Cleveland BioLabs Announces Acceptance of Entolimod Phase 1 Study; Threshold Offers Preclinical Data on TH-4000 Print E-mail
By Josh Gee   
Wednesday, 22 April 2015 18:38
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 22, 2015.
 
Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced findings from a Phase 1 clinical study of entolimod (previously known as CBLB502) have been accepted for poster presentation at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO), which will be held from May 29 - June 2 in Chicago, Illinois.
The poster, titled: "A phase I study of the toll-like receptor 5 (TLR5) agonist, entolimod in patients with advanced cancers," will be presented by Hatoon Bakhribah, MD, a Drug Development Fellow at Roswell Park Cancer Institute, during the Developmental Therapeutics - Immunotherapy poster session on May 30, 2015, between 8 a.m. and 11:30 a.m. CDT.
Entolimod is a toll-like receptor 5 (TLR5) agonist that has shown preclinical potential in the immunotherapy of cancer. Entolimod administration activates innate and adaptive immune responses and mobilizes immunocytes to organs -- such as the liver, intestine, and bladder -- that have high TLR5 expression. Enrollment in a Phase 1 open-label, dose-escalation trial of entolimod in patients with advanced cancer was completed in September 2014 at Roswell Park in the United States. The study, led by Alex Adjei, M.D., Ph.D., F.A.C.P., Chair of the Department of Medicine and Senior Vice President of Clinical Research at Roswell Park Cancer Institute, was designed to evaluate the safety, pharmacokinetic, and immunoactivation profiles of entolimod. Assessments for evidence of anticancer activity were also performed.
Dosing is ongoing in a follow-on study in Moscow, Russia intended to extend the clinical observations from the higher entolimod dose levels evaluated in the Roswell Park trial.
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Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) announced preclinical data on TH-4000, its proprietary, molecularly-targeted, hypoxia-activated, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) suggesting that TH-4000 may overcome resistance to therapy with convention al EGFR-TKIs. In a xenograft model of non-small cell lung cancer (NSCLC) in which both wild-type (normal) EGFR and mutant EGFR are present (a heterozygous model), TH-4000 was more active than the conventional EGFR-TKI erlotinib. Complete tumor control was observed in this model using human-equivalent doses of TH-4000 that were less than 15% of the maximum-tolerated dose defined previously in a Phase 1 clinical trial. The company believes the data support its planned Phase 2 clinical trials of TH-4000, including one in patients with EGFR-positive, T790M-negative NSCLC and the other in patients with recurrent/metastatic head and neck (H&N) cancer. The data were reported at the annual meeting of the American Association for Cancer Research (AACR) on Wednesday, April 22, 8 AM - 12 PM EDT (Abstract #5358 in Poster Section #28) in Philadelphia, Pennsylvania.
Aberrant EGFR signaling is implicated in the growth and spread of certain tumor types including NSCLC and H&N cancer. Clinical studies indicate that mutant EGFR-positive NSCLC with wild-type EGFR present (heterozygous) is associated with reduced response rates, progression free survival and overall survival outcomes on conventional EGFR-TKIs. In H&N cancer, wild-type EGFR signaling drives tumor growth. Both types of tumors are known to be hypoxic; thus, hypoxia-induced activation of wild-type EGFR signaling may be a mechanism of current EGFR-TKI resistance.
"Certain tumor types are addicted to EGFR signaling and current EGFR-TKI therapies are ineffective in shutting down that signaling due to dose-limiting toxicities of rash and diarrhea," said Adam Patterson, Ph.D., Head of Translational Therapeutics Team at the University of Auckland in New Zealand, and co-inventor of TH-4000. "At the same time, we know that these tumors are hypoxic, and hypoxia drives the overexpression of EGFR. Therefore, a molecularly-targeted, hypoxia-activated irreversible EGFR-TKI may deliver greater efficacy with fewer side effects than currently available treatments."
"Leveraging knowledge that the hypoxic tumor microenvironment enhances aberrant, wild-type EGFR signaling, we designed TH-4000 to selectively release an irreversible EGFR inhibitor upon encountering tumor hypoxia," said Jeff Smaill, Ph.D., Senior Medicinal Chemist, at The University of Auckland, New Zealand, and co-inventor of TH-4000. "Given Threshold's expertise in developing therapies that target tumor hypoxia, it's exciting for us to be working together on this next-generation approach of combining molecular and hypoxia targeting in a single drug candidate."
Preclinical data reported at AACR demonstrated that TH-4000 is a pan-ErbB inhibitor, releasing a potent irreversible TKI of wild-type EGFR, mutant EGFR and HER2. In the PC9 xenograft model of NSCLC, which is heterozygous for wild-type and mutant (deletion 19) EGFR, a single dose of TH-4000 (equivalent to 20 mg/m2 in humans) showed prolonged prodrug residency and EGFR shutdown in tumor tissue for a week. In addition, while treatment with erlotinib alone resulted in only modest benefit, treatment with TH-4000, resulted in 9/9 complete responses, suggesting an ability to prevent or overcome resistance to TKI treatment. Furthermore, the PC9 model was determined to be only 8% hypoxic, suggesting that the complete responses observed with TH-4000 were due to the ability of TH-4000, once hypoxia-activated, to diffuse into the surrounding normoxic tumor tissue. Preclinical data presented also demonstrated that TH-4000 is highly active against WT EGFR-driven tumors, whereas approved EGFR-TKIs are substantially less active. It is believed the 'masked' design of TH-4000 allows WT EGFR signaling in tumor tissue to be targeted via hypoxia while sparing normal tissue signaling in the skin and GI tract, providing a potential therapeutic window.
Also Wednesday:   
Air Methods Corporation (Nasdaq:AIRM), the global leader in air medical transportation, today announced that Gregg Lundberg has been appointed as president of Blue Hawaiian Helicopters. Lundberg will succeed Blue Hawaiian Helicopters founders David and Patricia Chevalier who are transitioning into advisory roles.
Avinger, Inc., (Nasdaq:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that it will release its financial results for the first quarter of 2015 after the close of trading on Wednesday, May 6, 2015. 
Balchem Corporation (Nasdaq:BCPC) today announced that its Board of Directors has appointed Theodore (Ted) L. Harris as President and Chief Executive Officer, succeeding Balchem's President and Chief Executive Officer, Dino A. Rossi, who will remain Chairman of the Board. Harris will also join the Balchem Board of Directors. 
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced that clinical data for its lead drug candidate CB-839, the Company's novel, orally bioavailable glutaminase inhibitor, will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held from May 29 to June 2, 2015 in Chicago, Illinois. 
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its cell therapeutic product candidate, CAP-1002, for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).
 
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced that the Company, in anticipation of growth in the Beijing vicinity and further development of the CAR-T platform, has signed a new five-year lease for a 15,000 square feet site slated for the Company's third GMP facility which will also expanded staffing in the Life Science Park, Changping District, Beijing, China. 
ChemoCentryx, Inc. (Nasdaq:CCXI) announced today that the Company's first quarter 2015 financial results will be released after market close on Wednesday, May 6, 2015. 
Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, announced today data presented from in vitro and in vivo studies for CUDC-427, an antagonist of inhibitor of apoptosis (IAP) proteins, at the American Association for Cancer Research (AACR) 2015 Annual Meeting.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM) which develops, assembles, markets and sells medical devices and wearable sleep respiratory products in China, today announced that the Company plans to release its financial results for the full year of 2014 ended December 31, 2014 on Thursday, April 30, 2015.
Diversicare Healthcare Services, Inc. (Nasdaq:DVCR) today announced that it is scheduled to report financial results for its first quarter ended March 31, 2015, on Thursday, May 7, 2015, after the market closes. 
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has resumed full manufacturing operations of BioThrax┬« (Anthrax Vaccine Adsorbed) after completing its internal manufacturing investigation of foreign particles discovered in a limited number of vials in two manufactured BioThrax lots. 
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that the company will hold its first Research & Development Day event for the institutional investment community in New York City on May 5, 2015. 
LHC Group, Inc. (Nasdaq:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today details for the release of its results for the first quarter ended March 31, 2015.
Marrone Bio Innovations, Inc. (Nasdaq:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, today announced the opening of its new greenhouse to facilitate and expand its research and product development capacity.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that the Company will release first quarter 2015 financial results after the close of trading on Wednesday, May 6, 2015. 
Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that it will release its first quarter 2015 financial results on Thursday, April 30, 2015 at approximately 8:00 a.m. Eastern Time. 
Sharps Compliance Corp. (Nasdaq:SMED) announced today that it will release its third quarter results for the period ended March 31, 2015, before the opening of the financial markets on Wednesday, April 29, 2015. 
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), announced today the publication of preclinical data highlighting positive results against Ebola virus Makona infection using a newly adjusted siRNA cocktail. 
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced its participation in three investor conferences during the month of May, including:
TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime┬« Abdominal Stent Graft System, today announced that the Company will release 2015 first quarter financial results after market close on Tuesday, May 5, 2015. 
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the presentation of positive data from an investigator-sponsored trial of triheptanoin (UX007) for the treatment of movement disorders associated with glucose transporter type-1 deficiency syndrome (Glut1 DS). Glut1 DS, also known as De Vivo disease, is a rare and potentially severely debilitating disease characterized by seizures, developmental delay, and movement disorders. 



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