Pieris Pharmaceuticals GmbH

Freising, Germany

Pieris Pharmaceuticals GmbH

Freising, Germany
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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.


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.


The present disclosure relates to methods of treating, ameliorating or preventing a disorder comprising administering a therapeutically effective amount of a composition to a subject in need thereof, which composition contains a lipocalin mutein or a fragment or a variant thereof capable of increasing the bioavailability of iron in the subject.


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.


Company to Host an Investor Conference Call Tomorrow at 10:00 AM EDT BOSTON, MA--(Marketwired - May 10, 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, today reported financial results for the first quarter of 2017 and provided an update on the Company's recent developments, including: During the first quarter of 2017, Pieris announced two significant partnerships. In January, the Company announced a global, multi-target, multi-year alliance in immuno-oncology with Servier to jointly pursue up to eight bispecific therapeutic programs, including Pieris' proprietary dual checkpoint inhibitor, PRS-332. Under the terms of the alliance, Pieris received an upfront payment of EUR30.0 million (approximately $32.3 million), and stands to receive, collectively, up to EUR1.7 billion (approximately $1.8 billion) in success-based milestone payments and up to double-digit royalties from potential sales. Pieris and Servier will jointly develop PRS-332, with Pieris retaining all commercial rights in the United States and Servier having commercial rights in the rest of the world. Pieris has the option, at a predefined time point, to co-develop and retain commercial rights in the United States for up to three programs beyond PRS-332. In February, Pieris announced that it had granted ASKA Pharmaceutical Co. an exclusive option to license development and commercial rights in Japan for its most advanced drug candidate, PRS-080, to treat anemia in dialysis-dependent patients. Under the terms of the agreement, Pieris received an option payment of $2.75 million, and should ASKA exercise its option to develop and commercialize PRS-080 following positive results from the forthcoming Phase 2a study, Pieris would be eligible for more than $80 million in combined option exercise fee and milestone payments stemming from successful commercialization of PRS-080 in the first indication in Japan. Pieris may receive further development milestones for additional indications, as well as in other countries within the ASKA territory, and may receive double-digit royalties on net sales of PRS-080 up to the mid- to high-teens. Following the close of the first quarter, the Company also announced a global strategic co-development and co-commercialization respiratory-focused alliance including PRS-060 with AstraZeneca. Details of this alliance are summarized below, and were also previously disclosed in a May 3, 2017 press release. During the first quarter, the Company made substantial advances across its key pipeline programs, covering all of its lead therapeutic areas: "During the first quarter of 2017 and the early part of the second quarter, we have built dramatically on the foundational work that was put into place last year. We have secured two global and transformative alliances in our two core therapeutic areas of immuno-oncology and respiratory diseases, and an important regional alliance for our anemia program, PRS-080, as we seek to divest that asset in a careful manner while we focus our organization on high-value therapies within immunology. Our partnerships with global leaders like AstraZeneca and Servier, and regional partners like ASKA, have generated approximately $80 million in cash flow in 2017, while our combined partnerships could result in more than $4.5 billion in potential milestone payments, plus royalties from future product sales, not to mention opportunities for direct commercial sales for several products in the United States. With our current balance sheet, we have the financial resources to invest more robustly into our proprietary pipeline, while extending our financial runway through a series of critical value inflection points," said Stephen Yoder, President and CEO of Pieris. "We also advanced our clinical and preclinical programs, and remain on track to take our wholly-owned lead IO asset, PRS-343, into a Phase 1 trial during the current quarter, while planning to advance our now-partnered lead respiratory asset, PRS-060, into first in human trials in the second half of this year in collaboration with AstraZeneca, in addition to making steady progress across all of our additional partnerships. Based on not only the corporate milestones achieved to date, but also the additional corporate milestones we intend to achieve later this year, we continue to believe that 2017 can be the most value-creating year in the history of our company." Cash Position -- Cash and cash equivalents totalled $55.2 million as of March 31, 2017, compared to $29.4 million as of December 31, 2016. This increase in cash was driven primarily by the upfront payment received from Servier and the option payment received from Aska, offset principally by $8.8 million operating expenditures during the quarter. R&D Expense­ -- Research and development expenses were $5.4 million for the quarter ended March 31, 2017, compared to $3.7 million for the quarter ended March 31, 2016. The $1.7 million increase was primarily attributable to a $0.9 million increase in pre-clinical development, CMC, and clinical costs for PRS-343 as we carry out IND-enabling studies and a $0.5 million net increase in CMC and other costs associated with PRS-060 as we continue IND-enabling studies. G&A Expense -- General and administrative expenses for the quarter ended March 31, 2017 were $4.0 million, compared to $2.0 million for the quarter ended March 31, 2016. The $2.0 million increase in G&A expenses was primarily due to $0.8 million in higher personnel related costs, including stock compensation, $0.9 million increase for professional fees principally on account of success-based fees, and $0.3 million increase in for administrative travel, recruiting, and other administrative costs. Net Loss -- Net loss was $8.0 million or ($0.19) per share for the quarter ended March 31, 2017, compared to a net loss $4.2 million or ($0.10) per share for the quarter ended March 31, 2016. Pieris management will host a conference call beginning at 10:00 AM Eastern Daylight Time on Thursday, May 11, 2017, to discuss the first quarter financial results and provide a corporate update. To access the call, participants may dial 877-407-8920 (US & Canada) or 1-412-902-1010 (International) at least 10 minutes prior to the start of the call. An archived replay of the call will be available by dialling 877-660-6853 (US & Canada) or 1-201-612-7415 (International) and providing the Conference ID #: 13652361. 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: 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.


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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