Idera-Pharma...es geht ab!?

Heute geht das Ding gut ab und es gibt noch keinen Thread.

laut iderapharma.com gibt es perspektivisch-gute Nachrichten:

¨Idera Expands Leadership Team and Strengthens Clinical Development Expertise in Oncology and Orphan Diseases¨  

wahrscheinlich war es viel mehr der Ausblick als das Ergebnis! Aber kann ja jeder selbst interpretieren;-)  

http://ir.iderapharma.com/...ewsArticle&ID=1908615&highlight=  

http://finance.yahoo.com/news/...ors-publish-promising-120000899.html  

Keiner mehr dabei- die ersten 50% eingesackt-macht nix, da stehen noch 3-stellige Prozentuale gewinne an  

http://www.iderapharma.com/sites/default/files/..._gsos_6_17_2014.pdf  

Patent
http://patft.uspto.gov/netacgi/...4&OS=8,431,544&RS=8,431,544

besser als ISIS ?  

Idera Pharmaceuticals Announces Cancer Immunotherapy Regimen With Intratumoral IMO-2055 Demonstrated Potent and Systemic Anti-Tumor Activity in Preclinical Models
Data Highlight Potential Opportunity to Enhance Activity of Emerging Class of Checkpoint Inhibitors With Idera's Proprietary Toll-Like Receptor Agonists
http://ir.iderapharma.com/...04&p=irol-newsArticle&ID=1994362  

http://ir.iderapharma.com/...04&p=irol-newsArticle&ID=2002272

- FDA grants Orphan Drug Designation for IMO-8400 for the treatment of Waldenström's macroglobulinemia

 

hier steht alles drin
http://seekingalpha.com/article/...ra-pharmaceuticals-going-into-2015  

Idera Announces Leadership Appointments
http://finance.yahoo.com/news/...adership-appointments-213000687.html  

Idera Pharmaceuticals Announces Pricing of Public Offering of Common Stock
http://finance.yahoo.com/news/...ounces-pricing-public-133000105.html
CAMBRIDGE, Mass. and EXTON, Pa., Feb. 13, 2015 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (IDRA) ("Idera" or the "Company") today announced the pricing of an underwritten public offering of 20,000,000 shares of common stock for a public offering price of $3.75 per share. The Company has granted to the underwriters participating in the offering a 30-day option to purchase up to an additional 3,000,000 shares of common stock. All of the shares in the offering are to be sold by Idera. The offering is expected to close on or about February 19, 2015, subject to customary closing conditions.  

schließlich gibt es in den USA ja jede Menge gute Biotechs..:-)
Idera ist interessant, aber noch in einer frühen Phase. Grundsätzlich ist die Technologie aber interessant sieht man sich mal ISIS Pharma und Alnylam an - beide wreden mit mehr als 5 Mrd USD bewertet..:-)
Sollte sich IDERA ähnlich gut entwickeln wäre das toll...trotzdem gab es bei ISIS auch immer viele Rückschläge und es ist nicht ganz klar, ob de Technologie jetzt wirklich reif für erfolgreiche Medikamente ist.


 

Ich denke Idera könnte es schaffen in den Biotecholymp auzusteigen..:-)))
vor allem wenn im 2 HJ die GSOs vorgestellt werden?
Und Toll-like Rezeptoren haben sie ja auch schon in der Klinik...
http://www.iderapharma.com/sites/default/files/...final_5.18.2015.pdf

dazu sehr gutes Management, und Fondsunterstützung...

da werden wir wohl noch viel freude haben?  

Idera Pharmaceuticals Enters Into a Strategic Clinical Research Alliance With MD Anderson Cancer Center to Advance Clinical Development of Intratumoral TLR9 Agonist in Combination With Checkpoint Inhibitors

- Intratumoral TLR9 Agonist Provides a Novel Approach to Immuno-Oncology -

- First Clinical Trial of IMO-2125 and Checkpoint Inhibitors to be Initiated 2H 2015 -

http://ir.iderapharma.com/...04&p=irol-newsArticle&ID=2057095  

http://www.umassmed.edu/Global/...wal%20PowerPoint%20presentation.pdf  

Idera to Collaborate With GSK to Identify 3rd Generation Antisense Molecules for Treatment of Renal Disease

CAMBRIDGE, Mass. and EXTON, Pa., Nov. 23, 2015 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced it has entered into an exclusive worldwide collaboration and license agreement with GSK to research, develop and commercialize selected molecules from Idera’s 3rd generation antisense platform for the treatment of selected targets in renal disease.

“We are excited to be working with GSK to apply our drug discovery and development efforts in renal disease.  This collaboration broadens the utility of our third generation antisense platform beyond the stated areas of focus for Idera in cancers and rare diseases,” stated Clayton Fletcher, Idera’s Senior Vice President of Business Development and Strategic Initiatives.  “Importantly, through such collaborations we have the opportunity to strengthen our balance sheet to enable us to further our own clinical development and commercial aspirations.”

Under the terms of the agreement, Idera is eligible to receive approximately $100 million in development and regulatory milestone payments, including a $2.5 million upfront payment.  Additionally, Idera is eligible to receive royalties on all sales upon commercialization at varying rates up to five percent on annual net sales in excess of $500 million.

“Advances in our understanding of chronic kidney disease have opened up new treatment opportunities,” said John Lepore, GSK Senior Vice President and Head of the Metabolic Pathways and Cardiovascular Therapy Area Unit. “Idera’s antisense platform offers a new path to explore whether gene silencing technology can help stop or slow chronic kidney disease.”
http://ir.iderapharma.com/...04&p=irol-newsArticle&ID=2114634  

Idera Pharmaceuticals Announces Several Key Leadership Additions

CAMBRIDGE, Mass. and EXTON, Pa., Nov. 30, 2015 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced several key leadership additions as the company continues to build the organization to support its clinical development initiatives and organizational growth.  Idera has appointed Mark J. Cornfeld, M.D., M.P.H., as Vice President and Medical Lead, Oncology; Kirsten L. Gruis, M.D., M.S., as Senior Medical Director, Rare Diseases; Tanya N. Lewis, Vice President, Regulatory Affairs and Quality Assurance and John J. Kirby, Vice President, Corporate Accounting.

“As we pursue our purpose of helping patients suffering from cancer or rare diseases, it is imperative that we continue to recruit outstanding talent,” stated Vincent Milano, Idera Pharmaceuticals Chief Executive Officer.  “Mark, Kirsten, Tanya and John are all highly qualified in their respective areas of expertise and of equal importance are perfect fits for the culture that we are building at Idera.”

Dr. Cornfeld most recently served in various oncology leadership roles at GSK including lead physician for afuresertib and clinical development lead as well as Director of Global Oncology Research and Development.  Prior to joining GSK, Dr. Cornfeld also held roles of increasing responsibility at Johnson & Johnson and Hoffman-LA Roche.  Prior to joining industry, Dr. Cornfeld held oncology leadership roles at several medical centers including the Fox Chase Cancer Center in Philadelphia, PA.  Dr. Cornfeld received his M.D. from the University of Pennsylvania, M.P.H. from Rutgers University and his Bachelor of Arts from the University of Pennsylvania.

Dr. Gruis most recently served as Director, Clinical Development at Alnylam Pharmaceuticals where she served as clinical lead for the Phase 3 program of Patisiran for familial amyloidotic polyneuropathy (FAP).  Prior to joining Alnylam, Dr. Gruis served as a Neuromuscular Clinical Lead at Pfizer.  Dr. Gruis received her M.D. from the University of Iowa, M.S. from the University of Michigan and her Bachelor of Science from Iowa State University.

Ms. Lewis most recently served as Vice President of Regulatory Affairs and Medical Writing at Tesaro, Inc.  Prior to joining Tesaro, Ms. Lewis held regulatory roles of increasing responsibility at Seaside Therapeutics, Vion Pharmaceuticals, Millenium Pharmaceuticals and Genzyme Corporation.  Ms. Lewis received her M.S. from the Massachusetts College of Pharmacy and Allied Health Sciences and her Bachelor of Science from Northeastern University.

Mr. Kirby most recently served as Assistant Controller at Endo Pharmaceuticals.  Prior to joining Endo, Mr. Kirby served as Vice President, Chief Accounting Officer and Corporate Controller at ViroPharma Incorporated.  Mr. Kirby began his career at KPMG, LLP and served as a Regional Audit Director at AstraZeneca Pharmaceuticals prior to joining ViroPharma.  Mr. Kirby received his Bachelor of Science from Villanova University and is a licensed certified public accountant.
http://phx.corporate-ir.net/...RssLanding&cat=news&id=2118629  

Idera Pharmaceuticals Reports Positive Data From Ongoing Phase 1/2 Clinical Trial of IMO-8400 in Patients With Waldenstrom’s Macroglobulinemia

ORLANDO, Fla., Dec. 05, 2015 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today presented initial clinical data from its ongoing Phase 1/2 clinical trial for IMO-8400, a Toll-like receptor 7, 8 and 9 antagonist, being evaluated for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia (WM).  These results provide evidence that IMO-8400 has clinical activity and is well tolerated.  Today’s results were presented during a poster session (Abstract #1540) at the 57th Annual Meeting of the American Society of Hematology (ASH) in Orlando, FL.

“Our clinical trial in Waldenström’s Macroglobulinemia represents the first step in our understanding of the potential role that TLR antagonism could play in B-cell malignancies, specifically in those harboring the MYD88-L265P oncogenic mutation which is highly prevalent in Waldenström’s Macroglobulinemia,” stated Vincent Milano, Idera’s Chief Executive Officer.  “We are pleased that the initial results from this ongoing trial met our objectives in determining safety and tolerability, as well as clinical activity of IMO-8400 in this patient population.  We are further encouraged that the safety profile seen to date will enable us to expand this study to evaluate higher dosing levels of IMO-8400.  

The results being reported are from 15 evaluable patients with Waldenström’s Macroglobulinemia who had a history of relapse or failure to one or more prior therapies and who completed at least one cycle of therapy with IMO-8400.  Patients enrolled in the multi-center, open-label, dose ranging clinical trial which evaluated 3 dose levels of IMO-8400 (06. mg/kg weekly, 1.2 mg/kg weekly, 1.2mg/kg twice a week) administration for a period of up to 24 weeks.  The primary objectives of the study were to assess safety and tolerability.  Secondary objectives were to assess clinical activity, PK and define the optimal dose for further clinical evaluation.  In addition to clinical treatment parameters, cytokine levels were analyzed as an exploratory endpoint in the trial.

Top Line Results

Safety

   IMO-8400 was generally well tolerated at all dose levels studied.
   The Maximum Tolerated Dose of IMO-8400 has not yet been identified.

Clinical activity

   Across all dose cohorts, 6 of 15 patients (40%) with relapsed or refractory WM had an objective response.
       Three responders were refractory to their last treatment, including 1 patient who was refractory to ibrutinib.
   In  the highest dose cohort  (1.2 mg/kg twice a week):  
        3 of 6 patients (50%) had an objective response and two had stable disease.
       The median time to first response was ~10.5 weeks.  
       There was improvement in bone marrow findings, hemoglobin and disease symptoms.
   An exploratory analysis showed a significant correlation between change in M-protein and a change in IL-10, with decreases in IL-10 being seen in responding patients.

Summary

   These data in patients with WM provide the first clinical evidence supporting inhibition of the TLR pathway as a potential therapeutic approach for B-cell malignancies characterized by the MYD88 L265P oncogenic mutation.
   Evaluation of higher IMO-8400 dose levels is planned.

The full poster presentation is currently available on the Investors Page of the Idera corporate website which can be found at
http://ir.iderapharma.com/...04&p=irol-newsArticle&ID=2120407  

Idera Pharmaceuticals Announces Initiation of Phase 1/2 Clinical Trial of Intra-tumoral IMO-2125 in Combination With Ipilimumab in Patients With Metastatic Melanoma

CAMBRIDGE, Mass. and EXTON, Pa., Dec. 14, 2015 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced that the company has commenced enrollment in a Phase 1/2 clinical trial evaluating intra-tumoral IMO-2125, a TLR9 agonist in combination with ipilimumab (an anti-CTLA4 antibody) in patients with previously treated metastatic melanoma.  The study is being conducted at The University of Texas MD Anderson Cancer Center and is being led by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson.

In this clinical trial, escalating doses of IMO-2125 ranging from 4 mg/kg through 32 mg/kg will be administered intra-tumorally into one of two selected tumor lesions, with a standard dosing regimen of ipilimumab.  The primary objectives of the phase 1 portion of the trial will be to determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLTs) of IMO-2125 when administered intra-tumorally in combination with ipilimumab.  The primary objective of the phase 2 portion will be to determine the efficacy of the combination utilizing the immune-related response criteria (irRC) in additional to traditional RECIST criteria.  Serial biopsies will be taken of selected injected and non-injected tumor lesions to assess immune changes and response assessments.  The trial will enroll approximately 45 patients.   The company expects initial data from the ongoing trial to be available in 2016.

Preclinical evidence shows that IMO-2125 delivered intra-tumorally in combination with anti-CTLA-4 mAb demonstrates improved inhibition of tumor growth, regression of metastases and infiltration of the number and nature of tumor specific immune cells in injected and non-injected tumor lesions versus monotherapy with either agent.  Additional pre-clinical evidence suggests that intra-tumoral IMO-2125 modulates checkpoint gene expression, including IDO1, PDL1, TIM3, LAG3 and CTLA4, in both treated and distant tumor nodules.  The company is currently considering additional clinical studies to evaluate IMO-2125 in combination with other select checkpoint inhibitors.

“We are eager to demonstrate translation of the compelling preclinical data into the clinical setting with this novel approach to cancer immunotherapy with intra-tumoral IMO-2125,” stated Joanna Horobin, M.B., Ch.B, Idera’s Chief Medical Officer.  “The momentum and enthusiasm among our team along with our research alliance partner, MD Anderson is very strong.  This is a beginning step in a broad strategy to demonstrate a major advancement in efficacy and safety over existing treatment regimens.”

“We are anxious to understand whether the local immune changes observed in the injected tumor will be transferred to non-injected tumor lesions and that both will correlate with improved clinical efficacy for our patients,” stated Dr. Diab.

About Toll-like Receptors and Idera's Immuno-Oncology Research Program
Toll-like receptors (TLRs) play a central role in the innate immune system, the body's first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intratumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs), and thereby potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically.

Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created using the company's proprietary chemistry-based discovery platform.  IMO-2125 has been shown to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile.  In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C.  Idera has conducted further preclinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data being presented at several medical conferences during the past twelve months.  The posters from these presentations can be found at
http://phx.corporate-ir.net/...RssLanding&cat=news&id=2122245  

interessante Technologie, ohne Lieferfahrzeug, für undruggable targets.

http://ir.iderapharma.com/...04&p=irol-newsArticle&ID=1551227
GSK ist schon mit dabei
gruss  

sollen 1 bis 2 Kandidaten p. a. in die klinik gehen? Cash soll bis q3 2017 reichen. Also wird geld gebraucht durch Auslizenzierung, Partner oder neuer Aktienausgabe. Letzteres denke ich erfolgt erst nach Kurspflege?  

The Company is currently conducting clinical, regulatory and commercial analysis activities and conducting IND-enabling studies with the plan to enter the clinic in 2017 for the first clinical development program.  In addition to these activities, over the first half of 2016, Idera generated 3GA compounds for a series of additional gene targets.  These will enable the Company to continue to expand its future pipeline opportunities for both internal development as well as partnerships in areas outside of Idera’s focus.  Idera plans to present pre-clinical data at several conferences in the second half of 2016.
http://ir.iderapharma.com/...04&p=irol-newsArticle&ID=2191763  

Die Aktie steht bei mir im Screener weit vorn, weil viele Short dabei sind und das Volumen zuletzt stark gestiegen war. Der Kurs ist wieder auf dem Ausbruchsniveau vom Sommer angekommen, aber die Fundamentalzahlen gefallen mir noch nicht.