Fibrosis split from MASH at some point on the pipeline chart:

https://www.cytodyn.com/pipeline

https://www.targetedonc.com/view/fda-clears-phase-2-trial-of-leronlimab-for-microsatellite-stable-crc

Holy cow. PACV kept that info quiet as possible. How can that be for a public company. How is that not material information?

Excerpt taken from the September Shareholder Letter:

In addition to CRC, CytoDyn is investigating the role for leronlimab in two other oncology indications via strategic and low-cost research and development opportunities, and in collaboration with several reputable institutions. I am pleased to announce that CytoDyn is working with a team of experts to resume the exploration of Triple-Negative Breast Cancer (“TNBC”), including colleagues from the University of Hawaii Cancer Center, MD Anderson Cancer Center, and the Pennsylvania Cancer and Regenerative Medicine Research Center. We will be working with this team in the coming months to design and conduct a preclinical TNBC study that will aim to confirm the mechanism of action of leronlimab in oncology and address the question of potential synergies with both antibody-drug conjugates and immune checkpoint inhibitors. The Company intends to use this preclinical study to form the basis for a potential partnership and better inform the design of a follow-up clinical study in patients with metastatic TNBC.

New SAB member:
Clinton Yam, MD, MS
Dr. Clinton Yam is an Associate Professor with dual appointments in the Departments of Breast Medical Oncology and Translational Molecular Pathology at The University of Texas MD Anderson Cancer Center. Dr. Yam is leader of the triple-negative breast cancer (TNBC) working group and Director of Team Science and Innovation in the Department of Breast Medical Oncology at MD Anderson. He is the principal investigator for several industry sponsored and investigator initiated clinical trials. Dr. Yam is very much involved in multidisciplinary efforts aimed at understanding the biology of TNBC to inform the design of innovative clinical trials to improve outcomes for patients with TNBC.

Who says they don't? We'll find out in due time. The trial does't start until early next year.

Tanya has done a great job steering CYDY to calm waters. I do think she may have been too strict directing Tyler along the way PR wise but that is just my opinion. She isn't going anywhere until Dr NP's trial is over and any lawsuit she is named in is dealt with.

It takes time for the info to be posted on the clinical trials site once the company finalizes the details. As per the PR, they are having a trial kick off meeting in late November. Could very well be some final trial planning decisions at that point so revisions are possible.

Details not posted on the clinical trials website yet.

As far as we know Cytodyn is paying for the phase 2 trial. If the results pan out, there is a great chance there will be multiple BP companies interested in partnering for a phase 3.

Definitely happy to see this long overdue news. Thanks for posting!

I'm happy they figured out the next steps with SMC and rather quickly, for them, initiated the additional studies. The CYDY team deserves some credit.

I was told to expect CR to respond to the SEC. Apparently he did not.

I'm not sure if CRXM even exists as a company at this point.

I am extremely disappointed in the CRXM management team for not communicating an update with shareholders.

https://www.sec.gov/files/litigation/opinions/2024/34-101312.pdf

CytoDyn Appoints Dr. Melissa Palmer, M.D., as Lead Consultant in Hepatology; Announces Follow-Up Inflammation Studies with SMC Laboratories
Download as PDFOctober 30, 2024 8:30am EDT
VANCOUVER, Wash., Oct. 30, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Dr. Melissa Palmer, M.D., has been engaged as Lead Consultant in Hepatology. In this role, Dr. Palmer will drive the Company’s strategy for research and development in Hepatology, leveraging her expertise to further CytoDyn’s clinical evaluation of leronlimab in treating liver conditions, including MASH and liver fibrosis. This engagement follows the recent breakthroughs with SMC Laboratories (“SMC”).

In addition, the Company announced that following promising initial results from its preclinical study with SMC, it has commissioned the lab to conduct two follow-up studies to confirm and extend the observation of fibrosis reversal observed in the study concluded in September 2024. Both follow-up studies are underway, with results expected in early 2025.

An internationally renowned hepatologist, Dr. Palmer brings more than three decades of deep research experience to the CytoDyn team. She has held leadership positions at several biotech and pharmaceutical companies, including serving as Chief Medical Officer of Gannex/Ascletis and Head of Liver Disease at Takeda Pharmaceutical Company. She has also worked as a hepatology consultant with over 60 biotech and pharmaceutical companies since 1991 and previously served as interim Chief Medical Officer of CytoDyn.

In addition to consulting, Dr. Palmer has been the primary investigator for numerous clinical trials in MASH and other liver diseases. Her work has been published in over 100 publications, abstracts, manuscripts, books and book chapters, including several guidelines she co-authored with colleagues from the FDA and EMA concerning drug-induced liver injury among patients in clinical trials evaluating potential drugs to treat MASH and other liver diseases. She also maintained a solo medical practice treating patients with liver disease for over 20 years.

Dr. Palmer will work with the CytoDyn team to oversee the two follow-up studies with SMC. These studies will again compare leronlimab alone and in combination with other therapies, including both resmetirom, the only approved treatment for MASH, and a GLP-1 agonist in an increased number of mice evaluated in both a proprietary STAM model of MASH which includes T2DM (previously studied), as well as a second model of liver fibrosis driven by CCL4 toxicity that is independent of fat deposition.

“As we continue to capitalize on our momentum and push forward the path of scientific discovery here at CytoDyn, we are pleased to welcome Dr. Palmer to the team,” said Dr. Jacob Lalezari, CEO. “Dr. Palmer’s robust research and consulting background, and past familiarity with CytoDyn, will provide the tailored expertise we need to maximize opportunities to pursue breakthroughs in new treatment paths for MASH and liver fibrosis.”

Dr. Palmer added, “This is an exciting time in liver health research, as scientific innovation paves the way for improved treatments for conditions like MASH and liver fibrosis. I look forward to collaborating with the CytoDyn team to advance clinical evaluations of leronlimab, including the studies in motion, and explore new treatments that have the potential to truly transform patient outcomes.”

Dr. Palmer trained in Hepatology at Mount Sinai School of Medicine, where she also received her M.D. degree. She also holds a B.S. from Columbia University and is a Fellow of the American Association for the Study of Liver Diseases.

I’m giving up my moderator position here on the CRXM board. Anyone interested in jumping in is welcome to do so.

Best to you all.

Does anyone know if a new entity has been formed and if our CRXM common shares affords us an ownership interest is this new entity?

Been well over 6 months since they filed the NT 10K. Do they even plan on continuing as a public company?

OTC Markets didn't find anything for CRXM when I checked. Given the SEC's latest letter to Gene Bio, can't say I am surprised. I will say I'm disappointed in CR at the moment. The least he could do is put a banner on the company website providing some clarity on where things stand. Chris, do the right thing and give shareholders an update!

Any information on how much success there has been raising money for the trial?

I’m not sure about trading again. It will require a huge investment to get current. Unless CR has come up with another project to pursue that being a public traded company would be of benefit. Or another indication for Generx that gets carved out from the hoped for trial and new investors.

Any unofficial updates regarding CRXM?

Is this related to PACV?

I understand CYDY has used AI to come up with additional formulas and indications for leronlimab. Unfortunately I don't think Chris has the money to do anything like that although it could present some options.

3 months or more since I have been aware of the $20m plan. Be nice to hear an update.

AAV research 2022 press release, plus 2024 pre-clinical poster abstract

Here's the July 2022 press release announcing the NIH grant for the AAV research with Leronlimab.

https://www.cytodyn.com/newsroom/press-releas...ional-cure

"The grant will fund the development and preclinical research of a single-injection gene therapy that codes for the leronlimab protein sequence and which will be delivered via an adeno-associated virus (AAV) vector. The study will examine if this gene-therapy approach could provide the potential for “functional cure,” i.e., sustained viral suppression to people with HIV without requiring them to take medications for the rest of their lives."

Here's the July 2024 poster abstract at
https://programme.aids2024.org/Abstract/Abstr...actid=3857

"In two of the RMs, SHIV viremia declined and reached undetectable levels between 10-40 weeks post-AAV, and those levels have remained undetectable through 70 weeks post-AAV. The remaining two RMs developed ADAs within 5-15 weeks post-AAV resulting in complete clearance of Leronlimab from plasma as well as a rapid decline in CCR5 RO. Spontaneous reemergence of CCR5 RO by Leronlimab was observed approximately 1 year post-AAV. One of the two animals has had full and sustained CCR5 RO, detectable plasma Leronlimab, and undetectable SHIV RNA in plasma for over 1 year post-reexpression. The second re-expressing animal has achieved and maintained 100% CCR5 RO for about 10 weeks, has detectable plasma Leronlimab, and has declined plasma viremia."

abstract released today
https://programme.aids2024.org/Abstract/Abstr...actid=3857

excerpts

Title
Delivery and long-term expression of CCR5-blocking monoclonal antibody Leronlimab with AAV for ART-free remission from SHIV viremia

BACKGROUND: CCR5 blockade represents a scalable non-transplantation approach for long-term ART-free HIV remission. Here, we tested if AAV vectors could induce long-term expression of CCR5-blocking monoclonal antibody Leronlimab in a SHIV-infected rhesus macaques (RMs).

METHODS: Four SHIV-infected RMs received AAV9 encoding macaque Fc Leronlimab with stabilizing, silencing, and half-life extending mutations (AAV9-MacLSLeron). Animals were monitored longitudinally for CCR5 receptor occupancy (RO), plasma Leronlimab concentrations, antidrug antibodies (ADAs), and SHIV plasma viral loads.

RESULTS: All four AAV9-MacLSLeron-treated RMs reached 100% CCR5 RO on blood CD4+ T cells within 1 week and plasma Leronlimab was detected (>1ug/ml) within 2 weeks of AAV administration. In two of the RMs, SHIV viremia declined and reached undetectable levels between 10-40 weeks post-AAV, and those levels have remained undetectable through 70 weeks post-AAV. The remaining two RMs developed ADAs within 5-15 weeks post-AAV resulting in complete clearance of Leronlimab from plasma as well as a rapid decline in CCR5 RO. Spontaneous reemergence of CCR5 RO by Leronlimab was observed approximately 1 year post-AAV. One of the two animals has had full and sustained CCR5 RO, detectable plasma Leronlimab, and undetectable SHIV RNA in plasma for over 1 year post-reexpression. The second re-expressing animal has achieved and maintained 100% CCR5 RO for about 10 weeks, has detectable plasma Leronlimab, and has declined plasma viremia.

CONCLUSIONS: While further investigation is needed to develop AAV vectors and/or regimens that reduce the incidence of ADAs, the transgene reexpression phenomenon we have observed highlights the need to further investigate the interplay between AAV establishment and the development of ADAs. Overall, these data demonstrate the potential of AAV vectors for sustained antibody-based CCR5 blockade as a gene therapy approach for long-term ART-free HIV remission.

Your idea of good news is what we should have as just normal operations.

Closing orders only according to Schwab this morning

If the company stays private, there needs to be a way to connect shareholders to buy and sell shares. I owned a shares of stock in a local community bank that was growing its business. The President of the bank had a list of buyers and sellers he would connect. Eventually a link on the banks website allowed shareholders to deal directly with each other.

It would be nice to hear progress details. I'm keeping my fingers crossed CR will be able to put the financing together to move forward with the study. It will be interesting to hear what is in store for CRXM as a company and common shareholders.

Where else would you find the most respected woman in meat?

You probably have to do the trade through a broker phone call.

Thanks for the update. We’ll see what happens but I’m not holding my breath.

Putting money in most of these OTC stocks is more like going to Vegas than real investing. PACV could have been different considering they have or perhaps had real products with revenue and employees. I'm not sure it is dead yet as a company but it might be over for us shareholders. It is extremely rare for companies to make it back when they get demoted to a lower exchange.

Nothing but silence for shareholders.

Shame. Thanks.

Hey, BTW, I just saw your private reply post to me from back in May.

I do have the document but I won't share more since I did the super secret handshake. LOL. Perhaps CR will make it available soon.

Yeah that is it thanks. Any idea what happened to him?

Anyone remember the alias of the guy who posted a few years back a fair amount. Older. Trader back in the day. Always dropping stories about deals he had been in on. Has not posted in a long time.

Experienced Leadership & Small Management Team: Gene Bio’s management team is led by Christopher
J. Reinhard, the founder of Gene Bio who has been a driving force responsible for advancing the Generx product
candidate from a pre-clinical lab study at the University of California-San Diego into this current FDA-cleared
Generx Phase 3 clinical study program. Mr. Reinhard was also instrumental in raising over $200 million to lead
and support the Generx development effort. He has also been responsible for three other successful FDA product
registrations.
Nostrum Pharmaceuticals operates multiple manufacturing facilities, supported by sales, marketing and
distribution activities. Nostrum sells generic drug products to hospitals and retail drug stores, by prescription
only, throughout the United States. Nostrum has facilitated the company’s recent financial restructuring and was
responsible for the development of a new Phase 3 clinical plan for FDA registration, and the commercial biologics
manufacturing plan for the Generx product candidate at FujiFilm Bio in Texas.
Nostrum currently owns approximately 75% of Gene Biotherapeutics and approximately 25% is owned by Gene
Bio’s formerly public company shareholders. Following completion of his funding, these shareholders will be
issued contingent value rights (“CVR”) for their proportional share from the net cash distribution entitlements
from the sale of Generx. Gene Bio investors currently own an 85% interest in Generx, and Huapont Life Sciences,
a Chinese-based, publicly traded, pharmaceutical company, owns a 15% equity interest in Generx, and Huapont
Confidential
4
has an exclusive right to manufacture (under certain conditions) market and sell Generx in mainland China
following FDA approval of Generx in the United States.
Nostrum has had some financial setbacks and challenges with its core business, which is why we are now seeking this financial strategic joint venture offering to secure external financial resources to accelerate the clinical developement and commercialization of our Generx product candidate at this time.

Business Strategy: Gene Bio is a small biotechnology research and development boutique, located in San
Diego, that operates with a near-virtual, cost-conserved operating structure. We have a small, highly
experienced team that is currently singularity focused on the successful clinical development and strategic sale
of Generx. This team has worked together on the scientific, medical and clinical development of Generx over the
past 15 years. Set forth below are the key contractors that will be utilized to complete the FDA-cleared Phase 3
Generx study:
(1) FujiFilm Diosynth Biotechnologies: FujiFilm Bio is a world scale operation located in College Park,
Texas. They have expertise in process development and cGMP manufacture of cell and gene therapy
products oncolytic viruses and virial vaccines. We have entered into a manufacturing agreement with
FujiFilm Bio to manufacture Generx supplies for the planned Phase 3 clinical study, and they also have
the current capability to commercially manufacture final Generx product following FDA approval. We
expect that it will take approximately one year to manufacture Generx supplies for the clinical study at an
estimated cost of $5.0 million. In addition, once the final Generx study product is manufactured, Gene
Bio will be required to conduct a preclinical biodistribution study in preparation for the submission of the
Generx Biologics License Application (BLA) with the FDA.
(2) Comac Medical: We are planning to enter into an agreement with Comac Medical, which is located
in eastern Europe, to conduct our final FDA-cleared, Phase 3 clinical study. Comac Medical will be
conducting the study at up to 35 clinical sites, that will include approximately 30 sites in eastern Europe
and Turkey and approximately five sites in the U. S. Based on a recently completed geographic survey,
Comac believes that it is feasible enroll up to all 225 patients during a 12-month recruiting period following
the availability of Generx from FujiFilm Bio. Based on this current plan, we estimate that this clinical
study will cost up to $10.0 million. A copy of this plan, as prepared by Comac Medical, is included in this offering document.

You should reach out to Chris Reinhard and ask for information if you are an accredited investor and have $1 million to invest. The return on investment is amazing. They ae looking to raise $20 million as of the end of May.

It would be great to know how much has been secured and is there an investment banker promoting the deal. If so, who?

How are the current common sharehoders of CRXM going to be treated should a sale happen?

Is CRXM going to stay "private" or get back to trading again and if so, which market?