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News Article | November 8, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Head And Neck Cancer,complete with analysis by stage of development,drug target,mechanism of action (MoA),route of administration (RoA) and molecule type. The report also coversthe descriptive pharmacological action of the therapeutics,its complete research and development history and latest news and press releases. Additionally,the report provides an overview of key players involved in therapeutic development for Head And Neck Cancer   and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios,enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Head And Neck Cancer - Pipeline Review, H2 2016 addition with 239 market data tables and 17 figures, spread across 1153 pages is available at http://www.rnrmarketresearch.com/head-and-neck-cancer-pipeline-review-h2-2016-market-report.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases,company/university websites,clinical trial registries,conferences,SEC filings,investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally,various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. 3SBio Inc. ,4SC AG ,AB Science SA ,AbbVie Inc ,Accelerated Pharma, Inc. ,Acceleron Pharma, Inc. Adaptimmune Therapeutics Plc ,Aduro BioTech, Inc. ,Advaxis, Inc. ,Advenchen Laboratories, LLC Affimed GmbH ,Alchemia Limited ,Altor BioScience Corporation ,Ambrx, Inc. ,Amgen Inc. ,arGEN-X BV ,ArQule, Inc. ,Aspyrian Therapeutics, Inc. ,Astellas Pharma Inc. ,AstraZeneca Plc ,Atara Biotherapeutics, Inc. ,ATLAB Pharma SAS ,Aura Biosciences, Inc. ,AVEO Pharmaceuticals, Inc. ,Bayer AG ,Betta Pharmaceuticals Inquire before buying  http://www.rnrmarketresearch.com/contacts/inquire-before-buying?rname=748028(This is a premium report price at US$2000 for a single user PDF license).


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 416.56K | Year: 2011

DESCRIPTION (provided by applicant): The goal of this phase I SBIR proposal is to generate the pharmacokinetic and pharmacodynamic data required to support the filing of an Investigational New Drug application (IND) to the Food and Drug Administration (FDA), of the tumor-penetrating peptide iRGD, in combination with gemcitabine as a new treatment for pancreatic cancer. Pancreatic cancer is a key funding priority for the NCI in 2011. iRGD, increases drug accumulation and penetration specificaly into tumors,when co-administered with chemotherapeutic agents, enhancing anti-tumoral activity and tolerability. Pancreatic cancers are characterized by a dense extracellular matrix and stroma that together with high tumor interstitial fluid pressure, acts as a physical barrier inhibiting drug access to the tumor. Increasing drug access deep into the tumor is essential for improving the clinical outcome of both current and future therapies. Preliminary data show that co-administration of iRGD with gemcitabine, the first-line treatment for pancreatic cancer, augments anti-tumoral activity in a xenograft model of pancreatic cancer. The goal of this proposal is to complete the pharmacokinetic and preclinical efficacy studies required to enable filing of an IND for iRGDin combination with gemcitabine as follows: Phase I Aims: 1. Biodistribution studies and optimization of iRGD dosing in combination with gemcitabine. 2. Demonstrate enhanced anti-tumoral activity of gemcitabine co-administered with iRGD in a mouse model ofpancreatic cancer. Phase II of this proposal will focus on completion of the required toxicology studies necessary to support filing of an Investigational New Drug application with the Food and Drug Administration. We expect iRGD- based therapies to define the new standard-of-care in pancreatic cancer. The clinical validation of iRGD as a method to enhance anti-tumoral activity of drugs, will support a broader effort to combine iRGD with other anti- cancer therapies. PUBLIC HEALTH RELEVANCE: Poorpenetration of drugs into tumors has recently been recognized as a significant contributing factor to cancer drug resistance. This is particularly true of malignancies such as pancreatic cancer which are characterized by a desmoplastic microenvironment oflow microvascular density. Our collaborators have discovered a way of overcoming the drug penetration problem. The goals of this Phase I SBIR proposal is to conduct pre-clinical studies aimed at applying this new technology to the treatment of pancreatic cancer, and in the process, define a new standard of care for this deadly disease.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 417.54K | Year: 2011

DESCRIPTION (provided by applicant): Pain imposes a tremendous burden on society, costing approximately US 1 trillion per year in medical treatment, loss of productivity and disability payments in developed countries, not to mention the human suffering associated with moderate to severe acute and chronic pain. Current treatments are insufficient to address the challenge of acute and chronic pain. Narcotics pose a problem of addiction and safety risk while other types of analgesics (e.g. NSAIDs, COX2 inhibitors, antidepressants and anti-epileptics) are hampered by limited efficacy and acute or long-term side effects. Moreover, the recognition of the progressive nature of pain, with pain evolving into persistent allodynia and hyperalgesia due to the presence of chronic disease (e.g. inflammation) and plasticity of neuronal mechanisms involved in pain, calls for the development of novel analgesic treatments with disease modifying potential. Future therapies should address pain transmission (analgesic activity) while ameliorating the cause of pain (e.g. inflammation) and reversing the abnormal neuronal changes causing allodynia and hyperalgesia. The recent discovery that lipid-mediators called resolvins, activate ChemR23 G-protein coupled receptors to induce analgesia, ameliorate inflammation, and reverse neuronal plasticity associated with chronic pain presents a unique opportunity to develop therapies with transformational potential. We propose an innovative approach to identify novel ChemR23 small molecule agonists by using new functional screening technologies based on label free formats, and signal transduction analysis to select and optimize molecules with optimal pharmacological profiles. Given the clinical validation of resolvins as anti-inflammatory ligandsand the correlation of ChemR23 mechanisms of analgesia with processes of clinical relevance, ChemR23 agonists may represent a novel new class of analgesics to treat acute and chronic pain conditions. PUBLIC HEALTH RELEVANCE: There is a critical medical need to develop novel treatments for pain that are safe and induce effective analgesia while reversing the pathology causing hyperalgesia and allodynia. This proposal details a new approach to develop novel pain treatments based on a new mechanism ofaction that has the potential to induce analgesia, ameliorate inflammation and reverse neuronal alterations that lead to and sustain chronic pain. Drug products developed in this program could be transformative in pain management with the potential of disease modifying actions in chronic pain.


News Article | April 23, 2015
Site: www.xconomy.com

It comes as no surprise that federal grants for innovative research or technology transfer have become a lifeline for many early stage life sciences startups in the San Diego area. What may be surprising, though, is the extent of such funding, and the number of local biotech and medical device companies that have gotten Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) grants over the past decade. Since 2005, the multi-agency National Institutes of Health alone has awarded more than $364 million in grants to at least 230 life sciences companies in the San Diego area, according to a review of innovation grant data by Xconomy and GrantIQ, a Santa Monica, CA, startup that aggregates public information on federal research and innovation funding. Casting a wider net to include funding from other federal agencies (Congress authorized 12 agencies to award innovation grants), GrantIQ reports that over $570 million has been awarded to companies throughout the San Diego area through 1,905 innovation grants. At my request, GrantIQ developed a public report for Xconomy that lists the 230 San Diego life sciences companies that received SBIR or STTR grants from the NIH. The interactive report, available online here, enables users (who can register for a free trial period) to search for information about grants awarded to each of the 230 companies over the past decade. GrantIQ operates SBIRsource.com, a subscription-based website that provides data, analytics, and insights about innovation funding. The list is a trove of unsung startups that represent a coming wave of life sciences innovation in San Diego, led by Prognosys Biosciences, a next-generation genome sequencing and analytics company that has been operating in stealth mode for 10 years. Other up-and-coming startups on the list are Genalyte, a startup developing photonic technology on a chip to perform as many as 128 diagnostic tests on a single drop of blood; Epigen Biosciences, a collaborative startup applying a host of drug discovery tools to reach proof-of-concept faster; Novoron Bioscience, a two-year-old startup developing new drugs for nerve regeneration; Aspyrian Therapeutics, an anti-cancer startup that uses near-infrared light to activate antibody conjugates; and Sirenas Marine Discovery, a four-year-old startup identifying new small molecule drugs from marine organisms. CEO Darren Rush said he co-founded GrantIQ with Chris Jones, director of strategic technology development at Bedford, MA-based iRobot, in 2012. “We leveraged a lot of Chris’s program knowledge, as he led iRobots’ SBIR efforts until the point they no longer qualified as a ‘small’ business, CEO Darren Rush said. GrantIQ’s customers “are more and more, larger organizations who use the SBIR programs as a hunting ground for new technologies to license, acquire, or partner,” Rush said. Altogether, federal agencies dispense roughly $2.5 billion each year through innovation grants. On its website for the program, the NIH says it will invest over $780 million through innovation grants this year to early stage life sciences companies. A key objective is commercializing … Next Page »


News Article | April 30, 2015
Site: www.businesswire.com

SAN DIEGO & RICHMOND, Va. & LJUBLJANA, Slovenia & SYDNEY--(BUSINESS WIRE)--AmpliPhi BioSciences Corporation (OTCQB:APHB), a global leader in developing bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced that M. Scott Salka has been appointed as the new CEO. Mr. Salka will replace Interim CEO and Chairman of AmpliPhi, Jeremy Curnock Cook, effective May 18. Mr. Curnock Cook will remain in his role as Chairman. “Mr. Salka’s leadership will enable AmpliPhi to execute on its mission to develop innovative therapeutic solutions aimed at the growing problem of combating antibiotic resistant bacterial infections,” said Mr. Curnock Cook. “His extensive experience in building biotech companies with a focus on technology development and discovery will accelerate the progress of our bacteriophage candidates towards the clinic, and his skill set, combined with over 25 years of experience, will further strengthen AmpliPhi’s position in this exciting field.” Since 2010, Mr. Salka has served as CEO of Aspyrian Therapeutics Inc., a company focused on developing near-infrared photoimmunotherapy (PIT) therapies. Prior to this role, he was the CEO of Ambit Biosciences (acquired by Daiichi Sankyo in 2014). During Mr. Salka’s tenure at Ambit, a company developing treatments for oncology, autoimmune and inflammatory diseases, he was responsible for transforming the company from a service contract business to a fully capable drug discovery and development enterprise. Prior to joining Ambit in 2001, he served as the President and Chief Executive Officer of two privately held genomics companies, Arcaris, Inc. and 454 Corporation (sold to Roche in 2007). He also previously co-founded one of the first commercial genomics companies, Sequana Therapeutics, Inc., a pioneer in the effort to commercialize the international Human Genome Project. Mr. Salka will be based in San Diego in his role as CEO. He is currently a board member and professor of entrepreneurship at San Diego State University College of Business Administration, and will continue to serve as a board member of Aspyrian Therapeutics Inc. He also previously served as a director and chairman of the audit committee for Sorrento Therapeutics. Mr. Salka received his M.B.A. from Carnegie Mellon University and his B.S. in finance from San Diego State University. “I am excited to have been selected as CEO of AmpliPhi at this important time in the company’s history,” noted Mr. Salka. “With a strong proprietary technology platform, first-in-class cGMP manufacturing capabilities and excellent lead pipeline candidates for addressing a major global health problem, AmpliPhi is strongly positioned to bring new therapies for treating deadly bacterial infections to market. I am eager to join the executive leadership team during what will surely be a critical growth period for not only the company but also the industry.” AmpliPhi is advancing three pre-clinical programs in methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa infections in Cystic Fibrosis and Clostridium difficile. AmpliPhi BioSciences Corporation (OTCQB:APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. The Company's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is collaborating with a number of leading organizations, including Intrexon Corporation (NYSE:XON), the U.S. Army, The Royal Brompton Clinic in London, UK and UK-based University of Leicester, to rapidly advance bacteriophage-based therapies. Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects. Statements in this press release about the potential use of bacteriophages to treat bacterial infections, including infections in biofilms and infections that do not respond to antibiotics, the development of bacteriophage-based therapies and AmpliPhi’s clinical, research and development plans are forward looking statements subject to risks and uncertainties, including without limitation the risk that the Company will not be able to commence clinical trials or complete IND-enabling studies as expected, that the clinical trials will not be successful, that further development of the Company’s products will require extensive and expensive nonclinical and clinical testing, may not be safe or efficacious, and may not be approved for marketing by the United States Food and Drug Administration or any foreign regulatory agency. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to AmpliPhi’s business in general, see AmpliPhi’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as amended, filed with the Securities and Exchange Commission (SEC) on April 15, 2015.


News Article | April 30, 2015
Site: www.businesswire.com

SAN DIEGO & RICHMOND, Va. & LJUBLJANA, Slovenia & SYDNEY--(BUSINESS WIRE)--AmpliPhi BioSciences Corporation (OTCQB:APHB), a global leader in developing bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced that M. Scott Salka has been appointed as the new CEO. Mr. Salka will replace Interim CEO and Chairman of AmpliPhi, Jeremy Curnock Cook, effective May 18. Mr. Curnock Cook will remain in his role as Chairman. “Mr. Salka’s leadership will enable AmpliPhi to execute on its mission to develop innovative therapeutic solutions aimed at the growing problem of combating antibiotic resistant bacterial infections,” said Mr. Curnock Cook. “His extensive experience in building biotech companies with a focus on technology development and discovery will accelerate the progress of our bacteriophage candidates towards the clinic, and his skill set, combined with over 25 years of experience, will further strengthen AmpliPhi’s position in this exciting field.” Since 2010, Mr. Salka has served as CEO of Aspyrian Therapeutics Inc., a company focused on developing near-infrared photoimmunotherapy (PIT) therapies. Prior to this role, he was the CEO of Ambit Biosciences (acquired by Daiichi Sankyo in 2014). During Mr. Salka’s tenure at Ambit, a company developing treatments for oncology, autoimmune and inflammatory diseases, he was responsible for transforming the company from a service contract business to a fully capable drug discovery and development enterprise. Prior to joining Ambit in 2001, he served as the President and Chief Executive Officer of two privately held genomics companies, Arcaris, Inc. and 454 Corporation (sold to Roche in 2007). He also previously co-founded one of the first commercial genomics companies, Sequana Therapeutics, Inc., a pioneer in the effort to commercialize the international Human Genome Project. Mr. Salka will be based in San Diego in his role as CEO. He is currently a board member and professor of entrepreneurship at San Diego State University College of Business Administration, and will continue to serve as a board member of Aspyrian Therapeutics Inc. He also previously served as a director and chairman of the audit committee for Sorrento Therapeutics. Mr. Salka received his M.B.A. from Carnegie Mellon University and his B.S. in finance from San Diego State University. “I am excited to have been selected as CEO of AmpliPhi at this important time in the company’s history,” noted Mr. Salka. “With a strong proprietary technology platform, first-in-class cGMP manufacturing capabilities and excellent lead pipeline candidates for addressing a major global health problem, AmpliPhi is strongly positioned to bring new therapies for treating deadly bacterial infections to market. I am eager to join the executive leadership team during what will surely be a critical growth period for not only the company but also the industry.” AmpliPhi is advancing three pre-clinical programs in methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa infections in Cystic Fibrosis and Clostridium difficile. AmpliPhi BioSciences Corporation (OTCQB:APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. The Company's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is collaborating with a number of leading organizations, including Intrexon Corporation (NYSE:XON), the U.S. Army, The Royal Brompton Clinic in London, UK and UK-based University of Leicester, to rapidly advance bacteriophage-based therapies. Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects. Statements in this press release about the potential use of bacteriophages to treat bacterial infections, including infections in biofilms and infections that do not respond to antibiotics, the development of bacteriophage-based therapies and AmpliPhi’s clinical, research and development plans are forward looking statements subject to risks and uncertainties, including without limitation the risk that the Company will not be able to commence clinical trials or complete IND-enabling studies as expected, that the clinical trials will not be successful, that further development of the Company’s products will require extensive and expensive nonclinical and clinical testing, may not be safe or efficacious, and may not be approved for marketing by the United States Food and Drug Administration or any foreign regulatory agency. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to AmpliPhi’s business in general, see AmpliPhi’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as amended, filed with the Securities and Exchange Commission (SEC) on April 15, 2015.


News Article | July 28, 2015
Site: www.finsmes.com

Aspyrian Therapeutics Inc., a San Diego, CA-based clinical stage drug development company creating precision-targeted therapies to treat cancer based on its proprietary Photoimmunotherapy platform, secured $4.25m as part of a Series A extension financing. The backers were not disclosed. Led by Miguel Garcia-Guzman, Ph.D., President and Chief Scientific Officer, and Dr. Merrill Biel, M.D. Ph.D., Chief Medical Officer, Aspyrian is advancing RM-1929 is an antibody conjugate with a non-toxic payload (IRDye® 700DX) that targets a specific cancer antigen that is expressed in carcinomas allowing treatment of a number of different cancer types, including cancers of the head and neck, esophagus, lung, colon, and pancreas. The conjugate is administered systemically but its pharmacological action is limited to the tumors where laser mediated activation triggers cancer cell killing. The financing will support the execution of Phase 1 Clinical Studies of RM-1929, the company’s drug therapy for the treatment of patients with recurrent head and neck cancer.


@JohnCFierce: I see R&D costs climbed to $7.1B at $PFE last year. Probably same again in '15. Citing Phase III costs. Release | Follow @JohnCFierce @DamianFierce: Per earnings statement, $NVS finally submitted the COPD combo QVA149 + NVA237 to the FDA late last year. Release | Follow @DamianFierce > Aspyrian Therapeutics, a San Diego-based startup developing a photoimmunotherapy-linked antibody drug conjugate for cancer, has raised $8.5 million, according to a filing with the SEC. Filing > The FDA has granted Insys Therapeutics ($INSY) an orphan drug designation for its Liposomal Encapsulated Paclitaxel candidate for the treatment of ovarian cancer. Release > BioCryst Pharmaceuticals has won fast track status for a new therapy for hereditary angioedema. Release @EmilyWFierce: IYCMI yesterday: Medtronic and Covidien to close $43B merger today with Irish High Court approval. Article | Follow @EmilyWFierce > Hoffman pleads guilty to murdering former Boston Sci exec in Minneapolis suburb. Report > J&J launches new, smaller, more precise vascular stapler for thoracic surgery. Article @EricPFierce: ICYMI from FiercePharmaManufacturing: Actavis explains the recall of generic Neurontin was limited to 2,000 bottles shipped to one customer. Story | Follow @EricPFierce > With generic losses on the horizon, Pfizer puts up a stormy 2015 forecast. Report > Novo will soon open plant in Russia. Article > Hospira recalls more saline after human hair found in a bag. Report > FDA slaps down another Indian plant, adding to the industry's woes. Story


News Article | January 27, 2015
Site: www.socaltech.com

San Diego-based Aspyrian Therapeutics>, which is developing technology to treat cancer tumors, has raised nearly $8.5M in a funding round, according to a regulatory filing. Details and investors in the company were not announced. Aspyrian is commercializing technology originally developed at the National Center Insitute, aimed at selective, surgical removal of cancer tumor cells. More information »

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