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The present invention relates to novel, specific-binding therapeutic and/or diagnostic lipocalin muteins directed against Glypican-3 (GPC-3). The invention also relates to nucleic acid molecules encoding such muteins and to methods for generation of such muteins and nucleic acid molecules. In addition, the invention also is directed to pharmaceutical compositions comprising such muteins and practical uses of these lipocalin muteins. In addition, the present invention provides methods of using muteins of human lipocalin 2 (Lcn2 or NGAL) for target-specific delivery of therapeutic moieties or detectable labels to cells expressing GPC-3, and related therapeutic and diagnostic utilization.


Patent
Pieris Pharmaceuticals GmbH | Date: 2015-05-20

The present invention relates to novel, specific-binding therapeutic and/or diagnostic polypeptides directed against the target of Swiss Prot Q16552 and novel, specific-binding therapeutic and/or diagnostic polypeptides directed against the target of Swiss Prot Q9NPF7. In addition, the present invention relates to novel, specific-binding therapeutic and/or diagnostic polypeptides directed against one or both of Swiss Prot Q16552 and Swiss Prot Q9NPF7. The invention also relates to nucleic acid molecules encoding such polypeptides and to methods for generation of such polypeptides and nucleic acid molecules. In addition, the invention is directed to compositions comprising the polypeptides, and therapeutic and/or diagnostic uses of these polypeptides.


Patent
Pieris Pharmaceuticals GmbH | Date: 2016-12-15

The present invention relates to a novel library for the generation of muteins and to novel muteins derived from human lipocalin 2 (Lcn2, hNGAL) and related proteins that bind a given target with detectable affinity. The invention also relates to corresponding nucleic acid molecules encoding such a mutein and to a method for their generation. The invention further relates to a method for producing such a mutein. For example, such muteins may serve to bind and deplete pathological forms of natural biomolecules such as the amyloid beta peptide in Alzheimers disease or may target the fibronectin extra-domain B, which is associated with tumor neovasculature.


The present disclosure relates to methods of treating, ameliorating or preventing a disorder comprising administering a therapeutically effective amount of a composition comprising a protein which inhibits the ligand of Uniprot #P05112 and/or the ligand of Uniprot #P35225 from binding to their respective receptors to a subject in need thereof. In some embodiments, the disorder is preferably associated with an increase of the Th2 immune response. In some embodiments, administration is preferably locally to the lung in order to treat, ameliorate or prevent allergic asthma, rhinitis, conjunctivitis, lung fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, pulmonary alveolar proteinosis or adult respiratory distress syndrome.


News Article | May 22, 2017
Site: www.marketwired.com

BOSTON, MA--(Marketwired - May 22, 2017) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, announced today that James Geraghty has joined the Company's Board of Directors, bringing the total number of directors to eight. Mr. Geraghty is an industry leader with 30 years of strategic and leadership experience, including more than 20 years as a senior member of executive teams at biotechnology companies developing and commercializing innovative therapies. Until 2016, Mr. Geraghty was an Entrepreneur in Residence at Third Rock Ventures, a leading biotech venture and company-formation fund, and previously served as Senior Vice President, North America Strategy and Business Development at Sanofi, which he joined upon its acquisition of Genzyme. Mr. Geraghty spent 20 years at Genzyme, where his roles included Senior Vice President International Development, President of Genzyme Europe, and General Manager of Genzyme's cardiovascular business. Mr. Geraghty also oversaw Genzyme's Humanitarian Assistance for Neglected Diseases (HAND) program, under which the company supported innovative development programs on a non-commercial basis. Mr. Geraghty is Chairman of the Board of Idera Pharmaceuticals and Juniper Pharmaceuticals and serves on the Board of Voyager Therapeutics and Fulcrum Therapeutics. He is also a member of the BIO Ventures for Global Health Board of Directors. He started his career in healthcare strategy consulting at Bain and Company. A graduate of the Yale Law School, Mr. Geraghty holds a M.S. from the University of Pennsylvania and a B.A. from Georgetown University. Commenting on the announcement Mr. Geraghty stated, "With the upcoming advancement of Pieris' lead immuno-oncology and respiratory drug candidates into the clinic and its recent strategic partnerships, Pieris is poised to make significant contributions to patients with critical unmet medical needs. I look forward to working with Steve and the rest of the team during this exciting time for Pieris." "It's a great pleasure to welcome Jim to the Pieris board," said Stephen Yoder, President and CEO of Pieris. "I'm confident Jim's strong life sciences pedigree and extensive background in company building will positively impact our Company as we continue our strong growth trajectory." Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes immuno-oncology multi-specifics tailored for the tumor microenvironment, an inhaled Anticalin protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin is a registered trademark of Pieris. For more information, visit www.pieris.com. This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to novel technologies and methods; our business and product development plans; the timing and progress of our studies, our liquidity and ability to fund our future operations; our ability to achieve certain milestones and receive future milestone or royalty payments; or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates; competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the SEC available at www.sec.gov, including without limitation the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and the Company's Quarterly Reports on Form 10-Q.


Patent
Pieris Pharmaceuticals GmbH | Date: 2017-03-29

The present invention relates to novel, specific-binding therapeutic and/or diagnostic polypeptides directed against the target of Swiss Prot Q16552 and novel, specific-binding therapeutic and/or diagnostic polypeptides directed against the target of Swiss Prot Q9NPF7. In addition, the present invention relates to novel, specific-binding therapeutic and/or diagnostic polypeptides directed against one or both of Swiss Prot Q16552 and Swiss Prot Q9NPF7. The invention also relates to nucleic acid molecules encoding such polypeptides and to methods for generation of such polypeptides and nucleic acid molecules. In addition, the invention is directed to compositions comprising the polypeptides, and therapeutic and/or diagnostic uses of these polypeptides.


News Article | May 1, 2017
Site: globenewswire.com

LEXINGTON, Mass., May 01, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) today announced that Darlene Deptula-Hicks has been named senior vice president and chief financial officer. Ms. Deptula-Hicks is an accomplished financial executive in the life sciences and medical technology industries and has nearly 30 years’ experience leading financial operations for both public and private companies. She brings a proven track record in financial strategy, capital raising, M&A, product commercialization, and the ability to build strong, external partnerships to T2. “We are pleased to have Darlene join as our chief financial officer during a critical time of growth for T2,” said John McDonough, president and CEO. “Her proven ability as a strategic and dynamic financial leader and in-depth knowledge of the industry will benefit our company as we look to increase contracts, form new strategic partnerships, and bring new products to market.” Ms. Deptula-Hicks was most recently CFO and senior vice president at Pieris Pharmaceuticals, Inc., a public biotechnology company, where she was responsible for financial strategy, capital raising, compliance and reporting, and investor relations. Ms. Deptula-Hicks joined Pieris, a German-based company, to lead its IPO, and subsequently managed its operations as a public company with facilities in Boston and Munich. Prior to Pieris, Ms. Deptula-Hicks served as the CFO for a variety of biotechnology and medical device companies, including in the areas of oncology, genomics, minimally invasive surgery, advanced image analysis, radiation oncology, and cardiology and orthopedic medical devices, among other specialties. Ms. Deptula-Hicks completed an executive education program at Dartmouth College’s Tuck School of Business and has her MBA from Rivier College. She received her bachelor’s degree in accounting from Southern New Hampshire University, and serves or has served on a variety of public and private company boards. About T2 Biosystems T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx® Instrument and T2Candida® Panel targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of patient sample types, including whole blood. For more information, please visit www.t2biosystems.com.


BOSTON, MA--(Marketwired - February 08, 2017) - Pieris Pharmaceuticals, Inc. ( : PIRS), a biotechnology company advancing its proprietary Anticalin® biotherapeutic technologies, announced today that President and CEO Stephen Yoder will present a corporate overview of the Company and meet with investors at the Bio CEO & Investor Conference. The conference will take place on February 13-14, 2017 at the Waldorf Astoria hotel in New York City. Mr. Yoder is scheduled to present on Monday, February 13th at 1:30 pm EST. The presentation will be webcast live and available for replay at http://www.veracast.com/webcasts/bio/ceoinvestor2017/26120145557.cfm and on the investor relations section of the Company's website at www.pieris.com. Accredited investors are also invited to request a one-on-one meeting with Pieris Pharmaceuticals management during the conference through the 1-on-1 partnering system. Pieris Pharmaceuticals is a clinical-stage biotechnology company that discovers and develops Anticalin-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes immuno-oncology multispecifics tailored for the tumor micro-environment, an inhaled Anticalin protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin® is a registered trademark of Pieris. For more information visit www.pieris.com. This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to novel technologies and methods; our business and product development plans and timelines; the timing and progress of our studies, development of therapeutic programs; ability to receive research funding; our liquidity and ability to fund our future operations; our ability to achieve certain milestones and receive future milestone or royalty payments; current or future partnerships; or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates; competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the SEC available at www.sec.gov, including without limitation the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and the Company's Quarterly Reports on Form 10-Q.


Novel Hepcidin Inhibitor Addressing High Medical Need in Anemia of Chronic Disease BOSTON, MA--(Marketwired - February 27, 2017) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform, today announced that it has granted ASKA Pharmaceutical Co., Ltd., an independent Japanese pharmaceutical company with annual sales of approximately $400 million, an exclusive option to license development and commercial rights to Pieris' anemia drug, PRS-080, in Japan and certain other Asian markets following completion of a multi-dose Phase 2a study to be conducted by Pieris in dialysis-dependent anemia patients. PRS-080 is a highly potent inhibitor of hepcidin, a key regulator of iron metabolism. Elevated hepcidin levels both prohibit iron uptake from dietary consumption and block the release of iron from body storage cells, such as hepatocytes and macrophages. Excess hepcidin is, therefore, often the root cause of iron deficiency and iron-restricted reduction of erythropoiesis, resulting in anemia in patients with chronic kidney disease (CKD) and other conditions. Current treatment options, which include erythropoietin stimulating agents and iron supplements, are associated with side effects, and not all patients respond to those agents. PRS-080 seeks to overcome these limitations by neutralizing hepcidin directly. A Phase 1 study conducted in healthy volunteers demonstrated that a single dose of PRS-080 was well tolerated and resulted in a dose-dependent increase in serum iron. Pieris has completed dosing of all patients in a Phase 1b study in CKD patients on hemodialysis and will next pursue a multi-dose, Phase 2a study in the same patient population, which is scheduled for completion in the second half of 2017. Under the terms of the option agreement, Pieris will receive an immediate option payment of $2.75 million USD from ASKA. Following an analysis period after the completion of the planned Phase 2a study conducted by Pieris, ASKA may exercise its option to obtain an exclusive license to develop and commercialize PRS-080 in Japan, South Korea and certain other Asian markets (excluding China). Should ASKA exercise the option, Pieris would be eligible for more than $80 million USD in combined option exercise fee and milestones associated with development and commercialization of PRS-080 in the first indication in Japan. Pieris may receive further development milestones in additional indications, as well as in other countries within the ASKA territory. Pieris may also receive double-digit royalties on net sales of PRS-080 up to the mid- to high-teens. "We are pleased to have found a very committed partner for PRS-080 in a key Asian market," stated Stephen Yoder, President and Chief Executive Officer of Pieris. "Importantly, this deal enables us to invest in improving drug manufacturing efficiencies while conducting our Phase 2a trial to enable seamless drug supply for future clinical studies by ASKA and other partners we may seek in other territories, as we focus our proprietary pipeline in immunology-related areas for long-term value creation." "Anemia in hemodialysis patients represents a substantial medical need in Japan, as physicians are not comfortable prescribing high doses of erythropoietin stimulating drugs, such as EPO and iron supplements. PRS-080 is well positioned to address this medical need in the future. We are thus very excited to have secured an option for this highly innovative drug," stated Takashi Yamaguchi, President and Representative Director at ASKA Pharmaceutical. "We are looking forward to conducting the planned Phase 2a study with PRS-080," stated Dr. Louis Matis, Senior Vice President and Chief Development Officer of Pieris. "At the same time, we continue to focus on readying a highly differentiated pipeline of novel biotherapeutics for clinical development, with our lead Immuno-Oncology bispecific drug candidate, PRS-343, scheduled to enter a first-in patient trial in the first half of 2017, as well as our inhaled drug candidate for the local treatment of asthma, PRS-060, anticipated to begin a first-in-human study around the middle of 2017." Pieris Pharmaceuticals is a clinical-stage biotechnology company that discovers and develops Anticalin-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes immuno-oncology multispecifics tailored for the tumor micro-environment, an inhaled Anticalin protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin® is a registered trademark of Pieris. For more information visit www.pieris.com. ASKA Pharmaceutical Co., Ltd. is a leading Japanese pharmaceutical company focused on three fields: Internal medicine, the obstetrics and gynecology and urology. Since its foundation in 1920, it has built up a record of achievement as a pharmaceutical manufacturer and marketing distributor of specialty hormone preparations with technical capabilities that are top-class among Japanese companies. For further information, please visit www.aska-pharma.co.jp/english/index.html. Anticalin proteins are derived from lipocalins, small human proteins that naturally bind, store and transport a wide spectrum of molecules. Anticalin proteins feature the typical four-loop variable region and a rigidly conserved beta-barrel backbone of lipocalins, which, together, form a shapeable cup-like binding pocket. Proprietary to Pieris, Anticalin proteins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin® is a registered trademark of Pieris. This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to novel technologies and methods; our business and product development plans and timelines; the timing and progress of our studies, development of therapeutic programs; our liquidity and ability to fund our future operations; our ability to achieve certain milestones and receive future milestone or royalty payments; current or future partnerships; or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates; competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the SEC available at www.sec.gov, including without limitation the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and the Company's Quarterly Reports on Form 10-Q.


Patent
Pieris Pharmaceuticals GmbH | Date: 2015-01-12

The disclosure provides a multi-specific polypeptide with a first moiety specific for a tumor-associated antigen on tumor cell surface and a second moiety specific for an immune checkpoint protein, which multi-specific polypeptide can be useful for biasing a T-cell-mediated response to a tumor micro-environment. For example, the polypeptide may contain: a) a first binding domain, for example, a full-length antibody or an antigen-binding domain of an antibody, specifically recognizing a tumor-associated antigen on tumor cell surface, and b) a second binding domain, such as a lipocalin mutein, capable of stimulating T-cell proliferation e.g., by inhibiting a protein receptor that down-regulates the immune system. The first binding domain may be genetically linked (i.e., peptide bond at its N- or C-terminus) to the second binding domain. The multispecific polypeptide also may contain a third or yet additional specific binding moieties, any of which can specifically bind a distinct immune checkpoint protein. The polypeptide may contain an Fc region of an antibody or of an antigen-binding domain thereof and simultaneously engage (1) a T cell receptor complex of a T cell, (2) a tumor-associated antigen on tumor cell surface, while (3) preserving the Fc function of the Fc region to Fc receptor-positive cell. The polypeptide is useful for the induction of an anti-tumor immunity in humans and/or animals. The disclosure also provides thermal-stable lipocalin muteins specific for CTLA-4. The disclosure further relates to a process for the production of the polypeptide or muteins as well nucleic acids encoding for the polypeptide or muteins, to vectors comprising the same and to host cells comprising the vector. In another aspect, the disclosure provides for a pharmaceutical composition comprising the polypeptide or muteins and medical uses of the polypeptide or muteins.

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