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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.


Company to Host an Investor Conference Call on Thursday, November 10, 2016 at 10:00 AM ET BOSTON, MA--(Marketwired - November 09, 2016) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer and other diseases, today reported financial results for the third quarter of 2016 and provided an update on the Company's recent developments. "I am pleased to report that during the third quarter, we built on the progress we made in the prior quarter, with continued advancement of both our pipeline and partnerships. Our most advanced Anticalin® program, PRS-080, for anemia of chronic disease, remains on track to complete dosing in our Phase 1b single ascending dose study by year end and to complete the multiple ascending dose phase in mid-2017. At the CRI-CIMT-AACR International Cancer Immunotherapy Conference, we presented preclinical data demonstrating a differentiated mode of action for PRS-343, our lead 4-1BB (CD137)-based bispecific immuno-oncology program, which is poised to enter clinical development in the first half of 2017," said Stephen Yoder, President and CEO. "Our inhaled asthma program, PRS-060, is differentiated from systemically administered competitor mAb efforts targeting the same pathway, and it remains on track for the initiation of a Phase 1 study in the first half of 2017. Beyond PRS-343, we continue to advance a next generation immuno-oncology portfolio of multispecific therapeutic proteins, as well as our partnerships with Roche, Sanofi and Daiichi-Sankyo, including the achievement last month of a significant preclinical milestone in our second program with Daiichi-Sankyo, while continuing to explore additional collaborations. Finally, we ended the third quarter in a solid financial position with sufficient capital to fund us through multiple milestones." Cash Position - Cash and cash equivalents totalled $36.6 million at September 30, 2016, compared to $29.3 million at December 31, 2015. The increase in cash was driven primarily by the $16.5 million gross private placement financing completed in June 2016. R&D Expense­ - Research and development expenses were $4.6 million for the quarter ended September 30, 2016, compared to $2.0 million for the quarter ended September 30, 2015. The $2.6 million increase was due primarily to a $1.6 million increase in pre-clinical development and CMC costs for PRS-343 as we carry out IND enabling studies and increased development costs for our other PRS-300 series programs, a $0.2 million increase for our PRS-080 program due to the initiation of the Phase Ib clinical trial in the first quarter 2016, and a $0.2 million increase in CMC and other preclinical costs associated with PRS-060 as we carry out IND enabling studies. Other R&D expenses also increased by $0.6 million primarily due to a $0.5 million increase in personnel related expenses, including stock-based compensation expense, an increase of $0.1 million for legal and patent fees, and $0.1 million increase for general lab costs. These increases were offset by a decrease of $0.1 million in recruiting and other costs. G&A Expense - General and administrative expenses for the quarter ended September 30, 2016 were $2.3 million, compared to $2.2 million for the quarter ended September 30, 2015. The $0.1 million increase in G&A expenses was primarily due to $0.3 million in higher personnel related costs, including stock compensation, and $0.2 million increase for recruiting and rent expense, offset by $0.4 million in lower legal, consulting, and other costs. Net Loss - Net loss was $6.2 million or ($0.14) per share for the quarter ended September 30, 2016, compared to a net loss $3.9 million or ($0.10) per share for the quarter ended September 30, 2015. Conference Call Pieris management will host a conference call beginning at 10:00 AM Eastern Time on Thursday, November 10, 2016, to discuss the third 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 # 13603006. About Pieris 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. Forward Looking Statements 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, 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.


BOSTON, MA--(Marketwired - November 01, 2016) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer and other diseases, will host a third quarter 2016 investor conference call on Thursday, November 10, 2016 at 10:00 AM (EST) to discuss financial results and provide a corporate update. To access the call, participants may dial 877-407-8920 (US & Canada) or 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 201-612-7415 (International) and providing the Conference ID #: 13603006. 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 registered trademarks of Pieris. For more information, visit www.pieris.com. Anticalin®, Anticalins® are registered trademarks of Pieris.


News Article | December 1, 2016
Site: www.marketwired.com

BOSTON, MA--(Marketwired - December 01, 2016) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer and other diseases, today announced that it has appointed Claude Knopf as Senior Vice President and Chief Business Officer. Mr. Knopf is an accomplished executive in the biotech industry and brings to Pieris a demonstrable track record of success in strategy, corporate development, licensing, alliance management, marketing and sales spanning more than two decades. "Claude's appointment follows our strategy of strengthening our leadership team in Boston with high caliber talent. His consistent track record of successfully leading teams spanning diverse therapeutic areas including oncology and immunology will bring immediate value to Pieris, and it's a pleasure to welcome him aboard," said Stephen Yoder, President and CEO. Prior to joining Pieris, Mr. Knopf served from July 2013 to July 2016 as Senior Vice President, Global Head Business Development & Licensing/Mergers and Acquisitions at Baxalta (formerly Baxter Bioscience) where through partnering and acquisitions he helped develop the Oncology business and pipeline and strengthened the Hematology and Immunology divisions. Prior to joining Baxalta, from 2001 to 2013 Mr. Knopf held several business development, alliance management, licensing and marketing roles at Novartis, most recently as the Head of Business Development and Licensing - Strategic Planning, Vaccines European Region. From 1995 until joining Novartis in 2001, Mr. Knopf also held several marketing, sales and finance positions at Merck Sharpe & Dohme. Mr. Knopf holds a Master of International Business Studies from the University of South Carolina, Moore School of Business and an BA in Economics from Manchester College. "I'm excited to join Pieris and a great team," said Mr. Knopf, "and I am looking forward to helping advance a pipeline of novel and highly differentiated therapies." In connection with the hiring of Mr. Knopf, the Company's Board of Directors authorized the grant to Mr. Knopf of a non-qualified stock option to purchase up to 500,000 shares of the Company's common stock, effective as of the first day of his employment. The option grant is an inducement material to Mr. Knopf's entering into employment with the Company in accordance with NASDAQ listing Rule 5635(c)(4). The option has an exercise price of $1.45 per share, the fair market value of the Company's common stock on the date of grant and will vest as to 25% of the shares on the first anniversary of Mr. Knopf's employment and as to an additional 6.25% of the shares per quarter thereafter, provided that he continues to provide service to the Company on the applicable vesting date. The option has a ten-year term and is subject to the terms and conditions of a stock option agreement. 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 and timelines;. 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.


Dublin, Dec. 23, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Anemia Drugs Market (Iron Deficiency, Sickle Cell, CKD, Aplastic Anemia): Analysis By Region, By Country (2016-2021)" report to their offering. Global Anemia Drugs Market is forecasted to grow at a CAGR of 9.05% during 2016-2021F, on account of rising incidences of anemia globally. Rising development of pipeline drugs combined with the growing awareness of disease in developing countries has resulted in the growth of Anemia Drugs market. Anemia Drugs has been majorly caused due to the lack of iron intake and less iron absorption mainly among pregnant women, women of reproductive age and young children. Among the various types of anemia, market is expected to be driven by CKD anemia, due to the growing research and development towards new biosimilars such as Hypoxia-inducible factors. However, launch of late pipeline drugs such as Rivipansel and Vepoloxamer for sickle cell anemia treatment are anticipated to drive the market in forecast period. While developed regions will continue to dominate the market in terms of revenue, emerging nations are expected to respond to the market optimistically due to the developing healthcare infrastructure and rising focus on healthcare among the growing middle class population. Key Topics Covered: 1. Research Methodology 2. Executive Summary 3. Strategic Recommendations 4. Global Anemia Drugs Market: An Overview 5. North America Anemia Drugs Market: An Analysis 6. Europe Anemia Drugs Market: An Analysis 7. APAC Anemia Drugs Market: An Analysis 8. Latin America Anemia Drugs Market: An Analysis 9. MEA Anemia Drugs Market: An Analysis 10. Market Dynamics 11. M&A and Licensing Route to the Anemia Drugs Treatment Market 12. SWOT Analysis 13. Porter Five Force Model 14. Company Profiling and Drug Market Potential - Acceleron Pharma - Akebia therapeutics - Bayer AG - Bluebird bio - Celgene Corporation - Eli Lilly - Fibrogen - GlaxoSmithKline - Global Blood Therapeutics (GBT) - GlycoMimetics - Mast Therapeutics - Onconova Therapeutics - Pieris Pharmaceuticals - Regen biopharma For more information about this report visit http://www.researchandmarkets.com/research/7hf3md/global_anemia


BOSTON, MA--(Marketwired - March 01, 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 Cowen and Company 37th Annual Health Care Conference. The conference will take place March 5, 2017 - March 8, 2017 at the Boston Marriott Copley Place in Boston. Mr. Yoder is scheduled to present on Monday, March 6th at 4:40 pm EST. The presentation will be webcast live and available for replay at http://wsw.com/webcast/cowen38/pirs and on the investor relations section of the Company's website at www.pieris.com. About Pieris Pharmaceuticals: 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. The Company's 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. Pieris has partnerships with Servier, ASKA, Roche, Sanofi, Daiichi Sankyo and Zydus. 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.


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.


BOSTON, MA--(Marketwired - October 26, 2016) - Pieris Pharmaceuticals, Inc. ( : PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer and other diseases, announced today the achievement of a success-based milestone payment in its R&D collaboration with Daiichi Sankyo Company, Limited ("Daiichi Sankyo"), headquartered in Tokyo. Specifically, the milestone was triggered by Daiichi Sankyo's decision to initiate a GLP toxicity study in non-human primates. In 2014, Pieris transferred the program to Daiichi Sankyo, who is responsible for further development of the program. Beyond this program, Daiichi Sankyo is currently pursuing an additional Anticalin-based program (DS-9001, anti-PCSK9) for dyslipidemia, which is in the clinical stage of development. "Today's news marks the ninth milestone payment within our collaboration with Daiichi Sankyo. In addition to the first program, DS-9001, this second program is reaching an exciting stage of development," commented Stephen Yoder, President and CEO of Pieris. "With our Anticalin drug discovery platform, we have been able to create value through several partnered programs, which complement our growing pipeline of highly differentiated proprietary product candidates in immuno-oncology, asthma and other indications in attractive markets." Under the terms of the 2011 agreement, Pieris receives committed research funding and payments for the achievement of research, preclinical, regulatory and commercial milestones. The partnership could encompass for Pieris more than EUR 100 million per program in license fees, funding and milestones, not including royalties on sales from marketed Anticalin proteins resulting from the collaboration. Daiichi Sankyo will have exclusive marketing rights worldwide for all such products. 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 registered trademarks of Pieris. For more information, visit www.pieris.com. Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.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; projected timing and outcomes of clinical trials or preclinical studies; future license fees, funding and milestone 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, 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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