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CVM: CRO Selected for Registrational Trial
12/09/2024
By John Vandermosten, CFA
NYSE:CVM
READ THE FULL CVM RESEARCH REPORT
CEL-SCI Corporation (NYSE:CVM) has made progress advancing the prerequisites for the upcoming registrational trial, selecting the contract research organization (CRO) that will run it and coming to an agreement with the FDA on which biomarkers are appropriate for selecting patients. The view of oncologists as expressed by the FDA’s ODAC is that using checkpoint inhibitors to treat low PD-L1 expressing patients provides limited efficacy and could even be harmful. This view opens the door for the use of Multikine, if approved, in the low expressing PD-L1 patient population based on its efficacy in this group.
CEL-SCI Milestones
Giovanni Selvaggi joins CEL-SCI as clinical advisor – June 2024
Presentation at the International Drug Discovery Science & Technology (IDDST) Congress – June 2024
CEL-SCI appoints Robert Watson as Chairperson of the Board – July 2024
Feedback from various regulatory agencies - 2024
Submission of license application to various agencies – 2024+
Grant of pediatric waiver by UK’s MHRA – September 2024
ESMO poster presentation provides new data – September 2024
UK’s MHRA grants pediatric waiver to Multikine – September 2024
Ergomed selected as CRO for confirmatory trial – October 2024
FDA ODAC opines against use of checkpoints in low PD-L1 expression patients – October 2024
FDA agrees to use of PD-L1 biomarker in Multikine registration study – November 2024
ESMO Poster Presentation
On September 16th, 2024, Dr. József Tímár, presented a poster entitled “Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy.” He presented at the European Society for Medical Oncology (ESMO) 2024 Congress which was held in Barcelona, Spain. The poster presented graphical data comparing high risk and low risk subjects who were evaluated in the IT-MATTERS trial measuring the probability of overall survival (OS) over time. The subpopulation included in the data set consisted of 114 subjects who met the target population selection criteria. The high-risk group included patients that presented a high risk of cancer recurrence and who were recommended to undergo chemotherapy following surgery (N=35). The low risk group included patients that were recommended to be given radiotherapy but not chemotherapy after surgery (N=79). Both groups showed a survival benefit for the Multikine arm.
The 79 patients who were recommended to receive only radiotherapy benefited to an even greater degree from pre-surgery treatment with Multikine compared to the wider 114 patient group. This target low risk population (n=38) had a 5-year overall survival of 82.6% when treated with Multikine vs. 47.3% when treated with standard of care alone (n=41), without overlap in their respective 95% confidence intervals. More recent analysis for the target low risk population (n=79) produced a hazard ratio of 0.27 (95% CI [0.12, 0.64], Wald p=0.0027) achieving a 73% reduction in overall risk of death.
While the overall survival benefit was clear and statistically significant (log rank p=0.0015) for the entire target population (n=114), the 79 patients who were recommended to receive only radiotherapy benefited to an even greater degree from pre-surgery treatment with Multikine than the group of 114 as a whole. This target low risk population (n=38) had a 5-year overall survival of 82.6% when treated with Multikine vs. 47.3% when treated with standard of care alone (n=41), without overlap in their respective 95% confidence intervals. More recent analysis for the target low risk population (n=79) showed a hazard ratio of 0.27 (95% CI [0.12, 0.64], Wald p=0.0027) achieving a 73% reduction in overall risk of death.
Looking ahead, CEL-SCI management postulated that the use of advanced imaging techniques such as positron emission tomography (PET) may help further improve patient selection and generate a higher success rate for Multikine. PET scans will be used in the upcoming confirmatory registration study for FDA approval.
Clinical Research Organization (CRO) Selection
CEL-SCI selects Ergomed to serve as its CRO for the upcoming confirmatory registration study of Multikine. Details of the selection were included in an October 1st press release. Ergomed had previously provided CRO services to CEL-SCI for the management of the IT-MATTERS trial. Ergomed will manage the trial globally at multiple sites. The announcement reminded readers that the trial will be a 212-patient study enrolling newly-diagnosed, locally advanced, primary head and neck cancer. It will focus on patients with no lymph node involvement and low PD-L1 tumor expression. The anticipated start of the confirmatory trial is 1Q:25.
FDA's Oncologic Drugs Advisory Committee (ODAC) Opinion
The FDA’s Oncologic Drugs Advisory Committee (ODAC) convened in September to evaluate the use of checkpoint inhibitors in different cancers and when certain therapies are appropriate depending on biomarker readings. The ODAC is a panel of expert advisors that provides recommendations to the FDA regarding cancer drugs and treat-ments. The committee consists of medical experts, oncologists, researchers, and other healthcare professionals specializing in cancer treatment whose primary role is to review and evaluate new cancer drugs, therapies, and treatments before they are approved for market use.
The ODAC provided an opinion on adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population, risk-benefit assessments in different subpopulations defined by PD-L1 expression and ade-quacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression. After reviewing the data, the ODAC voted 10-2 and 11-1 against the risk-benefit profile for PD-L1 inhibitors in various cancers in two separate votes. Committee members expressed concerns about the lack of benefit demonstrated for patients with low PD-L1 expression, while some members pointed to evidence that the use of the imm-une checkpoint inhibitors may add unnecessary toxicities for patients while also increasing financial burdens on patients. If our readers suffer from insomnia, a solution can be found in the near nine hour meeting on YouTube.
The ODAC’s view opens the door for products such as Multikine that work better in low expression PD-L1 tumors and could be a complement or alternative to checkpoint inhibitors for treatment of non-responsive patients.
rbl100
2 weeks ago
That is nice of you. Very altruistic. Which board is it? I don't know how to find boards moderated, and I may not have that search ability. I did follow you for a reason a while back. So I know you are righteous. You are not one of the wicked people here. There are many of those.
As a side note, I also helped out a friend that was on SSI his whole adult life since he has some kind of OCD disorder. His mother worked with my mother in the garment industry many years ago and I found out he lived up the block from me. Met him at work in a warehouse job by accident. We became friends even though he was 8 years older than me. Anyway his sister was a crack addict. I hung around with him because he made me laugh. Over the years his sister would steal his check $$$ each month. When his mother died, it got real bad since the father died many years before her. His sister drove up to Albany and blew threw a toll booth at 80 miles an hour and no one stopped them. She managed to retrieve $86,000 from a bank account of their mother's. She spent that money in 3 months on partying with drugs. She also got my friend's car impounded and the father's Town Car as well. So my friend could not go shopping. I drove him to the store for food. I gave him cigarettes too all the time. When his eventual "guardian" did not help him either, I stepped in again. His sister went into a coma sitting on the toilet and died at 40 years old a few weeks later all from crack.
So when he was all alone in the house, I helped him fill out paperwork to withdraw $10,000 in cash from another bank account under his deceased father's name. He needed money for spending because the guardian was not cutting it. I could have asked him to give me money too for helping him out. But I was honest as a fresh snow. In fact his mother promised me when she was alive one day after I cleaned their gutters for them. She told me directly "someday I will have a chance to really thank you". I assume that meant some kind of payment. Anyway I could have asked him for plenty of money and he would most likely have given it to me. But I don't roll like that. I guess I was a fool. Because now the State has all the funds and stocks like Raytheon, Oppenheimer, etc. worth tons in abandoned property and Mike is in an institution. So being a straight arrow in this world is not beneficial. The dishonest and corrupt people get all the $$$. But God knows I did the right things.
fung_derf
2 weeks ago
I just looked back at all your posts here....Geez, for 4 years you've been whining about our posts. Everyone else has come and gone and you're still here to complain. Maybe we should be discussing THIS genius post by you? Endgame??
rdneum
Re: trickledownfacists post# 38694
Friday, June 11, 2021 1:42:40 PM
Post#
38695
of 43913
As we get closer to the End Game. It appears some posters are re-examining risk. Instead of FOMO, Fear Of Missing Out, I'll call it FOBW, Fear Of Being Wrong. It's only natural.
rbl100
2 weeks ago
And another thing, I even gave my cousin Jack my best HO scale model railroad engine with coal car that my mother bought me for Christmas years ago because he liked it so much that was like brand new in the box. Was a fancy hand painted aqua blue and not black with red/black highlights. Just gave it to him to take back with him to Pennsylvania where he lived. My mother is dead, he is dead.
I also helped my friend get his one and only wife by talking with her after my friend left soon after asking her for her phone number as a cashier in a supermarket years ago. If I did not stay there and get her number for him, he would not be married today.
That same friend got his STATE job through a friend of his. Then when I wanted help from him, and gave him my resume to give to his boss, he said Hofstra threw my resume into the garbage.
He is FULL OF CHIT. He threw it in the garbage. So even my own friend stabbed my in the back. I helped him, but he never returned the favor.
And as a child fishing off Northport NY docks catching baitfish with my shiner net. A RICH phuck with a YACHT that had to be 50 foot... Asked me at 10 years old if I could use my net to RETRIEVE his heavy white BUMPER BOUY thing that fell off the rope. You know those big 2 foot fat ribbed white rubber bumpers? Well it was floating away on the water. So I agreed to get it for him. I lowered my net under it and pulled that heavy sumbitch up. It almost ripped my net. Then guess what? Never received even a $1.00 reward for doing that from this RICH bastard ! How do you like that chit? The more money people get, the more STINGY they become.
This all is why I don't believe anyone anymore. It's all talk and no action. I actually know what I did in life. I helped plenty of people even strangers.
rbl100
2 weeks ago
I don't know why you say I made fun. Where did I do that? I only quoted what you said.
Anyway, I have never seen anyone in this world help someone. I have been trading stocks since 2006. Not once was there someone helping someone else. Because if that were true, I would have been retired by now and many others would not be bankrupt. All people are in it for themselves. It's a big club and I am not part of it. All my get rich quick plans, have not materialized. I lost faith in men and women long ago. I wish I were rich like so many. I actually would go around giving it away in the form of paying for the needs and wants of others. If someone in my community needed a new roof, I would write the check, etc. as an example. Starting with the few family I have around me. In fact when I sold my house, I gave $30K OFF the price since it was my neighbors daughter who bought it because I actually am a compassionate man. BUT no one ever did anything for me. Everyone in this world is a scrooge even my father's side of the family who gave me nothing when my grandmother died. I was left out. The other three grandchildren split the estate. So I am used to cruel people.
fung_derf
2 weeks ago
Again,...reading skills required here. I already stated I owned it in the past.
You're still here. Do you own any?
Lemme know when FBIO at least gets through the 2.57 resistance. Right now, it's just another penny stock failure.
Let me give you some hints about penny stock investing.
First off, watch the volume...insiders know whats going on and tell their mothers who gossip. If this had great news within weeks, the share price would be higher already.
Secondly, read what the company actually does...
an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue
So, in other words, they don't even have their own products, they buy others discards? Pretty typical for a penny stock.
Lastly, Your biggest volume day by far was 9/20...so I looked into the news on that day...
commencing six months from the date of issuance, and will expire five and one-half years following the date of issuance.
In a separate concurrent private placement, the Chairman, CEO, and President of the Company (the “Insider”) purchased 763,359 shares of common stock at a price of $1.84 per share, which represents the consolidated closing bid price on September 19, 2024, and warrants to purchase up to 763,359 shares of common stock. These warrants were purchased at a price of $0.125 per warrant, have an exercise price of $1.84 per share, will be exercisable commencing six months from the date of issuance, and will expire five and one-half years following the date of issuance.
Lets see....6 months from 9/20 would be 3/20/25?? What do you think will happen then?
fung_derf
2 weeks ago
You need to read up on all the debt they enjoy taking on and see who they are getting it from.
product revenues of $14.9 million for the second quarter ended June 30, 2024.
General Corporate:
• In July 2024, Checkpoint raised $12 million in a registered direct offering priced at-the-market under Nasdaq rules.
• In July 2024, Fortress’ Board of Directors paused the payment of dividends on the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”) until further notice. The Company believes pausing the dividend is in the best interest of the Company and its stakeholders to maintain financial flexibility ahead of potentially significant inflection points. Dividends on the Series A Preferred Stock accrue in accordance with their terms; the pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the suspension should be lifted.
• Also in July 2024, Fortress reduced its total debt by entering into a new loan agreement maturing in July 2027 with funds managed by Oaktree Capital Management, L.P. (“Oaktree”), a leading global investment firm. The Company received an initial tranche of $35 million and is eligible to draw an additional $15 million with Oaktree’s consent. In connection with the new loan agreement, the Company repaid its prior term loan with Oaktree of $50 million resulting in an outstanding debt reduction of approximately $15 million of debt excluding accrued interest and prepayment fees.
• In September 2024, Fortress raised $8 million in a registered direct offering and concurrent private placements.
• In October 2024, Mustang Bio raised $4 million in gross proceeds from the exercise of existing warrants.
• In November 2024, Checkpoint received $9.2 million in gross proceeds through the exercise of existing warrants.
Financial Results:
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drkazmd65
3 days ago
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