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Piano, piano - Pieris Pharmaceuticals - 2019
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Pieris is na het debacle met PRS-080 en het uitstel van de testresultaten met PRS-342 helemaal weggezakt. Ook in 2019 is er niet veel beweging in het aandeel, iedereen zit te wachten op wat positiefs. Vandaag dan weer eindelijk wat nieuws. Het is oncologie, dus dan kan het altijd alle kanten op.. fc Pieris Pharmaceuticals Presents Preclinical Data forGPC3/4-1BB Bispecific PRS-342 at the 2019 AmericanAssociation for Cancer Research (AACR) Annual Meeting BOSTON, MA / ACCESSWIRE / April 2, 2019 /Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stagebiotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform forrespiratory diseases, cancer and other indications, today announced the presentation of preclinical data for PRS-342, a GPC3/4-1BB immuno-oncology bispecific drug candidate, at a poster session at the 2019 AmericanAssociation for Cancer Research (AACR) Annual Meeting. The poster, titled "Costimulatory T-cell engagement by PRS-342, a GPC3/4-1BB bispecific molecule, leads toactivation of T cells and tumor growth inhibition in a HCC humanized mouse model," demonstrated that T-cellactivation by PRS-342 led to NF-kB activation, increased production of IL-2 and dose-dependent cytolysis of GPC3-expressing tumor cells. PRS-342 also demonstrated a localized increase of tumor-infiltrating lymphocyte (TIL) levelsin a humanized hepatocellular carcinoma (HCC) xenograft mouse model. The data presented suggest potent T-cellactivation that is strictly dependent on the presence of GPC3-positive tumor cells. A copy of the poster presentationis available on the publications section of the Pieris website. About Pieris PharmaceuticalsPieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-based drugs to targetvalidated disease pathways in a unique and transformative way. Our pipeline includes an inhaled Anticalin protein totreat uncontrolled asthma, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeuticsvalidated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin® is a registeredtrademark of Pieris.
Langzaam komt er weer wat leven in Pieris. Vermoedelijk aangestuwd door verwacht positief nieuws op het astma front. In de laatste investor presentatie (maart) staat astma in het middelpunt van de belangstelling.content.equisolve.net/pierisag/media/... Oncologie gaat als gewoonlijk weer als een slak. De PRS-343 studie die in september 2017 is begonnen is nog steeds lopende en zonder ook maar één concreet resultaat gepubliceerd. fc
Pieris Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Corporate Update BOSTON, MA / ACCESSWIRE / May 10, 2019 / Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer and other indications, today reported financial results for the first quarter of 2019 ended March 31, 2019, and provided an update on the Company's recent and future developments. "We are looking forward to reporting detailed data from the phase 1 single ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for asthma, at the 2019 American Thoracic Society International Conference later this month," said Stephen S. Yoder, President and CEO of Pieris. "We are also looking forward to presenting data from the currently-enrolling phase 1 multiple ascending dose study of that candidate, including the drug's FeNO-reducing potential versus placebo, at an upcoming medical meeting. Beyond PRS-060, we continue to advance multiple respiratory discovery programs, both proprietary and in collaboration with AstraZeneca, driving value across our expanding respiratory franchise. We also continue to make headway in our immuno-oncology programs. We plan to report comprehensive data from the phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors later this year. We also plan to report data from the phase 1 combination study of PRS-343 with atezolizumab later this year. Additionally, we expect to file an IND application for PRS-344, a PD-L1/4-1BB bispecific drug candidate we are co-developing with Servier, by year-end. We continue to work hard on execution over the last year and are pleased to be able to share the resulting fruits of our labor with our shareholders over the coming months." * PRS-060: Pieris will present detailed data from the phase 1 single ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for asthma, at the 2019 American Thoracic Society (ATS) International Conference later this month. The Company previously announced topline data from this study, reporting that PRS-060 was found to be safe and well-tolerated in healthy volunteers. Pieris also plans to present data from the multiple ascending dose phase 1 study of PRS-060 in patients with mild asthma and elevated levels of fractional exhaled nitric oxide (FeNO), a validated biomarker of lung inflammation, at an upcoming medical meeting. This study evaluates the safety, tolerability and FeNO-reducing potential of inhaled PRS-060 versus placebo. PRS-060 is the lead candidate in Pieris' respiratory collaboration with AstraZeneca. Pieris is sponsoring the single and multiple ascending dose phase 1 studies and AstraZeneca is funding the costs. Assuming successful completion of the ongoing multiple ascending dose phase 1 study, AstraZeneca would sponsor and fund the phase 2a study. Upon completion of that study, Pieris may exercise options to co-develop and, later, co-commercialize PRS-060. * Respiratory Pipeline: Pieris continues to advance two discovery-stage programs as part of its respiratory alliance with AstraZeneca, under which AstraZeneca may initiate up to two additional programs. The Company also continues to advance the two proprietary discovery-stage respiratory programs initiated last year and intends to initiate additional proprietary respiratory programs in 2019. * PRS-343: Pieris continues to enroll and treat patients in a phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and intends to report comprehensive data from the study later this year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab and intends to report data from this trial later this year. * Immuno-Oncology Pipeline: Pieris plans to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific the Company is developing as part of its immuno-oncology collaboration with Servier, later this year.ir.pieris.com/press-releases/detail/6...
Pieris is nog steeds goedkoop ($3.30). Het presenteren van de fase I resultaten later deze maand van PRS-060 (AZD1402) kunnen tot een goede koersreactie leiden als het een beetje meezit. fc
Pieris Pharmaceuticals and AstraZeneca Present Single- Ascending Dose Phase 1a Data for Inhaled IL-4Ra Antagonist AZD1402/PRS-060 at the American Thoracic Society (ATS) 2019 International Conference BOSTON, MA / ACCESSWIRE / May 22, 2019 / Pieris Pharmaceuticals, Inc. (PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer and other indications, today announced the presentation of placebo-controlled single ascending dose Phase 1a data for AZD1402/PRS-060, an inhaled IL-4Ra antagonist being developed in collaboration with AstraZeneca intended for the treatment of asthma, at the American Thoracic Society (ATS) 2019 International Conference. The poster, titled "First-in-human data for the inhaled IL-4Ra antagonist AZD1402/PRS-060 reveals a promising clinical profile for the treatment of asthma," provides an overview of the results of the Phase 1a study, which demonstrated that AZD1402/PRS-060 was well tolerated when given as a single administered dose in 54 healthy volunteers. Forty-two volunteers received a nebulized dose ranging from 0.25mg to 400mg while 12 received an intravenous dose of 1mg or 2mg. AZD1402/PRS-060 is also being evaluated in a Phase 1b multiple-ascending dose study in mild asthmatics with elevated levels of fractional exhaled nitric oxide (FeNO), a validated biomarker of lung inflammation in asthma. The study will determine the local effects and dose relationship as measured by FeNO together with systemic exposure and overall safety and tolerability. "We are encouraged by the safety and tolerability of AZD1402/PRS-060 in this Phase 1a study, the first Anticalin protein dosed via inhalation," said Louis Matis M.D., Chief Development Officer of Pieris Pharmaceuticals. "We look forward to completing and presenting the data from the multiple-ascending dose study, which will evaluate the FeNO-reducing potential of this drug candidate versus placebo, at an upcoming medical meeting." A copy of the poster presentation is available on the publications section of the Pieris website. Hoewel verder weinig spectaculair en eigenlijk wat verwacht kon worden is bovenstaand nieuws voldoende om PIRS weer boven de $4 te laten noteren. Als in de lopende fase 1b met patiënten de uitkomsten positief zijn zal de koers hoger kunnen. fc
Heb ze vandaag ook gekocht, misschien te laat maar ja.....je moet wel kunnen...! We gaan het zien of we nog omhoog kunnen
FatCool schreef op 11 mei 2019 09:47 :
Pieris is nog steeds goedkoop ($3.30). Het presenteren van de fase I resultaten later deze maand van PRS-060 (AZD1402) kunnen tot een goede koersreactie leiden als het een beetje meezit.
Pieris sluipt weer langzaam verder omhoog. Noteert al een tijdje rond de $4,50, is vandaag op $4,75 gesloten. Komende woensdag na beurs de cijfers (vaak erg laat) en op donderdag 1 augustus voor beurs de toelichting op de cijfers. We hebben een goed zicht nodig op de komende resultaten van de studies in het tweede halfjaar van 2019. Persoonlijk verwacht ik het meest van PRS-060, het astma medicijn dat samen met Astra wordt ontwikkeld. fc
Ja mooie dag vandaag, nu hopen op goede cijfers en goede presentatie....!
PM 9,5%, gefeliciteerd. Maar is er nieuws?
FatCool schreef op 26 juli 2019 23:36 :
Persoonlijk verwacht ik het meest van PRS-060, het astma medicijn dat samen met Astra wordt ontwikkeld.
Het publiceren van de titel van de poster die op 1 oktober in Madrid wordt gepresenteerd is het ontstekingsmiddel: "Multiple ascending dose study of an inhaled IL-4Ra antagonist, AZD1402/PRS-060, in mild asthmatics demonstrates robust FeNO reduction and a promising clinical profile for the treatment of asthma." Blijkbaar was het falen van PRS-060 in de koers geslopen, want de reactie is een beetje buitensporig voor het bekend worden van slechts een poster titel: 17% in de plus. fc
Pieris was downgraded by analyst at robert w baird from an outperform rating to a neutrale rating. They nog have a $5.00 price target on the stock. 14,2% downside from the current price $5.83 read more krijg ik niet geopend! Wat houd dit nu concreet in?
Pieris Pharmaceuticals Reports Second Quarter 2019 Cash Position and Provides Corporate Update BOSTON, MA / ACCESSWIRE / August 1, 2019 / Pieris Pharmaceuticals, Inc. (PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer and other indications, today reported its cash position for the second quarter of 2019 ended June 30, 2019, and provided an update on the Company's recent and future developments. “In the first half of 2019, we made significant progress on our clinical milestones, and we expect that momentum to build into the end of the year,” said Stephen S. Yoder, President and Chief Executive Officer of Pieris. “Last quarter, we presented two clinical data sets, including data from the phase 1 single ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma that was found to be safe and well-tolerated in the study and demonstrated favorable pharmacokinetics and robust target engagement. Looking ahead, we are pleased to announce that we will present data from the phase 1 multiple ascending dose study of that candidate, including the drug’s FeNO-reducing potential versus placebo, at the European Respiratory Society International Congress this fall. We are also pleased to announce that we plan to present data from the phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, at a medical meeting later this year.” * PRS-060: Pieris will present detailed data from the ongoing phase 1 multiple ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, at the 2019 European Respiratory Society International Congress on October 1, 2019. This study is evaluating the safety, tolerability, and potential of PRS-060 to reduce fractional exhaled nitric oxide (FeNO) versus placebo in patients with mild asthma and elevated levels of FeNO. The Company presented data from the phase 1 single ascending dose study of PRS-060 at the 2019 American Thoracic Society International Conference earlier this year. In that study, PRS-060 was found to be safe and well-tolerated in 54 healthy volunteers, in addition to demonstrating favorable pharmacokinetics and robust target engagement. Upon completion of a phase 2a study sponsored and funded by AstraZeneca, Pieris will have separate options to co-develop and, subsequently, to co-commercialize the drug candidate. PRS-060 is the lead candidate in Pieris’ five-program respiratory collaboration with AstraZeneca. * Respiratory Pipeline: Pieris initiated an additional discovery-stage respiratory program in its alliance with AstraZeneca, bringing the total number of active programs to four; AstraZeneca may initiate one additional program within the alliance. Pieris also initiated an additional proprietary respiratory discovery-stage program and continues to advance the two proprietary discovery-stage programs it initiated last year. * PRS-343: Pieris continues to enroll and treat patients in a phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors and plans to report comprehensive data from the study at a medical meeting later this year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab and intends to report data from the study later this year. * Immuno-Oncology Pipeline: Pieris plans to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific the Company is developing as part of its immuno-oncology collaboration with Servier, later this year. Pieris holds exclusive commercialization rights in the U.S. for PRS-344 and will receive royalties on ex-U.S. sales for this program. * PRS-080: Pieris presented data from the phase 2a study of PRS-080, a half-life-optimized hepcidin antagonist for anemia, at the 24th European Hematology Association Congress. In that study, PRS-080 was safe and well-tolerated, potently inhibited hepcidin, yielded robust iron mobilization, and increased transferrin saturation. At 8mg/kg, there was preliminary evidence of hemoglobin increase in patients treated with PRS-080. ASKA Pharmaceutical Co. currently has an exclusive option for PRS-080 for Japan and other Asian territories. Following delivery of a final study report, ASKA will decide whether to exercise its option to develop and commercialize PRS-080 in those territories. * Board Appointments: Pieris appointed Dr. Maya Said to the Company's Board of Directors. Dr. Said is the founder and Chief Executive Officer of Outcomes4Me, a health technology company focused on providing patients diagnosed with cancer and other chronic life altering diseases with personalized treatment options as well as outcomes information. Her prior experience includes positions at Novartis, where she served as Senior Vice President, Global Head of Oncology Policy & Market Access, and at Sanofi, where she served as Vice President, Head of Strategy, Science Policy & External Innovation, Global R&D. * Cash Position: Cash, cash equivalents and investments totaled $99.7 million as of June 30, 2019, compared to a cash, cash equivalents and investments balance of $128.1 million as of December 31, 2018.
Op de cc, naast heel veel informatie over PRS-060, ook enkele belangrijke opmerkingen over PRS-343: Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst And then maybe just one last question on moving to 343. How much data can we expect later this year? I'm going to assume that it's probably going to be a meeting like SITC that you're probably planning to present that data. So on each tumor cohort, how many patients can we expect? And are we going to get enough of a readthrough on whether you plan to move forward with this program, with this data set? Louis A. Matis, Pieris Pharmaceuticals, Inc. - Senior VP & Chief Development Officer This is Lou. I'll take it. What we plan to present, I think, was really well-described in Steve's narrative. So we'll be showing data related to the drug's pharmacology, as well as data with respect to influence on the tumor microenvironment, biomarket data, as well as clinical responses. We can't, obviously, go to any details on what we've seen, but we're looking forward to presenting . And it'll be quite comprehensive in terms of the data we have from the single dose trial and as well as data that is emerging from the combination study. That -- the combination study, as you know, began significantly later in time relative to the monotherapy, so we're not quite as far advanced in the combination study as we are with the single-dose escalation study. Lou, have you made a determination on the appropriate dose to move forward with -- in the monotherapy cohort? Again, we will describe that at the meeting. We certainly have doses where we believe there will be activity. And whether that's the final dose or not, we are going to be determining over the next months, several months into the end of the year. But we're very pleased to be presenting the data that we have so far , which we -- obviously, the clinical data that we show with respect to biomarkers in the tumor microenvironment with respect to response data, as Steve said, we'll obviously be showing the doses at which we saw data that we'll be -- going to present. Sorry. It's a little bit complicated to express because you can't really go through the data now. But we're looking forward to presenting. En een stukje verder in de cc: Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst On 343, I know you can't discuss the numbers and the extent of the data at this point. But with -- I know, obviously, people are going to be looking for initial clinical responses, but I think it's also really important about the pharmacodynamic data and the biomarker data and tumor microenvironment aspects that you were discussing. So I guess, the way I would ask it, for the different levels of cohorts that you have in this study, are you pleased with the amount of, say, biopsy data and tumor microenvironment data with each cohort that you've been able to garner in the patients that agreed to it, and what are follow-ups or what have you to be able to put forth a good tumor microenvironment case? This is Lou. Obviously, we can't comment specifically, but we are, and have been since the initiation of the trial, collecting data, both with respect to pre- and post-therapy biopsies as well as clinical data and PK and so forth in every single patient. So the sites have been extremely cooperative and enthusiastic about executing on every aspect of the study. And to be able to correlate anything we see clinically with supported data with respect to tumor microenvironment, for example. Wel, vol verwachting klopt ons hart??? fc
Sessie 400 op 1 oktober op het ERS congres in Madrid van 28 september t/m 2 oktober. Poster abstract: Late Breaking Abstract - Multiple ascending dose study of the inhaled IL-4Ra antagonist, AZD1402/PRS-060, in mild asthmatics demonstrates robust FeNO reduction and a promising clinical profile for the treatment of asthma Ingmar Bruns, Mary Fitzgerald, George Mensing, Mei Tsung, Katerina Pardali, Philip Gardiner, David Keeling, Lena Axelsson, Marita Olsson, Cyrus Ghobadi, Oscar Walsh, Kristi Mclendon, Nicholas Farinola, Lara Hatchuel, David Close AZD1402/PRS-060 is a novel inhaled Anticalin® molecule antagonizing IL-4Ra. A multiple ascending dose clinical study (NCT03574805) was conducted in mild asthmatics (fractional exhaled nitric oxide (FeNO) levels = 35ppb), to assess the safety, tolerability, pharmacokinetics and pulmonary and systemic IL-4Ra target engagement of AZD1402/PRS-060. The drug candidate was administered by nebulized oral inhalation at delivered doses between 2 and 20mg, twice daily for 9 days with one dose on day 10. All doses of AZD1402/PRS-060 were found to be safe and well tolerated; no serious adverse events were observed. Lung target engagement was determined by reduction of FeNO levels and systemic target engagement was determined ex vivo by inhibition of IL-4-stimulated signal transducer and activator of transcription 6 (STAT6) phosphorylation in whole blood. Significant and pronounced (=25%) inhibition of FeNO was observed at all doses, including the 2mg delivered dose, where no systemic target engagement and minimal systemic exposure was observed. This suggests that local target engagement by the drug is sufficient to reduce airway inflammation, as measured by FeNO. The onset of FeNO reduction was rapid (after a single dose) and the maximum effect (day 4-5) vs placebo was sustained until dosing completion. Systemic target engagement was dose-dependent and closely aligned with systemic exposure of the drug. Pulmonary target engagement as shown by a substantial reduction in FeNO and the overall profile of the drug demonstrates its suitability for continued development as an inhaled therapy for asthma .
Gunstig, we gaan weer stijgen, afgelopen vrijdag flink nabeurs omhoog!
Pieris Pharmaceuticals Announces $32 Million Private Placement and Potential Funding Mechanism for PRS-060 Co-development Opt-in BOSTON, MA / ACCESSWIRE / November 4, 2019 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer and other indications, today announced that it has entered into a securities purchase agreement with existing and new institutional investors to raise $32 million. The private placement was led by BVF Partners L.P., with significant additional participation from EcoR1 Capital, Aquilo Capital Management, Surveyor Capital (a Citadel company), and Samsara BioCapital. The private placement will consist of 9,014,960 units, at a price of $3.55 per unit. Each unit will consist of (i) one share of Pieris' common stock or 0.001 non-voting Series C convertible preferred stock, and (ii) one immediately-exercisable warrant to purchase one share of common stock at an exercise price of $7.10 per share. Each share of non-voting Series C convertible preferred stock is convertible into 1,000 shares of Pieris common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.99% of the total number of shares of Pieris common stock then outstanding. The warrants are intended to facilitate Pieris' exercise of its co-development option for PRS-060/AZ1402 following the conclusion of a positive phase 2a study. If top-line results of that study disclose achievement of the primary efficacy endpoint and the stock reaches a pre-specified price, then the warrants will expire sixty days following such disclosure and may only be exercised for cash. Otherwise, the warrants will be exercisable for a period of five years from the date of issuance. The closing of the financing is expected to take place on or about November 6, 2019 and is subject to standard closing conditions. Pieris expects to use the proceeds from the financing for continued development of its immuno-oncology franchise, including PRS-343, its 4-1BB/HER2 bispecific, and PRS-344, its 4-1BB/PD-L1 bispecific in co-development with Servier. The Company also expects to use these proceeds for advancement of its proprietary pipeline of inhalable respiratory drug candidates following proof-of-mechanism with respect to PRS-060/AZ1402, validating the inhaled Anticalin platform as a potential drug class, as well as for working capital and general corporate purposes. William Blair & Company, L.L.C. acted as sole placement agent for the transaction.
Pieris Pharmaceuticals Presents Data DemonstratingMonotherapy Clinical Benefit with 4-1BB/HER2 Bispecific PRS-343 in Phase 1 Escalation Study at the Society for Immunotherapy of Cancer (SITC) 2019 Annual Meeting BOSTON, MA / November 9, 2019 / Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced the presentation of data from the phase 1 dose-escalation monotherapy study of PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in a late-breaking oral presentation at the Society for Immunotherapy of Cancer (SITC) AnnualMeeting. PRS-343 demonstrated single-agent anti-tumor activity, including partial responses, in heavily pre-treated patients across multiple HER2-positive tumors. Beyond demonstrating clinical benefit, PRS-343 showed a potent increase in CD8+ T cell numbers and proliferative index in the tumor microenvironment of responders, indicative of4-1BB agonism on T cells. PRS-343 was safe and well tolerated at all doses and schedules tested. "The data presented today demonstrate PRS-343's potential to make a meaningful difference for patients with tumors that are difficult to treat with currently-available therapies," said Geoffrey Y. Ku, medical oncologist atMemorial Sloan Kettering and the principal investigator for the PRS-343 monotherapy trial. "Beyond today's presentation, I look forward to sharing some of these case studies at Pieris' upcoming R&D day alongside emerging data from the study of PRS-343 in combination with atezolizumab." The ongoing phase 1 first-in-human, open-label multicenter trial has enrolled 53 patients, including 19 patients with gastric cancer, 14 patients with breast cancer, 6 patients with gynecological cancers, and 14 patients with other tumor types. Eleven dose cohorts have been evaluated at a Q3W dosing schedule, with the 11th dose level (8mg/kg) also being evaluated at a Q2W dosing schedule. Pre- and post- treatment biopsies were obtained from many of the patients. Trial objectives include evaluation of safety and tolerability, characterizing the pharmacokinetic profile, assessing pharmacodynamic and potential immunogenicity effects, and investigating clinical response. As of the cut-off date of October 23, 2019, 18 patients were evaluable for a response at active dose levels, which began at cohort 9 (2.5 mg/kg). * At the 8 mg/kg Q2W dose level, one patient with stage 4 gastric adenocarcinoma and one patient with stage 4 gynecological carcinoma achieved confirmed partial responses; the remaining patients experienced stable disease, for an overall disease control rate of 100% in this cohort as best response. * Across the remaining active dose levels and schedules, an additional five patients experienced stable disease. * Biomarker data from post-treatment tumor biopsies in patients receiving active dose levels and showing clinical benefit reflected a pronounced increase in CD8+ T cell numbers. * As of the cutoff date, treatment duration across active dose levels is over 30 weeks. * Treatment-related adverse events (AEs) were primarily grade 1 and 2. The most common AEs were infusion related reactions and fatigue. No patients experienced a dose-limiting toxicity and a maximum tolerated dose has not been reached. "In addition to being the first 4-1BB bispecific to enter the clinic, PRS-343 is our lead immuno-oncology asset, and we believe this dataset serves as early clinical validation of our 4-1BB-targeting immuno-oncology approach and the Anticalin bispecific platform," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "PRS-343shows promising signs of efficacy linked to clear biomarker evidence of 4-1BB agonism, in addition to being safe and well tolerated. We look forward to concluding this escalation trial in the near term and initiating an expansion trial informed by the emerging data. We also look forward to initiating clinical development of our 4-1BB/PD-L1 bispecific,PRS-344, with Servier in the first half of next year." A copy of the presentation is available at this link:d1io3yog0oux5.cloudfront.net/pierisag...
Nooit verwacht dat de mono-therapy er wel goed uit zou zien. Eigenlijk wel positief verrast. Nog even de conclusie van de presentatie op een rijtje. Conclusions: * PRS-343 as Monotherapy Well-tolerated, with a good safety profile in all doses and schedules tested * Demonstrated anti-tumor activity in heavily pre-treated patient population across multiple tumor types; treatment history indicative of 4-1BB-driven mechanism-of-action * Showed a clear increase in CD8+T cell numbers and proliferative index in the tumor micro-environment of responders * Future studies are planned for continued development in defined HER2+ indications fc
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Econosto
Edelmetalen
Ekopak
Elastic N.V.
Elia
Endemol
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Facebook
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First Solar Inc
FlatexDeGiro
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Frans Maas
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FX, Forex, foreign exchange market, valutamarkt
Galapagos
Gamma
Gaussin
GBL
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General Electric
Genfit
Genmab
GeoJunxion
Getronics
Gilead Sciences
Gimv
Global Graphics
Goud
GrandVision
Great Panther Mining
Greenyard
Grolsch
Grondstoffen
Grontmij
Guru
Hagemeyer
HAL
Hamon Groep
Hedge funds: Haaien of helden?
Heijmans
Heineken
Hello Fresh
HES Beheer
Hitt
Holland Colours
Homburg Invest
Home Invest Belgium
Hoop Effektenbank, v.d.
Hunter Douglas
Hydratec Industries (v/h Nyloplast)
HyGear (NPEX effectenbeurs)
HYLORIS
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IBA
ICT Automatisering
Iep Invest (voorheen Punch International)
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IEX Group
IEX.nl Sparen
IMCD
Immo Moury
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ING Groep
Innoconcepts
InPost
Insmed Incorporated (INSM)
IntegraGen
Intel
Intertrust
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Intrasense
InVivo Therapeutics Holdings Corp (NVIV)
Isotis
JDE PEET'S
Jensen-Group
Jetix Europe
Johnson & Johnson
Just Eat Takeaway
Kardan
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Kiadis Pharma
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La Jolla Pharmaceutical
Lavide Holding (voorheen Qurius)
LBC
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Mediq
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Merus NV
Microsoft
Miko
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Morefield Group
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MTY Holdings (voorheen Alanheri)
Nationale Bank van België
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NEPI Rockcastle
Netflix
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NIBC
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Nokia Oyj
Novacyt
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NR21
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P&O Nedlloyd
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Pershing Square Holdings Ltd
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Stellantis
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Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
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Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
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TITAN CEMENT INTERNATIONAL
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