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Re: LCTX ( post for archives).
Roach has Lucentis, but me thinks dry macular degeneration field has unmet remedy . ....and reason Roach with Genentech paid 50 million to ensure LCTX's ocular regeneration platform has some partnership and payoff with them, if LCTX scores future successes. This stock has been punched into huge share dilutions, and still had to agree for pittance hand out with highly solvent bettors. However their new expansion routine always deserves a peek ( not "real " money yet IMHO), as payoff in billions. I am deservingly eager for their success, after just having some highly successful cornea epithelium cell replacement therapy, but know too many who have no such immediate totally restorative remedies for their different
challenges...
https://endpts.com/lineage-cell-therapeutics-opens-new-california-rd-facility-and-expands-israel-manufacturing-site/
https://en.wikipedia.org/wiki/Lineage_Cell_Therapeutics
Holy crap, Holy ....". By partial investor, still caught my eye. This new IPO (PRME) bearing famous name in field with patents untested ( hoping to turn the human genome into a word processor), this Crisper 3.0 , will be valued at 1.7 billion.
https://endpts.com/david-lius-biotech-shoots-for-150m-ipo-raise-to-develop-crispr-3-0/
Re: AZ drugs 'vexing" a plus, I do not know what I do not know, but still personally awaiting just an "inflection point" from peer reviewed unanimously agreed data.
Unless there are probable interventions which can ameliorate dementia,
I see only those eager to marginalize the party subjected to such a prospect of decline, on the pathway to profit by the knowledge of such a consequential diagnosis..
In my opinion the value of very early dementia diagnosis would be mainly in the area
pertaining to becoming a useful tool accelerating scientific research in the search for real remedies.
AUTL and CAT-T ilk will in my opinion become more effective for larger players to mix and match, as new pathways are discovered which increase their platform's ultimate effectiveness by addressing the hidden "riffraff". Those obstacles which have stymied their drug cure platform targets. which may include turning on or off undiscovered proteins and influences which
interfere with the ideal primary routes customed targeted to be influenced toward a more effective controlled cure. Ha, each new middleman who adds a tweak (a fine adjustment) will add additional costs to the expensive treatments , but that is a matter to be resolved at another time.
ALS drug wins FDA approval despite questionable data (medicalxpress.com)
https://medicalxpress.com/news/2022-09-als-drug-fda.html
The core beliefs of most people are non-scientific, and I believe that the new experimental drug will enable Biogen and ilk to get a healthy return from the inroads
being pioneered in computational data mining which opens new avenues to encourage wholesome expressions of progress.
Sort of a balanced view of the "new" Alzheimer drug promise:
https://medicalxpress.com/news/2022-09-alzheimer-drug-phase-clinical-trial.html?utm_source=nwletter&utm_medium=email&utm_campaign=daily-nwletter
"..........could also put a serious dent in Medicare’s budget."
"CMS as gatekeeper: Why lecanemab is similar but also very different from Aduhelm
Zachary Brennan
Senior Editor
Both aducanumab and lecanemab — Eisai and Biogen’s Alzheimer’s drugs — are not only targeted at reducing the clumped beta-amyloid that has mystified and encouraged researchers for decades, using the same FDA accelerated approval pathway, and could also put a serious dent in Medicare’s budget.
Last night’s big unveiling of encouraging data for lecanemab — as clear a win as any in Alzheimer’s — also brought back memories of Aduhelm’s quick accelerated approval and tepid launch, thanks in a large part to CMS’ ultimate decision to require additional RCT data for the entire class of anti-amyloid mAbs.
But in the case of lecanemab, yesterday’s announcement regarding its ability to slow the rate of cognitive decline by 27% over 18 months versus placebo should be good enough to not only convert an accelerated approval to a full one in the FDA’s eyes, but to confirm exactly what CMS means when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”
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Whereas Aduhelm was studied in almost an exclusively white population, Eisai recruited about 25% of its total US enrollment from Hispanic and Black communities, which meets the diversity criteria specified by CMS, according to SVB Leerink.
While Eisai says it’s still working with CMS, and the FDA has until Jan. 6 to make an official decision on accelerated approval, the data still need to be presented next month at the CTAD conference in San Francisco, and published, with more discussion likely focusing on the clinical benefit, and the safety profile of lecanemab as the companies said total incidence of amyloid-related imaging abnormalities were in line with past data (ARIA-E and/or ARIA-H) or 21% in the lecanemab group vs. 9% in the placebo group.
The bigger question may be what this level of slowing the rate of cognitive decline is worth — in patient and value terms.
Eisai said in June that its annual value-based price of lecanemab “was estimated at $9,249 to $35,605 (Societal perspective: $10,400 to $38,053)” based on an early economic assessment.
And surely Eisai learned its lesson from Biogen’s fiasco with Aduhelm’s price slashed in half to $28,200 less than six months after launch. And where many thought Aduhelm could be the straw that breaks Medicare’s back, with tens of billions in new sales following approval, lecanemab could create the same sort of issues for government spending.
Ironically, President Joe Biden and his administration just yesterday announced and celebrated the fact that Medicare premiums next year would actually decline, thanks in a large part to Aduhelm’s lackluster traction and as CMS had previously projected billions of sales. Perhaps CMS will need to readjust those premium levels again given last night’s data.
Regardless, an FDA adcomm meeting to discuss the lecanemab data seems likely given the high stakes nature of the announcement made last night and the stock market reaction — Biogen shares $BIIB were up almost 50% in pre-market trading this morning, and even Roche $RHHBY, with another potential anti-amyloid drug on the way, was up 7%, as was Eli Lilly $LLY up almost 8%."
John Carroll — Endpoints News [john@endpointsnews.com]
Re: the :experimental Alzheimer’s drug. Notable to me:
the primary endpoint relies on qualified professionals" to essentially measure performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
In my opinion it is the secondary endpoint which deserves repeated confirmation: PROFILE OF AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA) ( 5% observed drop in plague load {17% to 12%}).
The benefit of approval to me rests on society determining the value of having a faithful" tool to meet the dreadful outcomes
of having nothing else to soften the onslaught of the consequences to all parties affected by Alzheimer's if the safety profiles are adequately met.
However this highly valuable palliative to reduce some of the depressing associative consequences of a diagnosis of Alzheimer's must
balance the ultimate dollar cost to the financial health of our health care system.
Could it be we already have the drugs which can reduce cancer mortality rates, but we just do not know how to apply the optimal doses?:
From Endpoint news (John Carroll — Endpoints News [john@endpointsnews.com]
"Pioneering Click Chemistry in Humans
Reimagining cancer treatments
Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.
Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.
The precision of click chemistry
A simple yet incredibly powerful scientific approach may be the key to unlocking the hidden potential of cancer therapies and improving their therapeutic index. This concept is called “click chemistry”, and it was first introduced in 2001 by Hartmuth Kolb, M.G. Finn, and Nobel prize winner Barry Sharpless.i It involves chemical reactions in which two molecules rapidly “click” with each other, ignoring their surroundings. When these types of reactions are conducted in a biological setting, they are termed bioorthogonal chemistry, as there is no interference from or to native biochemical processes.
“Bioorthogonal chemistry conducted inside a human body could open a doorway to improve the therapeutic index of chemotherapeutics and unlock new biological effects from cancer medicines” says Neal Devaraj, Professor of Chemistry and Biochemistry at UC San Diego and advisor for Shasqi.
Pioneering click chemistry in humans
Shasqi, a clinical-stage biotechnology company, has created the Click Activated Protodrugs Against Cancer (CAPAC®) platform, which uses click chemistry to localize and activate a ‘protodrug’ at the tumor site. Protodrugs are attenuated versions of powerful cancer therapies. When the protodrugs reach the tumor, their activation leads to the release of the full-strength payload (active drug) at the tumor site.
Shasqi’s first generation approach employs an intratumoral biopolymer injection to localize the protodrug activators at the tumor site. Shasqi’s lead asset, SQ3370, is based on a doxorubicin (Dox) protodrug and has established click chemistry in humans. SQ3370 is well-tolerated in patients in a phase 1 study. Despite dosing more than 10-times conventional Dox and up to 12 cycles, a maximally tolerated dose has not been identified to date.
SQ3370 unlocks the opportunity to exploit the full potential of the drug class. Novel immune regulatory effects, as described preclinically in 2021, were confirmed in humans. Increased cytotoxic T-cell activity observed at the higher dose levels of SQ3370 (> 6-times the conventional Dox dose) indicate immune activation, trending towards an increase in tumor cell death in heavily pretreated patients.
These findings establish exciting possibilities for SQ3370 and pave the way for advancing the program to Phase 2, which is currently enrolling patients. More importantly, they highlight how click chemistry in humans could one day truly transform cancer therapies and motivate the development of new protodrugs (e.g. auristatins, and taxanes) as well as new tumor-targeting agents.
Click chemistry and antibodies
Antibody drug conjugates (ADCs) enable the use of highly toxic and effective chemotherapeutic agents by linking tumor-targeting antibodies to potent payloads. ADCs have improved the lives of many cancer patients, but clinical applications remain limited due to narrow therapeutic indices and a limited set of suitable antigens that meet the criteria of ADCs.
By localizing click chemistry activators to the tumor with antibodies, protodrugs can be activated and payloads released at the tumor site. The CAPAC platform decouples the tumor-targeting component from the payload, spearheading the pursuit of non-internalizing antigens.
This feature expands potential target antigens to those that do not reside on the surface of tumor cells (e.g., in the tumor microenvironment). These antigens represent exciting new targets that are uniquely suited for click chemistry in humans. They hold great promise to expand the indications suitable for antibody-targeted therapies, especially with regards to solid tumors.
In addition, separating the tumor-targeting component from the payload enables unique therapeutic combinations. A single targeting agent can be used with two or more protodrugs, each exploiting a different mechanism of action. These potential regimens are currently inaccessible due to overlapping toxicities.
Disrupting cancer therapy as we know it
Improving the therapeutic index of cancer medicines is one of the biggest challenges we face today. Shasqi has unlocked click chemistry in humans and is poised to apply the technology to create unprecedented opportunities to explore curative options.
A key to accelerating the rate of progress against cancer lies in collaborating to activate the untapped potential of powerful cancer therapies by leveraging the precision of click chemistry.
“Bioorthogonal chemistry has the potential to improve the utility and outcomes for many anti-cancer treatment modalities. We see a future where combinations of therapies can be activated at desired areas of the body, resulting in much greater safety and efficacy than we have today” notes Carolyn Bertozzi, Professor of Chemistry at Stanford University and advisor for Shasqi."
DTIL 1.22 in.
LVTX more than double now:
https://ca.finance.yahoo.com/news/seagen-lava-therapeutics-announce-exclusive-120000733.html
Botox may have more general use than aspirin (in my own words).
".........it can alleviate depression"
........"By interrupting the feedback loop between the forehead muscles and the brain, botulinum toxin also changes the emotional feedback. "
https://medicalxpress.com/news/2022-09-botox-emotions-brain.html
"Protein design with AI quicker than ever before".
"Huge advances in artificial intelligence (AI) mean that researchers can design completely original proteins in seconds instead of months "( reported today in Nature's brief).
Own the tools and own a part of all drug discovery.
https://cen.acs.org/physical-chemistry/protein-folding/Protein-design-AI-quicker-ever/100/i33
At some time this Co. will probably go public?
https://www.businesswire.com/news/home/20220815005119/en/Monod-Bio-Closes-25M-Seed-Financing-to-Advance-Biosensor-Technology-Platform
"Third Harmonic Bio is a clinical-stage biopharmaceutical company focused on
advancing the next wave of medicine for allergy and inflammation."
I also can "safely" say, everything I utter represents the next wave in/of human thought.
AUUD 1.56 wearing armor as microscopic look into a stock with no committed sellers on marco conditions.
NCPL 2.39 restart on savagery.
JCTCF 5.32 almost LOY low float has room on upside now.
AUUD 1.59.
DTIL: (1.50's or lower target buying price) I am a sometimes investor as stock uses its shareholders to sponsor its expensive goals, But recent multiple handshakes with top tiered drug houses, insider buying, and recent share offering swallowed into current share price offered (to me) better safety than peers which lacked such a recent trifecta.
Highly notable to me and more comforting as an investor are the almost daily discoveries of new mechanisms which may introduce new solutions that for example may block or turn on or off influences which affect even approved CART-T safety and effectiveness. In my opinion, this implies that all Cart-T platforms have available outsource able safety nets to in theory most likely improve their platform in a significant profitable way, and made available to patients as long as the cost of their treatment has a market for their improved delivery system.
https://medicalxpress.com/news/2022-09-immune-cells-cancer.html?utm_source=
https://www.sciencedaily.com/releases/2022/09/220909191820.htm
(if a problem with the links) a copy and paste on Goggle did the trick for me.
POAHY 6.69: I get that and they plan on giving dividend to common shareholders, but
what theories to root for if IPO goes sky high, and is the common they are talking about exactly the same stock on this board?
AUUD 1.53 sellers gone fa sure.
Makenzmoney Ya almost got your 3 year membership as I failed to keep as chased another bleep, so we both failed by this much, but you can buy me one if ya had TMNA deep of this 5 bagger off my sold mistake...
MOB low low float at low of year 2.08!
Now just wait for the mob.
GRFX AUUD both up on 1000 point decline day, low floats may have special moat .
AUUD 1.45 not hit by almost 900 Dow drop, nice to note.
DTIL: (1.50's or lower target buying price) I am a sometimes investor as stock uses its shareholders to sponsor its expensive goals, But recent multiple handshakes with top tiered drug houses, insider buying, and recent share offering swallowed into current share price offered (to me) better safety than peers which lacked such a recent trifecta.
Highly notable to me and more comforting as an investor are the almost daily discoveries of new mechanisms which may introduce new solutions that for example may block or turn on or off influences which affect even approved CART-T safety and effectiveness. In my opinion, this implies that all Cart-T platforms have available outsource able safety nets to in theory most likely improve their platform in a significant profitable way, and made available to patients as long as the cost of their treatment has a market for their improved delivery system.
https://medicalxpress.com/news/2022-09-immune-cells-cancer.html?utm_source=
https://www.sciencedaily.com/releases/2022/09/220909191820.htm
(if a problem with the links) a copy and paste on Goggle did the trick for me.
AUUD went to 1.45 for a small bit then sat all day a little lower, so not AUUD old character, hate that when it becomes run of mill also ran?
NCPL did the Jan. effect for me finally all today with after hours high of 3.33 after letting me sell all worthless stock today to add to NCPL heavy below 3 most of early today, and even after hours.! MM acting like I saved his life and he owes me.ok do it again 10 times as I need payback for all my mistakes!
NCPL 2.94 added hard as principal left early, stay away dud!, I need to refill for cold winter!
NCPL Translation 3.34 after hours high (so far)!!!
NCPL 3.29 let some go as school yard trick can be replayed!
NCPL 3.25, 911 involved!
NCPL 3.15 principal broke up that scam!!!
TMNA watched minute by minute but mistook the goose from the gander.
NCPL 2.88 added with eyedropper as lunch room bullies seducing charts to take lunch room change from frail patsies.
GRFX 2.10.
AUUD 1.44, lo vol. let's see?
NCPL 2.91 added to largest load in one stock in decades.