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Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘ESMO 2014 Galeterone’

At the 2014 ESMO Congress in Madrid, Mary-Ellen Taplin, MD (Dana-Farber Cancer Institute, Boston) presented the results of the Tokai Pharmaceuticals (NASDAQ $TKAI) ARMOR2 clinical trial of galeterone in men with advanced prostate cancer.

ESMO 2014 Dr Taplin Galeterone ARMOR2 Presentation

Galeterone has a novel triple mechanism of action. In effect, it is a CYP17 lyase inhibitor (like abiraterone) that has additional anti-prostate cancer actions including androgen receptor (AR) inhibition (like enzalutamide). It also causes AR degradation that decreases AR levels.

Tokai’s IPO last month is reported by Renaissance Capital to have raised $98M for the company, with most of the funds going to prior investors including Novartis Bioventures which owned 28 percent.

Shares in $TKAI were initially priced at $15. They soared to a high of $30 thanks to high insider buying and a high trading volume. Novartis Bioventures were reported by Renaissance to have bought $20M.

As of publishing this post, the stock is now trading at $15.40, slightly above it’s IPO price. So have Novartis and others made a good investment?

Tokai Pharmaceuticals Stock Info Oct 3, 2014The market cap of $TKAI, according to their Investor Relations page (screenshot pre-market Oct 3, 2014 shown above) is $336M – not high for a company about to enter phase III drug development.

Readers are no doubt aware of the Feuerstein-Ratain rule that predicts a phase III cancer trial will be a failure when undertaken by a company with a market cap less than $300M. As Adam noted in his May 6 story on The Street earlier this year, “For companies with market caps between $300 million and $1 billion, the oncology phase III success rate is 59%.

The big questions now are did the data for galeterone from the ARMOR2 trial impress at ESMO 2014 in Madrid and what are the challenges and opportunities in the planned phase III ARMOR3-SV trial? 

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DISCLAIMER: Please note this piece offers no stock advice, is not a solicitation to invest in $TKAI and makes no recommendation on whether to buy or sell. It merely offers commentary and analysis of the data presented at ESMO 2014. Readers should do their own due diligence prior to making any investment decision.

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Dr Sandra Swain ESMO 2014 Cleopatra PresentationMadrid – it’s Day 3 of ESMO 2014 (#ESMO14), the annual Congress of the European Society for Medical Oncology, and the last day when we will be publishing a live blog from the meeting.

As predicted in our plenary preview, the highlight of the Congress is the overall survival data for the CLEOPATRA trial in HER2+ metastatic breast cancer where the addition of pertuzumab (Perjeta) to trastuzumab (Herceptin) and docetaxel chemotherapy resulted in an additional survival benefit of almost 16 months.

As Dr Sandra Swain noted in her presentation of the data in yesterday’s Presidential Symposium: “the 56.5 month median OS is unprecedented in this indication.”

Note that says MONTHS (almost 5 years) not weeks – it represents the new standard of care that all women with metastatic HER2+ breast cancer should now receive.

The prolonged applause at yesterday’s packed plenary session at ESMO 2014 summed up the feelings felt at hearing this practice changing data; the audience of medical oncologists live for moments like this! It’s truly the sort of stuff that makes you smile and go “Wow.”  We will be writing more about the commercial implications of the CLEOPATRA results and the breast cancer treatment landscape in our post-meeting coverage.

One thing that did capture my attention in the poster area at this year’s ESMO meeting was the bank of digital screens (the size of flat screen TVs) on which attendees could view digital copies of posters. What was even more bizarre was to see people taking pictures of an e-poster.

It will be interesting to see whether paper posters survive, or if they are now one of the last vestiges of the pre-digital era, destined to be phased out like paper cheques. I could see them becoming obsolete at scientific meetings in the not too distant future.

Instead we could have posters published online, with investigators interacting via chat or social media to answer questions from around the world during a dedicated interactive “poster viewing session.” I’ll let the social media gurus ponder that thought, but paperless and digital is the inexorable direction we appear to be going in.

My fervent wish is for conference organizers to ditch Flash-based apps that run on a USB key – these are pretty useless with a tablet – why not have a website with simple digital downloads for the PDFs?  Thankfully, quite a few of the posters achieved this via QR codes on their posters, making them more accessible and easier to read on the go while sparing trees.

ESMO 2014 E Posters

So what’s happening today at ESMO 2014?  Subscribers can login to read which sessions we’ll be at and, wifi permitting, read our thoughts as to what catches our attention during the day. Do follow @MaverickNY on Twitter if you don’t already.

Madrid – we’re here in Spain for the 2014 Congress of the European Society for Medical Oncology (ESMO). It’s proven to be a challenging and frustrating meeting on multiple levels so far, but hopefully it will redeem itself over the weekend as new data that changes the standard of care for cancer patients is presented.

At the end of the day it’s all about the data and making a difference to the lives of cancer patients.

The highlight of the meeting so far was yesterday’s Roche media briefing and the presentation by Dan Chen MD PhD on how the company is making advances in immunotherapy. We’ll be writing up the data he mentioned as it’s presented at the Congress. The quote he showed from Ira Mellman, PhD about the promise of Immunotherapy is one that resonates with us:

Roche Promise of Immunotherapy Quote

At prior ECCO/ESMO’s we’ve written about the industry satellite symposia that take place, many of which feature world-class experts talking about new drugs in development or the treatment landscape. It’s a big disappointment to be excluded from these events for the first time at #ESMO14, especially as many are educational in content or even organized by Continuing Medical Education (CME) companies.

That said, by dint of the fact ESMO can accept data several months after the ASCO abstracts have closed there is new data to talk about at this meeting and we have a very full schedule of sessions to attend today at the Congress.

If you would like to read more about which sessions we’ll be in and our initial impressions of data during the day, do sign-in if you’re a subscriber or sign up to keep abreast as the data rolls out.

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We continue our “pre-game” coverage of the 2014 ESMO Cancer Congress in Madrid with a look at what’s hot (or not) in prostate cancer at ESMO.

The treatment of advanced prostate cancer has been revolutionized in the recent years with the approval of new treatment options such as abiraterone acetate (Zytiga), enzalutamide (Xtandi) and radium-223 dichloride (Xofigo).  We’ve also seen some expensive flops in late stage development such as: dasatinib (Sprycel), TAK-700 (Orteronel), custirsen (OGX-011), lenalidomide (Revlimid) and cabozantinib (Cometriq) – all failed to show a significant overall survival benefit in large phase III trials.  In addition, sipuleucel-T (Provenge) although an approved new treatment, is considered by many to be a commercial failure, which highlights that it’s not just about obtaining regulatory approval as a key success factor.

The results of the accrued phase III trial with ipilimumab (Yervoy) in the pre-chemotherapy setting (recall that the ipilimumab post-docetaxel phase III trial was a failure) is eagerly awaited.

Next up in the pipeline we have next-generation androgen receptor (AR) inhibitors such as ODM-201 (Bayer/Orion) and ARN-509 (JNJ/Aragon). Phase III trials with these new AR inhibitors are recruiting for the treatment of non-metastatic castration-resistant prostate cancer (CRPC).

Other novel compounds of note earlier in development include galeterone for which a phase III trial is planned, and bromodomain inhibitors.

So what’s hot at ESMO 2014 in prostate cancer?

In the second of our preview series we take a critical look at some of the oral presentations in the preliminary ESMO program: what’s a rehash of ASCO 2014, and what new data are worth looking out for when the abstracts are published?

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