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  1. #41
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    Default Re: Curis Inc (NASDAQ:CRIS)

    It's unclear what will happen just yet, but I'm thinking that we'll see a pullback before we break to new highs. I'll be interested in buying on the pullback.




    There's going to be a conference call next week, July 28th.

    Curis to Release Second Quarter 2011 Financial Results and Hold Conference Call on July 28, 2011 - MarketWatch


    I believe todays rally is based on the positive statements made by Roche on their hedgehog inhibitor, now called Vismodegib. Curis stands to gain $115 million in milestone payments and single digit royalties. Something to keep in mind considering the market cap is currently of Curis is ~$330 million.

    Vismodegib, also we will file very soon and everything is proceeding very well. In fact the discussions we’ve had with the European authorities have been very positive, even though as you remember this is only a Phase II study and typically in Europe you could not file with this kind of data. We haven’t got the certainty it would be possible but we’re very hopeful we can file not only in the U.S. but also in Europe.
    Roche Holding's CEO Discusses Q2 2011 Results - Earnings Call Transcript - Seeking Alpha

    While I'm pretty sure the milestone payments for Vismodegib is a shoe in, there are numerous interesting clinical trials that will affect their royalties revenue such as the phase 2 pancreatic cancer trial. (Estimated Primary Completion Date: September 2011)


    What continues to be the most interesting of all is Curis' proprietary flagship products which are pathway inhibitors combined with a histone deacetylase inhibitor.






    I think the value of the company isn't just from one compound but their method of drug development. It's a method that reduces risk and maximizes profits. By taking the active structures of compounds with proven efficacy and combining it in a logical fashion, they enhance the chance their drug will work. As new pathways are exploited, Curis appears to be ready to make combination compounds of those too. (CUDC-901, Pi3K)


    What's also very interesting is that somehow their combination drug appears to be even more effective at inhibiting their targets than each drug by itself in vitro.

    The half maximal inhibitory concentration (IC50) is a measure of the effectiveness of a compound in inhibiting biological or biochemical function. This quantitative measure indicates how much of a particular drug or other substance (inhibitor) is needed to inhibit a given biological process (or component of a process, i.e. an enzyme, cell, cell receptor or microorganism) by half.
    The lower the IC50, the more effective the drug is.



    What we have here could be (emphasis on could) a stock on its way to the moon. The entire pipeline of the company is built like a space shuttle with Vismodegib as the booster rocket. It was partnered off to the 800lb gorilla, Genentech/Roche, and Curis will be paid a pretty penny for it. This raised funds to pay for the development of the rest of the pipeline which is the real payload they intend to send into orbit. Unfortunately this journey is expected to take years and I'm sure it'll have its ups and downs along the way.

    While this is my bullish big picture view it is the technical analysis that determines whether or not to buy/sell the stock and right now it looks like a buy too.
    Last edited by Ensui; July 22nd, 2011 at 04:48 PM.
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  2. #42
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  3. #43
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    Default Re: Curis Inc (NASDAQ:CRIS)

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  4. #44
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    Default Re: Curis Inc (NASDAQ:CRIS)

    Heads up, it looks like it's going to break out. Looking good.
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  5. #45
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    Default Re: Curis Inc (NASDAQ:CRIS)



    At this point we're waiting on the FDA acceptance of the NDA for the hedgehog inhibitor in metastatic basal cell carcinoma, which I think is generally accepted as a FDA approved drug. The mechanisms and proof of concept has been demonstrated and is quite conclusive with phase 2 data. This is something the market probably began pricing and running it up over a year ago when I mentioned it back before it broke the two dollar range.

    There's an FDA panel discussion November 1st in the pediatric medulloblastoma indication, a cancer originating in the brain primarily seen in children.

    November 1, 2011: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement

    I would expect that it will be well received by the FDA because out of all the cancers, these are the two cancers (BCC and medulloblastoma) whose pathology are directly linked to aberrant function in the hedgehog pathway. Early trials in this indication demonstrated very promising results and the side effects seem minor and transitory relative to this life shortening disease.

    All in all, the technicals look promising and the fundamentals (so far) look promising.
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  6. #46
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    Default Re: Curis Inc (NASDAQ:CRIS)



    The technicals continue to look good as this breakout looks like it's been confirmed. Mr. Market is likely running up in anticipation of the acceptance of the NDA and if my memory serves me correctly, the 60 days will be up in a week or two. This could be a very early runup to a, yet to be determined PDUFA date. I would say that it's likely they will get a priority review. It might even be a case where the stock will runup earlier than normal so it'll have to be sold earlier than normal. We'll see.

    I also read over the briefing documents and discussion questions from the pediatric oncology meeting. Long story short is that there's not much money to be made in the medulloblastoma, but CRIS will get paid handsomely anyways.

    http://www.fda.gov/downloads/Advisor.../UCM277585.pdf

    Vismodegib is a potent and effective inhibitor of the Hh signaling pathway.
    Vismodegib efficacy has been demonstrated in a pivotal study in adults with
    advanced BCC and an NDA has been submitted to the FDA for this indication.
    The biological mechanism of action for Hh pathway inhibition in oncology is most
    compelling in BCC and in Hh-pathway-driven medulloblastoma. However, BCC
    is exceptionally rare in children and advanced BCC in children has not been seen.
    Hh-pathway-driven medulloblastoma is rare occurring in approximately
    1 in 5 pediatric patients with medulloblastoma, and although there is no
    established diagnostic test, there exists a high unmet medical need for
    treatments of recurrent or relapsed medulloblastoma in pediatrics. Genentech
    welcomes discussion with the Pediatric Oncology Subcommittee of the ODAC
    regarding the potential for future development of vismodegib for this indication.
    Last edited by Ensui; November 4th, 2011 at 03:16 AM.
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  7. #47
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  8. #48
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    Default Re: Curis Inc (NASDAQ:CRIS)

    Promising preclinical data. Didn't do much in hyping up the stock though.
    Curis Presents Data on PI3K and HDAC Inhibitor CUDC-907 at the 2011 AACR-NCI-EORTC Symposium - MarketWatch
    Curis, Inc. CRIS +0.56% , a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced the presentation of data in a poster presentation at the 2011 AACR-EORTC-NCI International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, California. The poster presentation was titled "Anti-tumor activity of CUDC-907, a single small molecule inhibitor that targets both PI3K and HDAC, in hematologic cancer models" and was presented by Rudi Bao, M.D., Ph.D., Curis' Senior Director of Oncology.

    "As is the case with our other targeted agents, CUDC-907 has been designed to disrupt multiple points in cancer networks, in this case the PI3K pathway as well as several known mechanisms of resistance to single-target PI3K inhibitors, through CUDC-907's potent inhibition of its HDAC target," stated Dan Passeri, Curis President and Chief Executive Officer. "We are encouraged by its broad activity in preclinical cancer models, favorable performance compared to first-in-class PI3K and HDAC inhibitors and its oral bioavailability. We are continuing to advance this molecule through IND-enabling studies and currently anticipate that we will file an IND for an orally-administered form of CUDC-907 during the first half of 2012."
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  9. #49
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    Default Re: Curis Inc (NASDAQ:CRIS)

    CRIS was just viciously rejected the past few days.





    It has yet to be confirmed whether this is a true breakdown or just another bystander of the move in the major indices. We'll have to watch the price action of the next few days. On the technical front, the bears just got their hits in and now it will be up to the bulls to demonstrate the firmness of their resolve as they're now up on the ropes. I'm leaning towards a pullback scenario rather than a breakdown scenario but if these key support areas are violated I would quickly change my mind.

    From the fundamental side of things, the news flow has been getting better and better. This review on Pharmastrategyblog is very important because it demonstrates the concept that HDAC inhibitors are more effective as a combination therapy against cancer. Even though this is data from a competitor, this potential proof of concept could be the rising tide that floats all boats as far as speculation and stock prices go.

    What's hot at AACR molecular targets 2011 on breast cancer? | Pharma Strategy Blog

    What was news to me is that they used acetylation levels as a biomarker to determine if one is more likely to respond to the drug. The results were stunning.

    Adding Entinostat to general treatment of an aromotase inhibitor increased median PFS over the placebo from 2.3 to 4.3 months. Ok, that's nice but not "guaranteed big profits" nice. When they broke down the patient profiles, the patients that had high acetylation levels had improvements in their median PFS of 8.5 months. Now that's something to get excited about. CUDC-101 is still a loooong ways off so I wouldn't be trading based solely on this information but it's good to be prepared.
    Last edited by Ensui; November 22nd, 2011 at 04:42 AM.
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  10. #50
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    Default Re: Curis Inc (NASDAQ:CRIS)

    Interesting way to get funded.
    Curis Announces Agreement with The Leukemia & Lymphoma Society to Develop CUDC-907 for Lymphoma and Multiple Myeloma

    Nov 30, 2011 07:00:00 (ET)

    LEXINGTON, Mass., Nov 30, 2011 (BUSINESS WIRE) -- Curis, Inc. (CRIS, Trade ), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the Company has entered into an agreement under which The Leukemia & Lymphoma Society (LLS) will support Curis's ongoing development of its oral small molecule dual Pi3K and HDAC inhibitor CUDC-907, for patients with B-cell lymphoma and multiple myeloma.

    "We are delighted to collaborate with LLS to further develop CUDC-907. Our preclinical evidence suggests that its dual synergistic inhibition of PI3K and HDAC acts by disrupting cancer pathway networks that are important to the emergence and growth of B-cell lymphoma and multiple myeloma," said Dan Passeri, Curis's President and Chief Executive Officer. "LLS's capital commitment to this program, along with their extensive knowledge of hematological malignancies, will be important resources as we seek to advance this promising first-in-class molecule."

    This agreement was entered into as part of LLS's Therapy Acceleration Program (TAP), a strategic initiative to speed the development of therapies that have the potential to change the standard of care for patients with blood cancers, especially in areas of high unmet medical need.

    "We look forward to working closely with Curis to accelerate the development of CUDC-907 for patients with B-cell lymphoma and multiple myeloma, who are often in critical need of new treatment options" said Richard Winneker, LLS's senior vice president of research.

    Under the agreement, LLS will fund approximately 50% of the direct costs of the development of CUDC-907, up to $4 million. Curis is currently conducting preclinical studies of CUDC-907 required to file an investigational new drug application (IND) seeking to advance the molecule into a Phase Ia dose escalation clinical trial in B-cell lymphoma and multiple myeloma. Curis expects to file the IND and start patient enrollment in the second half of 2012. If this study is successful, LLS has also agreed to support Curis's subsequent Phase Ib or Phase IIa study in one or more specific indications as well as Curis' ongoing investigation of biomarkers for CUDC-907 in these diseases.

    Curis will be obligated to continue development of CUDC-907 following the term of this agreement, provided that study results are positive and that there is a regulatory path forward and would be required to make a payment to LLS if it did not continue development in this success scenario. In the event that future studies of CUDC-907 are unsuccessful, the funding received from LLS would be treated as a non-refundable grant to Curis. Assuming that Curis licenses or partners CUDC-907 in B-cell lymphoma or multiple myeloma, or, in the event that Curis commercializes the drug candidate itself in these indications, Curis would be obligated to pay LLS future milestones of up to 2.5 times the funding amounts received from LLS under the agreement, primarily upon meeting defined regulatory submission, approval and commercialization objectives.

    About The Leukemia & Lymphoma Society

    The Leukemia & Lymphoma Society (R) (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services. Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET. The Leukemia & Lymphoma Society® - Official Website .

    About Curis, Inc.

    Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis' website at Curis - Controling regeneration signaling pathways to restore human health .

    Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: the potential benefits of CUDC-907 in B-cell lymphoma and multiple myeloma, the anticipated development plans and timelines for this molecule, and the anticipated payments to be received by Curis under the arrangement. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "assumes", "will", "may," "could" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements, including without limitation: the Company may experience adverse results, delays and/or failure in its efforts to continue to successfully advance the preclinical and clinical development of CUDC-907; the Company may be unable to maintain its agreement with LLS on the terms outlined herein, or at all; the Company may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of CUDC-907, the Company may not be able to obtain the substantial additional funding required to conduct its research and development programs; and other risk factors described by the Company in its Annual Report on Form 10-K for the year ended December 31, 2011, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 and other filings that it periodically makes with the Securities and Exchange Commission.

    In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis' views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.

    SOURCE: Curis, Inc.
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  11. #51
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    Default Re: Curis Inc (NASDAQ:CRIS)

    It's clear now that the bulls have prevailed. I presume there will be some churning, possibly at this zone of resistance before a move higher to new 52 week highs.




    Sheffstation, a popular blogger of biotech has also recently been touting the merits of CRIS and GDC-0449.

    Sheff Station

    $CRIS..$4.08..GDC-0449 is part of the ACTNOW PROGRAM which is with the Amer Recovery & Reinvestment Act at the NCI. $heff's $tation of $tocks & $olid DD: CRIS..$4.08..GDC-0449 is a part of the ACTNOW PROGRAM

    $CRIS..Solid video on Vismodegib (GDC-0449) potential from a recent Dec 6th pres w Dr. Von Hoff at the Mayo Clinic. $heff's $tation of $tocks & $olid DD: Yes..Excellent video on Vismodegib (GDC-0449) potential from Dr.
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  12. #52
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    Default Re: Curis Inc (NASDAQ:CRIS)

    I guess it's time for an update on this. GDC-0449 was approved which wasn't a big surprise. Initially the stock sold off prompting many of those who follow biotechs to ask....wtf mate? While some claim it's because of the single digit royalties Curis is set to receive from the sales I find that that's probably the easy and wrong answer. To those outside of cancer research, it might be a surprise that Curis would only get paid $155 million and then such low royalties for what is potentially a drug worth a billion dollars, however had you done the research or knew about the background info, it seems more like a fair deal.

    First, in the deal, Genentech pretty much takes over and covers all the costs of development, application and marketing. At the time Curis was a young company that was in need of cash to develop their own proprietary pipeline so this gave them enough cash to go forward in developing their combo inhibitors without being bogged down with the development of GDC-0449

    Second, the odds were that the drug will only be useful in rare occurring diseases. There are only two cancers which we can say are caused by aberrant signaling in the hedgehog pathway. Basal Cell Carcinoma and Neuroblastoma.

    "Basal cell carcinoma is the most common malignancy in Caucasian individuals. Metastatic basal cell carcinoma is extremely rare (with a rate estimated as 0.03%)."

    Usually BCC would just be removed surgically and that is that. The reoccurence of the cancer after excision is very low. GDC-0449 is a systemic drug with significant side effects such as some mild to moderate hair loss and taste loss. It's hard to see someone choosing this drug over a small piece of missing flesh unless that flesh is a big piece in a cosmetically sensitive area such as the nose, eyelid or lip. Also, such indications are still up for the approval by the FDA as this drug is only approved for advanced cases of BCC. I think Roche/Genentech will get the approval eventually but it's unlikely that it will be commonly used because of the side effects.

    In a recent conference with the FDA in regards to Neuroblastoma, it was determined that this drug is effective in some populations but not all, so without a diagnostic test to determine which patients would respond to the therapy, it is not a viable compound for all neuroblastomas.

    In indications where aberrant hedgehog pathways are only implicated, the drug failed to prove efficacy in phase 2 trials, as seen in colorectal cancer and ovarian cancer. INCY's version of a hedgehog pathway inhibitor didn't prove to be successful in pancreatic cancer so it's less likely GDC-0449 will do well there either.

    Third, there is plenty of competition. Other companies are already going ahead with their own compounds that target other components of the hedgehog pathway. GDC-0449 is specifically an inhibitor of Smoothened(SMO) and there are plenty of other components of the pathway that can be exploited. There is a chance that the competitors can prove to be more effective too.

    All in all the deal seemed pretty fair but where does the stock price for CRIS go from here?
    Well, this is most easily demonstrated through the technicals.


    It has recently broken out of a base that was established in mid 2011 (blue) and broke past the down trendline (red).




    Considering that the price almost doubled in the past 2 months some sideways action in or above the support levels would not be surprising.




    This isn't really good for a hit and run trade as it appears most of the run has already occurred. It could be good for a quick short if it breaks below $4.25 but in my case I'm just sitting it through as a long term capital gain.

    So far it's the only biotech I see long term potential.
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  13. #53
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    Default Re: Curis Inc (NASDAQ:CRIS)

    A little pre ASCO update.

    CRIS has been consolidating within this range here.



    The price action hasn't really been that exciting IMO. It's actually been behaving very much in line with the fundamentals. It's pretty clear now that the FDA approval of their hedgehog inhibitor in BCC, now called Erivedge, was priced in well before it was actually approved considering the price has been chopping around sideways rather than taking off since the approval.

    The analyst estimate of potential sales from the drug is in the 2 billion dollar range per year which is not bad considering this is only from the treatment of ~1.5-2% of all BCC patients. If approved for the operable BCC indication we will see those sales double as the amount of treatable patients increases to ~4% of all BCC cases. Curis receives mid to high single digit royalties from the sales so it's not a whole lot of money to boost up shareholder value but what's more important is that they do not need to constantly dilute their shareholders to pursue their pipeline. They ended last year with 38 million in their coffers not including the 10 million milestone payment this year by Genentech/Roche. More milestone payouts are expected this year as Erivedge gains a foothold in the market.

    Now this is all in the past. What's coming up is very exciting and very scary. From what they've said at their latest conference seen here we are to expect 4 or 5? clinical trial updates on the use of their hedgehog inhibitor on pancreatic cancer. Most of it is phase 1 data which encompasses dosing and pharmacokinetics. Abstracts for these will be up soon so we'll have to wait until then for the details. I have my doubts on whether it will produce any meaningful results which is why this could be scary. The last time Erivedge failed to demonstrate efficacy in phase 2 trials we saw an overreaction by the market which dropped the stock nearly 60%.

    We'll have to wait until the abstracts are released to see exactly what they're presenting but the stock pretty much rides on the outcome of their home grown compound CUDC-101.




    If this drug works and more importantly if this concept (pathway inhibitor+HDAC) works, you're probably looking at a company that will carve out quite a significant chunk of the cancer drug market. If it fails, we'll just have to play the pump and dumps.

    I'm leaning towards success here as what they're doing is not exactly new. EGFR and HDAC are proven vulnerabilities in cancer that respond to inhibition so it would not be surprising if the drug works to some extent. How well it will work is going to be the crucial part. I guess we'll just have to wait until early June to find out. As far as trading goes, it might be worth buying some more shares in the event of a breakout but I don't think it would be a good risk/reward to stick around to find out what the results are.
    Last edited by Ensui; April 27th, 2012 at 06:51 AM.
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    Default Re: Curis Inc (NASDAQ:CRIS)

    Curis has broken out of its sideways consolidation. I will be looking to add positions on a pullback.




    The breakout coincided with a data release on June 19th about GDC-0449 (aka Erivedge) and its potential synergistic activity with gemcitabine on pancreatic cancer.

    Inhibiting Hedgehog Signaling Pathway May Improve Pancreatic Cancer Treatment

    Five patients achieved partial response, and another four patients had stable disease, yielding a 50 percent progression-free survival rate at three months.
    It's far too presumptuous to say their hedgehog inhibitor works, but in any case Mr. Markets has shown us that he likes what he sees, as indicated by the breakout. Personally, I have my doubts because we've already seen Infinity's hedgehog inhibitor fail in a trial similar to this one. Of course, these trials are under the control of almighty Genentech so if there's anyone that can squeeze something out of this, they probably have the best shot at it. Anyways, as far as trading is concerned, it would take a breakout above 5.50ish to be full on bullish.
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