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How hype fails cancer patients—Vinay Prasad
https://twitter.com/vinayprasadmd/status/982295472197939200?s=21
What % of the market do you think is normal or necessary in p1 safety studies of this type?
I agree. Any mention of a collaborator may be good for the SP. I’m just setting myself up to be surprised with low expectations now than be disappointed.
BTW just thinking out loud, if the stock pops on AACR, they might raise. They have quite a few trials planned for 2018. So if they do, given Pisces interim data will be only a few months away, the offering may be oversubscribed. Have seen oversubscribed offerings with two stocks that I owned in the last 6 months, also with one that I didn’t own recently, where the stock was down only the day the offering was announced and it went higher than offering price in the days that followed. So don’t despair if they announce an offering post AACR. All just my opinion of course!
AACR April 15. They are releasing full data from a tiny phase 1 TNBC pilot study. 2 of the 5* patients in the trial who were heavily treated with chemotherapy and failed, were treated with Opdivo after EP IL-12 and showed “robust objective response.” So will be interesting to see if they were PR/CR etc. After AACR oral poster they have a webcast in the evening to discuss new p2 combo trial in TNBC. Details of the trial may or may not move the needle.
* January PR on TNBC patients started describing the data with “To date...” I’m curious if they will have more patient (max 10 so 5 more) data at AACR. Also if it is just 5, were the remaining 3 being treated with Opdivo as well back in Jan and will they share new data from these *potential* combo patients at AACR is another question. All in all, it’s a tiny trial and I wouldn’t get my hopes too high. PISCES will be make or break for ONCS IMO.
Slightly dated but relevant article on the same topic:
What 60 Minutes Got Wrong About Rare Earths And China
https://www.forbes.com/sites/timworstall/2015/03/23/what-60-minutes-got-wrong-about-rare-earths-and-china/amp/
dangerM, jondoeuk, and hschlauch, it’s a pleasure to have you guys discuss scientific facts on the board. Thanks to everyone else as as well for your contributions!
Hope you all have a great weekend!
Should Bristol-Myers panic over Incyte’s skin cancer failure?
https://www.statnews.com/2018/04/06/bristol-myers-incytes-skin-cancer-failure/
The failed skin cancer trial that crushed Incyte and Merck on Friday could be cause for alarm over at Bristol-Myers Squibb, which is running a nearly identical study with two drugs of its own that work the same way.
...
(paywall)
Intratumoral Delivery of Immunotherapy—Act Locally, Think Globally
http://www.jimmunol.org/content/198/1/31
Intratumoral Delivery of Immunotherapy—Act Locally, Think Globally https://t.co/McBEE4Vyg7
— zach (@zbiotech) April 6, 2018
Intratumoral Delivery of Immunotherapy—Act Locally, Think Globally
http://www.jimmunol.org/content/198/1/31
Perhaps lol. Jamie Dimon has also taken his words back. He had once called bitcoin a fraud.
George Soros Prepares to Trade Cryptocurrencies
https://www.bloomberg.com/news/articles/2018-04-06/george-soros-prepares-to-trade-cryptocurrencies-as-prices-plunge
2017 was wild yet majority of market participants were individual investors. Wonder how institutional investors coming into the scene will affect the market. 2H 2018 will be interesting to watch.
Interesting observation from Brad that might be worth keeping in mind:
At yesterday's William Blair conference, $MRK presentation didn't have epacadostat/keytruda in a lung cancer pipeline slide. Katherine Zhu pointed it out to the Merck presenter, and he said it was just a clerical oversight.
At yesterday's William Blair conference, $MRK presentation didn't have epacadostat/keytruda in a lung cancer pipeline slide. Katherine Zhu pointed it out to the Merck presenter, and he said it was just a clerical oversight.
— Brad Loncar (@bradloncar) April 6, 2018
Completely different
INCY Epacadostat + Keytruda fails in p3 melanoma
Evolus touts equal efficacy for its Botox me-too drug in PhIII European/Canadian trials
https://endpts.com/evolus-touts-equal-efficacy-for-its-botox-me-too-drug-in-phiii-european-canadian-trials/
Unity Biotechnology files for an $85 million IPO
https://www.renaissancecapital.com/IPO-Center/News/55866/Unity-Biotechnology-files-for-an-$85-million-IPO
Unity Biotechnology, a preclinical biotech developing therapies for aging-related diseases, filed on Thursday with the SEC to raise up to $85 million in an initial public offering.
The Brisbane, CA-based company was founded in 2009 and booked $1 million in sales for the 12 months ended December 31, 2017. It plans to list on the Nasdaq under the symbol UBX. Goldman Sachs, Morgan Stanley and Citi are the joint bookrunners on the deal. No pricing terms were disclosed.
China, holding Treasuries, keeps 'nuclear option' in U.S. trade war
https://www.reuters.com/article/us-usa-trade-china-treasuries/china-holding-treasuries-keeps-nuclear-option-in-u-s-trade-war-idUSKCN1HB34M
[OT]Geologists now have evidence Africa is physically splitting into two continents
https://qz.com/1244443/scientists-now-have-evidence-africa-is-physically-splitting-into-two-continents/amp/
TENX (+108%) Announces Results of Pre-IND Meeting with FDA for Phase 2 Study of Levosimendan in PH-HFpEF Patients
https://www.businesswire.com/news/home/20180404005151/en/Tenax-Therapeutics-Announces-Results-Pre-IND-Meeting-FDA
Bahrain announces it has discovered 80 billion barrels of oil, which is as much as Russia's oil reserves
https://twitter.com/spectatorindex/status/981489981511249920?s=21
I agree on the need for a larger trial. Just a small observation btw, and I may be reading too much into it, but their January PR started describing the results with “To date...” so I’m just curious if the number of patients who were treated with Nivo will increase by a few more come AACR. Would still be a small sample anyway.
ONCS.
To date, five patients with TNBC have been treated with a single cycle of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation). Two of these five patients were subsequently treated with single agent nivolumab (Opdivo®) - an anti-PD-1 checkpoint inhibitor treatment - as their immediate next therapy. Both of these patients, who were heavily pretreated metastatic TNBC patients with chemotherapy refractory disease, experienced robust objective responses in both ImmunoPulse IL-12 treated and untreated lesions. These clinical observations have prompted the Company to further commit to a more definitive evaluation of the combined therapies.
BMY has made a big bet on IL-2 + Opdivo (with NKTR). Would they be interested in making any kind of bet on IL-12 + Opdivo?
High-flying biotech Loxo tempers bullish view for cancer drug
https://www.reuters.com/article/us-loxo-oncology-testing/high-flying-biotech-loxo-tempers-bullish-view-for-cancer-drug-idUSKCN1HA1BI
In record time, Loxo Oncology (LOXO.O) developed a novel drug for a wide variety of tumors that share a rare mutation. It recently struck a partnership with Germany's Bayer (BAYGn.DE). Its stock tripled in the past year.
But in an unusual move for biotech - where hype is often the norm - its founders are tempering expectations.
They are quick to point out that their task ahead is no small one: Getting doctors and insurers to agree to testing several hundred thousand cancer patients to find the one percent, or less, whose tumor has the mutation its drug targets.
"We're very cautious about this because we understand that for all of these patients to be identified, broad testing across the spectrum of human cancer has to happen," Jacob Van Naarden, Loxo's chief business officer, told Reuters. "It's an exquisitely rare patient population."
Because of its small size and narrow focus, Loxo is among the most dependent on adoption of widespread genomic testing. But they aren't alone. Bigger drugmakers, such as Roche Holding (ROG.S), are also working on treatments that depend on finding a mutation driving many different cancers.
Loxo, founded in 2013, leapt from obscurity last year. The turning point came at a major cancer conference in June, when it released data showing its pill, larotrectinib, shrank tumors significantly in 75 percent of patients with cancer in the lung, pancreas, colon or more than a dozen other locations.
Its stock skyrocketed and the company now has a market valuation more than $3 billion. (For a graphic, see tmsnrt.rs/2Id3kCD)
Loxo's trial tested 55 advanced cancer patients, all of whose tumors had the mutation, TRK fusion. Many had run out of treatment options, while some were children facing limb amputations.
Wall Street analysts expect U.S. approval this year and forecast annual larotrectinib sales reaching $500 million to $1 billion. Bayer, which expects to file for European approval this year, will help bring larotrectinib and a potential successor drug to market in a partnership worth up to $1.6 billion.
With Bayer in charge of pricing, the drug could cost $15,000 a month, said Bernstein analyst Wimal Kapadia.
In interviews at company headquarters in Stamford, Connecticut, Loxo executives addressed the hurdles ahead. For starters, "we don't actually know how many patients there are," Van Naarden said. An estimated 1,500 to 5,000 people may be candidates out of 500,000 U.S. cancer patients diagnosed each year.
To find them, new genomic tests will need to include the TRK fusion defect.
"These drugs will do well as people adopt this testing," said Dr. David Hyman of Memorial Sloan Kettering Cancer Center in New York, who led larotrectinib clinical trials.
But getting doctors and pathologists across the country to order that testing is a significant hurdle.
The U.S. government last month said the Medicare program for the elderly will cover so-called next generation sequencing (NGS) which looks for hundreds of mutations across all solid tumors for advanced cancer patients. Loxo will need TRK fusion to be included in those tests once its drug is approved.
For the moment, private insurers such as Anthem Inc (ANTM.N) and Humana Inc (HUM.N) typically only pay for narrow diagnostic tests for a particular type of cancer.
Given uncertainties around finding the right patients, "we don't think it's a billion-dollar drug," said Loxo Chief Executive Joshua Bilenker. Bayer said it was too soon to predict eventual sales.
GETTING TESTED Until now, cancer drugs that target mutations have been primarily limited to the tumor type against which it was tested. Pfizer Inc's (PFE.N) Xalkori works against ALK and ROS1 mutations in lung cancer. Roche's (ROG.S) Zelboraf treats melanoma with an abnormal BRAF gene.
Merck & Co's (MRK.N) Keytruda was the first cancer drug approved for many tumor types based on a single mutation and will benefit from large scale testing, though that remains a relatively small market for its treatment.
Newer players, such as Loxo, Blueprint Medicines Co (BPMC.O) and Ignyta, recently bought by Roche, target tumor mutations regardless of their organ of origin. This requires far more people to be tested, since such a small number of patients will have the mutations in any one tumor type.
These advanced tests, provided by Foundation Medicine (FMI.O), Thermo Fisher Scientific (TMO.N), Caris Life Sciences, and others, can detect hundreds of mutations from a tiny tissue sample. Testing positive for one of about of dozen of these mutations could directly influence treatment.
While the cost has dropped dramatically, to about $1,000-$1,500 per patient, private insurers argue such comprehensive testing amounts to funding research, not medical care.
Foundation and Thermo said they are talking to private insurers about coverage. Humana and Anthem said they are evaluating their policies following the Medicare decision.
"Reimbursement is a continuous and ongoing battle," said Foundation Chief Medical Officer Vince Miller.
Major cancer centers, which conduct extensive research, use tests that detect hundreds of mutations. But to justify such testing, community hospitals will need know it will identify the patients likely to benefit.
Bayer will reach out to cancer doctors about larotrectinib once it is approved, while Loxo will educate pathology laboratories on the need to test for TRK, Loxo said.
The companies say the cost is worth it since doctors could prescribe a highly effective drug if their patient has the TRK defect instead of more toxic chemotherapy or expensive immunotherapy with a lower probability of working.
"That's an amazing return on investment for the healthcare system," Bilenker said.
GRAPHIC: Loxo Oncology's quick rise tmsnrt.rs/2Id3kCD
ONCS to host research reception after AACR oral poster presentation
https://www.prnewswire.com/news-releases/oncosec-to-host-research-reception-during-the-2018-american-association-of-cancer-research-annual-meeting-300623187.html
They are going to discuss new p2 combo trial in TNBC. Will it be a partnership? The p1 pilot TNBC study had (only) 2/2 patients (out of a total of 5) who showed “robust objective response” after re-treatment with Opdivo. Will be interesting to learn what kind of response (PR/CR) they showed.
You are correct. This is an additional event after the oral poster presentation.
OncoSec to Host Research Reception During the 2018 American Association of Cancer Research Annual Meeting
https://finance.yahoo.com/news/oncosec-host-research-reception-during-120000596.html
Humana, MultiPlan, Optum, Quest Diagnostics and UnitedHealthcare Launch Blockchain-Driven Effort to Tackle Care Provider Data Issues
https://www.businesswire.com/news/home/20180402005181/en/Humana-MultiPlan-Optum-Quest-Diagnostics-UnitedHealthcare-Launch
Five leading health care organizations – Humana (NYSE: HUM), MultiPlan, Quest Diagnostics (NYSE: DGX) and UnitedHealth Group’s (NYSE: UNH) Optum and UnitedHealthcare – today announced that they are launching a pilot program applying blockchain technology to improve data quality and reduce administrative costs associated with changes to health care provider demographic data, a critical, complex and difficult issue facing organizations across the health care system.
The companies will explore how the technology could help ensure the most current health care provider information is available in health plan provider directories. Providing consumers looking for care with accurate information when they need it is essential to a high-functioning overall health care system.
Today, managed care organizations, health systems, physicians, diagnostic information service providers and other health care stakeholders typically maintain separate copies of health care provider data, which can result in time-intensive and expensive reconciliation processes when differences arise. Industry estimates indicate that $2.1 billion is spent annually across the health care system chasing and maintaining provider data.*
The pilot will examine how sharing data across health care organizations on blockchain technology can improve data accuracy, streamline administration and improve access to care.
The pilot will also address the high cost of health care provider data management, testing the premise that administrative costs and data quality can be improved by sharing provider data inputs and changes made by different parties across a blockchain, potentially reducing operational costs while improving data quality.
This isn’t a trend. This isn’t a fad. This is better technology.
HERE WE GO!
— Pomp 🌪 (@APompliano) April 2, 2018
Five large healthcare companies (Humana, MultiPlan, Quest Diagnostics, Optum and UnitedHealthcare) are piloting blockchain technology in effort to make the sharing and storing of data more efficient.
This isn't a trend. This isn't a fad. This is better technology.
Tesla: Robots are killing it
http://www.businessinsider.com/tesla-robots-are-killing-it-2018-3
—Analysts at Bernstein argue that Elon Musk has over-automated Tesla.
—The very robots that Musk says will revolutionize the car industry are baking in Tesla's mistakes and costing far more money than they're worth, they say.
In a rare win for humans over robots in the battle for labor efficiency, Wall Street analysts have laid down a compelling argument that over-automation is to blame for problems at the billionaire Elon Musk's electric-car company.
That is to say, the very innovation and competitive advantage that Musk says he's bringing to the car industry - his nearly fully automated plant in Fremont, California - is the reason Tesla is unable to scale quickly.
According to the Bernstein analysts Max Warburton and Toni Sacconaghi, it's the robots that can't pump out Tesla's highly anticipated Model 3s fast enough. The whole process is too ambitious, risky, and complicated.
"Tesla has tried to hyper-automate final assembly. We believe Tesla has been too ambitious with automation on the Model 3 line. Few have seen it (the plant is off-limits at present), but we know this: Tesla has spent c.2x what a traditional OEM spends per unit on capacity.
"It has ordered huge numbers of Kuka robots. It has not only automated stamping, paint and welding (as most other OEMs do) - it has also tried to automate final assembly (putting parts into the car). It talks of two-level final lines with robots automating parts sequencing. This is where Tesla seems to be facing problems (as well as in welding & battery pack assembly)."
I agree and think their primary focus will be on blockchain applications, not all of which need a cryptocurrency. But some may have use for digital tokens/assets down the line and if economically meaningful, they might use them. Stellar (cryptocurrency) has a partnership with IBM.
In the world of cryptocurrency buzz, blockchain is the real winner
https://www.cnbc.com/2018/01/10/in-the-world-of-cryptocurrency-buzz-blockchain-is-the-real-winner.html
IBM Evolution: Big Blue Is Finally Getting Serious About Cryptocurrency
https://www.coindesk.com/ibm-evolution-big-blue-finally-getting-serious-cryptocurrency/amp/
...Now, it would seem the floodgates are prepared to open, with the $140 billion IBM revealing to CoinDesk that it has been meeting with executives from commodities trading platforms, large corporations, and perhaps most importantly, central banks, to explore how cryptocurrencies can help save them money and generate revenue.
"We're seeing tons of demand for digital asset issuance across the board," said IBM's new head of blockchain development Jesse Lund, who was hired from Wells Fargo earlier this year to help develop the computer giant's cryptocurrency strategy.
But in interview, Lund said IBM is interested in expanding the business applications of cryptocurrencies in a number of ways.
...
ZSAN was pumped to $20+ earlier this month. People who are attracted to low float stocks are learning a painful lesson.
Definitely (eom).
Japan's Takeda weighs bid for drugmaker Shire
https://www.reuters.com/article/us-shire-m-a-takeda-pharma/japans-takeda-considering-approach-for-british-drugmaker-shire-idUSKBN1H4198
EDGE (-85% /PM) Ph3 Study Unlikely To Achieve Primary Efficacy Endpoint; DMC Recommends Discontinuation of Study #FAIL
$EDGE Ph3 Study Unlikely To Achieve Primary Efficacy Endpoint; DMC Recommends Discontinuation of Study #FAIL
— Andy Biotech (@AndyBiotech) March 28, 2018
‘Single biggest change in capital markets, maybe of all time’: China launches oil futures that could topple dollar
http://business.financialpost.com/commodities/energy/update-1-chinese-oil-futures-launch-may-threaten-primacy-of-u-s-dlr-ubs/
IBM Bets Company On Exponential Innovation In AI, Blockchain, And Quantum Computing
https://www.forbes.com/sites/jasonbloomberg/2018/03/22/ibm-bets-company-on-exponential-innovation-in-ai-blockchain-and-quantum-computing/amp/
GS expects gold to 'outperform' amid growing fears of a stock market correction
https://www.cnbc.com/2018/03/26/goldman-sachs-expects-gold-to-outperform-amid-growing-fears-of-a-stock-market-correction.html
—"Our commodities team believes that the dislocation between the gold prices and U.S. rates is here to say," Goldman Sachs analysts, led by Eugene King, said in a research note published Monday.
—Last week, the Federal Reserve approved the widely anticipated quarter-point rate hike to put the new benchmark funds rate at 1.75 percent. Central bankers, led by Jerome Powell in his first meeting as chairman, also hinted the path of rate hikes could be more aggressive.
—Gold prices were trading at $1,347.92 per troy ounce at 1:40 p.m. London time, after hitting its highest level since mid-February earlier in the session.
PTGX (-58%) Discontinues Phase 2b PROPEL Trial of PTG-100 for the Treatment of Ulcerative Colitis following Interim Analysis
https://www.prnewswire.com/news-releases/protagonist-therapeutics-discontinues-phase-2b-propel-trial-of-ptg-100-for-the-treatment-of-ulcerative-colitis-following-interim-analysis-300619191.html
Rare disease biotech Mereo BioPharma files for an $81 million IPO
https://www.renaissancecapital.com/IPO-Center/News/55663/Rare-disease-biotech-Mereo-BioPharma-files-for-an-$81-million-IPO
Mereo BioPharma, which is commercializing a portfolio of rare disease drugs acquired from large pharmas, filed on Friday with the SEC to raise up to $81 million in an initial public offering. It currently trades on the London Stock Exchange under the symbol MPH.
The London, United Kingdom-based company was founded in 2015 and plans to list on the Nasdaq under the symbol MREO. Mereo BioPharma filed confidentially on December 1, 2017. Cowen & Company, BMO Capital Markets and RBC Capital Markets are the joint bookrunners on the deal. No pricing terms were disclosed.