A researcher at the University of Texas MD Anderson Cancer Center is accused of stealing research funded by the U.S. government and attempting to take it back to his native China. #tradesecrets #cancerresearch #stealing #china #mdanderson #abc13houston #abc13 #fy #fyf #fyp
MD Anderson
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The room that @breezehunter showcased on TikTok looks like a typical college dorm. There are photos of her family and friends, a Texas A&M University blanket and a pop-up closet in the corner. But it’s not Hunter’s dorm in College Station. It’s her room at the University of Texas MD Anderson Cancer Center, where the 22-year-old has been living since she was diagnosed with an aggressive type of cancer. Click the link in our bio to read more. 📝: Evan MacDonald / Houston Chronicle reporter 📸: Karen Warren / Houston Chronicle photographer
H Town!! After 24 days in the hospital, MD Anderson gave me a 6day hotel stay. I’m required to stay close for 2-3 more weeks. IDK where I’m going after just yet but I’m so thankful to be here for now. Know anyone with short term rentals near medical center?? #iWillBeatCancer #cancerfighter #cancerjourney #leukemia #CARtCellTherapy #cancertok #MDAnderson #Houston #leucemia #cancersucks
Monroe Dunaway Anderson, cotton broker, philanthropist and namesake of Houston’s MD Anderson Cancer Center #texashistory #mdandersoncancercenter #houstontx #galveston #htx #texas #tennessee #philanthropy #history
At MD Anderson, we offer more than just world-class cancer care. Explore these featured amenities to make your visit more comfortable and enjoyable. Tap the link in our bio to learn more. #Houston #PatientCare #MDAnderson #MDAndersonCancerCenter #EndCancer
Thank you, MD Anderson, for making us feel so welcome and supported! What a great first visit. 🥰🙏🏻🤍🧠 #betonjosh #mdandersoncancercenter #cancer #braincancer #powerteam
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Gps - Revolutionary Immunotherapy for AML Remission Maintenance, Phase 3 Results are Now Due* and worth $50B to Big Pharma - this is the TRUE NORTH for $SLS Share Holder Value, $MRNA just added $40B to its Mcap in a Day for the Same Reason SLS is about to. Dec 10, 2024 60th Event \- Jan 23rd 2025 IDMC Unblinded Interim MOS and IR Data \- Dec 26th 2025 72nd Event \- May 11th 2026 78th Event \- 60 -72nd 1 Event Per month, 72nd to 78th 1 event Per 22.67 Days \--- its Now Been 4months and Day since the 78th while w await 2 events ='s Any Day Now. Gps - Revolutionary Immunotherapy for AML Remission Maintenance Phase 3 Results are Now Due and worth $50B to Big Pharma - this is the TRUE NORTH for $SLS Share Holder Value $MRNA just added $40B to its Mcap in a Day for the Same Reason SLS is about to. **The world's leading Hematological Oncologist, Dr. H. Kantarjian - the Chair of MD Anderson's Leukemia dept., is the SLS Phase 3 Trial Global Lead, and Steering committee Chair....** **A Legend in the HemeOnc world, with 20 Fda approvals to his credit is bringing the SLS Phase 3 trial Home.** We have 3 doctors Treating Actual Phase 3 Trial Patients on the Record Stating BAT for Control ARM Patients is "DISMAL" "Extremely Poor" "not Durable" Dr. Levy Said, Dir of Hematological research at BAYLOR Med. ... A Smart Knowledgeable doctor, Ven+aza/deci MOS is dismal just 6/8 months. the same thing dr. Tsirigotis Stated - MOS for patients on BAT is Extremely Poor - on the order of 5-7 Months. Dr. Jamy - was asked Point blank, what is the longest survival he sees in his practice for Second Remission CR2 Patients - he states MOS is just 6, 7 months using BAT / aza +ven and "you will not see survival past 12 months. We have at least 47 patients nearly 40% of the REGAL p3 enrolled population continuing to survive AT LEAST 30 months. ,What is Gps worth? • 12.5K AML CR2/3 Patients Year • 50K AML CR1 Patients Year • xCCO Published Estimated Pricing at $300K Per patient • Compounded by infinite dosing regime: 3 years CR2, 6 year dosing regime on avg. for CR1 • 300K Patients in Remission Right Now who'll benefit from Gps right out of the Gate. [$RVMD](https://x.com/search?q=%24RVMD&src=cashtag_click) set pricing $39,800 per patient per month. $477,600 Y1 Rasonque [$ABBV](https://x.com/search?q=%24ABBV&src=cashtag_click) / [$RHHBY](https://x.com/search?q=%24RHHBY&src=cashtag_click) and [$BMY](https://x.com/search?q=%24BMY&src=cashtag_click) who own Aza+VEN - the BAT for the CONTROL ARM PATIENTS - Know Precisely how their drugs work in AML CR2 Remission Maintenance. **- VIALE-M Phase 3 for CR1 Maintenance FAILED** **Aza+VEN the BAT for the SLS Phase 3 Control Arm Patients in SECOND REMISSION (CR2)** **FAILED a Large Phase 3 FIRST REMISSION (CR1) Trial conducted by $ABBV -it's not complicated.** \- VIALE- T Phase 3 for Post Transplant Maintenance - Failed \- VERONA high risk MDS/ AML precursor Failed \- VIALE-C - FAILED and 23% of the Patients taking Aza+VEN in the only Viale trial that succeeded Viale-A - Died from taking BAT - the BAT for the SLS Control ARM. \- VIALE-M P3 Combined Venetoclax with Oral Az /Onureg the SOC for CR1 Remission Maintenance - MOS 24.7 Months - Adding Ven did not increase Survival, added Tox. Meanwhile we continue to see Near miraculous Survival among the remaining 47 patients - about 40% of the 126 enrolled. Its Gps doing what its done in all 7 Prior Trials, including 2 Phase 2 Trials for AML Remission Maintenance - Prevent Relapse and Extend Survival - 2x 4x OS Benefit Directly correlated with Immune Response - very similar to the $MRNA cancer vaccine P3 that added $40B to its Mcap in a day. Since the IDMC Unblinded Actual SLS P3 MOS Data January 23rd 2025 SLS Market Cap Value is up 1,200%, Share Price +900%, Cash on Hand UP 1,110% Institutional Funds invested up to over 300 holding 60% vs just 39 w 8%. Smart Money Knows. it ain't BAT - its GPS.. We also have numerous Published Trials with supporting Data \- First Remission Landmark MOS is Just 17.3 Months ... CR1 Transplant Ineligible MOS is Just 17.3 months. \- Gps Phase 2 in CR1 was > 67.6 months \- GPs Phase 2 in CR2 was 21 months - in an older (74), ALL MRD+ much less healthy patient setting, who received Less Gps - a max of 12 doses in year 1 only vs 15 doses in Y1 in the P3 with Infinite Dosing beyond - 6 Doses in y2 + Quarterly booster in Year 3 + . **\* all sourced data - lmk if you would like links.** and for the Skeptics : SLS009 the Only Target and First Ever Safe CD Kinase 9 inhibitor s Already worth 2x 3x the current short rigged $2.33B Mcap. \-- just the Secondary asset Phase 2 Published Data at ASH for AML-MR patients - the most Dire AML subset, was better than Magrolimab P1 AML-MR data that $GILD bought for $4.9B SLS009 is now in an expansion phase 2 trial at the request of FDA: 80 patients dual arm trial RANDOMIZED and PIVOTAL with FDA greenlight data incoming next quarter – in Q4 2026. Kinase Inhibitors are Blockbuster Drugs with Household names: Kisqali Verzenio, Ibrance -- Long List Plus we already have P1 87 patient Safety/ data for PTCL/AML/DBCL and PDAC. [https://www.globenewswire.com/news-release/2025/07/15/3115485/0/en/SELLAS-Meets-All-Primary-Endpoints-in-Phase-2-Trial-of-SLS009-in-r-r-AML-and-Receives-FDA-Guidance-to-Advance-into-First-Line-Therapy-Study.html](https://www.globenewswire.com/news-release/2025/07/15/3115485/0/en/SELLAS-Meets-All-Primary-Endpoints-in-Phase-2-Trial-of-SLS009-in-r-r-AML-and-Receives-FDA-Guidance-to-Advance-into-First-Line-Therapy-Study.html)       https://preview.redd.it/033o0f5iu5ph1.png?width=1688&format=png&auto=webp&s=0458d2309bf96118ea351a1d0d91743cb464d818  https://preview.redd.it/sulca4e3t5ph1.png?width=1106&format=png&auto=webp&s=054a8f1bb105fb1be56da4a91864dbaf00aff568 https://preview.redd.it/z3b8w2e3t5ph1.png?width=2552&format=png&auto=webp&s=2e862ce92035e03288b46cc11f154293969b6d7a https://preview.redd.it/aifk5ieat5ph1.png?width=1602&format=png&auto=webp&s=c95bda72f821e420cd9feffc45bdd99d9f0697a3 https://preview.redd.it/v6lj0obet5ph1.png?width=844&format=png&auto=webp&s=fa9f7496ad9a21adab85713a2a95f1fd8751c591
Welcome to r/MDAndersonGSBS! Welcome to r/MDAndersonGSBS , a community for MD Anderson and UTHealth students, alumni, faculty, staff, and community members. This is the home for all things related to the joint MD Anderson UTHealth Houston Graduate School of Biomedical Sciences. # What to Post Post anything that you think the community would find interesting, helpful, or inspiring. Feel free to share your thoughts, photos, or questions about your time at GSBS. # Post Removal If you feel your post was removed wrongfully, send me a message. # Flairs Choose your flair on this sidebar according to your program(s), degree, and year!
Follow me to stay fully up to date on what’s going on around Austin! MD Anderson just committed $2.5 billion to build a full hospital in north Austin near The Domain. Not a clinic. Not a partnership. A real MD Anderson hospital — the same team ranked #1 in the country for cancer care — coming to Central Texas. Michael and Susan Dell donated $750 million personally to make it happen. Right now 25% of Austin patients leave the region for serious cancer treatment. A 300-500 bed hospital changes that completely. Groundbreaking starts this year. Doors open 2030. This is the most significant healthcare announcement Austin has ever seen — and Central Texas families needed it.
Forget the big name hospitals, this is the best hospital for nurses. Preface: I know that what constitute "best" is very subjective. However, some places are clearly better than the others, based on your experience and which priority you have in life. I've done a lot of research, I even worked at some very big and well paid hospitals. I've known about John Hopkins, Yale, MD Anderson, Duke, Stanford, UCLA, etc. I've learned that many times famous hospitals would pay you less because in their mind, their name is worth it on your resume. I work in San Francisco Bay area. The biggest systems around here are UCSF, Stanford, Kaiser, Sutter. I've been at some of them, and they all have pros and cons. So far, the best hospital is El Camino in Mountain View. If you are not from SF Bay area, most likely you haven't heard of them. Again, no hospital is 100% perfect, but they do a lot of things that are far better than the others. For example Wage: a new grad clinical nurse step 1 starts at $89/hr. My friend is a new grad working night shift, after differentials, she get $107/hr. -Their health insurance is free. It's an Aetna HMO plan. While they have to go to Sutter for care, their plan also cover other specialty hospitals like Stanford/UCSF. UCSF insurance premium is tied to your income, the higher you make, the more you pay. So it can easily be a couple hundreds a month. Stanford also made you pay for insurance, unless you opt for High deductible. Kaiser Permanente (KP) is free, but you can only go to KP hospitals. -Parking: free at El Camino, both locations. UCSF parking is crazy expensive, and Stanford is expensive at the main hospital too. Their satellite clinics are free. KP parking is also free. -Retirement: El Camino has free pension and 403b matching 4%. The pension is paid for by the hospital. UCSF pension will take 9% from your paycheck pretax, which is quite substantial, but they have more options, like 403b/457/Mega backdoor Roth. KP free pension, but their 401k get a paltry 1.25% match. Stanford only has 403b, but they get 5% free, plus 4% match. -PTO: 1st year will get 8.77 hours per paycheck, equal to 228 hr per year. Assuming you work 40 hours a week, that's more than 5 weeks time off. At 3 years, you get almost 7 weeks. That's with 1 week of sick leave a year. -They do observe California ratio law and break time. There are break nurses, and the nurse get 30 minutes unpaid lunch break, plus 2 15 minutes of paid break. The major downside with El Camino is that they are situated at the heart of Mountain View, one of the most expensive real estate market in the country. They are 2 miles from the nearest train station, so you can't take the train and walk to work, you have to hail an uber. Some people drove all the way from Tracy/Morgan Hill, even Antioch daily. I've know a nurse who super commute from San Diego. I do know people who can still buy a house on nurse salary here. The younger employees normally rent or still live with parents. Another downside is that they are smaller, so fewer position and very hard to get into.
Dr. Jacob Lalezari, CytoDyn, at the HC Wainwright Global Investment Conference 9/11/2026 [https://journey.ct.events/view/bf1c7d07-71f3-4c41-8928-f42479da2d71](https://journey.ct.events/view/bf1c7d07-71f3-4c41-8928-f42479da2d71) 00:25 Dr. Lalezari Thank you to HC Wainwright for the opportunity to present today CytoDyn's exciting new asset, which we think of as the next generation of monoclonal antibody therapy. The talk today will include a number of forward-looking statements, with all that that implies. 00:47 CytoDyn is a clinical-stage oncology company advancing leronlimab, our first-in-class humanized monoclonal antibody, which targets the CCR5 receptor, with therapeutic potential across multiple indications, including a number of solid tumors such as colorectal cancer and triple-negative breast cancer. 01:11 The leadership team includes myself, Robert Hoffman our CFO, and Tyler Block our chief legal officer. It is really the three of us that constitute the management team. Leronlimab is an IgG4 monoclonal antibody that has already demonstrated multiple mechanisms of action relating to its activity in solid tumor oncology. It is a drug targeting a large and growing market potential, not only CRC and TNBC, but a number of other solid tumors as well. Very importantly, leronlimab has a very well-tolerated safety profile, including more than 1,600 patients across more than 20 studies. We have strong retrospective data in triple-negative breast cancer, which really helped focus the company on solid tumor oncology. And since then we have launched the Phase 2 CLOVER study and have some very exciting early readouts from that study in metastatic colorectal cancer, supporting the proposed mechanisms of action associated with the drug. 02:28 Our near-term milestones include confirming the durability and safety of these efficacy readouts from the CLOVER study in CRC, with a presentation at ESMO in October in Madrid, where we are going to present extensive circulating tumor DNA (ctDNA) data on all 65 subjects, which includes the intent-to-treat population. And then at ASCO GI in January in San Francisco, we will be giving a more fulsome presentation of not only the ctDNA, but also the overall response rates and early progression-free survival. 03:08 https://preview.redd.it/wxihqg0l82ph1.png?width=1600&format=png&auto=webp&s=bb3ab231baf4b7c370348636d3c761a5fe94964a # The CLOVER study in colorectal cancer Starting with the exciting data being generated in CRC, the study is called CLOVER. It is a Phase 2 study, open-label, randomizing patients to either 350 or 700 milligrams of leronlimab, on a backbone of Lonsurf and Avastin. We targeted 60 patients and ended up with 65 patients dosed. This is our third-line metastatic colorectal cancer population that is microsatellite-stable, and therefore not a population one treats with checkpoint inhibitors. Our lead investigator is Dr. Kasi, our director of GI oncology down at City of Hope, and we fully enrolled the study this past April. The DSMB (Data Safety Monitoring Board) has met three times, initially to open up the 700-milligram randomization arm, and at two subsequent times. In all three meetings there have been no safety concerns raised. 04:15 https://preview.redd.it/ls0q35aw82ph1.png?width=1600&format=png&auto=webp&s=d39d55a68b01bc97a30d3d846c3e18941361349b The preliminary results from CLOVER are exciting in a number of ways. First, 100% of our screened patients tested positive for CCR5, and that includes either 10% expression on the tumor epithelial cells or 1% in the lymphocytes in the tumor microenvironment, significantly expanding the potential population of patients who could benefit from leronlimab. At a minimum, the second bullet point associated with leronlimab has to be its safety profile. It has been well tolerated, even in this study of very advanced and fragile patients. There are no serious adverse events related to leronlimab, and importantly, leronlimab has no dose- or treatment-limiting toxicity, meaning the leronlimab dose does not need to be adjusted for any adverse events. That excellent safety profile continues. 05:18 # The ctDNA data Very excitingly, at AACR in April, we presented our early ctDNA declines in the first patients enrolled through City of Hope, results which were obtained under standard of care. We have since finalized the partnership with Natera, and they are completing ctDNA analysis on the other half of patients, who were enrolled under the research protocol. 05:43 What is exciting is that nearly all the patients showed a decline in ctDNA, even as early as week two, with a median decrease of about 85% across all patients, and an early signal of a dose response, which is important. We are working with Natera to generate a comparative ctDNA data set that we can present to the FDA later this year. In the meantime, showing a dose response further drives home the point that these exceptional declines in tumor DNA are largely being driven by the contribution of leronlimab. 06:23 https://preview.redd.it/x1xamu6692ph1.png?width=1600&format=png&auto=webp&s=95c919f1dd2cbe71ecc20813a32fa8ec2090bc28 These are the data presented in April, the first 19 patients, fairly dramatic DNA declines even at week two in all or the great majority of patients. Importantly, about two-thirds of these individuals have a RAS mutation, so it appears that leronlimab's activity is agnostic to the presence of RAS. 06:58 https://preview.redd.it/ta1r6yma92ph1.png?width=1600&format=png&auto=webp&s=05251e2d0fa906c305a4c9ba469523a24115971f These were the week-two data, and then these are the first 23 patients, and you can see the trend has continued toward rapid and very significant declines in DNA. Again, we will be generating a comparative data set from the Natera database to compare this activity with the backbone alone. 07:20 https://preview.redd.it/919no27e92ph1.png?width=1600&format=png&auto=webp&s=891f09eb7e8e85f485472d0782ed737f09dd62fb And if you break down that early readout by dose, you see this very tantalizing suggestion of a dose response, which underscores that this is largely being driven by leronlimab and leronlimab dosing. 07:42 https://preview.redd.it/ke9xndvg92ph1.png?width=1600&format=png&auto=webp&s=d3eb926f0f6e9c4d17cf7f7db4cfd863b12d8742 # Scans, PD-L1, and the standalone-versus-prime-and-pair distinction In concert with these ctDNA declines, we are also reporting that the scans at week eight in the majority, three-quarters, of the patients are demonstrating shrinkage or classify as having stable disease, and we look forward to elaborating on that in the coming weeks and months at both ESMO and ASCO GI. 08:01 Importantly, we are reporting that there are numeric increases in PD-L1 observed in the majority of patients in that CRC study. **In CRC, we are really developing leronlimab as a standalone agent to be used in combination with standard of care. In breast cancer, as we will see in a moment, what we have observed is an induction of PD-L1, turning cold tumors hot, and thereby enabling, apparently, the use of a checkpoint inhibitor to create a pathway to sustained remission.** **So in CRC it is a standalone leronlimab, and in breast cancer it is more of a prime and pair. But the prime and pair works because of what leronlimab does as a standalone agent, priming the tumor for treatment with the checkpoint inhibitor, by disrupting the tumor microenvironment and allowing the host immune system access to the cancer. It is very exciting that in the CRC study we are also seeing increases in PD-L1. It is difficult to know what those increases will mean in terms of translating into clinical benefit when you add a checkpoint inhibitor, and that is something CytoDyn is about to start looking at. But in the meantime, that signal of increased PD-L1 in patients with CRC is a signal that the tumor is under stress, and that leronlimab's impact on the tumor microenvironment may well be allowing the host immune system access to the cancer, which it otherwise did not have, with the cancer responding by expressing PD-L1, trying to beat back that host immune system.** 09:40 Very importantly, speaking to the investigators, they are all excited by what we are seeing in terms of DNA, but in particular they are telling us that patients are doing well clinically. The investigators are writing fewer scripts for pain medication and observing that there are fewer hospitalizations in this rather end-stage population than they anticipated. 10:07 https://preview.redd.it/p7dv3ua422ph1.png?width=1600&format=png&auto=webp&s=e3494850b399fe603595c72ad1104e16eea01cd4 So we are excited about the DNA, and looking forward to reporting on the radiology outcomes and more extensive reports on progression-free and overall survival. Dr. Kasi at City of Hope is our principal investigator, who presented the data at AACR. 10:33 https://preview.redd.it/u3eqes7d22ph1.png?width=1600&format=png&auto=webp&s=5021a3056bf41bd920d8058df4a9d7029737abfb # The first-patient case study In addition, Dr. Kasi, on the next slide, observed the first patient he enrolled, who had a rapid decrease over two weeks, something he had not seen before in an end-stage patient with metastatic CRC. That patient's ctDNA level went from about 129,000 parts per million down to about 10,000 parts per million. 11:00 https://preview.redd.it/6abl9ppk22ph1.png?width=1600&format=png&auto=webp&s=dfe370f82aa6a0d557d1943740ac841a1294ddb1 And then what he saw on the following two scans, first in the liver, the baseline scan on the left and the week-8 scan on the right, this is in a patient who had a 97% decrease in ctDNA, you can see that the tumor volume decreased approximately 21% from baseline to week eight. And indeed, not only does the tumor get smaller, but it appears to become more translucent. 11:25 https://preview.redd.it/w308mjcq22ph1.png?width=1600&format=png&auto=webp&s=8897480e83dab4cb24fff2ecc459b8f2d73b9283 This is even more pronounced on the next slide, which is that same patient with lung metastasis, and you do not have to be a radiologist to appreciate the impact, the shrinkage of that tumor from baseline to week eight after starting leronlimab. 11:40 https://preview.redd.it/54yjnnfv22ph1.png?width=1600&format=png&auto=webp&s=2f5dc114168b39d09b473d38c068a3dbb241aab9 In addition, Dr. Kasi has performed liver biopsies on a number of patients, and we will be launching a study to really interrogate biopsy tissue from these patients treated with leronlimab, to tease out the effect the drug is having specifically on the tumor and the tumor environment. In the meantime, for this first patient, I think you can appreciate the slide on the left is with the PD-L1 stain, the slide on the right is similarly stained, and there is a significant impact on the tumor architecture. But what again is very exciting is the CPS score, the combined positivity score of PD-L1 expression on the tumor and tumor microenvironment, at baseline it was 1%, but in follow-up around week 14 it is up to 5%. And again, I think that indicates a tumor under duress, and CytoDyn is taking next steps to launch a study to explore the efficacy of a checkpoint inhibitor in these MSS CRC patients, for whom otherwise checkpoint inhibitors are not indicated. So, very exciting. 12:47 https://preview.redd.it/flcgg15732ph1.png?width=1600&format=png&auto=webp&s=2b221e539adc6ab873e82713eed9ee1ebb427a82 # The SUNLIGHT benchmark and the protocol amendment And **then the CLOVER study itself is looking to improve upon the current standard of care, which includes Lonsurf and Avastin, where the overall response rate reported in the Phase 3 SUNLIGHT study, in the New England Journal, indicated 6% of patients with a partial response, meaning a 30% decrease in tumor diameter, and there were no complete responders. More recent real-world data has been presented on a larger cohort of patients, indicating the overall response rate is just under 3%. So we very much look forward to presenting our overall response rate and demonstrating some improvement over the current standard of care.** 13:29 https://preview.redd.it/88f6418i32ph1.png?width=1600&format=png&auto=webp&s=3e57278652f053145fa831fd0c1bf79090df2db5 **With the CLOVER study continuing, we have amended the protocol such that patients who are doing well after 48 weeks can continue on treatment on their randomized treatment assignment. We also will be initiating very shortly a rollover arm, as salvage therapy, for patients who have documented progression, wherein they will increase their leronlimab dose up to 700 milligrams if they are not already there, and then add pembrolizumab as well.** # Additional colorectal studies: CHAMP, CLIOS, and pre-I-SPY There are a number of other studies in CRC coming. There is an investigator-initiated trial down at City of Hope, Dr. Kasi, in patients with metastatic CRC and multiple liver metastases, who will be receiving a hepatic artery pump and receiving floxuridine through that, in advance of hopefully curative surgery down the road. What Dr. Kasi is doing here is introducing leronlimab in an earlier line of treatment in patients with CRC. This is a project jointly funded in partnership with City of Hope. And Dr. Kasi is leveraging both the anti-tumor effects of leronlimab as well as the liver-protective, or anti-fibrotic, effects, which CytoDyn has published on from a number of both clinical and preclinical studies we previously performed. And then there are 13 different ctDNA timepoints from the 30 or so patients to be enrolled in what is called the CHAMP study. And we are excited to be able to then also look at some ctDNA results from patients on leronlimab monotherapy. In addition, we have other studies coming in CRC, including a thorough investigation of tumor tissue from patients who were treated with leronlimab. And as well, there is a newly formed network called CLIOS that has reached out and wants to consider studies of leronlimab, both in the neoadjuvant setting as well as in the molecular residual disease setting. And then finally, we are working with the pre-I-SPY network in CRC to launch a study of leronlimab and a checkpoint inhibitor. So a lot of activity in CRC. **And again, the main focus is leronlimab as a standalone.** # Triple-negative breast cancer: the retrospective data 16:05 https://preview.redd.it/l3uu6xn842ph1.png?width=1600&format=png&auto=webp&s=a3e5b80d0e58085dad09221841af94e091cd3e9b Then, turning to triple-negative breast cancer. Again, this is where we got the first signal of the potential of leronlimab in solid tumor oncology. There were three studies launched in 2020 that enrolled a total of 28 patients with triple-negative breast cancer. 16:15 https://preview.redd.it/p884pmzc42ph1.png?width=1600&format=png&auto=webp&s=36c780abd6e3b8e798022bfc76fdaccd21e0a4cb These patients had terribly advanced disease, with two prior lines of therapy in the metastatic setting. Two-thirds had visceral metastases, one-quarter had brain metastases. So this is a population whose survival, unfortunately, is very limited. 16:35 https://preview.redd.it/er7mi5ii42ph1.png?width=1600&format=png&auto=webp&s=481451f7ecb0468483ae760dd5ba43349f6d5cc5 And then what we found, when I came on, was that we wanted to publish the outcome of those studies, so we made phone calls and found out that there were actually 5 of the 28 patients who were still alive. We then went and obtained medical records to determine which patients did well on what treatment. And this slide summarizes that outcome. The seven patients on the right, there is no follow-up blood, so we do not have anything further to say about their outcome and correlation with treatment; this was in the middle of COVID and during lockdown. For the 21 patients on the left, their blue bars are the baseline measurement of PD-L1 on circulating tumor cells. PD-L1 is commonly understood to be something one measures on tumor tissue or the tumor microenvironment. The lab, Creatv MicroTech in New Jersey, has developed technology to use a fluorescent assay to measure PD-L1 on circulating tumor cells, and in particular the cancer-associated macrophage-like cells that break off from the tumor and enter the circulation. So the blue bars are the baseline. The negative control for that assay is about 175 RFUs, and so anything above 400 is considered to be clinically relevant. And you can see that the majority of patients actually did increase their PD-L1 expression after 30 to 60 days, above that 400 threshold, indicating that the tumor has gone from cold to hot, from a tumor that is typically not responsive to checkpoint inhibitors to one that might be. Then in the 7 patients in the red box, among these patients on the left: patient number 4 received a low dose of leronlimab and did not induce PD-L1. Patient 5 received 525 milligrams of leronlimab but likewise did not induce PD-L1. The five patients on the right, in the box, all five received either 525 or 700 milligrams. They all induced PD-L1 within that one-to-two-month time frame. They all received the checkpoint inhibitor either with or after leronlimab, and two of these patients had already previously failed a checkpoint inhibitor. And all five of them are alive today, five-plus years later, which I think is an extraordinary observation, albeit retrospective, and just not an outcome that I believe occurred by chance. Of these five patients who are still alive, three of the five are currently documented to have no evidence of disease, and two of those three started with lung metastasis, and one of those individuals started with both brain and lung metastasis, and we recently published our case report. 19:30 https://preview.redd.it/bwb7e4on52ph1.png?width=1600&format=png&auto=webp&s=4e1b02b7136bdbbb6e672d1df8f6cd071194ad4d In summary from the retrospective TNBC data: there is a 98% reduction in metastasis when you use a CCR5 inhibitor in a preclinical study. Our retrospective clinical data show a reduction in circulating tumor cells in the majority of patients after the first dose of leronlimab, which is very reminiscent of the data we are seeing in colon cancer with the decrease in circulating DNA. We are observing, retrospectively, an upregulation of PD-L1 on about 90% of patients' circulating tumor cells who received either the 525- or 700-milligram dose. And as I said, five out of five of the patients who upregulated PD-L1 and received a checkpoint inhibitor are alive today, five-plus years later. And unfortunately the converse is also true, that 100% of the patients who either did not upregulate PD-L1 or did not receive a checkpoint inhibitor are, unfortunately, deceased. Based on this retrospective data, we have heard from a number of potential partners that they want to see prospective data confirming this upregulation of PD-L1, and eventually the benefit of adding a checkpoint inhibitor. 20:50 https://preview.redd.it/1ylboovz52ph1.png?width=1600&format=png&auto=webp&s=e299e5c5a38ad443162c2a7ba436a2465906e814 # The breast cancer clinical plan On the clinical plan in breast cancer: first, we are working with the Pre-I-SPY network in patients with metastatic TNBC, doing a dose-escalation study, looking prospectively at ctDNA and PD-L1. We are thrilled to have Dr. Paula Pohlmann serve as our principal investigator. When the first cohort of that is done, we will be looking to design a part 2 of the study, which will examine the contribution of components with a checkpoint inhibitor, and that will be an adaptive study design in up to 120 patients. As well, when the first cohort with metastatic TNBC is done, the I-SPY network has indicated they want to launch a study of neoadjuvant leronlimab in patients with newly diagnosed HER2-negative breast cancer, again **significantly expanding the potential population to benefit from leronlimab**. Their proposal is to look at a month of leronlimab monotherapy in these newly diagnosed patients in advance of their hopefully curative surgery. **I think that makes sense as we move leronlimab up into an earlier line of therapy, because we are seeing very potent anti-tumor activity in a number of solid tumors, and the safety profile of leronlimab suggests it deserves an earlier line of treatment.** # Upcoming milestones and priorities To highlight upcoming milestones in the near and mid term: 22:35 https://preview.redd.it/74pze0mk62ph1.png?width=1600&format=png&auto=webp&s=7610b267ab69e2c15b013e9da0cc4921b019813b First and foremost, we are confirming the standalone benefit of leronlimab plus the backbone in CRC, both through biomarker collection, the disease control rate, and then the primary endpoint of overall response rate, as well as the crucial progression-free and overall survival. Second, as we have heard from a number of partner discussions, we need to prospectively demonstrate the induction of PD-L1 in triple-negative breast cancer, where we know that is a critical marker of benefit and is used for the approval of checkpoint inhibitors. We are seeing it prospectively in colorectal cancer, in microsatellite-stable colon cancer, where checkpoint inhibitors are not part of the conversation, but CytoDyn is keen to see if these increases in PD-L1 provide the opportunity to use a checkpoint inhibitor. In the 95% of patients with colon cancer where checkpoints are not indicated, we are prospectively hoping to demonstrate the clinical benefit of adding a checkpoint inhibitor in these PD-L1-induced patients. **And very importantly, to identify the optimal dose in solid tumor oncology. The earliest signals from the CRC study suggest that the 700-milligram dose might be better than 350, and at some point we are going to have to sort out whether there is a difference between 525 and 700.** 24:15 https://preview.redd.it/a16776tz62ph1.png?width=1600&format=png&auto=webp&s=9f525bd03a465ff9ce48fb725c316c58cfc4e5d6 Recent and upcoming milestones: we recently closed on $17-and-change million in funding. At the AACR meeting, we presented the initial ctDNA readouts in the CRC study. Those readouts generated a lot of excitement, and CytoDyn is now pursuing collaborations with the Mayo Clinic, MD Anderson, City of Hope, and a number of other major academic cancer centers. We are very pleased to have closed our strategic partnership with Natera, who is both running the Signatera ctDNA assay on our clinical subjects and providing that crucial comparative data set that we can use to help the FDA put our DNA data into context. There is the City of Hope investigator-initiated study called CHAMP, which will initiate shortly, as well as the Pre-I-SPY study in patients with metastatic TNBC. Both of those studies should be initiating in the next 4 to 8 weeks. I am looking forward to the presentation at ESMO in Spain, which will focus on a complete ctDNA data set for the entire enrolled population, and then at ASCO GI, tying the biomarker data with the radiologic outcomes and early progression-free survival. And there are a number of other additional studies in CRC, including **interrogation of whether adding a checkpoint inhibitor to leronlimab, in patients who produce PD-L1, provides an avenue for treatment with a checkpoint inhibitor in CRC, and then studies both in the neoadjuvant setting and in patients with molecular residual disease.** # FDA and partnerships In terms of the FDA and potential partnerships: partners have been wanting to see data as monotherapy, and they wanted to see prospective data. So we are confirming the durability of these exciting safety and efficacy readouts from the Phase 2 CLOVER study. **We will be presenting the biomarker data and early clinical data at ESMO, and we plan on putting together a package for the FDA and submitting that for Breakthrough Designation before the end of the year. We are presenting the updated biomarker and more extensive clinical data at ASCO GI, and throughout, a top priority for CytoDyn is our continued evaluation of strategic partnership opportunities.** With that, thank you again for the opportunity to present. I think these data are tremendously exciting. It is important to remember that targeting the CCR5 mechanism and showing proof of concept in colorectal cancer is not only important for CRC, but that the CCR5 mechanism is relevant to a lot of other solid tumors: pancreas, prostate, glioblastoma, kidney, urothelial tumors, and of course breast. And so having proof of concept in a solid tumor such as CRC means a little bit more to a company like CytoDyn, where what remains is the potential to have an impact on quite a few other solid tumors. Thank you so much Jay.
Advice: PA School Application Stats Hi! I’m wanting to apply to PA school next year when a couple of programs near me open. I’m currently an ICU RN, but think the NP programs need a serious overhaul and I just can’t bring myself to accept their curriculum that lacks in science courses. Anyways, here’s what I would be applying with (please let me know how I can improve my application): EDUCATION BSN - 2023, 3.5 GPA, accelerated program (All A’s and B’s) BSc Biology - 2020, 3.4 GPA, biomedical sciences (major upwards trend with approx. 3.7 last 60 hrs) (Post-bacc class: OChem 1 retake, I got an A in my undergrad degree and another A last year. I retook it because it was “old” for CRNA school, however I shadowed a CRNA recently and I hated it. I’d much rather work as a diagnostician etc. and not deal with surgeons all day everyday.) EXPERIENCE ICU RN, Feb 2024 - Present (est. 3700-4000 hours) \- Staff Nurse, Relief Charge Nurse, and Preceptor to nursing students and new grad RNs \- I regularly run codes until a provider gets there, titrate pressors, manage vents (within scope), utilize invasive hemodynamic monitoring, I’m ultrasound-guided PIV trained, and I usually am assigned the sickest patients. Clinical Research Nurse, MD Anderson, Oct 2023 - Feb 2024 (est. 675 hours) (I thought about leaving this one off since I wasn’t here long due to increased commute requirement, which wasn’t what I agreed to when I signed on) LEADERSHIP \- ICU Relief Charge Nurse \- ICU Preceptor for RNs \- Sepsis Champion (unit resource for sepsis protocols) LICENSES & CERTIFICATIONS RN License, Sep 2023 - present BLS, ACLS, PALS - all current CCRN (Certified critical care RN) (I am about to take the test but I will have this when I apply) VOLUNTEERING Belize dental mission trip in May 2020, 1 week spent applying sealant and fluoride treatment to kids in rural areas of the country (I was thinking about volunteering at a local wildlife rehab as this is just something that brings me joy outside of medicine) SHADOWING (I haven’t shadowed a PA yet but I do work with NPs who would let me shadow literally anytime I ask. I will find PAs to shadow but we don’t have any in the inpatient side of the hospital. Since I work acute inpatient care, I’d really like to shadow some outpatient setting PA’s.) LORs \- Current ICU manager \- ICU NP and/or MD \- a few other MDs would write me one That’s what I have as of now. Any suggestions? I was thinking about graduate level science classes to show I can handle them since I’ve been post science degree (not including nursing) for about 6 years now.