Big Data and Precision Medicine Trending at CHI Tri-Con in SF

Moscone North Hall, Feb. 17, 2015. After walking the halls in the exhibit area at the recent annual CHI Tri-Con event in San Francisco, I discovered that a theme came together after I passed by various booths.

For one thing, the words “precision medicine” seemed to be resonating among those firms that were exhibiting and I asked some of them, “Is that the same thing as “personalized medicine” or “individualized medicine?”” I noted to that person that President Obama had recently made some kind of a speech that was promoting the idea of precision medicine so maybe the time has come for precision medicine to take the spotlight.

In any event I also found that there are other themes there such as big data. It is being used in a number of different biomedical research areas. I stopped by the Illumina booth spoke with the lady there whose name was Kathleen. She said that she had just joined the company about two months ago from Roche where she was involved in the clinical area. She said that her firm is moving into the data management side of their business with a focus on clinical diagnostics and take advantage of the fact that a lot of NexGen sequencing is now being used for clinical types of applications and will be generating lots and lots of data.  So big date is the theme here as well. They’re hoping to sell their systems into the clinic and hospital type settings so that they develop some very useful software systems to make sense of all that data. Data analytics is going to be a big deal.

I walked around and came across another booth that was also telling the story of powerful computer power and big data and that was the guy at Cray Computer that is famous for supercomputers in the past, but today they are using many many computers together as a cluster, a Hadoop and have another one they called SPARK. I’ll have to check out what “Spark” means. It seems to me that quite a lot is happening in the software.

CHI had other usual events that they have at the Exhibit Hall such as a raffle in which an attendee might win some kind of electronic gadget. This part of the event also featured a discussion tables. There were 40 tables that could handle as many as 8 to 10 people.  I noticed that just about every table was filled up in the hall and some of the tables had probably 10 to 15 people there, so they must have had some very popular topics to discuss. Traditionally, this part of the exhibit area has been very popular in past meetings that I’ve attended.

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Simple Cancer Biomarkers are Inadequate to Enable Personalized Medicine

It seems that researchers are finding that using single cancer biomarkers to develop companion diagnostics (CDx’s) to be used with future targeted therapeutics is very challenging. An article in the November 15 issue of Genetic Engineering and Biotechnology News, called Traversing the Cancer Biomarker Labyrinth, by Kathy Liszewski, is a very interesting read.

Apparently progress in this field has slowed in finding clinically useful biomarkers for diagnostics and making other tests that guide doctors for disease prognosis and prediction. Researchers are using a variety of reductionist technical approaches that range from analysis of certain glycans, key microRNAs, and epigenetic changes, to big data analysis of massive data stores of genomic data to tease out more clues to what is going on in cancers.

Scientists seek to develop early detection blood tests that can detect cancers of interest.  Such a blood test could be considered a ‘liquid biopsy’ and might include a panel of a dozen or more miRNAs that represent a biomarker signature.  An oncologist might one day be enabled to quickly screen certain patients with a blood test that would help them diagnose, stage or predict the potential outcome of a cancer.

Ebola, Tekmira Pharma, Highlight SF BIO Investor Forum Meeting

San Francisco, The Palace Hotel, BIO Investor Forum meeting, Tues. Oct. 7, 2014. The annual BIO Investor Forum opened its meeting at midday with welcome remarks and a program change that included new information about the urgent subject about healthcare developments in Ebola among other topics. The welcome remarks featured a short discussion with Tekmira Pharmaceuticals’ CEO, Dr. Mark Murray PhD about his firm’s involvement in this fast moving healthcare area. Dr. Murray touched on the fact that Tekmira is working on a promising early stage antiviral drug to treat patients infected by the ebola virus. More details would follow at his afternoon investor talk

Dr. Murray said in his afternoon investor talk that Tekmira Pharmaceuticals uses an RNA interference based therapeutic in their ebola drug development program.  RNA interference (RNAi) is a naturally occurring internal cellular process that shuts down the production of targeted proteins. Dr. Mark Murray also talked about Tekmira’s drug therapy developments in nine clinical programs underway.  He said that Tekmira can trigger RNAi, but needs a delivery technology that uses the LNP-RNAi trigger mechanism.  They are working on the TKM-PLK1, TKM-H8v, TKM-ebola drug programs.  The firm is using the FDA orphan drug rare disease designation for HTG, GSD4 and so on. Their Lipid NanoParticle (LNP) partner, is Anylum, using their ALN-TTR02 platform.

Tekmira has nine products in its clinical pipeline. Dr. Murray said that its lead products include two antiviral programs.  The TKM-HBV is being developed to treat Hepatitis B and is being readied for sometime in 2015. The TKM-Ebola program is in phase 1 clinical testing.  The FDA gave Tekmira a‘Fast track’ designation for the program.  Dr. Murray added that the product formulation gave a very high survival result in animal testing using monkeys.  Tekmira will work with the World Health Organization (WHO) in the West African region for its ebola drug human clinical testing program.

Oncology product programs. The TEK-PLK1 product acts on pololukekine-1, which is found in many tumor types, usually ones linked to poor outcomes.  The tumor types include GI neuroendochrine tumor and adenocortico cancer.

Rare disease program. Hyper trigliceridemia. The condition leads to pancreatitis.  GSD glycogen is a rare condition.

Financials. Tekmira Pharmaceuticals (TKMR) is a public stock company located in Toronto, Canada, is on the NASDAQ stock Exchange and has a $528Million market cap.

Drug Program Status.

  • 2014    PLK1 Phase I/II
  • 2015    Follow on of clinic activity.

Dr. Murray concluded his talk by saying that for further information go to the company website at ir@tekmira.com.

Several hundred investors and presenting company officials gathered at this year’s BIO Investor Forum meeting for one-on-one partnering meetings, 128 company presentations, plenary informational talks, workshops and networking.

 

Growing Ebola Outbreak in West Africa Fosters Urgent Need for More Drugs and Tests to Help

A man who recently returned from west Africa to Dallas, Texas yesterday was admitted to a hospital there sick from Ebola. He is the first US case of a tourist to be infected by the deadly disease. The CDC confirmed his diagnosis. The newswires are abuzz about how this man traveled from Africa on a commercial airliner to the US while infected with the Ebola virus.

This story follows the two Ebola infected US doctors who were airlifted in a specially equipped airplane to an Atlanta hospital where they were treated and recovered. This Ebola outbreak is the largest one since it was discovered in 1976 in the Congo.

Since the Ebola cases double every 21 days, public health experts estimate that there might be 300,000 to 500,000 cases in west Africa by year-end and perhaps a million cases by mid-January 2015. The US has committed 3,000 troops to the area to provide supportive care to the decimated health care workforce.

Several drug companies have developed experimental drugs and vaccines that are in clinical trials that may be fast tracked to African patients a some point in the future.

  • Mapp Biopharmaceutical of Sorrento Mesa –ZMapp serum
  • Newlink Genetics Corp.  Earlier in the month, FDA gave it the OK Phase clinical trial for its Ebola vaccine.
  • Sarepta Therapeutics Inc. Sarepta is developing a treatment designated AVI-7537 to treat the Ebola virus.
  • GlaxoSmithKline PLC .Glaxo is working with the National Institutes of Health’s Vaccine Research Center to help develop of an early stage vaccine for Ebola.
  • Tekmira Pharmaceuticals Inc. TKM-Ebola is in Phase 1, clinical trials.

Achillion vs. Actelion More Biotech M&A’s to Come

Last week’s announcement by Swiss drug maker, Roche Holding AG, that it was buying biotech firm InterMune, Inc. for $8.3 billlion sparked speculation by industry watchers about who would be the biotechs that might be involved in the next round of M&As. InterMune makes a drug, Esbriet (pirefnidone) that treats a lung condition, idiopathic pulmonary fibrosis. Esbriet is approved in Canada and Europe. The drug has the potential to become a blockbuster seller. InterMune’s product would join Roche’s Pulmozyme and Xolair to build up its lung drug portfolio.

A number of names popped up such as Achillion Pharamaceuticals, Actelion, Puma Biotechnology, Intercept Pharmaceuticals, and others. Maybe people heard Achillian but were attracted to similar sounding Actelion.

  • Achillion Pharamaceuticals makes Phase II hepatitis C virus (:HCV) candidate, ACH-3102.
  • Puma Biotechnology is developing its Phase III breast cancer candidate neratinib, PB272.
  • Intercept Pharmaceuticals makes its phase II nonalcoholic steatohepatitis drug, obeticholic acid, OCA.
  • Actelion Pharmaceuticals makes a cancer drug to treat a rare form of non-Hodgekin’s lymphoma.

Some in the big pharma side are still holding out hopes of buying a biotech that can make their next blockbuster. So which will it be? Achillion? Actelion? Others? To be sure, we will need wait and see.

Acute Need for Early Warning Dx for “Silent Killer” Cancers

There is a need for early warning diagnostics to detect “silent killer” cancers such as pancreatic, liver, GI and lung cancers. Most of these cancers are discovered at the late stage when acute symptoms appear and no cure is possible.  Maybe an annual simple screening test could be developed that could accurately detect a molecular signature of these cancers.

It is a very sad situation indeed to see patients die just after two, four or six weeks post-diagnosis.  Just this past weekend, our co-writer and industry analyst for this blog and our market research firm succumbed to an aggressive cancer of unknown primary origin that spread to the liver.  She died in less than five weeks from diagnosis.  The FDG- PET CT scan showed active cancers in the liver, pancreas, uterus and breast. Ultimately the oncologist concluded that the cancer likely came from the pancreas. May she rest in peace.

Close relatives interested in getting a PET scan for themselves were advised that the Radiology Dept. would only offer a PET scan after a patient was already diagnosed to have cancer.  Whereas a PET scan is good at detecting cancer, it is a very expensive resource that hospitals choose to limit access to.

What is needed is an annual pre-symptomatic, accurate, low-cost multiple-molecular-marker, blood test that can screen for cancer at the earliest point – before a tumor is formed. The screening test would likely use a panel of biomarkers associated with the “silent cancers.”

British Tech Network and New Products at MacWorld/iWorld 2014

SAN FRANCISCO (HighTech Reports), Moscone North, March 27, 2014 – MacWorld/ iWorld 2014. We watched a panel discussion session at the Second Stage presented by the British Tech Network (BTN) with speaker Paul Wheatley, User Experience Consultant and Host at the BTN. Paul and the panelists talked about the pros and cons of a bigger screen on the current or future iPhone, among other topics. He said that consumers are buying bigger iPhones, but the panel still preferred iPhones with smaller screens because they fit better in men’s pants pockets.

The panelists also talked about two interesting new products that they saw at the expo, BearExtender Edge and the Ring. The BearExtender Edge is long range Wi-Fi repeater/ booster that works with Macs, iPad/iPhone, and other devices (PCs with Wi-FI, other phones or tablets with Wi-Fi). The one-piece Wi-Fi repeater block plugs into an AC outlet and has an antenna that repeats/ boosts the Wi-Fi signal in the area. It does not require software or USB connector.  BearExtender also makes a high power standalone USB Wi-Fi radio adapter with an external antenna that increases the range of a Mac’s Wi-Fi signal by nearly four times that of an internal AirPort card. It adds Wi-Fi to older Macs or Windows PCs that do not have a built-in Wi-Fi adapter.

Paul and the panel were very intrigued by a new product called the Ring from Logbar, Inc., a San Carlos, California-based company.  It is a wearable technology product that fits on a finger as a finger ring.  The new Kickstarter funded device transmits hand movements or gestures to an iPhone or other Bluetooth enabled devices. The Ring works as an in-the-air pointing device that drew a largish crowd around its booth. A spokesperson from the Asian firm that is making the device suggested that the Ring is still in beta-test.

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