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George S. Kaufman
I agree with all of that.
GLP-1's look like the class could become the biggest selling class of drug with MANY branded versions.
In that, it reminds me of the statins which became the biggest selling class of drug, with 16 branded versions.
OT: In answering your question, I just realized that iHub removed my longstanding avatar photo. He's back now and hopefully will remain undisturbed.
Bonus points if you can ID him.
PS, agreed about Denmark ultimately supporting Wegovy. There's really no reason not to. (Well, except that it might perhaps rub up against their national self-image as that of a nation of fit and trim people.)
For some reason, I never appreciated it until now.
I checked Jim’s X account (@JamesEKrause), and the last time he posted about VKTX was Jun 2023.
OT:
I doubt that obesity is much of a problem in Denmark. When I visited the country, it was easy to spot the Americans in Copenhagen for obvious reasons. But, yes, you'd think they would show some support for their largest company, if only for international PR reasons.
I would argue that the two MoAs are more different than similar. Excision Bio’s approach of editing the cccDNA does not rely on the immune system—or on any host response whatsoever.
Irony? Denmark’s national healthcare system does not reimburse for Wegovy.
No I have procedures that day
I’ll catch the replay
Are you planning to tune in?
re CSU
BPMC has targeted an IND filing this quarter for an oral kit inhibitor for csu
they have an investor day focused on csu/mast cell therapeutics this thursday
https://ir.blueprintmedicines.com/news-releases/news-release-details/blueprint-medicines-host-webcast-and-conference-call
HBV
Reminder that IMCR has a program targeting a functional cure similarly by hitting infected hepatocytes
Here is a PR of some initial clinical data from the program:
https://ir.immunocore.com/news-releases/news-release-details/immunocore-announces-presentation-initial-data-phase-1-immtavr
They are also looking at the drug in HBV infected patients w HCC now
UBX—Beware when a company increases the statistical power of a clinical trial in midstream:
https://www.globenewswire.com/news-release/2024/04/23/2867620/0/en/UNITY-Biotechnology-Announces-Extension-of-Phase-2b-ASPIRE-Clinical-Study-Evaluating-UBX1325-in-DME.html
I know that Biotech Jim has followed MDGL for many years, not sure how he stands on VKTX which has been very strong this year. He has posted here recently and it would be interesting to see his thoughts on this...congrats for your excellent coverage on VKTX.
The fact that new corporate entrants will emerge to challenge the NVO/LLY duopoly means that prices will decline. The market size will still increase because of wider adoption and increased manufacturing capacity.
Most new entrant may have only niche marketability. The degree to which any drug has significant success in this space will be measured by how well in competes with Zepbound for tolerability and weight loss (in that order).This is why I believe VKTX's VK2735 will be a major player.
VKTX- VK2809 in NASH should read out ph2a 52 week biopsy (Fibrosis and NASH Resolution) data very soon. I'm modifying my best guess of when to be tomorrow Wednesday April 24th after the close to coincide with the VKTX earnings release.
Previously Viking readout 12 week top line data that was considerably better than MDGL rezdiffra (resmetirom). I expect VK2809 data to again be better than rezdiffra.
LS. as a follow up . Renvela is also swallowed but most require 2 pills ( fairly large ) with each meal.
OLC ( Lanthanum ) is far more effective at lowering serum pho
https://unicycive.com/wp-content/uploads/2023/05/Renazorb-Phosphate-Binders-Daily-Medication-Volume-Poster.pdf
Kiwi
LS. good question
My wife prescribes a lot of Sevelamer (Renvela® or Renagel®) largely because its what the issuers will cover . Her patients hate the drug and most are nowhere near serum pho goal .
Those who absolutely refuse Sevelamer , she will go thru the prior authorization hurdles for them to get Fosrenol ( which I believe costs more ) .
If a brand pho binder that patients will take ...1 small pill with meals , swallowed , is approved and the copay is affordable , the thinking is that more Nephrologists and patients will push for it.
The current SOC re pho binders is a failure . 85% of the roughly 400,000 US dialysis patients on these SOC binders are nowhere near pho goal because of pill burden and taste .
Note ...the existing Fosrenol generic is CHEWED ( or in powder form ) Patients hate the taste. The OLC bio equivalent is SWALLOWED .
I don't have a clear idea on pricing , rebates etc except they need to make the copay affordable ...something ARDX did not do with their Xphazoh.
But first they need their final " tolerability " trial to succeed.
Kiwi
B-I has_a fusion protein_for NASH that_hits GLP-1/FGF21:
https://www.genengnews.com/news/boehringer-ingelheim-yuhan-launch-up-to-870m-nash-collaboration/
Could be an alternative to combination therapy.
UNCY questions...
I don't know the space, but have a few questions?
1) Fosrenol and other serum pho binders are generic? And these are the current SOC?
2) If question 1 is true, then why would PBM's cover a bioequivalent version of a generic without a significant (>70%) rebate?
Addendum—This program is very early, but if the MoA works it would rid hepatocytes of HBV cccDNA and thereby cure the disease.
Private company attacking HBV via CRISPR-based editing_of_viral_DNA:
https://www.globenewswire.com/news-release/2024/04/22/2867238/0/en/Excision-BioTherapeutics-Announces-Oral-Presentation-Highlighting-Positive-Data-from-its-HBV-Program-EBT-107-at-the-Upcoming-ASGCT-2024-Annual-Meeting.html
ABEO—(-53%/AH)—receives CRL due to CMC issues:
https://finance.yahoo.com/news/abeona-therapeutics-provides-regulatory-pz-200500676.html
UNCY ...my pitch
First this is a risk only what you can afford to lose spec. Trial failure ...to many dropping OLC due to side effects especially nausea and PPS will be at least cut in half ...JMO
Upside potential ...for what it's worth
Disagree re reminiscent of Statins .
I've been on them all since late 1986 ( the first Mevacor was approved in 1987 )
In 1986 I was a " Lab rat " at UCSF ...denied health insurance due to family history of heart attacks .
UCSF provided some coverage provided I'd be in their CV trials ...was on the first statin for about 6 mths as part of a safety study before approval .
Back then AST /ALT Liver tests very mth .
Biggest change was the introduction of Lipitor. ....first high intensity Statin
Kiwi
Reminiscent of statins.
IMMNOV.ST—(+36%)—also_has liquid-biopsy for pancreatic cancer:
https://www.prnewswire.com/news-releases/immunovia-announces-positive-results-from-the-model-development-study-for-its-next-generation-pancreatic-cancer-detection-test-302123066.html
13 new obesity drugs could hit the market by 2029 amid surging demand
https://seekingalpha.com/news/4091726-13-new-obesity-drugs-could-hit-the-market-by-2029-amid-surging-demand
Promising Early Pancreatic Cancer Detection (Medscape 4/10/24)
https://www.medscape.com/viewarticle/liquid-biopsy-has-near-perfect-accuracy-early-pancreatic-2024a10006ut
Skip Virgin is impressive.
Education and Early Career
Herbert "Skip" Virgin, also known as Herbert W. Virgin IV, has a distinguished academic background. He completed his undergraduate studies at Harvard University, where he received his AB degree. He continued his education at Harvard Medical School, earning both an MD and a PhD. His thesis work focused on host immune responses to Listeria monocytogenes
Medical and Postdoctoral Training
After his doctoral studies, Virgin completed his residency in internal medicine at Brigham and Women's Hospital. He then underwent postdoctoral training in viral genetics and pathogenesis in the laboratory of Bernard Fields
Academic Positions
Virgin served as the Edward Mallinckrodt Professor and Chair of the Department of Pathology and Immunology at the Washington University School of Medicine (WUSM) in Saint Louis, USA. He held this position until 2018 and was succeeded by Richard J. Cote
Research Contributions
Throughout his career, Virgin's research has been influential in the fields of virology and immunology. His laboratory used genetic, structural, computational, and sequencing methods to explore the relationship between host genes, the virome, and disease pathogenesis. Notably, his team discovered the first murine norovirus and developed the first culture and genetic systems for a norovirus. They also identified the role of bacteria in norovirus persistence and linked changes in the enteric virome with human inflammatory bowel disease
Virgin's work has also contributed to understanding the roles of autophagy and interferon-stimulated genes during viral infection. His research has implications for a range of conditions, including chronic viral infection, lung inflammation, and autoimmune diseases
Industry Experience
In the industrial sector, Virgin served as Chief Scientific Officer at Vir Biotechnology from 2018-2022. During his tenure, he directed the discovery of the monoclonal antibody sotrovimab for the treatment of COVID-19 in at-risk individuals
Altos Labs Involvement
Most recently, Virgin was appointed as Chief Medical Officer and Head of the Altos Institute of Medicine at Altos Labs, where he was responsible for leading work on the translatability of scientific discoveries to transformative medicines. However, as of December 2023, he is no longer serving in this role
Honors and Memberships
Virgin is a member of several prestigious societies, including the National Academy of Sciences (NAS), the American Society for Clinical Investigation (ASCI), the American Association of Physicians (AAP), the American Academy of Microbiology (AAM), and the American Association for the Advancement of Science (AAAS). He also serves on the editorial boards of prominent journals such as Cell and Science
Publications
Virgin has authored numerous influential publications, some of which include studies on herpesvirus latency, interferon responses to murine norovirus, and the discovery of a proteinaceous cellular receptor for a norovirus
Contact Information
While specific contact details are not provided in the search results, professional profiles such as LinkedIn and institutional affiliations can be used to establish contact with Dr. Virgin
Summary
Herbert "Skip" Virgin's CV reflects a career dedicated to advancing the understanding of virology and immunology through both academic and industry roles. His contributions to the field have been recognized by his peers and have had a significant impact on medical research and treatment development.
VAXX -37%/AH on voluntary delisting:
https://finance.yahoo.com/news/vaxxinity-announces-intention-voluntarily-delist-202700884.html
Ideal PR for a Friday evening, LOL.
HEPA terminates NASH trial:
https://www.globenewswire.com/news-release/2024/04/19/2866379/0/en/Hepion-Pharmaceuticals-Initiates-Wind-Down-Activities-in-Phase-2b-ASCEND-NASH-Trial.html
I'm going out on a limb and calling this biotech company a scam. $HEPA https://t.co/1EhBQEue5C
— Roy Friedman (@DewDiligence) January 29, 2020
ChatGPT or not ChatGPT? That was the question, briefly, as Microsoft cut employee access to AI tool
https://www.geekwire.com/2023/chatgpt-or-not-chatgpt-that-was-the-question-briefly-as-microsoft-cut-employee-access-to-ai-tool/
Drug/biotech companies have_qualms_about chatbot security risk:
https://www.fiercepharma.com/marketing/two-thirds-top-20-pharmas-have-banned-chatgpt-and-many-life-sci-call-ai-overrated-survey
That makes sense (eom).
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