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Good News Badger & Surkast on our %’s helping save lives. Without Iovance’s
Amtagvi, all hope appears lost in the patients treated with Amtagvi.
We have a big few weeks ahead of us & the market as usual has its head buried SO deep in the sand, they cannot see the forest thru the trees.
Shocking to me just how dumb they are.
#CureCancer
Surfkast, response rates continue to improve with those percentages going higher as Amtagvi moves to earlier lines of treatment. The trial rates were exceedingly good given the health and condition of the earliest trial patients who had failed on everything else and had no other options at the time. Now we have Amtagvi being recommended for earlier lines which has been demonstrating better response rates and a possibility that Amtagvi will be a possible first line treatment in specific patient types.
Good news keeps rolling in. ASCO will likely offer even more support and data for earlier treatment recommendations.
The therapy, called lifileucel and commercially known as Amtagvi, is marketed by San Carlos-based Iovance Biotherapeutics.
Clinical trials of lifileucel for metastatic melanoma that worsened while on standard treatment found that about 30% of 153 patients who received the therapy had their tumors shrink or disappear. Of those, 40% experienced no progression of their cancers for at least 18 months after the one-time infusion.
Good article Badger, Stanford released a video & a photo showing the nurses after their 1st infusion of Amtagvi.
Not sure of my recall where I saw it, most likely on StockTwits under BFunk17 (or BFunk77)
If I remember correctly.
His posts are intriguing & usually bring value to look into to verify.
We are on the right track, regardless of our SP today or tomorrow.
Over 60 job posts on Iovance Website indicates they are very active in moving forward one day at a time.
I’d love to extend an Ihub invite to BFunk17 or Bfunk77 to bring additional insight to this great public forum.
#CureCancer
Stanford Medicine delivers first FDA-approved cell-based therapy for solid tumors
The FDA recently approved the first cell-based therapy — widely used in treating blood cancers — for solid tumors. Stanford Medicine treated the first patient with advanced melanoma.
May 6, 2024 - By Krista Conger
https://med.stanford.edu/news/all-news/2024/05/car-t-melanoma.html
Just wanted to share what's getting posted elsewhere. I don't recall seeing this on iHub.
Badger, I listened intently to the video as I am sure all here will do.
I must admit, IF all of this is true & we will know soon, we have a Secretariat in the Stable waiting to duel all former Triple Crown Winner$ so to speak.
It is Triple Crown Season & 2024 is going to go down in history as the year Iovance became Secretariat of the Curing Cancer Sprint Race to solve humanities most difficult health related disease in human history to date.
Curing Cancer one step at a time.
Cheers to the brave, tough minded longs who survived so many lies & deceptive posts on message boards trying to scare us to dump our shares.
Time will tell my Ihub Iovance “Brothers & Sisters”
Stay Strong we are getting so close to a massive sudden upswing that may just be imminent.
In my opinion.
#CureCancer
Sunman, thanks for confirming that the video provides a good snapshot and summary of what many here have been saying and discussing.
On a different note and pertaining to one of your points, I still think that some of the problem we face is the limitations that may be on insiders and potentially on large institutional owners with trading restrictions tied to the new insider trading rules:
https://www.sec.gov/news/press-release/2022-222 (just a snippet)
If shorting is permissible and they're fully aware of trading restrictions placed on major owners who would want to be buying shares, whether insiders or funds, the shorting parties (hedge funds, individuals, whatever) in my opinion can gain an upper hand during an orchestrated short attack. I plead full ignorance as to how the new rules may have helped or hurt the marketplace, but my experience tells me that all things government done in the name of improvement often fail in some unexpected way.
There's certainly far more variables tied to the recent share price and trading action, but I don't wish to discount this scenario as a possible variable as well.
Here's hoping for a very good ASCO report.
Great find Badger. This video nicely summarizes what most of us have been saying all along. My biggest concern is why is SP tanking in a free fall and why are the big boys are not placing some breaks. I’ve seen this free fall with many biotech stocks I’ve owned before which eventually spiked and believe it is done to transfer shares from small guys to big guys and make money on puts prior to releasing big news. Overall Response of over 60% in 10 patients data is not enough to impress FDA to do away with requirement for Phase 3.
To be impressive. I hope they are announcing data in at least 30 patients (50 even better) at ASCO to prove initial data (60% OR) seen in first 10 patients reproduces similar results in subsequent cohorts of 10 patients over and over again. This will set the SP back on the right trajectory as concerns about high expenses and low revenue will abate. All that will
Matter is demand is going to be blockbuster and big pharma is more likely to take over sooner. Risk of dilution may still exist in later part of 3rd Qtr or early 4th Qtr to improve negotiations with the big pharma buyer. Bottom line, I sure hope SP goes back up early next week and jumps up on announcement of outstanding news. My best wishes to all of us who own IOVA shares and believe in TIL technology and its place in cancer treatment in the decades to follow.
I offer the following video that was posted to another board. I haven't vetted this video. It says most of the same things that we've been saying and sharing. It's well put together, but I'll say again, I did not vet this video so I offer it with that disclaimer. It's intriguing:
Dropping the price to before approval levels is crazy. Makes zero sense.
The only like actually logic for a dip like that is imminent dilution or some bad news. Sure hope WR and others don’t allow it to dip below $10 and add some excitement with SP rise in to ASCO.
With ASCO around the corner and a key abstract being released next week, I’d say we are ready to go back to $12, not $9. This precipitous drop from $13 to $10 has been too drastic. Shorts are super confident management is struggling to drive revenue as expected while expenses keep rising. In my opinion, near term, only way to back off the short attack is for management to release upbeat news about growing demand, outstanding results with clinical trials in progress and a comment about about avg. reimbursement per case being recognized based on treatments completed to date.
Dennboy66, I concur that a secondary at this time would contradict all that the company has stated numerous times in that they have enough for ongoing operations well into next year with their cash position and what is coming in and expected to come in from Amtagvi. I understand that another offering could happen next year, but it will likely occur (if at all) following a real discussion of revenues along with actual forward guidance. That's several Q's away at the earliest.
Keep sharing, much appreciated. This board seems to be shaping up to be a very good group with everyone offering insights and challenges along the way. Iron sharpens iron...
This is a bit off topic, but here's an oldie but a goodie in helping to understand all of the nonsense that can happen on stock message boards. This will actually read like a how to if you want to be one of those negative posters. This is only offered as a reminder that not everyone is posting with honor, integrity, and a desire to help the group make better investing decisions. I offer this only to reinforce what many of us already know about certain posters but need to remind ourselves of every now and then.
https://www.griproom.com/fun/how-to-spot-fake-comments-on-stock-boards
Sunman - as far as the hall pass. It is quite rare for someone to not have a secondary to Medicare. If they don’t have a conventional supplement then Medicaid is the most common supplement. Medicaid will typically cover a portion of the 20%.
I am not sure that they would do a secondary this soon after earnings where they stated that they have a runway until next year without a huge spike in SP where they could greatly capitalize without a large share count addition.
Just my 2 cents.
Team, I appreciate you for taking time to share your thoughts. Your explanation is logical. I hope IOVA management can provide this clarification to dispel rumors at the next fireside. I hope they can provide clarity about any un-enrollment numbers from the initial 100 who were deemed as enrolled.
Im assuming minimum $480k collected out of $615k billed per treatment. Some patients with secondary will pull additional revenue and some patients with no secondary may get a hall pass.
I’m excited about ASCO update to add some visibility to Amtagvi Phase 3 results. It will convince everyone TIL platform does lot better when used earlier in the disease.
Current SP of $10 reflects some degree of hedging done by big boys holding large positions as they know more than we do. I would not be surprised if they do a 30M to 40M share dilution upon announcement of stellar data for Amtagvi plus Keytruda to preserve share price. Alternately they announce a buyout sooner than later. I’m holding on to my core position no matter what.
Those numbers look sound as that would be about 80% of the ASP. The supplement would cover the other 20%.
To understand this topic of reimbursement by Medicare, one must understand how they work.
From reading the news, one can see that there is a push for Medicare to be able to negotiate drug prices directly with companies and there is a list of 10 or so drugs that they have been given the go ahead to negotiate.
Otherwise, this is how it works.
Medicare pays for some separately payable Medicare Part B-covered drugs and biologics using the average sales price (ASP) methodology. Medicare pays most separately payable drugs and biologics at a rate of ASP plus 6%.
https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price#:~:text=Medicare%20pays%20for%20some%20separately,rate%20of%20ASP%20plus%206%25.
https://www.hhs.gov/about/news/2023/08/29/hhs-selects-the-first-drugs-for-medicare-drug-price-negotiation.html#:~:text=As%20a%20result%20of%20negotiations,NovoLog;%20NovoLog%20FlexPen;%20NovoLog%20PenFill
This Pepper poster on ST appears to have other motives IMO. It became apparent today when he posted a 2022 study outcome section about deaths. He only posted the excerpt about deaths and did not post the full study outcome so as to conceal the pre-approval initial study for lifileucel.
Good morning Team, I read the Q1 earning call transcript one more time. It became clearer that actual reimbursement rate is a blind spot at patient enrollment and this may lead to some degree of patient un-enrollment.
This appears to be the reason nor some panic. Until the company shares more definitive information, speculation rules.
2 new variables have gained prominence; actual reimbursement and patient un-enrollment. How many of the 100 enrolled actually get infused and what is the actual revenue recognition for this cohort of 100? Let’s say 90 get infused and revenue is $480k per patient. That’s $43M spread over Qtr 2 and 3. Now they have 60 more being screened of which may be 50-55 may get infused in Q3 for another $24M recognition. That’s $67M for both Q2 and 3. Assuming Q4 pulls in $50M, we still end up with $117M-$125M. For 2024. At burn rate of $113M per Qtr, they will run out of cash by 2025 Q2 and dilute $350M to operate in 2025 and early 2026. There is considerable financial risk. With that said, positive data from Phase 3 combination with Keytruda will support increasing demand and possible buyout. Doing it alone has big financial risk as this product requires a lot of planning, logistics and dependence on payors. Now I better understand why the short position has increased. I welcome your thoughts and rebuttals.
Sunman, I did a quick review of some of that poster's posts. The ST board seems to discount his/her posts to some degree, but occasionally valid concerns are raised. I could show where the posts have missed the point on numerous comments, but I don't want to fully discount the thoughts as they do drive us to stay vigilant. I do my own share of speculating, but I try not to overreact with emotion, but rather I try to slow down and dig in a bit deeper to make sure that I'm not missing anything.
Forgive this message as I don't want to come across as condescending, but just trying to be matter of fact.
I'm still holding strong for whatever that's worth.
Have a great day. Off to visit with family. Gonna hit de 80's today up nort here, doncha know.
Sunman, I don't believe the 75% reference was properly defined in your discussion. Here's the section discussing the 75% number (from the Q1 call transcript):
"Early launch data indicates that more than 75% of patients enrolled for Amtagvi are commercially insured which aligns with our expectations."
From the following, per Jim Ziegler: "...We are observing month over month growth and we anticipate sustained growth throughout the year as the number of ATCs expand and there is broader utilization of Amtagvi. In the short time since approval, favorable reimbursement trends and medical coverage policies have set us up for success and broad access for patients. Early launch data indicates that more than 75% of patients enrolled for Amtagvi are commercially insured which aligns with our expectations. Thus far payers responsible for more than 200 million lives have approved at least one patient for Amtagvi treatment and notably 13 payers responsible for approximately 90 million covered lives have already published medical coverage policies that are consistent with label, clinical trials and the recently updated NCCN guidelines..."
https://uk.finance.yahoo.com/news/iovance-biotherapeutics-inc-nasdaq-iova-163350605.html
Please share your thoughts after reviewing this section again if you would, please.
I think any discussion of actual reimbursement amounts is speculative, but the analysts hopefully have a handle on some of that in what they offered regarding revenues for the coming Q's.
If anyone has actual experience with CAR-T reimbursement, that might help a bit.
Regarding the aggressive shorting, that may simply be the perfect storm of timing. Sell the news following Q1 call, insiders can't trade currently due to SEC rules (assuming non-public material info), and some major funds that have ties to insiders even though they don't own 10% may also be holding back from trading to avoid appearance of impropriety and insider trading violations.
Shorts may have free reign right now and if they know they do, wouldn't they take advantage?
Just a few thoughts.
Badger, I think we discussed the Medicare Reimbursement rate a while back & it was $400k on Amtagvi & appx $80k on
Proleukin(spelling off)
I think IF I remember this accurately????
Badger please chime in here to verify or not verify.
Grand Total Reimbursement for the complete treatment at $480k minus surgery to remove part of tumor & chemo.
I will attempt to verify from an outside Insurance source I have.
#CureCancer
With all of the analyst looking at Iovance roll out and execution and trying to come up with projections it seems someone has this information and it is factored into the projections. It is too obvious to miss on something this big and obvious. It would have brought up by now, on a call or in an analyst work.
Sunman, hopefully we can validate the reimbursement % by Medicare elsewhere.
I worked in the Insurance space for nearly 30 years up to 2012 so it was too long ago to confirm.
At the time it was 80% reimbursement rate.
However, the patient was on the hook for the remaining balance, 20%.
Personally I find that post as horribly misleading & we cannot give it ANY credence until we find out the facts.
Worrisome, possibly.
In my opinion, the patient will be responsible for a % over & above Medicare’s reinbursement policy.
This may be why patient un-enrollment rates were leaked recently.
I don’t recall the % & do not desire to state with any confidence yet the patient’s responsibility % until Iovance tells us what it is.
I am going to use my Insurance contacts to try to find out more concrete information & will let all know on Ihub IF I get it done & confirmed 1st.
#CureCancer
What do you all think of. Pepper214’s post on Stocktwits? Can someone validate actual reimbursement from Medicare?
He posted:
“I figured out Why we are down and Stock has been shorted....The price of Amtagvi is 515000 and Prolukein is 100000 so the list price is 615000 but I GUARANTEE that while insurance will pay , it will pay a negotiated rate which could be like 100000 for the sum total.....My chemo was approved by insurer with a billing rate of 81000 per round and insurance paid 7400 per round...I am 100% certain that someone at one of the insurers is aware of reimbursement rates and has shared this to whomever is shorting....Company Didn't provide a revenue reimbursement rate only that 75% of Insurers would cover..They didn't lie BUT they never said reimbursement rate only % of Insurers who approved coverage....Honestly that is misleading and…”
Thank you for correcting me. I don't follow the stock very close.
I appreciate this board. MNGopher picked up on some news I missed, Sunman provided immediate clarity.
How nice to have a message board with posters that actually bring value and are considerate with their posts. We don't have to agree, but civil discourse is always appreciated.
Thank you all.
Badgerkid
Sunman, thank you for the correction and clarification. Too many cancers and too few treatments for now. The treatment options are growing which is wonderful.
Thank you Sunman for the clarity with Amgen’s approval.
Appreciate the good news for Iovance’s potential in the NSCLC space.
#CureCancer
Thank you Badger for the prompt & professional response based on what you/we know today.
Clearing the deck for Iovance so to speak where I agree, TIL Therapy is going to be used in my opinion for many Cancer applications & will find its place in the
NSCLC Arena.
#CurrCancer
MNGopher, the latest approval is for a very specific and small segment of lung cancer, small cell. Iovance and TIL therapy is targeting non-small cell lung cancer with its over 230,000+ new cases of nsclc in the U.S. each year. Amgen's new drug is also dealing with some very serious side effects. With that said, it may buy time for that portion of patients that are months away from dying. TIL therapy will still prove to be a significantly better option for many if not most of the NSCLC patients but as of yet we don't know what it will do for Small Cell Lung Cancer. TIL still appears to be the future treatment for many solid tumor cancers, but there are so many genetic variables that still have to be worked out that anything right now that offers some hope to even a handful is a step hopefully forward until TIL gets approval.
If anyone can offer more detail right now regarding Amgen's new drug, it would be appreciated, but I still understand that TIL therapy and all its future improvements over the coming years and decades offers far more hope for a much larger portion of all solid tumor cancers.
Amgen got approval for SCLC. IOVA TIL is for NSCLC. Different indication!
https://amp.cancer.org/cancer/types/lung-cancer/about/what-is.html
Amgen got approval for SCLC. IOVA TIL is for NSCLC. Different indication!
I don't think it is good that AMGN got FDA approval. It just gives IOVA more competition and a smaller piece of the pie. Likely they will also be at a price disadvantage to AMGN
Amgen got FDA approval for late stage
NSCLC 17 hours ago according to Seeking Alpha.
How will this affect our own aspirations in the same space?
If IXBR & Iova get approved too, again how will this affect Iovance’s NSCLC & Our Aspirations?
#CureCancer
Thanks for your great DD on keeping the board informed!
Sunman, GMH, MNGopher, Surfkast, and all board members. ASCO is right around the corner and I expect we'll all be pleased with the information. I don't know that it'll be share price moving, but it should add support to why we're long IOVA.
Here's the bonus info: if my ability to read is correct, the abstract will be made public prior to the presentation date. I believe the release date is 5/23/24 at 5 pm. My hope is Iovance will immediately releases this info at the same time. Refer to "Abstract presentation 6" in the link below and click on Abstract #9505.
https://meetings.asco.org/2024%20ASCO%20Annual%20Meeting/15784?presentation=233024#233024;
"The full, final text of this abstract will be available at abstracts.asco.org at 5:00 PM ET on May 23, 2024"
If anyone is able to access this at that time, please share here.
Even if the information is currently known by any number of people, my gut tells me that our insiders and large funds can't trade in IOVA right now due to material info that hasn't been made public as of yet. I don't know if that info is the ASCO material that will be shared, or if there is some other info that remains under wraps, but every which way I look at it, it reads like SEC insider trading rules have prevented more positions from being taken by the insiders. I believe it also applies to 10% stake holders, but even those funds with less than 10% may choose to avoid any appearance of impropriety due to their known working relationships. If the shorts were aware of this, and they often are when there's such an orchestrated attack, that window to play may be closing soon for them.
Time will tell, but my reasons to be long (and patient) hasn't changed. I'm confident in the future, I'm just not excited about giving back so much of our gains in the present.
IMHO of course.
Good luck to the longs.
In 3 months we will all be more knowledgeable as we will know how many of the 160 screened actually received treatment. That should set a benchmark for attrition rate. With that said, over time, attrition rate should keep reducing for some the variables you have outlined.
Bottom line, treatment with Amtagvi requires multiples steps and a significant level of planning and timely execution. As they gain experience, turn around time should continue to improve.
If they manage to treat over 250 patients (low end) in 2024 and set run rate to treat over 500 (low end) in 2025, all is well.
I believe the big ace is excellent clinical data for Amtagvi plus Keytruda in early lines of treatment for melanoma. ASCO should shed more light and color about this one.
Hawkeye, Wow what a hogpog of questions with no real answers here.
It’s alot to digest & thank you for pointing out all these pitfalls we appear “trapped in” for now.
These many questions could truly be the why here in the constant Red we see for what 2 straight months.
I’d like to think Wayne knows the “why” here, but he is intensely private & favors
Dropping good news bombs in his own time frame.
His history points to this as his strategy, good or bad.
WR seems to enjoy seeing the price drop daily so his buddies can scoop up shares at a discounted premium.
He plays the long game like the seasoned investor he is.
He looks at the big picture in keeping a very tight lid on communication to us outsiders & goes crazy IF info is leaked early.
All we can look at in the in-term is to see if we get more insider large purchases of Iova to signal good news is around the corner.
We should know more on 5-31 with trial results being communicated to us little guys on the outside.
My own opinion is always as you know, follow the $$$
If insiders are selling it’s trouble & if they are buying, we are in good shape for now.
I’d love for Investor Relations to reply to you.
I’ve tried so many times myself & crickets is what I get from them.
I suspect your pointed questions will receive the same fate, silence.
It stinks & we are frustrated, I know I am.
Playing the long game or selling shares is about all we can do for now in my opinion.
Good Luck Longs
As I like to say
“In Wayne We Trust”
#CureCancer
Have had company in town so have not posted but have been watching this huge sell-off. In thinking about what is driving this, I really think it comes down to communication. Before I retired, I had worked with several C-suite execs and, when we were pulling together presentations for S&P or Investor groups, the best ones always said "What story are we looking to tell" and then we would build the presentation based on the message we wanted to send. If you do not do that, analysts will create their own story and it will almost certainly be worse than the message you are trying to send.
Specific to Iovance, I was trying to create a patient pipeline to see where the 160+ patients fell and what would be the attrition rate at each step. In doing so, I started to find a lot of unanswered questions and to how much of the 160+ would actually generate revenue. Specifically:
1) Screening - how is this defined and what is the drop out criterial? Outside of label (heart, pulmonary, renal issues) is for sure, but anything else. I think the "not melanoma" actually generated more questions here even though I suspect it was an oddity that they pointed out. I do have a question to IR to define criteria for sceening vs enrolled, but having waited a week, radio silence, which does not help.
2) Enrolled
a) Insurance - drop out rates due to insurance denial (in policy and Medicare/Medicaid should be low but what about single case agreements).
b) Surgery - inability to get appropriate biopsy or selected tumor site is dead - should be low due to screening, but not sure
c) Manufacturing - ability to extract get sufficient TIL from sample - 10% was given but does this include any of the above
d) QA step - TIL cells did not multiply to appropriate volume - assume this was include in the 10% but again, not sure. Again, sent request to IR and nothing.
e) Health status - how many patients have health deterioration during the overall process which generates a failure and is this included in the 10%?
Then you have the differing timelines:
1) Screening - 1 week for referral, travel, consultation and doctor/patient decision? May depend on distance to Cancer Center.
2) Insurance Authorization - 3-4 days where policy agreement exists and Medicare/Medicaid??? and 3-4 weeks for SCAs?
3) Surgery - 3-4 days (but may also depend on travel/distance
4) Manufacturing and Assay QA - 22 days and 12 days respectively
5) Scheduling infusion - 2 days to 2 weeks?
The more I break this down, I can see where analysts may be including a pretty high attrition rate. I understand why Iovance does not want to provide guidance since there is a lot of unknowns in projecting the future, but they really should be disclosing known facts (patients in each phase and drop out rates if they are known to Iovance and if not, say so). Fred saying "I cannot give that number because then you would get revenue" was probably the wrong answer. There are still unknowns but analysts will come up with their own answer anyway so unless the number is "bad" or you really need to put context around it (i.e. full patient journey timeline), not giving it raises doubts.
In going thru this step process, I can see where analysts could be concerned about the attrition rate and thus revenue. On top of that, the timeline is longer as people were thinking (myself included) as everyone was focused on the 34 days, but you have screening, surgery, insurance authorization and scheduling infusion delays as well. The problem in this space is that it is not just pushing revenue into the next quarter but if the patient deteriorates during that time, it could be a complete loss of revenue.
I just hope they start disclosing more facts because if they do not, people will make up their own facts and will almost be certainly worse than reality.... in this case, silence is NOT golden.
Thank you Sunman, looking forward to the report.
Sunman, read the Yahoo MB posts, good info, thank you.
Look forward to the Oncologist reports from the Iovance Posters.
I agree with your perspective on Iova’s future.
Exciting times lie ahead in 25/26.
#CureCancer
My most recent IOVA posts on yahoo MB should provide a reality check for all.
One of my Oncologist colleagues is going to ASCO and has agreed to track IOVA posters and presentations. He also started a position. In IOVA at $11. Will revert back when we learn more.
Is anyone here going to ASCO? Maybe to get some CE credits? If so, please check in on the Iovance booth and share some feedback.
It would be greatly appreciated.
Sounds good to me Badger & it makes complete sense…as Tom Brady loved to say; Let’s Fu**ing Go Iovance!!
#CureCancer
https://seekingalpha.com/news/4105055-merck-discontinues-testing-of-experimental-skin-cancer-combo-therapy
Good Morning from Florence Italy, what a pleasure to read this morning that Merck
Discontinued its skin cancer combo therapy! No Dice together & hello to
Iovance as a stronger future buyout partner
Its possible they already know the combo of Keytruda & Amtagvi is a Winner together 66.7% success rate was already reported on Iovance’s website.
Our Future is so bright, we gotta wear shades!
#CureCancer
MNGopher, sail on my friend, no rush to get back, the big pop in share price will still take a couple of quarters. The bigger pop is next year. The market wanted more detail at the Q1, the company delivered great news and info, but not the specific rev. numbers that apparently the market wanted. They need to be spoon fed and they weren't, so IOVA got spanked a bit even though the market is the one acting like a child. Margin calls will wind down (probably by day's end tomorrow), and then we go back to trading with the sector and the market, waiting for news, and us trying to add a few more cheap shares to our respective accounts.
Cruising in the sea along Italy's coast sounds a lot more fun right about now.
Safe travels.
Thank you Badgerkid, its smooth sailing so far. Hopefully the MM’S stop continually plunging our amazing company downhill.
#everydoghashisday!
#CureCancer
MNGopher, safe travels. I predict your future Iovance gains will provide for many more trips (should you want to travel again).
Good luck to the longs.
Thank you Dennboy66 for what 50 years plus of insight!
This was a fabulous post & solidifies us “longs” line of belief in Iovance & our TIL Therapy.
As I set sail on a long Italian Cruise today from Rome, reading your post is a perfect way to begin our journey!
To me this post is Spot On & we are in Iovance’s infancy with so many doubters I cannot wait to shut them down once & for all.
For all of us who believe in Curing Cancer, today Iovance gives humanity it’s first big step up in the right direction to cure cancer.
#CureCancer
Iovance Biotherapeutics is pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
We are a patient-centric, collaborative organization that is driven to change the way cancer is treated. We are agile in our thinking and strive for excellence and innovation while acting with high integrity to create value for all stakeholders.
Tumor infiltrating lymphocytes (TIL) are naturally occurring immune cells that fight cancer. TIL are on constant surveillance to recognize, attack and kill cancer cells. When cancer invades and prevails, the TIL are unable to perform their intended function. Investigational TIL therapies are designed to reinvigorate a patient’s TIL to fight cancer. A patient’s naturally occurring TIL are collected and grown outside the body so they can be administered back to the patient as a one-time treatment. Once inside the body, Iovance TIL therapy deploys billions of personalized, patient-specific TIL to recognize and target diverse cancer cells.
TIL monotherapy and TIL combination therapies are being investigated in clinical studies in multiple advanced solid tumor cancers including melanoma, non-small cell lung cancer, cervical cancer and head and neck cancer.
AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy
AMTAGVI deploys patient-specific immune cells that recognize and fight cancer
SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.
AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. The proposed mechanism for AMTAGVI offers a new cell therapy approach that deploys patient-specific T cells called TIL cells. When cancer is detected, the immune system creates TIL cells to locate, attack, and destroy cancer. TIL cells recognize distinctive tumor markers on the cell surface of each person’s cancer. When cancer develops and prevails, the body’s natural TIL cells can no longer perform their intended function to fight cancer.
AMTAGVI is manufactured using a proprietary process to collect and expand a patient’s unique T cells from a portion of their tumor. AMTAGVI returns billions of the patient’s T cells back to the body to fight their cancer.* Authorized Treatment Centers (ATCs) will administer AMTAGVI to patients as part of a treatment regimen that includes lymphodepletion and a short course of high-dose PROLEUKIN® (aldesleukin).
https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvitm-lifileucel-receives-us-fda-accelerated
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