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An interesting article from Eric Topol that summarizes the history of the Corona Virus's evolution under selection pressure from vaccines and how this evolution has greatly reduced the effectiveness of these vaccines against the latest variants.
A potent SARS-CoV-2 neutralising nanobody shows therapeutic efficacy in the Syrian golden hamster model of COVID-19
Abstract
SARS-CoV-2 remains a global threat to human health particularly as escape mutants emerge. There is an unmet need for effective treatments against COVID-19 for which neutralizing single domain antibodies (nanobodies) have significant potential. Their small size and stability mean that nanobodies are compatible with respiratory administration. We report four nanobodies (C5, H3, C1, F2) engineered as homotrimers with pmolar affinity for the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. Crystal structures show C5 and H3 overlap the ACE2 epitope, whilst C1 and F2 bind to a different epitope. Cryo Electron Microscopy shows C5 binding results in an all down arrangement of the Spike protein. C1, H3 and C5 all neutralize the Victoria strain, and the highly transmissible Alpha (B.1.1.7 first identified in Kent, UK) strain and C1 also neutralizes the Beta (B.1.35, first identified in South Africa). Administration of C5-trimer via the respiratory route showed potent therapeutic efficacy in the Syrian hamster model of COVID-19 and separately, effective prophylaxis. The molecule was similarly potent by intraperitoneal injection.
...
We have isolated four nanobodies that bind different epitopes on the receptor binding domain (RBD) of the SARS-CoV-2 spike (S) glycoprotein with high affinity and potently neutralise the virus in vitro with picomolar potency. We have explored their binding to and neutralisation of two newly emergent variants (B.1.1.7 and B.1.351), identifying a potent cross-reactive agent. We have shown that treatment either systemically (intraperitoneal route) or via the respiratory tract (intranasal route) with a single dose of the most potent nanobody prevented disease progression in the Syrian hamster model of COVID-19.
https://www.nature.com/articles/s41467-021-25480-z
From The Washington Post:
Why young people are using preventive Botox, and what they need to know
Story in today's email on The Atlantic Daily list
America Is About to Go Botox Wild
An article by the South China Morning Post that echos one of Dew's frequent warnings
“[Abbreviated message] links fail in the iHub app but work from a browser.”
This problem looks to be fixed, at least for my iPhone and iPad.
Do you know if that is a record?
Could you please provide references to this literature? Thank you.
Tyme Technologies (TYME) is touting updated survival results from its P2 open-label study of SM-88 "in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred After/on First Line Chemotherapy". TYME favorably contrast the study's current median overall survival of 6.4 months with the historic OS for this patient population of around 2 months. I note, however, that an inclusion requirement for the trial is "life expectancy >3 months, in the judgment of the investigator." Also note that only 38 of 49 patients were included included in the analysis on a per-protocol basis.
From a PR: "Based on these results, TYME plans to initiate a randomized pivotal trial for use of SM-88 in patients with pancreatic cancer in Q3’2019." And from an ESMO poster: "920 mg/day dose has been selected for further evaluation in anticipated future SM-88 pancreatic pivotal registrational trials."
Other than humans and rats I cannot think of any species that has worldwide distribution. There are species isolated to specific areas of the planet where they have been greatly reduced or eliminated, such as passenger pigeon, buffalo, some large predators.
“DMA.V/DMAC sells 4.1M shares @$4.00 in US IPO”
This looks like another underfunded quasi-Canadian biotech. It has been listed on the TSX Venture exchange for years, and this offering came as a 48% discount to its last close TSXV close.
This PR lists five "primary investors" in the project but no percentage breakdown:
https://www.cbc.ca/news/canada/british-columbia/kitimat-lng-canada-1.4845831
Dr. Vincent Picozzi, Director of the Pancreas Center of Excellence at Virginia Mason Medical Center in Seattle and a principle investigator for the trial stated, “This protocol has generated more interest and excitement among patients with pancreatic cancer than any I have ever seen."
He should get out of his office more often.
Re: JAK inhibitors associated with increased risk of lymphoma
The article in Blood is less definitive than that news report. See page 13 of the PDF of the article:
“ I have only $1600 (100 sh * $20 = $2000 - $400 tax) to
buy stock B. “
In this calculation you are also paying tax on the the original investment.
Fake News is invading iHub.
The TYME website has not improved since I looked at in March: vague statements on what the compound does and how it works.
AACR 2017: LifeSci Capital is publishing its notes for AACR 2017 presentation (links below). Their notes may be useful for comparison with your own notes. Be sure to read the Disclosures at the end of the articles.
Notes for the first three days
1. https://lifesci.bluematrix.com/sellside/EmailDocViewer?encrypt=fede41f7-e830-41b8-b4e5-7a3ea4219fc1&mime=pdf&co=Lifesci
2. https://lifesci.bluematrix.com/sellside/EmailDocViewer?encrypt=73fb7ee6-c6e2-40b1-9fe0-ed86aef0ef3b&mime=pdf&co=Lifesci
3. https://lifesci.bluematrix.com/sellside/EmailDocViewer?encrypt=0b12fb8b-b51e-4e42-bb95-a1f0ea68d6d4&mime=pdf&co=Lifesci
TYMI
A quick look at their website does not show much useful information.
Two SEC filings contain the following excerpts:
FORM 10-Q
December 31, 2016
Tyme Tech was incorporated in the State of Florida on November 22, 2011, to engage in the business of producing, marketing and selling an ultra-premium vodka product to retailers. Management determined to cease the ultra-premium vodka business and attempt to acquire other assets or business operations that would maximize shareholder value. Effective as of September 18, 2014, the Company (then constituting a Florida corporation with the name Global Group Enterprises Corp.) reincorporated in the State of Delaware by merging into its wholly-owned Delaware subsidiary, Tyme Technologies, Inc., which was formed on August 22, 2014 specifically for this purpose (the “Reincorporation”). Tyme Technologies, Inc. was the surviving corporation in such merger.
On March 5, 2015, Tyme Tech consummated a reverse triangular merger with Tyme (the “Merger”). The Merger resulted in Tyme becoming a wholly-owned subsidiary of Tyme Tech. Tyme is a clinical-stage biopharmaceutical company focused on the development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications for humans. Tyme was incorporated in Delaware in 2013 and its operations to date have been directed primarily toward developing business strategies, research and development activities and preparing for clinical trials for human oncologic product candidates.
During the fourth quarter of calendar 2015, the Company’s Investigational New Drug Application for its SM-88 drug candidate for breast cancer patients (the “IND”) was accepted by the United States Food and Drug Administration (the “FDA”). Subsequent to the FDA’s acceptance of our IND for SM-88 and approval of our clinical trial for breast cancer, we made a determination, based on input from various sources and the strong interest of several clinical sites, to prioritize our clinical trial objectives by initiating a study in prostate cancer. On June 13, 2016, we announced that we have begun recruiting for a phase Ib/II clinical trial, using our proprietary compound, SM-88, to use in human prostate cancer. We are also evaluating protocols for clinical studies of SM-88 in pancreatic cancer.
AMENDMENT NO. 3 ON FORM S-1 TO FORM S-3 REGISTRATION STATEMENT
September 9 , 2016
SM-88 is a novel combination of a proprietary novel molecule with three currently-marketed drugs that are generally considered safe for their already approved indications, which are in areas other than cancer treatment. We believe that SM-88 is capable of synergistically targeting the unique metabolic features of cancer cells and selectively altering the susceptibility of cancer cells to oxidative stress. This selectivity is underscored by evidence indicating that, to date, the SM-88 drug combination drug candidate has been shown to be nontoxic to noncancerous cells, unlike most current anticancer drugs and treatments. SM-88’s therapeutic potential is based on its ability to increase the availability of free radicals at the cancer site and promote their entry into the cell by stripping the cancer cells of their normal barriers to these toxic electrons. The active components of SM-88 are all administered in low doses.
We believe, based on SM-88’s mechanism of action and proof-of-concept clinical data, that our drug may ultimately improve overall response rates, clinical outcomes and survival rates in cancer patients. Based on its novel proposed mechanism of action and the factors described below, SM-88 may prove particularly beneficial to cancer patients who have relapsed following traditional cancer therapies.
SM-88 is designed to penetrate only living cancer cells, where it introduces multiple mechanisms to kill cancer cells without toxic effects and without involving healthy body tissue. Based upon preliminary data and responses from a phase I clinical trial study and IRB compassionate care studies, we believe that the mechanism of action for SM-88 may induce the transfer of electrons in cancer cells that allow catalyzed external free radicals to react and stress the cancer cells, creating an engineered metabolic response that results in decreased mucin and decreased defense to reactive oxygen.
Baker Brothers selling all or a big chunk of their holdings:
http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1hSFIwY0RvdkwyRndhUzUwWlc1cmQybDZZWEprTG1OdmJTOWtiM2R1Ykc5aFpDNXdhSEEvWVdOMGFXOXVQVkJFUmlacGNHRm5aVDB4TVRRMk1UYzROU1p6ZFdKemFXUTlOVGM9JnR5cGU9MiZmbj1JbmN5dGVDb3Jwb3JhdGlvbl80MjRCN18yMDE3MDMxMC5wZGY=
Jbog, This is not the Canada in which I live; here medical care is under Provincial jurisdiction. The Federal Government has agreements with the Provinces to provide some funding for medical care, but there is no Canada wide pharmaceutical coverage. So Provinces bargain individually with pharmaceutical companies. There are rumours that the Provinces might organize and create a joint bargaining team for pharmaceuticals, but so far no. What you describe looks like something the Federal Government might offer to its employees or Federal officials.
Yesterday LifeSci Capital put out a report on ADXS with some useful information. It is available here
GNRO.PA:
LifeSci Capital released a report on GeNeuro SA (GNRO.PA), which recently had an IPO. See the full report. The material for this post was obtained from LSC's report and from the company's web site.
The company is developing treatments for neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing putative causal factors that are encoded by human endogenous retroviruses (HERV). MSRV-Env is an HERV genetic element that is normally unexpressed in people but often expressed in multiple sclerosis (MS). GNRO's first product, GNbAC1, is a monoclonal antibody against this protein. GNRO "reported positive data from a P2a trial that tested the safety, tolerability, and pharmacokinetics of GNbAC1 in 10 MS patients. GNbAC1 was found to be safe and well-tolerated and showed no signs of immunogenicity or broad immunosuppression. In addition, although the sample size in this study was small, the trial did show a slowing of disability progression" (LSC's report).
GNRO has a partnership with Servier that covers the use of GNbAC1 to treat MS. Servier is providing €37.5 million ($42.4 million) to finance the Phase IIb trial and has an option to license GNbAC1 after the trial's completion. Following the exercise of this option, Servier would cover the cost of Phase III development. GNRO has full rights in the US, which represents about two-thirds of the MS market, as well as Japan. GNRO also has full rights to develop GNbAC1 in other indications, and Servier has right of first negotiation within its territories. GNRO can receive up to €325 million ($366 million) in development and sales milestone payments as well as tiered royalties.
IPO on 14 April 2016 netted €29.4 M from 2,538,500 shares sold @ €13.00
July 18 GNRO reported cash and revenue for Q2 2016
- Cash: €42.4 million at 30 June 2016
- Revenue: €2.5 million in Q2
Upcoming events:
- Presentation at Rodman & Renshaw’s 18th Annual Healthcare Conference, September 11 to 13 in New York.
- First half 2016 results: Thursday 29 September 2016 (after trading hours)
near-term milestones
- H2 2016 – start P2a POC for GNbAC1 in type 1 diabetes.
- 2017 – Completion of enrolment for P2b in MS.
- Q4 2017 – Preliminary results from CHANGE MS P2b in RRMS.
Comment: The MSRV-Env hypothesis for MS is reminiscent of the amyloid hypothesis for Alzheimer's: correlation might mean causation. Trials, however, might be easier for GNRO.
Disclosure: I have no position and no plan to start one this year. And I have no connection with LSC or GNRO.
ONCY: I see an F has been appended to the trading symbol. I suggest that ONCY is the Canadian equivalent of PPHM. But it has been a great gig for Brad Thompson. I admit to being a shareholder who exited in 2005.
This article from The Guardian has more balance and context than the four points picked by the author of the SA article: http://www.theguardian.com/environment/2015/sep/30/no-long-term-future-in-tar-sands-alberta-rachel-notley
The so-called socialist parties in Canada tend to be pragmatic.
Two paragraphs from the Guardian article highlight the attitudes of the Provincial Premier and the Federal Prime Minister
Peter, this is the last paragraph of AKBA's description of their HIF technology (http://akebia.com/hif-technology/) ...
Deleted message, wrong forum
It wasn't a direct route from Canada to Merck
"maybe we have 14 million with amd?"
This link has several graphs of prevalence and percentages by groups:
https://www.nei.nih.gov/eyedata/amd
In 2010 the US had around 2M with AMD.
"it was a joke"
That was obvious on reading it; my response was in kind.
Adam did pass on reports from his hedge-fund buddies about serious AEs with ARIA's Ponatinib well before the market knew about them.