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Very interesting. Thanks for sharing jbog!
Thanks! Looking forward to MDGL data in the meantime.
Has anyone done rough estimates for when VK2809 data might be available in Q1 (Jan or Feb or March) based on trial length, and enrollment start and finish dates from PRs? Thanks
Agreed!
Discovery of Second “Don’t Eat Me” Signal May Lead to Tighter Cancer Immunotherapy
https://genengnews.com/gen-news-highlights/discovery-of-second-dont-eat-me-signal-may-lead-to-tighter-cancer-immunotherapy/81255213
Tax Changes for Overseas Cash Could Ripple Through Markets
https://www.wsj.com/amp/articles/tax-changes-for-overseas-cash-could-ripple-through-markets-1512222877
A tax break for repatriations could distort currency markets and squeeze funding for firms that benefit from the money held abroad
...
[pay wall]
We’re Going to Need More Lithium
https://www.bloomberg.com/graphics/2017-lithium-battery-future/
- There’s plenty in the ground to meet the needs of an electric car future, but not enough mines.
Starting about two years ago, fears of a lithium shortage almost tripled prices for the metal, to more than $20,000 a ton, in just 10 months. The cause was a spike in the market for electric vehicles, which were suddenly competing with laptops and smartphones for lithium ion batteries. Demand for the metal won’t slacken anytime soon—on the contrary, electric car production is expected to increase more than thirtyfold by 2030, according to Bloomberg New Energy Finance.
[OT](Saudi Aramco IPO) Why Saudi Prince bin Talal's 'friends' have abandoned him
https://www.cnbc.com/amp/2017/12/01/why-saudi-prince-bin-talals-friends-havent-protested-his-arrest-commentary.html
You are correct. I should have looked at the SEC filing (with the details) instead of the blank iHub news blurb. Would have avoided the speculation that way.
KITE filed one a month before BO by GILD for what it’s worth. But it could just be for a future collaboration and not a BO. Anyway, something is coming soon, IMO. Maybe we’ll find out in January.
ONCS—Confidential Treatment Order filed this afternoon.
http://ih.advfn.com/p.php?pid=nmona&article=76213310&adw=1126416
Why Companies File SEC CTO Requests
https://www.benzinga.com/node/8847394
FWIW, in the case of ICPT, the CTO was accompanied by BO rumor.
Confidential Treatment Order
https://ih.advfn.com/p.php?pid=nmona&article=76213310
And for people (like me :) who are looking to re-enter some stocks (VKTX included). Expect more volatility if the president resigns in coming weeks.
I think the new FDA rules, if implemented, may help potential PIIM trials in solid tumors advance quickly. This is good from not only ONCS’ perspective, but even from a potential acquirer’s perspective, hypothetically speaking, as they can see an ROI sooner, if they ever acquire ONCS. This will be good for the industry overall.
For the patients, it might be 50-50 as there will definitely be some good treatments that will get approved fast and there will also be some bad ones that sneak through.
Robots May Steal As Many As 800 Million Jobs in the Next 13 Years
http://fortune.com/2017/11/29/robots-automation-replace-jobs-mckinsey-report-800-million/
Thanks for sharing this Pazzo!
Hschlauch, would love to read your take on this and how it compares wrt to ONCS’ data. I know you have already compared them once before, I know which post. Just curious if there’s anything new here. Thanks!
Could it be JNCE?
Jounce nabs first big deal in $2.6B I/O tie-up with Celgene
https://www.fiercebiotech.com/biotech/jounce-nabs-first-big-deal-2-6b-i-o-tie-up-celgene
FDA Aims to Expand Early-Approval Program for Promising Drugs
https://www.bloomberg.com/news/articles/2017-11-30/fda-aims-to-expand-early-approval-program-for-promising-drugs
Commissioner proposes approval based on early, small trials
...The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.
Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.
The FDA is now looking at ways to conditionally approve an experimental drug if it shows increased survival in early trials in a small number of patients, Gottlieb said.
Typically, early trials are used to determine how best to craft larger studies and aren’t used for approval. But Gottlieb wants early trials to be used for approval if they show an outsized survival benefit. Any drug cleared based on early-trial data would later have to be proven in larger trials to maintain the benefit.
Gottlieb was speaking before the House Energy and Commerce Committee’s health panel on the FDA’s implementation of the 21st Century Cures Act, a bill passed last year that is meant to accelerate development of new pharmaceuticals. The commissioner has also tried to boost competition and ease drug development in an effort to lower prices.
Earlier this year, the FDA said it would update policies to help drugmakers gain approval of treatments targeting specific gene mutations that can spur tumors. Makers of cancer drugs are increasingly embracing such genetic therapies, compared to the traditional manner of identifying cancers by the affected body part, such as the lung, breast or kidney.
FDA Aims to Expand Early-Approval Program for Promising Drugs
https://www.bloomberg.com/news/articles/2017-11-30/fda-aims-to-expand-early-approval-program-for-promising-drugs
Commissioner proposes approval based on early, small trials
Scott Gottlieb speaks before House subcommittee on health
INCY for example has 211M shares outstanding.
Warrants increase fully diluted OS. That’s a given. The number is still small if you compare to other biotechs that are trading much higher. Anyway, if ONCS is ever to be bought out, we will need to use this number in the denominator.
FYI...
at ISI, $CELG says 'theoretically possible' for them to acquire some of currently ptnr'd/licensed assets...but depends on many factors
at ISI, $CELG says 'theoretically possible' for them to acquire some of currently ptnr'd/licensed assets...but depends on many factors
— zach (@zbiotech) November 30, 2017
Will have to wait and see, if they make any changes at all, and what it could mean for ONCS, for example, if Pisces gets AA, what would the prospects for another combo look in terms of approval. Still a lot of details and time needed but nevertheless a right step forward for biotech.
Gottlieb: FDA working on a proposal for cancer drugs already approved for one indication where approval for a suppl. app., for 2nd indication can sometimes rely on a more targeted data set, like a single-arm study. Guidance coming to clarify circumstances when appropriate.
Gottlieb: FDA working on a proposal for cancer drugs already approved for one indication where approval for a suppl. app., for 2nd indication can sometimes rely on a more targeted data set, like a single-arm study. Guidance coming to clarify circumstances when appropriate.
— Zach Brennan (@ZacharyBrennan) November 30, 2017
Gottlieb: FDA working on a proposal for cancer drugs already approved for one indication where approval for a suppl. app., for 2nd indication can sometimes rely on a more targeted data set, like a single-arm study. Guidance coming to clarify circumstances when appropriate.
Gottlieb: FDA working on a proposal for cancer drugs already approved for one indication where approval for a suppl. app., for 2nd indication can sometimes rely on a more targeted data set, like a single-arm study. Guidance coming to clarify circumstances when appropriate.
— Zach Brennan (@ZacharyBrennan) November 30, 2017
This robot aced an exam without understanding a thing—here's why you should be worried
https://www.cnbc.com/2017/11/30/this-robot-aced-an-exam-without-understanding-a-thing.html
Novo Nordisk CSO warns NASH market will develop slowly, urges all to 'moderate expectations'
https://www.thepharmaletter.com/article/novo-nordisk-cso-warns-nash-market-will-develop-slowly-urges-all-to-moderate-expectations
Professor Thomsen says the area has been "very much hyped over the past year, with almost all major pharmacos investing in biotech firms that have one or more candidate in development."
"It's a market that doesn't exist, but everybody thinks that it will be a huge market, so we've seen dealmaking as if there were no tomorrow."
"We are still lacking the right way of diagnosing the disease - people have to take liver biopsies to make a diagnosis and most patients are not willing to do this because it's risky."
"So, it's an example of an area that becomes 'sexy' and 'hot' but we all need to moderate our expectations and just follow the usual way, where things take time."
As well as the potential need for biotechs to partner with diagnostics firms to solve this problem, Professor Thomsen cautions that any potential therapy for NASH, a new disease area, will face market access hurdles as companies will have to "convince payers that you can treat patients for five years to avoid sclerosis and liver transplantation."
[OT] Federal Reserve starting to think about its own digital currency, Dudley says
https://www.cnbc.com/2017/11/29/federal-reserve-starting-to-think-about-its-own-digital-currency-dudley-says.html
Promising New Cancer Immunotherapies Have Arrived—But Not For Everyone
https://www.wired.com/story/cancer-immunotherapy-has-arrived-but-not-for-everyone
When immunotherapy works, it really works. But not for every kind of cancer, and not for every patient—not even, it turns out, for the majority of them. “The reality is immunotherapy is incredibly valuable for the people who can actually benefit from it, but there are far more people out there who don’t benefit at all”...
...
Merck and Bristol-Myers Squibb have dominated this first wave of immunotherapy, selling almost $9 billion worth of checkpoint inhibitors since they went on sale in 2015. Roche, AstraZeneca, Novartis, Eli Lilly, Abbvie, and Regeneron have all since jumped in the game, spending billions on acquiring biotech startups and beefing up in-house pipelines. And 800 clinical trials involving a checkpoint inhibitor are currently underway in the US, compared with about 200 in 2015. “This is not sustainable,” Genentech VP of cancer immunology Ira Mellman told the audience at last year’s annual meeting of the Society for Immunotherapy of Cancer. With so many trials, he said, the industry was throwing every checkpoint inhibitor combination at the wall just to see what would stick.
You are most welcome!
Industry Pulse: New drugs and the search for growth
https://www.biopharmadive.com/news/industry-pulse-new-drugs-and-the-search-for-growth/
$RHHBY $NVS $GSK $LLY $BIIB $CELG $ABBV
Can’t say for that drop but when Adam Feuerstein wrote the article comparing the two companies’ data and said they were similar, INCY was around $105. The drop from that point onwards could be attributable perhaps.
Will tiny $ONCS break out with promising melanoma immunotherapy study results? https://t.co/L0I2NmuFyv $INCY #SITC2017
— Adam Feuerstein ✡️ (@adamfeuerstein) November 8, 2017
Similar results, so investors — besotted by all things cancer immunotherapy — must be equally enthusiastic about OncoSec and Incyte, right?
Nope, not even close. Incyte carries a $23 billion market value, with the still-unapproved epacadostat accounting for approximately half of that. OncoSec’s total market value: a microscopic $40 million. Shares of OncoSec closed Tuesday at $1.25.
Investors have largely ignored OncoSec’s approach to boosting patients’ response rates to cancer immunotherapy, but that might start to change with the updated data being presented Wednesday at the Society of Immunotherapy for Cancer (SITC) annual meeting.
My thoughts one major competition to watch out for INCY in 2018
Will be interesting to see if $ONCS beats $INCY’s CR *again* (38% vs 11%) with upcoming PISCES readout in mid 2018. Same with duration of response and safety profile. 2018 will be an interesting year indeed.
— Titan V (@titan_v16) November 28, 2017
Definitely. With the internal applicator and Genesis, more visceral tumors can be accessible for in situ electroporation. I think as hschlauch suggests we could see a slew of new clinical trials with the PIIM construct in the near future.
This is the German Merck (KGaA) btw and is not connected to the American MRK and Keytruda.
EP Vantage—I/O combos—What will be hot in 2018?
$INCY $BMY $MRK $ARRY
https://twitter.com/epvantage/status/935542810983452672
[OT] The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm586505.htm
Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.
Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications. The FDA has received a report that one patient taking high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.
ONCS Expands Intellectual Property Estate, Announces Issuance of Patents for ImmunoPulse® Platform
https://finance.yahoo.com/news/oncosec-expands-intellectual-property-estate-130000992.html
The first patent, JP06174632, encompasses a device for post-resection electroporation ("EP") delivery of an agent (including nucleic acids) to prevent recurrence of resected tumors and expires in 2030. The patent family was added to the Company's portfolio as part of a 2011 asset purchase agreement.
The second patent, US 9,610,634, adds to the ImmunoPulse® IL-12 portfolio, and includes coverage for reducing tumor angiogenesis while increasing T cell proliferation by the EP delivery of plasmid encoded IL-12. The second patent expires in 2025.
"OncoSec is continuing to build a broad portfolio of patent assets encompassing compositions of matter and methods of use across diverse oncology applications with compelling unmet needs," said Daniel J. O'Connor, Chief Executive Officer of OncoSec. "We are pleased with the progress of the ongoing PISCES/KEYNOTE-695 clinical trial which benefits, in part, from the second issued patent."