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They are moving beyond quadruple edited to build a sextuple-edited CAR-T therapy for glioblastoma.
https://www.cnbc.com/2025/06/18/fda-approves-gilead-hiv-prevention-injection-lenacapavir.html
This should be great news, but from a financial, shareholder perspective, there are concerns about cost and availability, with U.S. government programs cutting funding for HIV prevention programs.
I've heard that an MD Anderson team is developing an off-the-shelf IL-21 armoured CAR-NK cell therapy that will target EGFR and IL13Ra2 https://www.cell.com/cancer-cell/abstract/S1535-6108(24)00272-1
They are also testing another off-the-shelf NK cell therapy with containing deleted of TGFBR2 and NR3C1 in recurrent glioblastoma. This makes the NKs resistant to tumour- and corticosteroid-induced immunosuppression, respectively. Going forward, they plan to test these NKs with Delta-24-RGD https://ascopubs.org/doi/10.1200/JCO.2017.75.8219
When combined with NKs, they found that treatment with Delta-24-RGD altered the immunosuppressive tumour microenvironment and increased the recruitment, antitumour activity, survival, and memory of endogenous NKs as well.
It will be interesting to see GILD's KITE-753 clinical data. The only difference between it (and KITE-363) is a reduced production time.
However, based on preclinical data, KITE-753 exhibited higher expression of both CARs and increased proportion of CCR7+/CD45RA+ T-cells* compared to the KITE-363 benchmark.
Also, KITE-753 exhibited enhanced cytokine production, enhanced proliferation, increased peripheral peak expansion, and superior antitumour efficacy compared to the KITE-363 benchmark.
* CCR7+/CD45RA+CD4+ of ~60% vs ~5%, and CCR7+/CD45RA+CD8+ of ~80% vs ~15%. High circulating CCR7+ populations positively correlate with antitumour response https://www.nature.com/articles/s41591-020-1061-7
The UPenn team have been developing this https://jitc.bmj.com/content/11/Suppl_1/A323
One company is developing an off-the-shelf version https://www.kiragenbio.com/our-science
ASCO: Kite's CAR-T passes lymphoma safety trial with flying colors https://www.fiercebiotech.com/biotech/asco-kites-car-t-passes-lymphoma-safety-trial-flying-colors
Dual-target CAR T cell therapy slows growth of aggressive brain cancer https://medicalxpress.com/news/2025-05-dual-car-cell-therapy-growth.html
$GILDDr. Paul Marik:
— Asher Press (@AsherPress) June 19, 2024
Hospital Would not allow me to Use Vitamin C, but wanted me to Use Remdesivir, Which Increases risk of Kidney Failure by 20X & increases Death by 4%
The Federal Government will give Hospitals 20% Bonus if you prescribe Remdesivir pic.twitter.com/Rk0F024jBf
Yulp.
New Management style = Company first lay offs.
AIDS is cured.
HepC is cured
Cancer is a nothing burger but a management waste of money
All they got is Prep.
I'm thinking a golden opportunity to short this top heavy pig. They got nothing in the pipeline but cost cutting.
~sold the 2/14 $108 calls @.20c
~bought the 2/14 $108 calls @.05c ahead of earnings today
Looks like the National Sales meeting in Vegas, has employees dumping after this high.
Management must not be painting much hope for the future.
I can't wait to hear what the pump is to keep employees from bailing out.
They now add an investigational HIV vaccine to its portfolio https://www.fiercebiotech.com/biotech/gilead-buys-hiv-vaccine-spanish-biotech-following-success-clinical-collab
Data on the vaccine in combination with vesatolimod https://www.ddw-online.com/hiv-combination-regimen-could-lead-to-viral-remission-22215-202302/
Based on recent data*, I would have thought that getting KITE-509 into the clinic (for GPC3+ solid tumours, not just 3L+ HCC) would be a priority.
* https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4019 https://www.nature.com/articles/s41586-024-08261-8
CEO is talking now.
The stock is selling off on great words.
Go figure! 6month Prep shot is a game changer. Generics are already being made for third world nations. These guys are going to eradicate AIDS.
They should be allowed to make a buck or two.
I want $250 a share please, I've held it way too long.
Two years later, and here are some of my takeaways...
- They know they need to expand into more (rural) areas and that might include pre-built clean rooms. Slides 21-26 show how difficult it is to drive uptake further. "Majority of future growth expected from establishing new ATC's in community." These centres need to establish new relationships with others for apheresis, local ER's for (CRS/ICANS) emergencies and even local freezer storage requirements, which is it's own thing. So much goes into treatment that has nothing to do with manufacturing.
- Forgot ZUMA-12 data was that good. A 86% CR rate and 81% three-year survival from 1L patients. Not sure how to compare that to later line trials, but decades from now, let's hope we are at the point we treat this front line (vs SOC now). Kite said their COGS is <50% from day one, which is now likely <$75k, but who knows how to account for all the R&D and acquisitions. Another 25% reduction coming via automation and scale. So an ~80% margin by 2030.
- Non-viral and in vivo have been moved to the back of their timeline. Anito-cel, dual CARs, autoimmune, allo NKs, solid tumours and three day manufacturing ahead of it. Transposons gets a mention on slide 84. I hope they drop the latter and go with CRISPR as it allows for site-specific integration.
- 20k Kite patients treated
''There have been more than 250 HIV vaccine trials, most of them early-stage, looking at whether the vaccine is safe and whether we mount an immune response following vaccination. There have been very few vaccine trials—10 or so—that have advanced to the point of looking at efficacy. Of those, one showed 31% efficacy at 42 months. That was the most promising trial, but the efficacy fell off very quickly, and it was only 31% and only against clade B. Whether that would translate to the other clades is not clear.'' https://publichealth.jhu.edu/2022/why-dont-we-have-an-hiv-vaccine
How the hell is Dan O'Day still making 26 mil? A monkey throwing dart would have been better than this dimwit
— Jack Shaw (@JackSha90859576) October 19, 2024
Featured on CNBC-TV this morning, 8:40 a.m. time frame.
NICE!
clutch stock with a disruptive cure prevention vaccine for HIV people would rather take 2 shots a year not to get HIV then taking oral pills for treatment!
$GILD
Adding shares and calls under $80..00
HIV Cure Vaccine is a big deal data is incredible flawless. Oncology pipeline is building nicely.
$GILD
$GILD
Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors
https://finance.yahoo.com/news/compugen-announces-fda-clearance-ind-110000034.html
FDA clearance triggers a $30 million milestone payment from Gilead
Target is $100-$120 by Q2 2025
$GILD
HIV Prevention CURE Shot 2x a year
Great growing oncology pipeline!
my $80 vertical Calls from last week are looking golden!
$GILD
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174602784
"Gilead plans to share new preclinical data for an oral GLP-1 at the upcoming American Diabetes Association conference starting June 21… The asset, dubbed GS-4571, has previously demonstrated 5% to 8% weight loss in monkeys in 28 to 30 days…"
How about oral GLP-1 news? CNBC-TV AH today. Portal Innovations CEO interview.
There is barely any move on this news. Seems the market had already written it off. O'Day needs to go, they need to rebuild in areas they have expertise in and refocus in oncology.
They guided that a third of revenues will be from oncology by 2030...! https://www.businesswire.com/news/home/20240530516266/en/Gilead-Provides-Update-on-Phase-3-TROPiCS-04-Study
''Using independent datasets, we validate that CD8-fit T cells (1) are present premanufacture and are associated with clinical responses in individuals treated with axicabtagene ciloleucel, (2) longitudinally persist in individuals after treatment with CAR T cells and (3) are tumor migrating cytolytic cells capable of intratumoral expansion in solid tumors.'' https://www.nature.com/articles/s43018-024-00768-3
https://medicalxpress.com/news/2024-05-cancer-optimal-cells.html
The oNKo-Innate team, along with scientists at Kite, have just published a research article https://onlinelibrary.wiley.com/doi/10.1002/cti2.1507
Optimised manufacturing dramatically improves lentiviral transduction efficiency of primary human NK cells. The field has progressed greatly with CAR transduction rates in human NK cells (it was ~5% just a few years ago). The oNKo-Innate R&D team were able to raise CAR transduction efficiency to ~80%. After testing various NK cell sources, they conclude that the exponential expansion pre- and post-transduction and high on-target cytotoxicity make PB-derived NK cells a feasible and attractive CAR-NK cell product for clinical utility.
''No doubt CAR-NK cells have faced several challenges in oncology settings, and we hope our new findings assist researchers in addressing some of these challenges while also improving the potential for CAR-NK cell therapies in treating autoimmune disease such as lupus'' said Nicholas Huntington, PhD, oNKo-innate's CSO.
The management has been substandard for many years https://www.fiercebiotech.com/biotech/gilead-gives-49b-antibody-solid-tumor-plan-unravels and https://www.fiercepharma.com/pharma/gilead-writes-24b-trodelvy-ceo-underscores-time-focused-execution
IL-12 is the new IL-2! https://www.oncologypipeline.com/apexonco/xilio-gets-gilead-shaped-reprieve
Interesting (preclinical) data from another company. It summarises two distinct phenotypes of cells within the product (they are manufacturing), each of which plays a different role in responding to cancer cells. Each cell population were separated based on whether they produced CD4 on their surface (CD4+ vs. CD4-). Cells negative for CD4 (CD4-) were better able to kill target cancer cells via the CD19 CAR. In contrast, CD4+ cells proliferated faster in response to CD19+ cancer cells. The two groups of cells also produced a different cytokine response in response to CAR activation.
Kite Analyst & Investor Event https://s29.q4cdn.com/585078350/files/doc_events/2024/Mar/14/gild_kite-analyst-investor-event-14-march-2024.pdf
I found the poster, but nothing on the design of the CARs, data on ex vivo expansion, or the percentage of CD62L+ NKTs https://www.jci.org/articles/view/83476 https://journals.aai.org/jimmunol/article/201/7/2141/107140/IL-21-Selectively-Protects-CD62L-NKT-Cells-and
Preclinical API-192 data https://ash.confex.com/ash/2023/webprogram/Paper181271.html
It is a first-in-class OTS CAR-NKT cell therapy that expresses dual CARs (targeting CD19 and CD20) and sIL-15. API-192 is the first development candidate out of a '21 collaboration and license agreement with Kite.
Another next-gen collab https://www.businesswire.com/news/home/20231030344859/en/Kite-and-Epic-Bio-Announce-Collaboration-to-Develop-New-Therapies-for-Cancer
There have been a number of these over the years, but nothing seems to come of them
The ACLX partnership looks like it could be be a gold mine. The ASH data completely dooms TSVT https://ash.confex.com/ash/2023/webprogram/Paper189761.html
If Breyanzi can't take share from Yescarta, Abecma doesn't stand a chance. They made sure to point out how Carvytki is giving some Parkinsonian-like events where they have not seen it (yet). Carvykti vs ddBCMA is going to be a battle down the road.
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