insulin glargine. The development of MK-1293 builds on an agreement between Merck and Samsung Bioepis established in February 2013 to develop and commercialize multiple biosimilar candidates across different therapeutic areas. Under the terms of a subsequent 2014 agreement, Merck is responsible for the clinical development, manufacturing and, if approved, commercialization of MK-1293. Samsung Bioepis is partially funding its development.
Read more: http://www.businesswire.com/news/home/20160613005707/en/Merck%E2%80%99s-Investigational-Insulin-Glargine-MK-1293-Met-Primary