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Didn't you "Move On". Sooooo, move on.
Here comes the rain again... " While CEL-SCI may have received positive feedback from the FDA, their small sample size and lack of long-term data raises concerns about the efficacy of Multikine for treating advanced head and neck cancer. Investors should proceed with caution, as there are still many uncertainties surrounding this drug."
LOL still glad. My loss will offset some of my gains this year. Done with hopium.
So glad I sold. Another pump&dump of hopium. 18 years of lies is enough for me. Fool me once, etc.....
Not a clue - but I am guessing it can't hurt.
Do you think this event will have any effect on the pending standard of care application in the UK?
Yeah - that's not entirely spelled out in the new Cel-Sci report document. However, I am guessing that they can get enrollment done much more efficiently than they did with that previous trial. Man that was a train-wreck last time with the CRO issues that they had. n
They should be able to get the tumor shrinkage and biomarker data under their belt rapidly. I suspect that they should be able to get enrollment relatively rapidly now as well with the existing supporting data. But survivorship data is just going to take the time to get it done.
They might go fishing for a partnership with a big pharma - or perhaps get a buyout offer on the table? As de-risked as Multikine is at this stage, some big oncology pharma might make 'us' an offer.
No mention of accelerated approval, but they could be sitting on that maybe.
FDA guidance recommends that confirmatory trials be underway at the time an accelerated approval is granted. But since guidance does not carry the force of law or regulation, the FDA has limited leverage to ensure the trials are initiated at that time
I also read it numerous times looking for an estimate of when this trial is expected to end and results presented to the FDA but could not find a timeline. Is it gonna be based on 5 year survival which would mean probably 7 or so years including enrollment, setup, etc.
Unless I missed something within the report, it didn't disclose the length of the new trial period.
Yeah another 20 years before approval
CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer
Critical milestone achieved—the FDA accepted CEL-SCI’s selection criteria defining the Multikine target population before surgery
Selected patient population had 73% survival with Multikine vs. 45% without Multikine based on analysis of completed 928-patient Phase 3 randomized controlled trial
212-patient confirmatory study is de-risked, backed by robust efficacy and safety data from completed Phase 3 trial, the largest in advanced primary head and neck cancer
View CEL-SCI’s comprehensive report regarding the FDA’s go-ahead and the Company’s value proposition for investors here: https://cel-sci.com/wp-content/uploads/2024/05/CEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf
CEL-SCI Corporation (NYSE American: CVM) today announced a significantly positive outcome from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding the path to approval for its first-line investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection). Based on strong safety and efficacy data from CEL-SCI’s completed Phase 3 head and neck cancer study, the FDA indicated CEL-SCI may move forward with a confirmatory Registration Study of Multikine in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).
“Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer. The survival benefit was so strong and clear in the target patient population that our confirmatory study needs to enroll only 212 people to confirm what was already achieved in the Phase 3 study. This gives us a clear path forward,” stated CEL-SCI CEO, Geert Kersten. “We are eager to begin the study as soon as possible.”
CEL-SCI published a report on the FDA’s agreement and Multikine’s path forward. Please click on this link https://cel-sci.com/wp-content/uploads/2024/05/CEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf to read the full report. Highlights include:
The FDA agreed to a 212-person confirmatory Registration Study based on the strength of the safety and survival benefit data in the selected target population from the prior 928-person Phase 3 study. The confirmatory study will be a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone. As presented at the ESMO cancer conference in October 2023, Multikine-treated patients in the selected group had a 73% 5-year survival vs a 45% 5-year survival in the control group who did not receive Multikine.
Generally, patient selection for different treatments in newly diagnosed head and neck cancer is done only after surgery. That presented CEL-SCI with a challenge, because Multikine has to be given before surgery. By analyzing Multikine's biological mechanism of action, as supported by the completed Phase 3 study, CEL-SCI developed criteria for selecting, before surgery, those patients who would have the best survival from Multikine. The FDA accepted the selection criteria and the proposed study design, which now permits CEL-SCI to enroll patients in the confirmatory study.
CEL-SCI met a very high bar set by the FDA, which requires more stringent analysis for newly-diagnosed patients than for terminal cancer patients. One regulator called these newly-diagnosed cancer patients “much more delicate” and explained that the standard for permitting a new study with these patients has to be more stringent, since they are not all expected to die.
CEL-SCI has been advised by statisticians and physicians that the confirmatory study has a high likelihood of success because a large survival benefit has already been demonstrated in the target population in the completed Phase 3 study. The much smaller confirmatory study—less than a quarter the size of the prior study—will focus on the patients who saw the greatest survival benefit when treated with Multikine.
If approved as a pre-surgical treatment, Multikine should be added to the standard of care for the target population.
The FDA also acknowledged in the meeting that there is a great unmet need in the target population for improved therapies. This is an important factor that weighs in favor of approval for Multikine.
CEL-SCI believes that its de-risked value proposition for investors presents a unique opportunity to invest in a Phase 3 oncology company with a large body of data demonstrating not only tumor responses, but also long-term survival, in the target patient population. The goal of our smaller confirmatory study is to confirm these positive results in a prospectively defined target population.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In the completed Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.
After analyzing data from the Phase 3 study, we have better defined the target population for Multikine, which is locally advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival in this target population, showing that Multikine cut the risk of death in half at five years vs control.
Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
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, 2023. 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/20240508140076/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
It is still money I worked for. I am still pissed off to this day from BHUB (Big Hub) where I lost $100 because some CORRUPT judge who got paid and was on the take decides that retail shareholders are chumps. That "judge" belongs in Leavenworth. I want my $100 back. I had 20,000 shares.
It's done. There is no production only dilution. Time to move on.
Whine about lousy $800 loss with a $20k gain somewhere else. Lmao but smh
Brilliant move. Wait 18 years , then sell it as it goes into production.
I sold everything at a major loss (90%). Lost more than $800 today. I am done with this monkey dyck stock. I was a dumb azz 18 years ago for wasting my money on it.
SOLD ! Got the fook out after 18 years ! Lost over $800 on this POS. Paid over $900 into this company and ended up with $84 today. Got tired of looking at it. Glad I have a loss now to counter my $20K gain this year from a 100% principal protected investment of real gains. Good riddance !
That would appear to be the case Sir!
I guess we are in wait and see mode???
This board is dead….I guess we are in wait and see mode???
Looks that way.
Been here for 15+ years. The trial showed some tumors shrank and a few disappeared, so why has not a big pharma attempted a buy out. Is Geert not looking, do they feel it is a scam or is he just happy using it as his personal ATM.
Apparently Mr. Market is very much NOT impressed by this addition to the BOD.
CEL-SCI Appoints Mario Gobbo to Its Board of Directors
9:00 AM ET 4/23/24 | BusinessWire
VIENNA, Va.--(BUSINESS WIRE)--April 23, 2024--
CEL-SCI Corporation (NYSE American: CVM) today announced the appointment of Mario Gobbo to its Board of Directors.
Mr. Gobbo has nearly 40 years of banking and corporate finance experience in healthcare and energy. His expertise encompasses venture capital and private equity as well as investment banking and strategic advisory services. He has served as an officer or director for a number of companies including several biotech companies: Xcovery, Ocimum/Genelogic and Helix BioPharma. Prior to that, Mr. Gobbo worked in the financial industry for Lazard LLC, Swiss Bank Corporation, the European Bank for Reconstruction and Development, Natixis Bleichroeder, Inc., and International Finance Corporation (the private sector arm of the World Bank). Mr. Gobbo holds a Bachelor of Arts in Organic Chemistry from Harvard College, a Master of Science in Biochemistry from the University of Colorado and an MBA, a Master of Business Economics and a PhD (Management) from the Wharton School of the University of Pennsylvania.
"Mr. Gobbo has a unique background where science and Wall Street interact to create new medicines. He has backed many successful healthcare ventures and he has excellent contacts in that part of finance that is interested in building medical breakthroughs into great companies. We are honored to receive his help in bringing Multikine to market as a treatment for head and neck cancer," stated CEL-SCI CEO Geert Kersten.
Mr. Gobbo commented, "This is an exciting and extremely important moment to join the board of CEL-SCI as it is on the brink of developing a product that will revolutionize certain head and neck cancer therapies and probably other deadly cancers. I am proud and honored to become part of the CEL-SCI team."
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Multikine* (Leukocyte Interleukin, Injection) is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.
After analyzing data from the Phase 3 study, we have better defined the target head and neck cancer population for Multikine, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control.
Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
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, 2023. 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/20240423365855/en/
CONTACT: Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
SOURCE: CEL-SCI Corporation
Copyright Business Wire 2024
> Dow Jones Newswires
April 23, 2024 09:00 ET (13:00 GMT)
From Zack's:
CVM: Parallel Engagement On Four Fronts
04/15/2024
By John Vandermosten, CFA
NYSE:CVM
READ THE FULL CVM RESEARCH REPORT
First Quarter Fiscal Year 2024 Update
CEL-SCI Corporation (NYSE:CVM) reported its fiscal 1Q:24 on February 7, 2024 with the submission of its Form 10-Q with the SEC followed by a press release. Subsequently, news was released regarding its secondary LEAPS candidate, a capital raise and the manufacturing facility. In the European Union, CEL-SCI was granted a waiver of pediatric requirements. Last December, Multikine was evaluated as a new standard of care in the UK. Health Canada advised the company to request advance consideration and, along with the FDA, was awaiting target population data. CEL-SCI has also commissioned its Multikine manufacturing facility near Baltimore, Maryland and raised additional funds in a public offering. The LEAPS vaccine program also had a day in the sun as a paper examining the candidate’s role in rheumatoid arthritis was published in Frontiers of Immunology.
Financial Review
CEL-SCI recognized no revenues for its fiscal first quarter ending December 31, 2023 and incurred operating expenses totaling $6.5 million during the three-month period. This resulted in a net loss available to common shareholders of ($6.7) million, or ($0.14) per share.
For the quarter ending December 31, 2023 versus the same prior year period:
? Expenses for research and development fell 19% to $4.4 million from $5.4 million. Lower pre-commercialization, Phase III study, and employee stock compensation costs contributed to the decrease;
? General and administrative expenses declined 6% to $2.1 million from $2.3 million on lower consulting fees and employee stock compensation expense partially offset by an increase in miscellaneous administrative expenses;
? Other non-operating items were ($26,000) compared to ($222,000) in the prior year;
? Net interest expense of ($0.2) million compared with ($0.2) million;
? Net loss totaled ($6.7) million versus ($8.0) million or ($0.14) and ($0.18) per share, respectively.
As of December 31, 2023, cash and equivalents totaled $3.2 million. Cash burn for the three-month period amounted to approximately ($5.0) million, up from last year’s ($4.7) million. In fiscal 2Q:24, CEL-SCI raised approximately $7.8 million in a common stock offering. CEL-SCI holds no debt on its balance sheet.
EMA Waives Pediatric Requirements
As part of its ongoing application process in the EU, CEL-SCI was able to obtain a waiver for conducting further studies in the pediatric population for Multikine in Squamous Cell Carcinoma of the Head and Neck (SCCHN). All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver.
A pediatric waiver from the European Medicines Agency (EMA) allows a pharmaceutical company to be exempt from having to conduct studies in the pediatric population. The main benefit of the pediatric waiver is that it reduces the burden of conducting potentially unnecessary pediatric studies, which can be costly, time-consuming, and may unnecessarily expose children to an investigational medicine. Pediatric waivers are typically granted when the medicine is intended to treat a condition that affects the adult population, the investigational product does not provide a significant benefit to pediatric patients or the disease does not occur in the pediatric population. The waiver will help CEL-SCI avoid substantial time and cost burdens while still allowing Multikine to be used in the target population if approved.
LEAPS Article Published in Frontiers in Immunology
The scientific journal Frontiers in Immunology published an article in its March 2024 issue on CEL-SCI’s Ligand Epitope Antigen Presentation System (LEAPS) technology as reported in a March 19th press release. While there are approved treatments for rheumatoid arthritis (RA) including adalimumab and other TNF blockers and JAK inhibitors they do not balance adaptive immune homeostasis. These classes of drugs also present the risk of stimulating other disease. CEL-SCI’s CEL-4000 therapeutic vaccine may be able to treat RA while limiting negative side effects by promoting antigen-specific regulatory rather than inflammatory responses, thereby modulating the immunopathological course of RA. In CEL-SCI’s article entitled Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines, the authors discuss in-development and approved products for the disease and preclinical data for CEL-4000. CEL-SCI’s candidate is able to redirect autoreactive pro-inflammatory memory T cells towards rebalancing the runaway immune/inflammatory responses that characterize the disease. The drug’s features require the use of more advanced trial design such as adaptive trials and the use of biomarkers for endpoints. The article concludes by asserting that an antigen-specific immunomodulating vaccine, such as CEL-4000, may deliver therapy for RA without weakening important immune defense mechanisms against microbial infections or cancer.
Any news from the annual share holders meeting last week?
Agreed. Everything and everyone are so quiet lately. What is the next update……it’s been a while. Dying on the vine. LFG CVM!!! It’s time !!!
It’s up .06 cents….must be an offering AH
Well - we're about half through 'the month' now and we could use some positive news,....
Wow. Well if either of these go anywhere you should be good. I wish you luck my freind.
I have 41k shares of NWBO and unfortunately 30k shares of this pos
Yesterday's daily short sale volume was 68.62% (as reported by FINRA) but despite all the manipulations by the shorts, the PPS went up 0.56%! The short borrow fee is still at 13.28%! With all the facts and clarifications that we got in the latest Letter to Shareholders and the news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts still have a position of currently 6.97 million shorted shares (short float of 13.34%). The CEO promises us an interesting month: "We are looking forward to a month filled with several very important meetings designed to bring our cancer therapy Multikine to market. We will keep you updated on our progress." I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!!
Been in this one for a long time. Same with NWBO. One of these companies has to come to approval at some point… this is taking way too long. Makes me wonder if either is going to actually be a success. I want them both to work out but it is taking alot of patience. Just venting…..maybe we get a miracle this coming week? Praying…
That's what toxic financing will do to ya.....I warned people here years ago.
Not a great day for us shareholders,... I wonder what the 'looming' bad news is that's driving this?
I think that LEAPS has a ton of potential. That's a fact. However, LEAPS is a developmental-stage platform that's many years, and lots of $$s away from being anything other than a developmental-stage platform.
If Multikine doesn't pull this company up and start generating revenue, LEAPS will never be more than just a clever idea.
Leaps Technology rising from the dead. New article out.
I just read an article on Pfizer’s investor conference:
“Pfizer plans to focus on four main types of cancer: breast cancer; genitourinary cancer, which impacts urinary and genital organs or functions; thoracic cancer, such as lung, head and neck cancer; and hematology-oncology, or cancers of the blood, such as multiple myeloma and lymphomas.”
They also said they are moving away from the lab/small molecule meds and getting into more of the biologics…..
Sorry if this is redundant or old news but it would be nice if they just bought CVM out or at least went into a partnership. CVM appears to be exactly they type of new product they are trying to get in too. What is the hold up?? This is taking a crazy long time.
IMO you're on the right track with your bit about the history of drawn-out finance deals. But I would assert that in addition the long, long, long delays in getting their Phase III rolling soiled the management's reputation. That initial CRO flaking out on them really put a crimp on their getting the trial ramped up - that cost them a couple of years, a lot of both financial and social capital.
Then the study post-treatment period ended up being longer than was stated it would be. Then it took forever to get the data locked, analyzed, and the initial whole-cohort population (as a whole) didn't appear to meet the primary endpoints for success. Then it took them what seemed like years to get the biomarkers for the target subpopulation and the patient assessment criteria in place.
Recent financing of operations has at least been generally transparent. In the past, that definitely could not be said to be true.
They do appear to have at least most of their ducks in a row and marching steadily forward now. That's promising.
Yes, i think it has hurt them, however for such a small bio company to stay in business for as long as they have, and accomplish what they have done w/o a big partner is remarkable. You can't build a successful company without a great deal of money. I think we are in the home stretch with the finish line in sight.
Just my opinion of course.
I typically have a great feel for if a company is legit or not, but this one has kept me confused.
The company puts out a great report, however, apparently no one is buying into it.
The only thing that makes any sense at all is all those toxic finance deals they've done in the past are killing them. I don't know if this is still how they are financing their operations.
It's a very positive letter for us shareholders, the company, and potentially for a lot of cancer patients.
It's only a matter of time now. :D
CEL-SCI Corporation Issues Letter to Shareholders
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.
Dear CEL-SCI Shareholders:
Last year we successfully moved our investigational Multikine® (Leukocyte Interleukin, Injection)* cancer therapy forward on the clinical, manufacturing, and regulatory fronts by overcoming several challenges as the biotechnology sector went through very difficult times. The results from our Phase 3 trial presented us with a conundrum in that we had great survival data with Multikine as a pre-surgical treatment in head and neck cancer when followed by surgery and radiotherapy only, but not when followed by surgery, radiotherapy, and chemotherapy. The key issue was how to determine who should be treated with Multikine, which is given before surgery, while the determination of who gets chemotherapy added to their treatment is made after surgery. We solved this issue with great success and presented the selection criteria at a major oncology conference:
CEL-SCI identified the target head and neck cancer patient population for Multikine that will be the basis for the Company’s regulatory filings for marketing clearance. In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The target population, which saw its 5-year risk of death cut in half, can be identified prior to surgery upon diagnosis with tests that physicians routinely use in cancer screenings, a key finding for Multikine, which is a neoadjuvant therapy. A summary of Multikine’s results in the target population include the following:
Risk of death cut in half at 5 years vs. control
73% survival for Multikine vs 45% in the control at 5 years
28.6% absolute 5-year overall survival benefit versus control; statistically significant p = 0.0015 and hazard ratio = 0.35
Tumor reduction rate >13% and tumor downstaging >35%
Low PD-L1 tumor expression (as compared to high PD-L1 where Keytruda and Opdivo work best)
No safety signals or toxicities vs standard of care
Target population is an estimated 145,000 patients (global, annual) with newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) who present with:
No lymph node involvement (via PET scan)
Low PD-L1 tumor expression (TPS<10) (via biopsy).
Physicians routinely assess these features at baseline; no extra tests needed. These features make it easy to write a label for Multikine, which is essential for drug approval.
CEL-SCI estimates that low PD-L1 patients represent about 70% of locally advanced primary SCCHN patients.
In manufacturing, a major issue was the U.S. government’s rules prioritizing companies that make COVID products to receive medical supplies. This caused delays in our work commissioning our Multikine manufacturing facility. Fortunately, we were able to finish this critical work in January 2024:
CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine. The Company’s manufacturing trade secrets, capabilities, and know-how are high-value key strategic assets that are very difficult for others to replicate.
Usually companies pursue only one regulator, presumably because it is a great deal of work to pursue more. Since Multikine is a unique pre-surgical cancer drug, we decided to in parallel talk to the world’s leading regulators: FDA (U.S.), EMA (Europe), MHRA (UK) and Health Canada (Canada). In our discussions so far, we have been well received, and we have been told that clinically our results are very meaningful and promising. Regulators have been responsive and willing to help us. Here is an update of what we can share with you:
CEL-SCI has submitted the target population data and a proposed study protocol for a confirmatory study of 212 patients to the U.S. Food and Drug Administration (FDA) in Q1 2024.
Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy.
The United Kingdom’s National Institute for Health and Care Excellence (NICE) selected Multikine to be evaluated as the potential new standard of care for SCCHN. NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.
The European Medicines Agency’s (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). The waiver is a big step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.
Meetings with the UK regulators and the EMA are expected H1 2024.
New PD-L1 biomarker findings from the Phase 3 study, which have been integrated into the new target population, demonstrated that Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression. This is in stark contrast to approved checkpoint inhibitors, such as Keytruda and Opdivo, which most often show longer survival in a proportion of patients with a higher level of tumor cell PD-L1 expression, suggesting a combination therapy could boost patient outcomes. CEL-SCI filed a patent for the use of Multikine in tumors expressing low levels of PD-L1.
We also presented new data at a number of leading scientific conferences:
10th European Congress on Head & Neck Oncology (ECHNO) 2023
“Leukocyte Interleukin Injection (LI) immunotherapy followed by radiotherapy extends overall survival (OS) in treatment naïve locally advanced primary squamous cell carcinoma of the head & neck: the IT-MATTERS Study” (Link to data)
European Society for Radiotherapy and Oncology (ESTRO) 2023
“Histopathology population (HPP) confirms Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma SCCHN)” (Link to data)
American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer 2023
“Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naive locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study” (Link to data)
European Society for Medical Oncology (ESMO) Annual Congress 2023
“Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS Study” (Link to data)
CEL-SCI Has All The Ingredients For Approval
We can identify at diagnosis the patients most likely to have pre-surgical responses to Multikine. The survival statistics in this target population are so good that it is hard to imagine how they could be challenged or ignored. Multikine’s safety profile is very favorable compared to other oncology agents. And, we have a manufacturing plant that can make an estimated $2 billion worth of Multikine annually.
CEL-SCI is ready — and we believe patients and doctors are, too. A new drug for our targeted disease (previously untreated locally advanced primary resectable squamous cell carcinoma of the head and neck) has not been approved by the FDA in decades. The current standard of care provides only a 50-50 chance of living past five years. Large companies have tried and failed to improve this figure. Patients desperately need better treatments.
We now have the ingredients for delivering results to investors as well. While the biotech stock market always has its ups and downs, the clinical data will stand firm and drive the final success for CEL-SCI.
CEL-SCI plans to seek approval for immediate patient access to Multikine without waiting on the results of a new trial wherever possible. There are regulatory pathways specifically designed for such approvals that CEL-SCI is pursuing worldwide. These pathways are called “conditional approvals” (or, in the U.S., accelerated approval) which means you can be approved first while a confirmatory study is ongoing and before that study is completed. Our situation—where we have selected a portion of the Phase 3 study for our target population—is precisely why these regulatory pathways were adopted by regulatory bodies, so that patients do not need to wait many years before gaining access to promising drugs that have already been shown to provide clinical benefit.
Thank you for your continued support.
Sincerely,
Geert Kersten
Chief Executive Officer
I disagree that he is bearish
That author is usually fairly bearish - but this article is relatively evenhanded for him/her.
Anyone have access to the 2/12 CVM story on Seeking Alpha? You have to be a Premium member to see it. If so, could you post it here?
Depends totally on the financing arrangements.
Someone just invested $7.2 MM in CVM. Would they do this if they were not confident in getting to see results?
You armchair CEO’s are a dime a dozen. Why the hell would he do a huge offering at a 28% discount when they are certain marketing is soon. Smart move would be small incremental steps up the ladder. How the hell did you come up with 40%. What the hell ever anyway , sell button is in same place it always was. Have at it. Or buy up offering yourself!
Cel-Sci Corporation (CVM)
https://www.youtube.com/watch?v=auAihG3rtC4
Multikine® (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
Multikine, CEL-SCI's lead investigational immunotherapy, is an immunotherapeutic agent that is being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved for use following completion of CEL-SCI's clinical development program, Multikine would be a different kind of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors.CANCER - MULTIKINE
Multikine may also have the potential to be a first in a new class of cancer immunotherapy drugs. It is the first investigational combination immunotherapy thought to have both passive and active immune properties. More...INFECTIOUS DISEASES - L.E.A.P.S.(TM)**
L.E.A.P.S is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. L.E.A.P.S. compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.
This new technology has been shown the potential in several animal models to preferentially direct immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed pathway. Diseases for which antigenic epitope sequences have been identified, such as some infectious diseases, cancer, autoimmune diseases, allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's) may be potential candidates for development using this technology platform. More...* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or by any other regulatory agency. Similarly, its safety of efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products
Partnering Philosophy & Corporate Partners
CEL-SCI's partnering philosophy is guided by the belief that any partnership entered into should serve the best interests of:
CEL-SCI is open to any reasonable partnership proposals that will accelerate its being able to bring its medicines to market.
Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
CEL-SCI has a unique expertise in the development and manufacture of complex biologics. CEL-SCI is not a company that markets and sells drug products at the current time. Regardless, CEL-SCI believes it will be capable of marketing and selling Multikine on its own for head and neck cancer in both the United States and Europe if and once it is approved by the FDA (or EU regulators). Since its primary target is head & neck cancer surgeons, a rather small audience, CEL-SCI does not believe that a large sales force will be needed to commercialize Multikine, if and once it is approved by the FDA (or EU regulators) following the review of the total Multikine Biologics License Application.
Current Corporate Partners:
a. | Agreement Signed August 2008 | ||
b. | Territory - Israel, Turkey, expanded to also cover Serbia and Croatia in August 2011. | ||
c. | Revenue Share | ||
d. | Website - http://www.tevapharm.com/ |
a. | Agreement Signed November 2000 | ||
b. | Territory - Taiwan, Singapore, Hong Kong, Malaysia, expanded to also cover South Korea, the Philippines, Australia and New Zealand in the Fall of 2008. | ||
c. | Revenue Share | ||
d. | Website - http://www.oep.com.tw/ |
a. | Agreement signed August 2011 | ||
b. | Territory - Argentina and Venezuela | ||
c. | Revenue Share | ||
d. | Website - http://www.gp-pharm.com/ |
Based on the Company's L.E.A.P.S.TM** technology, as long as a disease epitope is available, CEL-SCI may be able to develop an effective treatment/vaccine using the L.E.A.P.S. technology. The two leading candidates derived from this technology are the H1N1 treatment being developed as a possible treatment option for hospitalized patients and the Rheumatoid Arthritis treatment vaccine currently being tested in animal models of the disease.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products.
http://stockcharts.com/h-sc/ui?s=CVM&p=D&yr=3&mn=0&dy=0&id=p60195179833http://stockcharts.com/freecharts/gallery.html?CVM
http://finance.yahoo.com/q?s=cvm&ql=1
https://frugalnorwegian.com/cvm Insight into CVM P3 Trial Results
https://www.cvmresearch.com Insight into CVM P3 Trial Results & FDA Chances of Approval
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