Is constantly trying to figure out what the h#ll he is doing.
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An interesting article out of Australia. Evolution has apparently come up with an anti-COVID protein 'viricide' that can block COVID infection by binding to the CAP protein that permits the virus entry into a cell. Sounds similar to the artificial version that NNVC 'claims' they want to make. Not that they ever seem likely to get the work done.
https://www.sydney.edu.au/news-opinion/news/2023/02/10/scientists-discover-receptor-that-blocks-covid-19-infection.html
Scientists discover receptor that blocks COVID-19 infection
10 February 2023
The receptor sticks to the virus and pulls it away from the target cells
University of Sydney scientists have discovered a protein in the lung that blocks SARS-CoV-2 infection and forms a natural protective barrier in the human body.
Left: Control Lung. Right: Immunofluorescent staining shows expression of new SARS-CoV-2 spike-receptor LRRC15 (green) in post-mortem lung tissue section from individual with COVID-19 [Credit: Loo and Waller et al.]
Left: Control Lung. Right: Immunofluorescent staining shows expression of new SARS-CoV-2 spike-receptor LRRC15 (green) in post-mortem lung tissue section from individual with COVID-19 [Credit: Loo and Waller et al.]
This protein, the leucine-rich repeat-containing protein 15 (LRRC15), is an inbuilt receptor that binds the SARS-CoV-2 virus without passing on the infection.
The research opens up an entirely new area of immunology research around LRRC15 and offers a promising pathway to develop new drugs to prevent viral infection from coronaviruses like COVID-19 or deal with fibrosis in the lungs.
The study has been published in the journal PLOS Biology. It was led by Professor Greg Neely with his team members Dr Lipin Loo, a postdoctoral researcher, and PhD student Matthew Waller at the Charles Perkins Centre and the School of Life and Environmental Sciences.
The University study is one of three independent papers that reveal this specific protein’s interaction with COVID-19.
“Alongside two other groups, one at Oxford, the other at Brown and Yale in the USA, we found a new receptor in the LRRC15 protein that can stop SARS-CoV-2. We found that this new receptor acts by binding to the virus and sequestering it which reduces infection,” Professor Neely said.
“For me, as an immunologist, the fact that there's this natural immune receptor that we didn't know about, that's lining our lungs and blocks and controls virus, that's crazy interesting.
“We can now use this new receptor to design broad acting drugs that can block viral infection or even suppress lung fibrosis.”
What is LRRC15?
The COVID-19 virus infects humans by using a spike protein to attach to a specific receptor in our cells. It primarily uses a protein called the angiotensin-converting enzyme 2 (ACE2) receptor to enter human cells. Lung cells have high levels of ACE2 receptors, which is why the COVID-19 virus often causes severe problems in this organ of infected people.
Like ACE2, LRRC15 is a receptor for coronavirus, meaning the virus can bind to it. But unlike ACE2, LRRC15 does not support infection. It can, however, stick to the virus and immobilise it. In the process, it prevents other vulnerable cells from becoming infected.
“We think it acts a bit like Velcro, molecular Velcro, in that it sticks to the spike of the virus and then pulls it away from the target cell types,” Dr Loo said.
“Basically, the virus is coated in the other part of the Velcro, and while it's trying to get to the main receptor, it can get caught up in this mesh of LRRC15,” Mr Waller said.
LRRC15 is present in many locations such as lungs, skin, tongue, fibroblasts, placenta and lymph nodes. But the researchers found human lungs light up with LRRC15 after infection.
“When we stain the lungs of healthy tissue, we don't see much of LRRC15, but then in COVID-19 lungs, we see much more of the protein,” Dr Loo said.
“We think this newly identified protein could be part of our body’s natural response to combating the infection creating a barrier that physically separates the virus from our lung cells most sensitive to COVID-19.”
Implications of the research
“When we studied how this new receptor works, we found that this receptor also controls antiviral responses, as well as fibrosis, and could link COVID-19 infection with lung fibrosis that occurs during long COVID,” Mr Waller said.
“Since this receptor can block COVID-19 infection, and at the same time activate our body’s anti-virus response, and suppress our body’s fibrosis response, this is a really important new gene,” Professor Neely said.
“This finding can help us develop new antiviral and antifibrotic medicines to help treat pathogenic coronaviruses, and possibly other viruses or other situations where lung fibrosis occurs.
“For fibrosis, there are no good drugs: for example, idiopathic pulmonary fibrosis is currently untreatable.”
Fibrosis is a condition in which lung tissue becomes scarred and thickened, causing breathing difficulties. COVID-19 can cause inflammation and damage to the lungs, leading to fibrosis.
The authors said they are developing two strategies against COVID-19 using LRRC15 that could work across multiple variants – one which targets the nose as a preventative treatment, and another aimed at the lungs for serious cases.
The researchers also said that the presence or lack of LRRC15, which is involved in lung repair, is an important indication of how severe a COVID-19 infection might become.
“A group at Imperial College London independently found that absence of LRRC15 in the blood is associated with more severe COVID, which supports what we think is happening.” Dr Loo said. “If you have less of this protein, you likely have serious COVID. If you have more of it, your COVID is less severe.
“We are now trying to understand exactly why this is the case.”
Declaration: Professor Greg Neely is funded by the National Health and Medical Research Council (NHMRC) project grants, the NSW Ministry of Health, and a philanthropic donation from Dr John and Anne Chong. Dr Lipin Loo is funded by a Dr John and Anne Chong Fellowship for Genome Editing and seed funding from the Drug Discovery Initiative at the University of Sydney, and Mathew Waller is funded by a Research Training Program (RTP) Scholarship from the Australian Government.
Hero image: Abstract depiction of human fibroblasts and virus generated using OpenAI’s DALL·E 2 [Credit: Greg Neely]
Yep. Hiring is a good sign that they think that they are going forward with production. Why take on salary if you don't think revenue is going to follow at some point in the relatively near future?
I got yet another call from the proxy people for NNVC this morning. I'm hoping that the other non-voting hold outs are also telling NNVC to get stuffed.
Looks like the presentation was received with enthusiasm - market is pretty happy with Citius today.
What makes you think that I have lost any money? There are only two days when the price of a security or asset is important.
The day you buy it.
The day you sell it.
I haven't sold CVM yet. So I haven't lost money on CVM yet.
Your opinion on that matter has been noted. I'm going to continue doing what I do because it works for me.
Did I stutter? Yes, I am investing absolutely correctly for my own needs and purposes. You think 'trading' is the same as investing. It's not.
I regularly check the prices of everything in my overall portfolio. It's doing fine as a whole - although it has taken a bit of a downturn like most of the rest of the market the last few quarters. Since I don't need that capital in my accounts 'now' and since I expect it all to rebound before I need that capital years from now - I'm just continuing to slowly add and accumulate in the meantime.
Similarly, since I plan to hold my CVM shares past the point where they get their BLA submitted and their revenue stream going rolling - a year or two from now - the current price is kind of irrelevant. CVM is a small fraction of the securities that I own, but once they do get their revenue stream going that fraction will make a big gain, and I will plan on starting to sell it off in pieces and reinvest those gains into something else.
Again - I don't need that capital that is in CVM 'now', because I don't put ANY of my money into the market that I need 'now'. Buying something for $2.27 now that I figure will be worth 10-20X that (or more) if I just sit on it a year or so is a good wager. Besides - I can wait out the long-term capital gains taxes when it does pay off.
I refuse to listen to people like yourself - because your strategies are very different than mine. You refuse to listen to people like myself - because your strategies are different than mine.
And no - I don't generally buy lottery tickets. Once in a while when like the Powerball gets sky-high I buy a ticket for $2 - but I don't expect to win. CVM at this stage is an excellent wager. Check back here after their BLA is filed.
Nope - I'm doing it exactly correctly for myself. Your opinion here is irrelevant.
The vast majority of my investment & retirement $$$ goes into boring index funds and things that pay dividends. This is just my speculative fraction of what I hold.
Yeah - I'm not a particularly big fish as regards NNVC - but the idea to redomicile in Delaware doesn't sit well with me. Not that Nevada is particularly shareholder friendly - but Delaware's corporate rules favor insiders too much over other investors IMO.
I'm guessing that one or more big shareholders also didn't like that idea.
Cash from my regular, planned, automatic deposits that I didn't otherwise have a specific EOY purchase plan for. Nothing too huge.
I don't really 'trade' in and out of anything. I tend to buy things to accumulate them, and with the plan to sit on them for a while. It was enough to buy 'round number' of shares at those depressed prices to add to my existing stash.
I actually got a call from the company yesterday that I let go through to voicemail - "Reminding" me that I needed to vote my proxies. I intentionally didn't vote last time and helped them miss having a quorum.
:D
Oh Boy!!!! Another conference announcement!
/sarcasm off/
NanoViricides, Inc. to Present at the Biotech Showcase(TM) 2023 Conference in San Fransisco on January 9th at 10:30am PT
6:35 AM ET 1/4/23 | Dow Jones
SHELTON, CT / ACCESSWIRE / January 4, 2023 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), announces that the Company's President, Dr. Anil Diwan, will be presenting a talk in person at the Biotech Showcase(TM) 2023 Conference in San Fransisco on Monday, January 9th at 10:30pm PT.
Event Biotech Showcase(TM) 2023 Conference
-------- --------------------------------------------
Dates January 9-11, 2023
-------- --------------------------------------------
Location Hilton San Fransisco, Union Square
-------- --------------------------------------------
Website https://informaconnect.com/biotech-showcase/
-------- --------------------------------------------
Event NanoViricides Presentation
-------- -----------------------------------
Date January 9, 2023
-------- -----------------------------------
Time 10:30 am PT
-------- -----------------------------------
Location Track: Yosemite C (Ballroom Level)
Hilton San Fransisco, Union Square
-------- -----------------------------------
Dr. Diwan will present the Company's Assets NV-CoV-2 and NV-CoV-2-R, and the NanoViricides Drug Encapsulation and Site-Directed Delivery Platform Technology. His talk will focus on the Company's lead drug candidate, NV-CoV-2 for the treatment of COVID-19 and long covid. A highly effective, broad-spectrum drug candidate like NV-CoV-2 is an unmet need in the COVID-19 pandemic that is now entering the endemic phase, with novel variants arising continuously. Recent variants have led to reduced effectiveness of vaccines, including the newest 'bivalent' vaccines, and have led to all of the antibodies losing emergency use authorizations (EUAs) due to loss of effectiveness. Paxlovid (Pfizer) has been found to be of no benefit except in patients that are at high risk of severe disease due to co-morbidities such as diabetes. However, its use is restricted even in those populations due to interactions with other life-saving drugs that the patient may be required to take. The most recent variant, XBB.1.5 is even more resistant than the prior BA.4/5 variants and is rapidly leading to a potential new wave of large numbers of infections and hospitalizations in the US. Further variants will continue to arise that could be more severely pathogenic. Thus NV-CoV-2, an antiviral agent that is expected to continue to work even as the virus keeps changing, is sorely needed for the global societies to resume normal functioning without accepting an undue cost in morbidity and mortality.
Dr. Diwan will also discuss the Company's rich pipeline of broad-spectrum drug candidates against many other viral diseases.
"Presenting at Biotech Showcase is an important step towards our partnership strategy for drug development," said Dr. Anil R. Diwan, adding, "The strong effectiveness of NV-CoV-2 and the strength of our encapsulation platform as demonstrated by NV-CoV-2-R match unmet needs sought after by potential partners."
Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry's largest gatherings and busiest weeks.
"We are delighted that NanoViricides will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."
About Biotech ShowCase
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place. Investors and biopharmaceutical executives from around the world gather at Biotech Showcase during this bellwether week which sets the tone for the coming year. Now in its 14th year, this well-established, highly respected conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.
About NanoViricides
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide(R) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-Cov-2 into Phase I/II human clinical trials.
NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of
NV-CoV-2 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour(R) nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
(MORE TO FOLLOW) Dow Jones Newswires
January 04, 2023 06:35 ET (11:35 GMT)
I had some spare cash in one of my accounts at EOY that I didn't have any specific plans for - so I bought some more shares of CVM at about $2.28 on Thursday. Looking pretty good now and lowered the old cost-basis a bit more as well.
2023 should be a good year for us long holders. Hope everybody had a safe and enjoyable New Year's weekend.
Good to see it more or less on time and as scheduled. Still no obvious mention of a timeline for getting the BLA process started though.
Also noted that - at least as of the end of the last quarter - they were still 'validating' the manufacturing labs. I wonder if that's part of the hang-up? Would nice if it were part of the problem - that they would just come out and say so.
Markets have been massively bearish - with justification. Until CVM makes an obvious move toward seeking FDA approval - CVM will remain bearish - with justification.
Hope you all are having a safe and happy set of holidays.
And - that was a lot of nothing - like everything else.
https://finance.yahoo.com/news/nanoviricides-inc-present-rhk-capital-114500122.html
2023 could develop into a very good year for this little pharma company.
I would have thought that there would have been more positive sentiment at this announcement.
ContraFect Announces ANSM Approval of Clinical Trial Application for Exebacase in Prosthetic Joint Infections
by
Globe Newswire
November 28, 2022 8:00 AM | 6 min read
https://www.benzinga.com/pressreleases/22/11/g29868511/contrafect-announces-ansm-approval-of-clinical-trial-application-for-exebacase-in-prosthetic-joint
YONKERS, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) -- ContraFect Corporation - CFRX
CFRX, a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, announces today that ANSM, the French National Agency for the Safety of Medicines and Health Products, has authorized its Clinical Trial Application (CTA) for the study of intra-articularly administered exebacase, in the setting of a minimally-invasive arthroscopic debridement, antibiotics, irrigation, and retention (DAIR) procedure in patients with chronic prosthetic joint infection (PJI) of the knee due to Staphylococcus aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS).
"This is a significant milestone for our company as it represents the next opportunity for exebacase to recapitulate the positive and durable results we have observed clinically in the compassionate use setting, after dosing 16 patients. Exebacase presents the potential for a truly revolutionary change to the current treatment paradigm for patients with prosthetic joint infections, which consists of the chronic use of ineffective antibiotic agents leading to expensive and debilitating surgery, whereby the joint is removed and reimplanted 6 to 8 weeks after the patient's confinement to a hospital bed," said Roger J. Pomerantz, MD, President, Chief Executive Officer, and Chairman of ContraFect. "PJIs are a completely underserved area of medicine, where no randomized clinical trials have been completed. As the population of the developed world ages, we must find a safe, effective and minimally-invasive way to treat these infections or millions of patients will continue to suffer. Based on promising activity we have seen with exebacase in vitro, in vivo, and in compassionate uses to date, we look forward to completing what could be the first successful blinded and randomized trial in the field of PJIs."
The Phase 1b/2 study of exebacase is a randomized, double-blind, placebo-controlled two-part clinical study to be conducted in France to assess the efficacy and safety of exebacase in the setting of an arthroscopic DAIR procedure in patients with chronic PJI of the knee due to S. aureus and/or CoNS. Part 1 will evaluate the safety, PK, clinical outcomes, and microbiologic response in patients through Day 42. Up to 2 dose levels of intra-articularly administered exebacase in addition to systemic antibiotics will be studied in up to 2 patient cohorts. Part 2 will consist of a long-term follow-up study of safety and efficacy parameters in patients who complete Part 1 of the study. Follow-up assessments will be performed on Days 90, 180, 360 and 720.
About ContraFect
ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our platform of DLAs, which include lysins and amurin peptides. Lysins are a new class of DLAs which are recombinantly produced antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. Amurin peptides are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. We believe that the properties of our lysins and amurin peptides will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. We have completed a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis, with our lead lysin candidate, exebacase, which is the first lysin to enter clinical studies in the U.S. Exebacase was granted Breakthrough Therapy designation by the FDA for the treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics.
Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.
Forward-Looking Statements
This press release contains, and our officers and representatives may make from time to time, "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding ANSM approval, the CTA and the clinical trial, statements made by Dr. Pomerantz, the conduct of the Phase 1b/2 study, ContraFect's ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, whether ContraFect will address life-threatening infections using therapeutic candidates from its DLA platform, whether lysins are a new class of DLAs which are recombinantly produced, antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics, whether amurins are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, and whether the properties of ContraFect's lysins and amurins will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control, including, without limitation, that ContraFect has and expects to continue to incur significant losses, ContraFect's need for additional funding, which may not be available, the occurrence of any adverse events related to the discovery, development and commercialization of ContraFect's product candidates such as unfavorable clinical trial results, insufficient supplies of drug products, the lack of regulatory approval, or the unsuccessful attainment or maintenance of patent protection, changes in management may negatively affect ContraFect's business and other important risks detailed under the caption "Risk Factors" in ContraFect's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 and its other filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Relations Contacts:
Michael Messinger
ContraFect Corporation
Tel: 914-207-2300
Email: mmessinger@contrafect.com
CEL-SCI Corporation Issues Letter to Shareholders
https://feeds.issuerdirect.com/news-release.html?newsid=8500063869860512
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
Dear CEL-SCI Shareholders:
I wanted to write to update you on our progress. Our story is following the well-worn path of all successful biotech companies—we had always hoped our investigational drug Multikine* (Leukocyte Interleukin Injection) would help patients, but now we know that it does. Our 10-year Phase 3 trial showed that Multikine immunotherapy significantly extended the lives of patients with locally advanced primary squamous cell carcinoma of the head and neck (“SCCHN”) – oral cavity/soft palate. This form of cancer is particularly difficult to treat, and there has been no improvement in first-line therapies for those who would get surgery as a first treatment in more than 50 years, despite major efforts, including by large Pharma.
Current drug therapies for SCCHN from Merck and Bristol Myers Squibb (BMS) are approved as a last resort for recurrent tumors after treatments have failed or for patients who are not candidates for surgery. By contrast, Multikine is given to newly-diagnosed patients following initial diagnosis — it’s the first of its kind with substantial survival benefit in a randomized Phase 3 trial in locally advanced primary SCCHN. The Multikine treated study population showed the following advantages over control:
A median overall survival improvement of 46.5 months— nearly four years .
62.7% of Multikine patients were alive after five years vs. 48.6% in the control.
Nearly one out of every six patients had their tumors shrink by more than 30% in just 3 weeks.
Five patients had their tumors completely disappear in just 3 weeks.
Tumor shrinkage/disappearance cut the death rate by a factor of three .
There are approximately 210,000 patients diagnosed globally each year who would be eligible for Multikine treatment following approval, with about 25,000/annually in the U.S. This group reflects patients who are deemed at “lower-risk-of-recurrence” per the Guidelines of the National Comprehensive Cancer Network. Despite the “lower-risk” label, the disease survival rate is only about a 48% chance of living past five years. Multikine increased the survival rate to more than 62% at five years. For patients deemed at “higher-risk-of-recurrence,” Multikine is not suitable because those patients receive chemotherapy following surgery, which we think negates Multikine’s biological mechanism of action. The lower-risk-for-recurrence patients, by contrast, do not receive chemotherapy.
CEL-SCI’s data compares favorably to other already approved SCCHN therapies. Merck’s drug Keytruda was approved for recurrent SCCHN based on a single-arm trial with a 16% tumor response rate—we showed the same response rate in a randomized controlled trial. Keytruda did not show a survival improvement—we showed a 29% survival improvement. BMS’s drug Opdivo was approved based on only a 2.4-month life extension—we showed a median 46-month improvement in life extension. Furthermore, Multikine has a much more favorable toxicity profile than these approved products.
You might ask what is taking so long? For one, our treatment approach is new – no one has done this before successfully in this disease, and our data are unprecedented. Giving a treatment before surgery is called “neoadjuvant,” and this is a completely new approach for treating SCCHN. None of the currently-approved immunotherapies for SCCHN are indicated as a neoadjuvant – to be given first after diagnosis. New discoveries such as ours are exciting and can provide great benefits to patients and shareholders, but they inherently take longer to move forward because they require more discussion and more proof. There is little precedent we can use to leverage our drug forward, and we have to prove safety and efficacy from scratch without standing on the shoulders of those who have come before us. This takes time.
We also do not have the resources of Merck or BMS, and this contributes to the timing as well. Simply put, we have a much smaller team. Nevertheless, I am proud to say that we have assembled an incredible bullpen of experts. We have brought in consultants who used to work at FDA, world-class biostatisticians, and Key Opinion Leaders to help us. Our team is working 24/7 on the approval process for Multikine in this horrible cancer.
My personal belief in the success of Multikine is evidenced by the fact that I have not personally sold a single share of CEL-SCI in the past 20-plus years. In fact, I have repeatedly invested more. There is a very great need for the benefits that Multikine has shown it can provide. We are dealing with a devastating cancer. Tongues are removed at surgery, people’s faces are disfigured, affecting speech, eating, breathing, and so much more. For decades, despite much effort, every study in locally advanced primary SCCHN has failed to show any survival benefit—until this pivotal study for Multikine. In our study, which is the largest and longest SCCHN study ever, Multikine added significant overall survival advantages to patients who received only radiotherapy but not to those who had chemotherapy added to the treatment. And Multikine did not appear to add any safety issues over and above those of the normal standard of care. A highly effective cancer drug that does not appear to add toxicity is truly unprecedented .
Our detractors say that our clinical trial results are spurious, but these folks just don’t understand. The lower-risk analysis was pre-specified in our protocol before the study even began, so we did not cherry-pick the data. The survival benefit was driven by tumor shrinkages and tumor disappearances, which were seen with greater than 99.9999% certainty. And the reduction in death rate from having a smaller tumor following Multikine and before surgery was shown with greater than 99.99% certainty. You can’t argue with the numbers— these benefits are real and they are the direct result of Multikine .
I believe that this product needs to be made available to patients because it can save lives. That is what we are working towards and for you as a shareholder, whether you hold for profit or personal reasons, or as many do, for both, that is what matters. We all have seen the ravages of cancer and we need to do better. We will do all we can to bring Multikine to those patients who would get the large survival advantage that we saw in the Phase 3 trial.
Thank you for your continued support.
Sincerely,
Geert Kersten
Chief Executive Officer
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2021. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221122005329/en/
Gavin de Windt
CEL-SCI Corporation
( 703) 506-9460
I haven't put any new money in NNVC for years.
Politicians like Rokita are a reason why I am always glad that while I am a native of the state of Indiana - that I have not lived there for almost 30 years.
From the most recent quarterly,....
Hey there as well lief. Hope life is treating you well.
Gracias!
*crickets* Very loud crickets.
OK - it's been a month+ since I last posted here. Anybody heard of any updates on the spin-off company idea? As I recall - the company said something about trying to do that during the 2nd half of 2022. We're rapidly running out of 2022 according to the old reliable wall calendar.
Agreed - both about the other poster, and about what I hold in CVM.
I own a significant enough number of CVM shares that I will do quite nicely when the company *does* finally get its BLA act together and gets its FDA approval rolling forward. However, even in the (IMO unlikely) event that doesn't happen and the company does go bust, I haven't gone off the deep end with sunk money to lose.
My day-job definitely pays the bills and then some. I hold some shares in other biotechs as well, but similarly haven't gone too deep down any one of those rabbit-holes either. Most of my investment bucks go into boring index funds and dividend yielders. This is the 'gambling' money here.
AdamF is a useless shill for stock price manipulators - he's noteworthy primarily for being a stooge.
I sold what I had left for the tax loss this morning. No way I was going to pay a reorganization fee to the brokerage for this failed company. Once that R/s was approved I knew the time had come.
Luckily, I had some profits from an account that I closed earlier this year and I can offset some of that with the loss from Ampio.
All sounds quite promising. Now GET IT DONE!
Agreed. I've been figuring to take this as a stock loss to offset some other gains I made earlier this summer.
I think I'll go ahead & do that shortly. I did hang around long enough to vote NO on the R/S though.
Your opinions have been long noted Sushi.
They're biased, intentionally slanted & inaccurate opinions in most ways, but everyone is entitled to their opinion.
Don't be caught holding short in the foreseeable future though.
Why am I in no way shocked that the annual report is going to be late. And I am guessing it's not because they are about to announce starting a clinical trial.
Surprisingly little positive movement after such a bit of good news today.
Interesting little *pop* out of nowhere this afternoon.
Only the foolish would think that the Meeting Abstract and presentations - which gave absolutely no new information - would do much of anything for current share prices.
This stock will not move much - one way or the other - until the pre-BLA meeting has been scheduled, and until the BLA package has been submitted to the FDA for review.
Until then, there's no good reason to expect this stock to consistently appreciate in value.
You mistake anger for massive indifference about a specific poster that youreference. That poster is irrelevant.
Not worth considering actually.
You're amusing. Go away.
Generally agreed on all points - and at some point in the relatively near future - when the BLA is finally submitted I think there are going to be a lot of shorts massively pissing themselves, and a lot of latecomers attempting to jump onto the bandwagon.
And I am just going to smile broadly, and enjoy the fun.