Cel Sci Corporation New (CVM) Opciones

CVM: Fiscal Year 2024 Results
02/10/2025
By John Vandermosten, CFA

NYSE:CVM

READ THE FULL CVM RESEARCH REPORT

CEL-SCI Corporation (NYSE:CVM) reports fiscal year 2024 financial and operational results. The press release and Form 10-K filing encapsulate a year of preparation for confirmatory registration studies around the globe. CEL-SCI cleared its proposed 212-patient registration study of Multikine with the FDA. This narrowed the population to patients with squamous cell carcinoma of the head and neck (SCCHN) with no lymph node involvement and low PD-L1 tumor expression. A contract research organization (CRO) was selected to run the trial and data was presented from the IT-MATTERS study showing 73% survival for Multikine vs. 45% in the control arm at five years. Outside of the US, the European Medicines Agency (EMA) Pediatric Committee and the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granted Multikine a pediatric waiver, streamlining the process for obtaining approval in these jurisdictions.

Financial Review

CEL-SCI recognized no revenues for its fiscal year ending September 30, 2024. It consumed $26.4 million in operational expenses generating a net loss of ($27.6) million or ($0.51) per share.

For the year ending September 30, 2024 versus the same prior year period:

Expenses for research and development fell 19% to $18.2 million from $22.5 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease and were partially offset by increases in other research and development costs;
General and administrative expenses decreased 9% to $8.2 million from $9.0 million on lower employee stock compensation and other miscellaneous expenses;
Other non-operating items were $177,000 compared to ($43,000) in the prior year;
Net interest expense was relatively constant at ($0.7) million related to interest income from cash balances and expense from finance leases;
Derivative modifications totaled ($659,000) compared to ($172,000);
Net loss totaled ($27.6) million versus ($32.4) million or ($0.51) and ($0.73) per share, respectively.
As of September 30, 2024, cash and equivalents totaled $4.7 million. Cash burn for the twelve-month period amounted to approximately ($18.9) million, up from 2023’s ($23.2) million. Following the end of the fiscal year, CEL-SCI closed on a gross $5 million stock offering. CEL-SCI holds no debt on its balance sheet. The company estimates that the confirmatory trial will cost $30 million.

FDA Confirmatory Study Acceptance

Last May, CEL-SCI announced that its selection criteria for populating a confirmatory study and study design was cleared by the FDA. In a subsequent meeting, the agency indicated that the company may move forward with a confirmatory registration study of Multikine to evaluate its safety and efficacy in squamous cell head and neck cancer (SCCHN). Acceptable patients will be newly diagnosed with advanced primary SCCHN with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). Statistical analysis indicates that 212 subjects will be required to generate the confirmatory data. In November 2024, the FDA and CEL-SCI agreed upon the use of the PD-L1 biomarker to select patients for the trial.

Based on a discussion of the path forward with the FDA which was included in a 29 page report, the agency responded in written notes accepting the eligibility criteria. It further acknowledged that the nonclinical data appears to be sufficient, the stratification factors appear reasonable and CEL-SCI’s approach for product specifications is acceptable. Furthermore, the FDA had no safety objections to further treatment of patients with Multikine.

Similar to the IT-MATTERS study, we anticipate that eligible individuals will have a diagnosis of untreated SCCHN, measurable tumor, normal immune function and no use of immunosuppressives in the previous year among other criteria. Based on the performance in the Phase III trial, further population characteristics for the confirmatory study will include patients with no lymph node involvement of the disease and low PD-L1 tumor expression.



The study design calls for a two arm, two stage, 1:1 randomized controlled trial enrolling 212 subjects. The first stage will examine pre-surgical response rates, which can be determined shortly after completion of enrollment. Stage two will assess overall survival (OS) as the primary endpoint. Histopathology biomarkers will also be measured.



In its confirmatory trial, CEL-SCI anticipates that it will need to surpass a hurdle of a 10% improvement in overall survival (OS) and produce a hazard ratio of 0.72 or less to merit approval. In the IT-MATTERS study, the target population achieved a 28.5% improvement in OS and produced a hazard ratio of 0.35.

In a December 12th press release, CEL-SCI explained the biologic rationale for the use of Multikine in the confirmatory registrational head and neck cancer study. The discussion referred to the results from the IT-MATTERS study and emphasized the significant rates of tumor regression before surgery in both the Phase II and Phase III studies and the 73% survival with Multikine vs. a 45% for the control patients not treated with Multikine. Other supporting points include:

Benefit to the patient prior to surgery and when the immune system remains strong;
Statistical significance of p=0.0015 and hazard ratio of 0.35 in 114 patients for overall survival (OS);
Eligible patients have no lymph node involvement and low PD-L1 tumor expression;
No excess toxicity beyond the standard of care.
Links to Previous Reports and Background on Multikine

Summary of ESMO Poster Presentation – discussion of lymph node spread and PD-L1 expression
Review of IT-MATTERS population analysis & overall survival comparison
FDA ODAC Opinion
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 – Fall 2024
FDA agrees to use of PD-L1 biomarker in Multikine registration study – November 2024
Full enrollment of confirmatory trial – 2Q:26
Clinical Research Organization (CRO) Selection

CEL-SCI selected 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.

Capital Raise

CEL-SCI announced the closing of its $5 million offering on December 31st in a press release. The company sold 16,130,000 shares of stock and pre-funded warrants at $0.31 per share. ThinkEquity served as the placement agent for the transaction.

Summary

CEL-SCI is completing the necessary prerequisites for launching its registrational trial in the United States. The trial design has been completed with plans to enroll 212 subjects that conform to specific biomarkers. The trial will include low-risk patients that are appropriate for radiotherapy but not chemotherapy and with low PD-L1 expression. CEL-SCI has also selected its CRO, Ergomed, which also provided these services for the IT-MATTERS trial. Other positive news for immunotherapies are the opinions shared at the November ODAC meeting. At that meeting, a majority of experts asserted that on the whole checkpoint inhibitors could be harmful for patients with low PD-L1 expression, providing support for alternatives such as Multikine if it is approved.

At new 52 week low, it appears to be telegraphing the reverse split in 5 weeks. The confirmatory trial would have to be announced soon and be spectacular to avoid it. Sorry

That's awesome FD ! Ah speaking of Indian Reservations reminded me.... My father LIVED on their reservations for quite some time and no WHITE man is allowed to do so. Reason being is because my father befriended them and gained their trust. And he lived on there because he had no money to live normally. My father ate out of dumpsters for a time. He would take the discarded old food from restaurants. Must have shamed him to no end to do that. Probably because my father would not take a dime from government handouts.
Oh and that 13 day hell for me was not just in Arizona but across the whole Continental United States. I live in New York and I drove home in a UHAUL with his items. Took me 5 days that should have taken me only 3 at most.

P.S. My father used to come home to New York from Tucson Arizona and make it in only 36 hours. No sleeping and cruising average speed of 110 miles per hour in his '64 Buick. State Trooper once tried to catch him and he had to pull over and wait for the Trooper to catch up LOL. My father asked the Trooper "do you have kids"? Trooper said "yes", my father said "you would risk your life having children just to give me a speeding ticket"? That's not too smart my father told him.

I have an Arizona travel story as well. It includes Indian reservations and a cattle stampede

That one and the story of when my father died in Arizona and I had to retrieve his belongings. That was just about a life and death battle. It was survival in a way after an event occurred. I should say two events. I do have a couple of excellent titles in mind too for a movie. Problem is I don't trust Hollywood. They would steal my life event true story and give me nothing in compensation. Guaranteed that movie would be a blockbuster. Because you could not make this chit up what happened to me in those 13 days of Hell with that trip. It was really really phucked up. After that, I now know what the human mind is capable of thinking. Put it that way. Could not even grieve my father's death properly. As a side note, I am convinced my mother was killed/murdered - at the very least an early demise by euthanasia. Still trying to find a lawyer to take my case for no upfront costs. No luck yet.

Well that's true, but a mountain of a man!

Geez. Sounds like the makings of a good screenplay. Put in on paper and get your story told

That's one man's opinion.

I will check into that as you said. Maybe one day I will be able to restore my father's car to its former glory a 1964 Buick since I never saw my father much. He was around maybe 20 months in my whole life. Was hoping I would win the lottery by now, but it hasn't happened in the 24 years since he died. My mother is dead too and I am an only child. The only survivor left of my family and family name.
Have to honor my mother though, she raised me all by herself without any help from anyone. That is where the credit goes. I stayed honest and never did drugs. She had no help from my father who became destitute after losing all their money by opening a lounge in 1967 at a cost of $50,000 cash in those days. Put all the money into someone else's building - yes DUMB! Then after losing it all within 6 months and having a nervous breakdown, he stayed in it to try and recoup the $$$. Then he ended up owing $250,000 to the mafia and spent the rest of his life paying them off. So my mother had no support whatsoever and worked 6 days a week basically to raise me and keep us off welfare and out of homelessness. Yep, big money back then. He was a good father but made a truly stupid business decision. Well one day I will be rewarded, just maybe not on this side of eternity.

I'm SHOCKED to see this stock has a couple of buy recommendations from real sources. You just don't see that with a .38 stock.
This has been one of the few penny stocks that I've always thought MAY have a real product.....I dunno for sure, but I still say their financing in the past will keep them down.
I think their last reverse split was in 2017....but not sure what their other options are?
Nothing about this stock would give me hope, and yet.....I wouldn't rule anything out.
BTW, "not ruling anything out" is my highest rating I would give to a penny stock.

The stock is on the reverse split clock that expires, ironically, on the Ides of March. The company previewed that it would have preliminary results on the new trial in the first quarter. Expect to hear the result in the next few weeks. Worth a spec for a few Shekels at this 30- 40 cent level.

Geez! That reads like a very depressing Christmas card!
There is time to turn it around. Quit listening to the wrong people and start investing for slow and steady.
I post on my board what I'm buying and selling, its not a trade secret.
Sometimes I am wrong, but try to err to the conservative side. Better to lose opportunity than dollars.

Again you were right FD ! I was wrong and admit it all. I stopped all OTC stocks long ago. Even the NASDAQ stocks play the game of R/S then offerings, then rinse and repeat. Got burned there too. Just as in CRKN. Lost over $100 on it. Hope you are prospering in the market. Some of us just are not blessed I guess. I was always a loser anyways in life, so it is expected. Same as my friend Tim. We had similar lives and he is dead now. Both of our families lost their wealth. He was a good guy and as they say we finish last.

I've been telling anyone who will listen here for years. Legit company or not, they tied in with a toxic finance company whose only goal is to dump stock when possible.
This is the penny stock world. Why won't people learn?

Wow dropped even more. Glad I sold for an $800 loss at $1.79 long ago. This thing gets worse and worse. I am done with nasdaq and amex stocks. Just like OTC stocks. Can't buy those anyway since my broker does not allow non reporting stocks. Just buying NYSE stocks going forward, but must learn which ones to try first. All the other exchanges are CORRUPT. I have seen enough. Stocks run for no legit reason and others who make business go down the tubes. Everything is backwards in this world to logic.

And,... still no news on a start date,...

I don't see it in the near future. However it's possible for it to happen if they can't get the price above 1.00 before the deadline around March. We need some news on the trials progress to move the price higher. I've been here since 2009. Been through in one RS, really don't want to go through another. This company has done amazing well as a small biotech. I wouldn't still be here if I didn't believe they will succeed! Let's hope it's not to painful for shareholders before they bring this very effective drug to market. Got to keep the faith they will make it.

If you are a fan of the pump and dump, sometime between now and 3/15 you'll see a pump to near a $1. Then if history repeats, a fall to a new low.
This is just another small pharma who did a terrible death spiral finance deal in the past.

Do you see a RS in the near future? Thanks

So the price went below 1.00 on Sept 14th, a company is usually given up to 6 months to get the price back up above 1.00 for 10 consecutive days. That means we have until around March. We should get some kind of positive news before that, and the price goes above a dollar. Lets hope that happens before a reverse split.

This is BETTER than you expected?

Well - to be honest - share price is holding up better than I anticipated post dilution. Still stinks - but could be worse. Now they just have to get the confirmatory trial underway.
!
Happy New Year all!

That's odd. But makes sense it was free for a while because I posted. LOL

Oh I thought that Capitol Trades was legit ? You might be right. Here is what I saw:


Michael McCaul
RepublicanHouseTX
EQV VENTURES ACQN CORP -REDH
EQV:US
18 Dec
2024
12 Nov
2024
days
33
Spouse
buy
100K–250K
$9.92

https://www.capitoltrades.com/trades/20003780146

My board has been premium for the last few years. I believe premium boards were open to all last week as a gift. I need to see if they will change it back to free.
Again, show me any proof that Congressmen are buying EQV. This sounds like hoooey to me. If I thought it was in any way legit, I'd also put $100k into it.....but I won't. Sounds like internet hype to me. Don't believe everything ya read.
And Happy New Year to you as well. Lets invest smarter for 2025. It ain't gonna be as easy this year.

Thank you FD ! Happy New Year to you and your family ! Will talk to you tomorrow after 4pm. For some reason your board changed to Premium ??? LOL Won't let me post now. Very strange. And YES I bought that EQV stock. To my understanding it is a shell. I only bought 10 shares because people in Congress loaded up buying $100K+ worth. Out of my league, but I spend what I can risk and afford. Peanuts to many LOL.

A nice move??? It's far below last week's low.
If you look at the volume days, other than 12/19, all the volume days were selling.
The largest day of trading was 12/30, which looks like a big tax loss selling day. Would large positions be selling with good news on the way?

Looks like a nice move off the low.

Your statement about the lack of volume is misleading. In fact, the daily volume is also at multiyear highs . Looks like accumulation to me by people expecting good news in th4e near future.

Interesting phraseology by you.....

Your belief that phase test results are revealed before they are announced is erroneous.

Guess you'd have to define "revealed".
I would say, in ALL companies, insiders know info before common shareholders. News leaks via friends and family. Volume rises.
Chart reading is an art form, that typically posters on IHUB do poorly.

No offense taken. I've owned this quite a while back so its still on my follow list.
However, I am a researcher of penny stock posters. I try to expose the distrustful ones and teach the naive ones.
Why would anyone be opposed to varied viewpoints?
I exposed this stock some years back for having made a terrible death spiral finance deal with a known fraudulent company.

No offense, I am curious why you post on this board when you admittedly own no shares.
I am not here to pump the stock which now trades at multiyear lows. I believe the technology will prove to be a lifesaver and a great investment for those who stayed the course.
Your belief that phase test results are revealed before they are announced is erroneous.

No offense, but your sentiment is one that has been shared here since I made my first post on this board.
Considering the lack of volume, and the fact this stock has done nothing but sink for years, I would say, this is DEFINITELY NOT the time to be buying this stock. Should this trend change, there will be more than enough time to buy in.
The only value now, is to anyone looking to pump then dump the stock. On your own personal level, I am curious.....would you feel at all bad making money on this stock if it was totally due to getting in early on a pump and dump scheme? Knowing full well you'd be sticking your shares to someone else presumably on this very website?

The lack of success here can be attributable to the failure to date of Multikline as a cancer cure or mitigator of head and neck cancer not the CEO. That being said, this can still be a huge winner, especially given the cheap entry point now, should the ongoing tests, with preliminary results expected in the current quarter, prove successful. If you are lucky, this can be your personal ATM.

Indeed

The reason the company filed for an extension of the 10K is that the deal which just occurred does not close until tomorrow and must be included in the 10K.

Geerts hitting his personal ATM
Hopefully we will get back over $1 before this huckster calls for a reverse split. Been here over 15+ years should have bailed when it stood for months at $25 but had faithin Multikine, should have realized Geert was taking too long with telling full results. Geert is a huckster in it only for himself and what he can make with it.

Sometime in the first quarter there should be some preliminary results on the CRO Confirmatory trial study. If positive, the stock should trade above $1 making the need to reverse split the stock moot. I'm adding here.

Something WAS going on.

A $5 million offering was announced today at 31 cents per share.

Shorts smelled that one out!

OS expands to over 78 million shares. Going to be hard to avoid another reverse split in the future.

Friday's daily short sale volume was 74.61% (as reported by FINRA) and it seems that the shorts are trying hard to manipulate the market! The short borrow fee is 12.87% and the shorts have increased their position by another 600'000 shares to 6.14 million shares that are currently shorted. 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. I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!!

IF....something is going on, it's proof of why you don't hold a penny stock for 10 years. Not only was the stock trading at $16.25 ten years ago, but you had all that money tied up in a non paying dividend stock that you could have easily bought tomorrow for a fraction of the price.
Not to mention there's really nothing conclusive proving this isn't just another pump and dump created by Aegis Capital.

Interesting. Something is going on. It’s about time. 10 years……let’s go baby!! Maybe it’s time……good luck to all the longs that have stuck it out. Praying for good outcomes not only for us shareholders but patients as well. It can be both. Lol.

Someone wanted a lot of shares and paid up to 1.09 for them.  Wow

6.34 Million now traded. Something is up - just not necessarily something good.

5.73 million shares traded and top price of 1.04 very weird stuff going on this week.  Probably another toxic funding offering coming as usual with this stock

Weird volume so far today as well - and up >25%. Share price is still just sad - but maybe something positive is actually going on behind the scenes?

A lot of weird trading going on. I have theories. but no evidence. Very small trades....

12/18/24 05:38:25 PM D O 29 0.9891 TI
12/18/24 05:38:25 PM P 0.9746 MB 1.0100 38 X 7 BBO
12/18/24 05:38:25 PM P 971 1.0000 T
12/18/24 05:38:25 PM D O 500 1.0001 T
12/18/24 05:38:23 PM P 1.0000 MB 1.0100 9 X 7 BBO
12/18/24 05:38:22 PM P 1.0000 MB 1.0100 15 X 7 BBO
12/18/24 05:38:22 PM P 469 1.0000 Y FT
12/18/24 05:38:20 PM P 1.0000 MB 1.0100 20 X 7 BBO
12/18/24 05:38:08 PM P 1.0000 MB 1.0100 14 X 7 BBO
12/18/24 05:38:07 PM P 1.0000 MB 1.0100 20 X 7 BBO
12/18/24 05:38:03 PM P 1.0000 MB 1.0100 22 X 7 BBO
12/18/24 05:38:02 PM P 1.0000 MB 1.0100 16 X 7 BBO
12/18/24 05:38:00 PM P 1.0000 MB 1.0100 2 X 7 BBO
12/18/24 05:38:00 PM P 164 1.0000 T
12/18/24 05:38:00 PM P 418 1.0000 T
12/18/24 05:38:00 PM P 418 1.0000 T
12/18/24 05:37:58 PM P 1.0000 MB 1.0100 12 X 7 BBO
12/18/24 05:37:54 PM P 1.0000 MB 1.0100 8 X 7 BBO
12/18/24 05:37:50 PM P 1.0000 MB 1.0100 4 X 7 BBO
12/18/24 05:37:50 PM P 1000 1.0000 Y FT

Yesterday's run up in after hour trading was a mystery. The price got to $1.16 with over 2M shares traded in that time period before petering out and falling back to almost the closing price for the day. I saw no news, no headlines, and nothing on CVM's website to explain the move.

After Hours Wednesday Over $1.05 at 5:08 PM. Over 2M shares trading.

Zach's Small Cap Research logo
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.

I think you can only post on there on weekends for free. Don't be afraid to ask questions. Just don't get mad if you don't like the answer.