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Prelude - Pieris Pharmaceuticals - 2018

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Roche en Sanofi haken af, dat is een domper. Pieris krijgt alle rechten terug op de lopende programma's en evalueert de opties op strategisch gebied. Zo te lezen worden er in Q4 belangrijke resultaten verwacht van een aantal onderzoeken. Even wachten tot de koers onder de $5 duikt en dan een aantal oppikken, leuke gok.
DeZwarteRidder
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Roche Collaboration: Pieris recently received notification of Roche’s intent to discontinue the companies’ research collaboration and license agreement, effective August 21, 2018. The Roche collaboration, signed in 2015, pursued the discovery of Anticalin proteins specific for an exploratory immuno-oncology target selected by Roche. Pieris received an upfront payment of approximately $6.4M for the collaboration. Anticalin proteins generated under the collaboration will be wholly owned by the Company; Pieris is currently reviewing the data generated under this collaboration and will consider its strategic options thereafter.

Sanofi Collaboration: Pieris recently received notification of Sanofi’s intent to return to Pieris all rights to the tetraspecific Anticalin program targeting P. aeruginosa, effective August 23, 2018. The program originated from a 2010 collaboration from which Pieris received an upfront payment of €3.5M and three milestone payments totaling €1.2M. Sanofi will transfer all related materials, data, and reports to Pieris, who will gain full control over the program. Pieris intends to review this data package and consider its strategic options thereafter.
FatCool
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Van de CC na de kwartaalcijfers (27 augustus)

This is Pam Barendt, on for Chris Shibutani. We're really looking forward to the initial clinical trial readouts toward the end of this year, for 343 in particular. Could you help frame for us how we should be thinking about the results? Remind us what kind of results for key endpoints you're trying to achieve? And what endpoints, in particular, will be most important for informing your plans for next steps?

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Stephen S. Yoder, Pieris Pharmaceuticals, Inc. - CEO, President & Director [15]

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Okay. Thanks for the question. I think we'll, again, let Lou start with this answer, given the scientific nature here.

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Louis A. Matis, Pieris Pharmaceuticals, Inc. - Senior VP & Chief Development Officer [16]

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Yes, thanks, Steve. So with respect to PRS-343, as I mentioned earlier, as we move forward through the cohorts and the trial is recruiting extraordinarily well. There's a lot of excitement from all of our investigators. As you know, obviously, it's a multiple dose-escalation trial. And so we want to be able to establish the PK safety, immunogenicity of the drug, how well tolerated it is. So obviously, that's -- those are the primary endpoints of a Phase I dose-escalation trial in these patients. In addition, we have serial biopsies, and what we can say is that all of our sites are complying beautifully with that. And we're getting very high frequency of patients getting the pre and post biopsies that we've asked for. So we intend to be mining a considerable amount of data from that. And that data will include, as you might expect, evidence of immunologic activity within the tumor microenvironment; increases or not in CD8-positive T-cells as well as CD8 T-cell Treg ratios, which is another emerging biomarker in pre- and post-treatment studies in immuno-oncology drugs as evidence of likely clinical response. We're also doing RNA analysis and looking for what would be known as an inflammatory signature that develops with the drug. And so clearly, we'll be reporting on that. And then we'll also be reporting on evidence for objective responses in the patients with respect to tumor shrinkage. So with respect to PRS-060, we'd be reporting the Phase I study. And in that study, obviously, we'll be looking at -- and that was in healthy volunteers. So we'll be talking about the drug's -- [both] pharmacology, how well tolerated it is, lack of immunogenicity. And in addition, we may have some assays to demonstrate drug activity against the target, even in the healthy volunteers. This being said, we're now moving with the -- a multi-dose escalation in patients with mild asthma, but that won't be reported out until next year.

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Operator [17]

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The next question is from the line of Biren Amin with Jefferies.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [18]

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I think last month you disclosed that you enrolled 15 patients in the 343 Phase I trial through 6 cohorts. So given your comments today that you've enrolled more patients in a 3+3 typical design, did those additional patients come in at cohort 7? And I guess, what led to your choice to increase patient enrollment beyond a 3+3? Was it DLTs or some other reason?

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Louis A. Matis, Pieris Pharmaceuticals, Inc. - Senior VP & Chief Development Officer [19]

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Yes. So we've actually -- we're moving forward seamlessly through all of the cohorts. As I said, we have (inaudible) tremendous enthusiasm. And actually to be honest, the reason that we're increasing the enrollment in different cohorts is because we have so many patients that are being brought in or being proposed to us by all the sites, we're letting every patient that the sites wish to enroll to get enrolled because the higher the numbers we get at each dose cohort, the more reliable the data will be from the standpoint of what we see at a particular dose with respect to immunologic activity, safety and so forth. So really, it's -- the reason why we're enrolling more patients is a good one. It's -- and all of the investigators are extremely appreciative of the fact that they're not having to [particularly] compete at each dose level for getting their patient in. So that's the primary reason. And since then, we've been enrolling seamlessly through each cohort. Again, if the patient gets treated and with the safety at 3 weeks, if there's a go, we start enrolling the next cohort. And so we've had no delays whatsoever.

fc
Yearling
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PIERIS PHARMACEUTICALS ANNOUNCES DOSING OF FIRST PATIENT IN PHASE I COMBINATION TRIAL FOR PRS-343 PLUS ANTI-PD-L1 IMMUNOTHERAPY
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BOSTON, Sept. 04, 2018 (GLOBE NEWSWIRE) -- Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, announced today that it has dosed the first patient in the Company’s Phase 1 combination clinical trial of PRS-343, its lead proprietary immuno-oncology drug candidate targeting HER2 and 4-1BB, plus atezolizumab (Tecentriq®), an approved PD-L1 inhibitor.

The trial, a multicenter, open-label, Phase 1 dose escalation study, is designed to determine the safety, tolerability, and potential synergistic anti-tumor effects of PRS-343 plus anti-PD-L1 immunotherapy in patients with advanced or metastatic HER2-positive solid tumors. Elevated HER2 expression is associated with multiple cancers, including gastroesophageal, bladder, breast, and a range of other tumor types. The trial is fully funded and sponsored by Pieris, while Roche is supplying atezolizumab.

“The initiation of the combination trial of PRS-343 with an anti-PD-L1 immunotherapy marks the beginning of Pieris’ investigation into the potential synergistic effects of its 4-1BB-targeted therapy with PD-1/L1 blockade,” said Louis Matis, M.D., Senior Vice President and Chief Development Officer of Pieris. “Given evidence from multiple preclinical studies demonstrating synergistic anti-tumor activity from concurrent 4-1BB activation and PD-(L)1 pathway blockade, we believe that combination therapy with PRS-343 and atezolizumab has the potential to provide significant clinical benefit for patients. We are enthusiastic to be initiating this trial and look forward to reporting our findings from this combination study next year.”

About PRS-343

PRS-343 is a bispecific monoclonal antibody-Anticalin fusion protein comprised of a HER2 tumor-targeting antibody genetically linked to a potent Anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based bispecific therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the tumor microenvironment (TME). 4-1BB is a potent costimulatory immunoreceptor and an established marker for tumor-specific infiltrating T lymphocytes, and is, therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.

About HER2-Positive Malignancies

HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells and is associated with aggressive disease progression. Multiple tumor types can express HER2 including breast, gastroesophageal, bladder, biliary (cholangiocarcinoma), colorectal, endometrial, ovarian, non-small cell lung, pancreatic, head and neck, and other cancers.

About Pieris Pharmaceuticals

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.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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 and our business and product development plans, including the advancement of our proprietary and co-development programs into and through the clinic. 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, including our ability to recruit and enroll patients in our studies; our ability to address the requests of the FDA; 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, 2017 and the Company's Quarterly Reports on Form 10-Q.

Company Contact:
Allan Reine
SVP & Chief Financial Officer
+1 857 444 4276
reine@pieris.com

Investor Relations Contact:
Maria Kelman
Director, Investor Relations
+1 857 362 9635
kelman@pieris.com

Pieris Pharmaceuticals.jpg

Source: Pieris Pharmaceuticals, Inc.
FatCool
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Pieris was bijzonder zwak de laatste weken. Positie daarom weer uitgebreid rond de $5.10.

Een deel van de extra aandelen PIRS gisteren weer verkocht op $5.71 om een aantal aandelen in Sophiris (SPHS) te kopen. Beslist interessant maar gezien de cash positie een stuk meer risicovol dan Pieris.

fc
Guy-vdk
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Van dit beloftevol aandeel schiet intussen niet veel meer over.De laatste maanden alleen maar gezakt,bijna 50% tgo begin dit jaar.Wordt eens tijd voor een remonte..
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quote:

Guy-vdk schreef op 26 oktober 2018 21:05:


Van dit beloftevol aandeel schiet intussen niet veel meer over.De laatste maanden alleen maar gezakt,bijna 50% tgo begin dit jaar.Wordt eens tijd voor een remonte..


- verstgevorderde kandidaat PRS-080 liet teleurstellende resultaten zien. Is nog maar afwachten of ASKA de licentie
neemt en of er evt. andere partners worden gevonden. Zal me niks verbazen als het hele programma wordt
weggemoffeld komend jaar.

- er is vertraging in data read out phase 1 van tumor kandidaat PRS-343. Wordt nu pas verwacht tegen de zomer van 2019. En dan nog afwachten wat die resultaten brengen, in de concerence call klonk het allemaal niet overtuigend.

- PRS-060 resultaten phase 1 worden waarschijnlijk pas ergens in het voorjaar van 2019 gepresenteerd op een conferentie samen met AstraZeneca. Onderwijl krijgt Novartis fast track voor hun asthma kanditaten en gaat al richting fase 2 = concurrentie.

- alle andere programma’s zijn nog in een heel vroeg stadium.
- de cash burn zal alleen maar toenemen, en een emissie zal ongetwijfeld weer gaan plaatsvinden

Voorlopig het beste om aan de sell kant te zitten.
FatCool
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Inderdaad weinig reden om te gaan kopen op huidige koers. Is van beloftevol aandeel afgegleden naar "er blijft weinig over".

Die emissie duurt echter nog wel even, er is aardig wat geld in kas en met het floppen van PRS-080 en PRS-343 hoeft er nauwelijks meer geld uitgegeven te worden aan eigen grote studies. PRS-060 wordt betaald door Astra. En Servier en Seattle betalen de oncologie studies.

Maar zoals gezegd, nauwelijks aanjagers voor een hogere koers op korte termijn, indien al ooit.

fc
Guy-vdk
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Gelukkig alles kunnen verkopen met een beperkt verlies.Aandeel is afgegleden naar waardeloos ondertussen..
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Vertraagd 14 feb 2020 22:00
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