Biotech Strategy Blog

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

Posts tagged ‘Biotech Drug Development Strategy’

Coit Tower San FranciscoAt the recent ASCO 2016 Genitourinary Cancers Symposium (ASCO GU) that took place in San Francisco the week before the JP Morgan Healthcare Conference (JPM), one of the noteworthy presentations was on a novel target for men with advanced prostate cancer.

While JPM may have been a “dud” for many, several companies did take the opportunity to update and discuss their corporate strategy going into 2016, which gave a surprising amount to comment on in our 3 blog posts from the meeting: JPM Day 1, JPM Day 2, JPM Day 3.

In this post we look at the “take homes” from the ASCO GU presentation, and what looks like it could be a new race to market.

It’s good to see novel targets for men with advanced prostate cancer, and potential new treatment options on the horizon!

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San Francisco JPM16 Day 1It’s Day 1 of the annual pilgrimage to San Francisco for the JP Morgan Healthcare conference. In light of the success of the daily rolling blogs we’ve done around the conferences we cover, for the first time we’re doing a rolling blog for each day of #JPM16.

Throughout the day (schedule permitting) we’ll be updating the post with commentary around noteworthy news.

Company presentations mentioned in this post include: $PBYI, $CELG, $GILD, $INCY, $SGEN, $MDVN. There’s also commentary on several of the deals announced by Roche, Juno, Novartis, Sanofi, AstraZeneca & Merck.

If you want to follow along yourself, here’s the link to the JPM16 webcasts & conference agenda.

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BIO-CEO-2012-New-York-CityThe 2012 BIO CEO & Investor conference starts today in New York.

The meeting from February 13-14 is being held at the landmark Waldorf-Astoria hotel.

I’m looking forward to seeing some of the iconic hotel features such as the 1893 lobby clock originally produced for the Chicago World Fair.

With Wall Street analysts and investors in mind, the main focus of the 14th annual conference is on publicly traded biotechnology companies.

I expect that a number of the corporate presentations will be webcast, but if you are unable to be in NYC, you can follow the #BIOCEO2012 twitter conversation below:

 

As always, part of the attraction of these events is the opportunity for networking.

Rodman & Renshaw are hosting a party at the Rockefeller Center’s sunken plaza restaurant.

I hope to see you there or at one of the BIO CEO 2012 receptions.

 

Update Waldorf-Astoria Hotel 8.13 am February 13, 2012
I was all set-up with my trusty Zi8 flip camera to record a few clips of Moncef Slaoui’s fireside chat to share with blog readers, but was publicly told off by BIO staff that I could not shoot any video, despite a media registration. The head of media relations for BIO was not readily available when I asked to speak with her about this.

I’m sorry BIO but you’ve lost the plot. There’s no unpublished scientific data at this meeting, no information that is not publicly available, being webcast or being tweeted. If I’m not welcome, I do have other things to do with my time than attend your meeting, write blog posts about, do a video report & tweet about it. #fail

Update Waldorf-Astoria Hotel 8.58 am  February 13, 2012

Waldorf-Astoria-Hotel-Lobby-ClockAfter 20 minutes I have given up waiting for a BIO media rep to talk to about the “no video” policy for this meeting.

If organizations have a specific photo/video policy for a conference they should take the trouble to communicate this beforehand, at registration or prior to a session starts. Nobody bothered to do that at BIO CEO 2012 today. That’s inept organization.

What BIO did communicate by email to those who registered for BIO CEO 2012 in advance was that:

“By registering for this meeting, attendees authorize BIO to use any photographs taken during the Conference, which may be included in promotion materials.” 

BIO could at the same time clearly have indicated any photography/video policy for media or attendees.  They didn’t.

In the absence of any specific instruction otherwise and the fact that all attendees had consented to be photographed, I had no reason to believe that video or photography was prohibited.

What’s more, I shot a video report at BIO 2011 that I am sure the folk at BIO were aware of. I received no complaints about it, and if I shot a video report before it would not be a leap of imagination to expect I might shoot another video report.

Nobody likes to be publicly humiliated or told they can’t do something in a public forum after a session has started.  I certainly didn’t enjoy that happening to me today.

As a result of my experiences at BIO CEO 2012, Biotech Strategy Blog will not be providing any publicity, promotion or coverage of any future BIO event.

I am sorry if this inconveniences any blog readers. However, on reflection, I don’t think it’s a great loss given that there’s no breaking science or clinical trial data presented at any BIO meeting and company presentations are usually webcast or otherwise publicly available.

Head and neck cancer is not something we hear much about when it comes to new therapies, yet it is the sixth most common non-skin cancer in the world.

Head and neck squamous cell carcinoma (HNSCC) has an incidence of 600,000 cases a year, with 50,000 of those occurring in the United States.

Outcomes remain disappointing for patients, with disease free survival (DFS) rates of only 30-40% for patients with locally advanced HNSCC.  Five-year survival rates of around 50% have improved little for many years.

Zalutumumab failed to show OS benefit

The challenge of drug development in this area was highlighted by the failure of the phase III trial for zalutumumab (Genmab).  Zalutumumab was a monoclonal antibody against the epidermal growth factor receptor (EGFR).

Despite promising phase II data, the phase III trial did not show an improvement in overall survival against best supportive care (BSC) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who had failed standard platinum-based chemotherapy.  Genmab subsequently dropped zalutumumab from its pipeline in June 2011.

These results are interesting because they raise the question of why this agent failed when Erbitux (cetuximab), an EGFR monoclonal from Lilly/BMS succeeded?  Cetuximab is approved in the first-line setting in combination with radiation and in the relapsed setting with 5FU and as a single therapy in refractory patients.  Clearly not all EGFR therapies are equal.

Oncolytics Biotech Phase III trial ongoing

Another company trying to crack head & neck cancer is Canadian based Oncolytics Biotech, who have started a phase III trial with REOLYSIN® in combination with paclitaxel and carboplatin for patients with platinum-failed head and neck cancers.  A poster on their phase II data was presented at the AACR-EORTC molecular targets meeting in San Francisco last year (Abstract C22).

Reolysin is a proprietary formulation of the human reovirus (respiratory enteric orphan virus).  According to the company website, “in tumour cells with an activated Ras pathway, reovirus is able to freely replicate and eventually kill the host tumour cells.” It’s beyond the scope of this post to go into the science of oncolytic viruses.

The company recently announced CDN $18.5M of additional financing. According to the clinicaltrials.gov site, the primary completion date for the 280 patient, 53 site trial (NCT01166542) is estimated to be June this year.  The primary endpoint is again overall survival (OS) and it will be interesting to see whether they can succeed.

Which brings me to some interesting science in HNSCC that caught my attention earlier this week.

Low-level expression of miR-375 correlates with poor outcome & metastasis

Research published online first on January 9, 2012 in the American Journal of Pathology by the Albert Einstein College of Medicine and Montefiore Medical Center in New York showed that low-level expression of micro RNA-375 (miR-375) correlated with poor outcome in tumors of HNSCC patients.

Sally Church, Ph.D on Pharma Strategy Blog recently wrote about how microRNA (miRNA) can be used as a potential biomarker in breast cancer, allowing for earlier detection.

She noted, “miRNA looks to be a promising fledgling area for biomarker research in the early detection of cancer.”

Thomas Harris and colleagues showed that HNSCC patients with low miR-375 tumor-to-normal (T:N) expression ratio had a worse prognosis.

miRNA expression status was assessed as a ratio of miR-375 expression in the tumor relative to adjacent normal tissue collected from the same patient to provide a normalized ratio across the study population.

The Kaplan Meier curves in their paper show the significant correlation.  The data showed that:

Patients with lower miR-375 T:N expression were more likely to die of disease (HR: 12.8, 95% CI: 3.4 to 48.6) than those with higher miR-375 T:N.

The authors suggest that the correlation between low miR-375 tumor versus normal tissue expression and outcome may be due to the effects of miR-375 on tumor cell invasion.

The identification of a potential biomarker associated with head and neck cancer prognosis is promising.  The paper concluded that:

The identification of patients with a poor prognosis, especially in the case of early-stage disease, could lead to additional therapeutic interventions, such as suppressing tumor cell invasiveness, to achieve better outcomes.

Geoffrey Childs, Ph.DGeoffrey Childs, Ph.D, the co-senior of the author of the paper noted in a news release:

we hope that miR-375 will become part of a laboratory test to determine which patients have potentially lethal tumors and therefore should be treated aggressively following initial diagnosis.

There is an unmet medical need for novel therapeutics in HSNCC. Hopefully, new drug development targets will follow from the identification of biomarkers and a greater understanding of the molecular biology.

ResearchBlogging.orgHarris, T., Jimenez, L., Kawachi, N., Fan, J., Chen, J., Belbin, T., Ramnauth, A., Loudig, O., Keller, C., Smith, R., Prystowsky, M., Schlecht, N., Segall, J., & Childs, G. (2012). Low-Level Expression of miR-375 Correlates with Poor Outcome and Metastasis While Altering the Invasive Properties of Head and Neck Squamous Cell Carcinomas The American Journal of Pathology DOI: 10.1016/j.ajpath.2011.12.004

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