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Position Title: Research Assistant & Associate
Participate in development of chemiluminescence immunoassay (CLIA).
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MabVax Therapeutics Presents Two Posters at the American Association for Cancer Research (AACR) Annual Meeting on a Novel Radioimmunotherapy Treatment for Pancreatic Cancer
– Company presents results of IND enabling studies supporting development of radioimmunotherapy product MVT-1075 and synopsis of the Phase 1 clinical trial design — Company also presents manufacturing, quality, and stability work completed to support the manufacture of clinical grade MVT-1075 drug product — Patient enrollment of Phase 1 trial in patients with advanced pancreatic cancer expected in Q2 2017-
SAN DIEGO, April 5, 2017 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, announces that it will present two posters in this morning’s session featuring MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company’s novel fully human antibody-based radioimmunotherapy (RIT) currently in clinical development, initially being evaluated for the treatment of pancreatic cancer and other CA19-9 positive malignancies, at the American Association for Cancer Research (AACR) Annual Meeting being held April 1-5, 2017 in Washington, D.C.
Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, “We look forward to sharing the significant progress we have made through these preclinical investigations that add to a growing body of safety, efficacy, and manufacturing data supporting further development of MVT-1075 in clinical studies for the treatment of pancreatic cancer and other CA19-9 cancers. MVT-1075 represents a more potent analog of our fully human HuMab-5B1 therapeutic antibody. We believe the data being presented today bring us an important step closer in providing a much-needed treatment option for patients who have these devastating cancers.”
The Company will present the following posters today, Wednesday, April 5, 2017 from 8:00 – 12:00 PM EDT:
Title: Preclinical development of MVT-1075 as radioimmunotherapy for pancreatic cancer and other CA19-9 positive malignancies
Abstract Number: 5204, Wednesday Apr 5, 2017 8:00 AM – 12:00 PM, (Houghton, et al)
Presenting Author: Toni Jun, Ph.D., Director of Pharmacology, MabVax Therapeutics, Holdings
The poster summarizes the IND supporting preclinical pharmacology, efficacy, and safety studies of MVT-1075 that supported starting dose determination and includes a synopsis of the phase I clinical trial design. These non-clinical studies include xenograft and orthotopic models of human pancreatic cancer and demonstrate tumor growth suppression and regression after a single dose of MVT-1075. These investigations provide supporting evidence that efficacy of MVT-1075 when administered as a single dose or as a fractionated dose is maintained. Fractionated doses may be useful to potentially minimize adverse effects. Biodistribution data comparing normal to tumor bearing mice demonstrate that approximately 70% of the dose administered was bound to tumor tissue within 24 hours of administration.
Title: IND enabling investigations of MVT-1075, a CA19-9 targeting Radioimmunotherapy (Gately, et al)
Abstract Number: 5206, Wednesday Apr 5, 2017 8:00 AM – 12:00 PM
Presenting Author: Paul Maffuid, Ph.D., Executive Vice President, Research and Development, MabVax Therapeutics, Holdings Inc.
The poster summarizes the chemistry, manufacturing, and controls (CMC) IND enabling investigations conducted to support the manufacture of clinical grade MVT-1075 drug product and includes details of the manufacturing process and characterization studies including product stability. MVT-1075 can be reproducibly manufactured as a high-quality product with conditions that maintain antibody affinity and integrity. Stability investigations support product manufacturing, storage and shipment to clinical trial sites.
MabVax received notification from the U.S. Food and Drug Administration (FDA) in January of 2017 to proceed with a phase I clinical trial to establish safety as well as a phase II clinical dose for MVT-1075 in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies. MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1) combines a potent radiotherapy with the tumor targeting specificity of the Company’s HuMab-5B1 antibody. The Company plans to initiate patient enrollment in during the second quarter of 2017 and evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status and early readouts on product effectiveness will be evaluated based on tumor measurements using RECIST 1.1 criteria.
In February 2017 MabVax reported encouraging positive data on the clinical safety and target specificity of the HuMab-5B1 antibody from the phase I trial of MVT-5873, the Company’s therapeutic antibody, and the phase I trial of MVT-2163, MabVax’s immunoPET imaging agent. The Company has initiated three clinical programs in the past fourteen months that are based on discovery of the HuMab-5B1 antibody from the immune responses of patients with cancer who had been vaccinated with one of the Company’s proprietary cancer vaccines.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of fully human monoclonal antibody products based on the protective immune responses generated by patients who have been vaccinated against targeted cancers with the Company’s proprietary vaccines. MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a phase I trial at Memorial Sloan Kettering Cancer Center. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers, making the antibody potentially broadly applicable to most patients suffering from this type of cancer. Additional information is available at www.mabvax.com.
Forward Looking Statements:
This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to presentations at the AACR Annual Meeting. We have no assurance that all the product development pipeline will be fully developed by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2016, as amended and supplemented from time to time and the Company’s Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
SOURCE MabVax Therapeutics Holdings, Inc.
SOUTH SAN FRANCISCO, Calif., April 5, 2017 /PRNewswire/ — NGM Bio, a research-driven biotechnology company that translates powerful biology into transformative medicines, today announced that new data from the company’s lead product candidate, NGM282, will be presented in oral and poster presentations at The International Liver Congress 2017, hosted by the European Association for the Study of the Liver (EASL) to be held April 19-23, 2017 in Amsterdam.
Dr. Stephen A. Harrison, M.D., Medical Director of Pinnacle Clinical Research and Visiting Professor of Hepatology at the Radcliffe Department of Medicine at the University of Oxford, UK, will present results from NGM Bio’s exploratory Phase 2 trial of NGM282 in nonalcoholic steatohepatitis (NASH) on Saturday, April 22nd at the oral late-breaker session. Patients with biopsy-confirmed NASH treated with NGM282 for 12 weeks showed rapid and highly significant reductions in magnetic resonance imaging (MRI) measures of liver fat content and serum biomarkers of liver function and fibrosis.
NGM Bio will also present a poster outlining the mechanism by which the human hormone FGF19 induces hepatocellular carcinoma in rodents, as well as in vitro and in vivo evidence that this signaling mechanism was engineered out of NGM282. A second poster will present nonclinical and clinical data demonstrating that NGM282-induced increases in serum LDL cholesterol were rapidly and completely mitigated by co-administration of a statin while maintaining the efficacy of NGM282.
Details on the oral and poster presentations are as follows:
Title: NGM282, a novel variant of FGF19, significantly reduces hepatic steatosis and key biomarkers of NASH: results of a Phase 2, multicenter, randomized, double-blinded, placebo controlled trial in biopsy-confirmed NASH patients
Session: Late Breaker Session, Abstract LBO-07
Authors: S.A. Harrison, M.F. Abdelmalek, J.F. Trotter, A.H. Paredes, H.L. Arnold, M. Kugelmas, M.R. Bashir, L. Ling, S.J. Rossi, A.M. DePaoli, M.E. Rinella, R.S. Loomba
Date: Saturday, April 22, 2017
Time: 17:30 – 17:45 CEST
View Abstract (pdf)
Title: Activation of IL-6/STAT3 signaling mediates FGF19-driven hepatocarcinogenesis
Session: Liver tumours: Experimental and pathophysiology, Abstract FRI-104
Authors: L. Ling, M. Zhou, H. Yang, R.M. Learned, S.J. Rossi, A.M. DePaoli, H. Tian
Date: Friday, April 21, 2017
Time: Guided poster tour with Professor Tom Lüedde, RWTH Aachen University, 11:00 – 11:30 CEST
View Abstract (pdf)
Title: Serum cholesterol changes associated with NGM282 treatment in obese insulin resistant cynomolgus monkeys are reversed with either a statin or a PCSK9 inhibitor
Session: Fatty liver disease: Experimental and pathophysiology, Abstract FRI-353
Authors: J. Luo, B. Ko, X. Ding, S.J. Rossi, A.M. DePaoli, H. Tian
Date: Friday, April 21, 2017
Time: Oral ePoster presentation by Jian Luo, Ph.D., NGM Bio at 12:30 – 13:30 CEST
View Abstract (pdf)
Additional information about the congress can be found on The International Liver Congress website.
About NGM282 in NASH
NGM282 is a non-tumorigenic, engineered variant of the human hormone FGF19 that dramatically reduces liver fat content and improves liver function by targeting multiple pathogenic pathways of nonalcoholic steatohepatitis (NASH). NGM has generated robust preclinical and early clinical evidence supporting NGM282’s ability to significantly improve steatosis, inflammation and fibrosis. This wholly-owned, single-agent therapeutic has the potential to resolve NASH rapidly, completely and across a broad spectrum of patients.
About NGM Biopharmaceuticals, Inc.
NGM Bio is a research-driven biotechnology company committed to discovering and developing novel biologics for the treatment of life-threatening diseases. NGM Bio’s portfolio consists of multiple programs in clinical testing and more than a dozen additional programs in various stages of preclinical development. The company’s most advanced compound, NGM282, is a wholly-owned asset that has completed a Phase 2 trial in nonalcoholic steatohepatitis (NASH) and is being evaluated in a Phase 2 trial for the treatment of primary sclerosing cholangitis. NGM Bio has established a broad strategic collaboration with Merck. NGM Bio is backed by The Column Group, Merck, Prospect Ventures, Topspin Partners, Rho Ventures, Tichenor Ventures and other leading investors around the world. For more information, please visit www.ngmbio.com.
SOURCE NGM Bio
Creative Medical Technology Holdings Files Patent on Reducing Radiation Toxicity Using AmnioStem Universal Donor Stem Cell Product
Company Aims to Leverage Stem Cell Neuroregenerative Activity to Reduce Adverse Effects of Brain Radiation
SAN DIEGO and PHOENIX, April 4, 2017 /PRNewswire/ — Creative Medical Technology Holdings, Inc. (OTCQB:CELZ), a clinical stage stem cell company, announced today filing of a patent application covering the use of its AmnioStem Universal Donor stem cell product as a treatment of radiation toxicity. The Company plans to leverage the ability of its amniotic fluid based stem cell product to induce a process termed “neurogenesis” in which specific areas of the brain are activated to repair damaged tissue. The AmnioStem product is derived from amniotic fluid, and possesses advantages of fetal stem cells without harming the fetus.
“Having seen first-hand in my brain cancer patients the horrific effects of post-treatment radiation toxicity, I am excited about the prospect of having something to offer that potentially could reduce cognitive impairment in this group of patients,” said Santosh Kesari, MD, PhD, FANA, FAAN, scientific advisory board member to Creative Medical Technology Holdings, Inc. and patent coauthor. Dr. Kesari is Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, as well as Director of Neuro-oncology, Providence Saint John’s Health Center and leads the Pacific Neuroscience Research Center at Pacific Neuroscience Institute.
“Numerous research data support superior effects of the AmnioStem stem cell product in comparison to other stem cell types in terms of growth factor production, regenerative activity and lower cost of manufacturing,” said Thomas Ichim, Ph.D, Chief Scientific Officer of Creative Medical Technology Holdings. “It is exciting for us to develop a rather novel approach to a problem that limits potentially curative effects of existing treatments for brain cancers.”
“In the situation of radiation countermeasures, our product falls under the FDA ‘animal rule’, which allows for FDA clearance on the basis of studies in two validated animal models1. This potentially rapid path to market positions the Company for collaboration and funding from agencies such as BARDA2,3 which have previously supported stem cell companies for radiation production,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings, Inc.
In November 2016, the Company obtained an exclusive license from the University of California San Diego (UCSD) for issued patent #7,569,385 covering amniotic fluid derived stem cells4. These stem cells, which are the basis for the Company’s AmnioStem product, have the ability to regenerate injured neurons and protect brain function in animal models neurological insults5.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to www.creativemedicaltechnology.com.
OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission’s website at www.sec.gov.
5 Tajiri et al. Therapeutic outcomes of transplantation of amniotic fluid-derived stem cells in experimental ischemic stroke. Front Cell Neurosci. 2014 Aug 13;8:227. http://journal.frontiersin.org/article/10.3389/fncel.2014.00227/full
SOURCE Creative Medical Technology Holdings, Inc.
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