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Looks like someone dumped a big block today. Why if this has so many buy recommendations?
Feb 16, 2024 day of FDA approval for Amtagvi, high for IOVA was $10.44. (news came out late on a Friday which dulled the initial price response).
First full trading day post approval IOVA high was $13.41, and XBI high was $93.84.
Feb 28, XBI hit it's one year high at $103.52 the same day that IOVA hit it's high of $18.33.
Today XBI is currently $87.55, down 15.4% from it's recent high and IOVA is currently $12.05, down 34.3% from it's high on the same day that XBI hit it's one year high.
IOVA is trading 2-3x XBI (that's the correlation).
It's been said by many of us who are bullish on Iovance that this is not a short term play. Revenues will drive price, the price will not run-up significantly until such information is verified or additional good news comes in on other items such as foreign market approvals, positive trials and PDUFA dates being established for other TIL therapies for other solid tumor cancers.
Of course, a buyout at any time is possible, but more likely after a few Q's of reported earnings from Amtagvi.
IMHO
Thankfully it appears Badger is spot on with the Middle East issues this past weekend.
Luckily not a 9-11 outcome for Israel, a huge shoutout to our friends in the region. What a hot mess this region is day in & day out.
For now, As Badger said its Middle East 101 & we should luckily get past a market meltdown like we had in the 9-11 debacle & such a huge loss of American lives.
Stay Strong Longs, Much Brighter Days Lie Ahead!
#CureCancer
We are still at 33 approved ATCs. I do think this will be back-loaded because of the time commitment for training that is required to become an approved ATC.
Slow down, MNGopher. These are all measured responses with intent to show force without a likelihood of much damage. It could escalate, but it will more than likely just be business as usual in the Middle East (as sad as that may be). When you announce what you're going to do as Iran did, the intention is more of a warning and retribution as opposed to all out war. It's a dangerous game to play, but it's not that unusual in that part of the world.
Agreed, it does add volatility to the markets, but just how much is hard to say. This is Middle East 101 to give it a college class moniker.
My hope is that our friends and family over there stay safe.
Badgerkid
Well everyone, the markets will be in turmoil more then before
Oil prices will spike up quickly & the sell off begins on Monday
In my opinion.
Buy what should be a major meltdown, 10-20% if its like 9-11 was.
We may see 9-10 like I thought IF this happened.
Will present a great “timely” buying opportunity before earnings.
Good Luck & Hold Your Shares & Don’t Panic.
#CureCancer
Iran’s drone attack against Israel has begun, per news alert just received.
For me, nothing has changed since the approval and lifting of the halt on the NSCLC trial, so my intrinsic value price target has not changed. The next catalyst will be patient starts reported at Q1 ER.
In regards to being a good buy here, I generally will not increase my cost basis unless there is new facts that emerge (doing so has cost me dearly in the past). I will add exposure specifically for upcoming catalysts by using the options market. I generally try to use structures that limit premium outlay though.
Still rated a buy? Good news on Monday to stop this from drifting down any further?
Just a reminder, the reason we want Iovance to succeed is not only because we'll do very well with our investment, but there's the human factor of improved health and lives well lived. Good luck. Check out Toni's story on the website if you need a refresher on Amtagvi and that human component.
https://www.amtagvi.com/
https://vimeo.com/amtagvi (Toni's story)
Good luck to the longs.
I wanted to clarify why I thought 9-10 is in play in the next 1-4 weeks before 1st Qtr report.
Geopolitical events coming soon in the Middle East, may set off a downward spiral like 9-11 did.
If Israel & Iran literally go “toe to toe”
Bombing each other n their respective interests, we could see 9-10.
Otherwise, Personally I’ve stated before the “Floor” to me has been $12.50
Based on Insiders buying at these price points months ago.
Good Luck & hold onto your positions.
Whatever Macro events affect us, its NOT Iovance as a company & Amtagvi as a treatment for Cancer Patients.
#CureCancer
MNGopher, I think you're low guesses exceed what all of the options and insiders are telling us. We're seeing slow acquisition right now regardless the overall market sentiment. The overall market would really have to tank for those levels IMHO. I think today's action is the typical overreaction to news that was already known. Lemmings! Interest rate hikes. Interest rate reductions. Hold those rates. Seems like a shell game at times, doesn't it?
The reasons to own IOVA haven't changed, the share price has. Seemingly painful in the short term, but I suspect we'll all be happy by this time next year (or sooner).
It wasn't that long ago I couldn't wait for us to get up to this current price. After approval, others said that this current price was possible due to the softening demand and the departure of the hot money. Those same people said they'll be adding once again if the stock price came back down to this price point. Looks like they were correct and I suspect they and others will be adding more aggressively now that it has. I may not have enough powder left for a big bang just yet, but I will add a few more shares at these levels.
Let's see what the next few Q's bring.
Good luck to the longs.
IMHO
Wednesday Bloodbath in BioTech
LABU & XBI getting slaughtered after hot CPI this morning.
Inflation battle is far from over & The Fed is now losing the battle.
Interest Rates will possibly rise again n again.
Interest Rate cuts Wall Street was expecting this year look like its in 2025, not in 2024.
Buckle Up Longs, We are headed straight down possibly between 9 & 10.
Looks ugly to me on the short term, but good/great news will send us soaring upwards after Q-1 Report n hopefully good Q-2 Forward Guidance.
#CureCancer
Don't expect it with share price dropping from $14.82 on March 28th. too $13.15 now, unless the price rises above $14.82 before April 15th.
3/28/2024 Short interest report: now 46.38 million shares short, only slightly down from 47.43 million. FWIW
I suspect that number will drop a bit more for the 4/15/24 report.
Allison was one of the investigative physicians while at NY MSK so if anybody would not need additional training, it would be her. I think that they need to provide the training purely for quality control and to make sure everyone knows the approved protocol, which may be a bit different than that used during the trials.
Did not see my previous post so I re-wrote... sorry for the redundancy.
I just re-listened to the Allison Betof-Warner video with AIM. At the 33 minute mark, she discusses payers and how Medicare approved within hours of the submission, but she also notes that other payers (plural) are also covering but may take some assistance from providers and that she had actually just finished one earlier. The video was posted on 3/14 so seems to be more than a handful from Stanford alone. Given that the treating physicians are required to put in 200-300 hours to become an ATC, I would think that treating physicians in other ATCs would be similarly supportive of recommending this treatment.
GMH, do we know if those 300 hours of training are independent of other training? If a new Amtagvi ATC has already been approved by other companies as an ATC for administering CAR-T or some similar therapy/treatment, would they not already have a significant amount of the necessary training? I truly don't know the answer to this but having sat with friends and family at various treatment centers, there's a lot of training that is necessary but training that may be redundant for any number of meds, etc thereby not requiring a repeat of training that has already been conducted (a transfer credit so to speak).
Just thinking out loud on this one.
I was just re-listening to the AIM video with Allison Betof-Warner. Interesting to note at the 33 minute mark where she discusses reimbursement and payers. Specifically, the ease at which Medicare approved the treatment (45% of patients) as well as her discussion that "the discussion with each payer is different" implying engagement with multiple commercial insurers. She also said patient advocacy may be needed and she was "working with one insurer on that earlier today."
This video was posted on 3/14 (30 post approval), but it sounds like Stanford had at least a handful of patients in process at that time. I know Allison was an investigator in the trial and has been a big proponent of TIL approval. I just hope we have similar people in the other ATCs. Given that it takes 200-300 hours of training by the physician to become an approved ATC, it is not a small investment so the physicians should be supportive of the treatment. Its not like a phama rep coming in with a brochure trying to get the physician to switch preferred drug percriptions.
A few items of note regarding some of the larger positions:
Perceptive Advisors holds 19.2 million shares with an avg cost of 12.94, Blackrock has 19.1 million with an avg cost of 10.07, State Street holds 16.4 million shares with an avg cost 12.50, and Avoro holds 6.7 mil with an avg cost of 16.58.
Additional increases did occur after approval and there doesn't seem to be any rush for the exits.
Good luck to the longs.
Agree with everything you stated. I am reluctant to add more because I generally have not done well when raising my cost basis. I am hoping for break-even earlier than end of 2025 (but I can be overly optimistic at times). I think NSCLC will continue to progress well, especially with the early data on the EGFRwt subgroup. In biotech, everyone wants daily readouts, but it often becomes a long waiting game and people lose interest and move on until the next "surprise" catalyst.
I’ve been investing in small biotechs for a long time and had predicted we may see $12-13 range before we see $20 plus. I plan to load up at these levels and trust the company leadership will exceed expectations with initial ramp up and point to a revenue trajectory which supports breakeven by end of 2025.
Also, I trust the company to achieve positive results with confirmatory trial for metastatic melanoma. Success with NSCLC study will be icing on the cake. Thanks all for sharing your thoughts and progress updates.
Here is a link with recent (2018-2023) Biotech buyouts and premiums paid. Once you get into the MC size that IOVA is currently, the premium is around 75%-100% of previous close price, so we would be looking at a buyout price of $25-$28. I think that may be a fair price for MM, but the other indications are worth as much, if not more due to TAM. I am willing to wait, at least until mNSCLC data comes out. If we can get approval, even if limited to EGRFwt where we are seeing the greatest efficacy (similar to CAR-T), that could easily generate $2-3B in annual revenue in 3-5 years. I am no spring chicken, but I can wait that out (as long as the data continues to come in favorably of course) and will take a 10x (and go it alone) then vs a 2x now.
https://www.biopharmadive.com/news/biotech-pharma-deals-merger-acquisitions-tracker/604262/
No doubt Badger Big BioPharm needs to buy Iovance before the price gets very expensive.
Pfizer stated publicly they moved away from their Pill Based strategy & 9 year exclusive’s to the new Immunotherapy based Pfizer platform to capitalize on the 14 year exclusive & Badger mentioned in am earlier post an additional 4 yr exclusive for Amtagvi. That put us to 2042 in exclusive protection.
Imagine the new indications that will be approved & these long term exclusivities are the KEY to big BioPharm.
The Buyout most likely occurs prior to NSCLC & Cervical are approved, which for us investors we hope for a triple figure cash/stock shares buyout if this occurs.
Time will tell….
#CureCancer
Regarding the links for posted articles - just a heads up, if you click on the links to the previously listed articles, your first click may give you the full article - read it or find a way to copy it. The second try for me led to a snippet of the article along with a sales pitch.
Sorry, fair warning, but I should have known that there's no free lunch with these publications.
The obvious point is that Iovance's patents and the length of their exclusivity may be just what some other companies need to bolster their income stream.
IMHO of course.
Why Iovance patents may be worth more than what we give them credit for - Barron's article: "Big Pharma Stocks Need a Rethink. Investors Keep Making the Same Mistake. Pfizer’s patent expirations are great for humanity but terrible for investors. It’s a common story across the pharmaceutical industry." By Josh Nathan-Kazis, April 04, 2024.
https://www.barrons.com/articles/big-pharma-stocks-investors-mistakes-90e3c575
Some food for thought while we go golfing, bowling, or in my case - going to my real job (I thought that was funny).
The article was fully available on my first visit, but it's now limited by a sale's pitch. Wish I would have copied it and shared it in full. If anyone can provide a link to the full text, please share. The article has a lot of good detail.
FWIW, great NCAA final for women's basketball, even though I was rooting for the Hawkeyes (this time, I am a Badger after all).
Badgerkid
Here's another brief summary regarding patent cliffs:
https://thehealthcaretechnologyreport.com/the-looming-patent-cliff-big-pharma-giants-brace-for-fall/#:~:text=Big%20pharmaceutical%20companies%2C%20including%20industry,dollars%20in%20sales%20at%20risk.
You are correct, Warren & Charlie dont invest in Biotech as far as I know.
But yes, go away play golf, bowl or whatever you like to do like watch the Iowa Hawkeyes Women in todays NCAA Championship, Good Luck!
The message resonates the same, now we sit n patiently wait, financially all we do is add shares & wait & relax
Day to day ups n downs are market induced reactions/ Manipulations, etc
We wait on solid news to build out our long term strategy.
#CureCancer
I don't think either Buffet or Munger would ever invest in the biotech space for that reason. You do need to stay on top of developments (which is why I think, if you do the homework, you can pick the winners in this space as well as other small caps), but it does take work. The problem is that there is no sense in updating the models if nothing changes (no new data). Daily stock price action means nothing, but somehow it makes people nervous. My problem is that I am looking for any little tidbit of data, but in all likelihood, I could/should just go away until Q1 ER update and I wouldn't miss a thing.
Hawkeye, Charlie Munger one of my favorite investment gurus I follow, (Charlie passed recently) would comment on your watching the paint dry post.
He would say More often then not, U Invest in Good Companies (Buffett too) at a Fair Price & then do nothing but wait.
Patience is what creates great wealth, not the buying & selling.
My personal opinion is to add shares on the dips the whole way through the process & Hold & Wait For The Inevitable Buyout Offer Wayne cannot refu$e.
#CureCancer
I think I am watching this too closely which is part of the problem. With no new data emerging, it is really just watching the leaves on the tree blow in the wind.
Good thing is that the weather here is good enough so I can start to go play golf and do other things outside, so will be doing less "watching the paint dry". Spend a couple hours in the AM doing some updates and then letting all my positions percolate.
To that point of drifting with the sector:
XBI down ~4.5% on the week, IOVA down 8% on the week. The correlation persists with IOVA trading around 2-3x XBI on the daily, weekly, and now monthly. Over the last month, IOVA was down 19.6% with the XBI down 9.6%. Iova is just riding the wave of the sector with a little more volatility. IOVA may get a little break free moment with the guidance for Q2 at the Q1 call. Until then, there's nothing to really fear, but nothing to move the needle just yet either. It'll be the numbers at the end of this year that will tell us the story of just how smart we all were with our investment in Iovance. Until then, more up days than down in the sector sure would be nice if this correlation holds true.
I contend that the Iovance team is performing admirably (even though many of us would like to get weekly updates). The three healthcare conference chats that took place over the past month provided many good insights, but they were careful not to give guidance as such. Still, there was a lot of meat to their messages.
I'm in for the long haul. IOVA will have many up days that break free from the sector funds as more clarity on earnings becomes evident.
Good luck to the longs. Have a great weekend. IMHO as always.
Badgerkid
I do not rely on analysts' estimates as they can be all over the place and updated infrequently. I build out my own valuation model (especially in the biotech space). This allows me to update my intrinsic value as new facts emerge. Last updated facts we have is the Approval and lifting of the NSCLC halt. Since then, nothing has changed. Looking forward to next ER when we will probably get patient starts, which will allow me to compare my estimates vs actuals and adjust accordingly. Until then, it is as Badger said, we drift with the sector.
I have never been really concerned about the patents. I think this technology is way to complicated for a "generic" knock-off, even after patent expiry. They would still have to charge in the 200k range and currently, there just isn't enough volume to support that level of investment. However, it is good to know that even that is not a risk for the next 14 years... do not think I will be in this name that long, but you never know.
It appears that most targets still put this over $20 this year. I am glad the pre and post market trades have basically dried up. I believe there were a lot of stop losses triggered when this dropped from the recent high.
Oops, my previous message, I meant to say "we will then get 2025 guidance. That is when I think IOVA will be at a significantly higher value..."
Surfkast, IOVA is mostly trading with the sector right now. I've noticed that it's somewhat common for IOVA to trade at 2-3x XBI on any given day. If XBI is up 1%, IOVA may be 2-3% up. If XBI drops 1.5%, IOVA may be down 4% (just a correlation observation). Obviously there are numerous factors causing IOVA to "drift," but the hot money has moved on to other shiny stocks and will return to IOVA when there's needle moving news.
All of the recent news that we've been getting is mostly baked into the share price, so we drift with the sector. The news we're getting certainly supports my reasons for staying long and holding a core position, but it's not outside of anything that most of us would have guessed or assumed. We're ahead of the game just a bit, so we're all waiting for the rest of the market to catch up to what we see as the future potential and market value. Most analysts agree which is why their one year targets average is $26.00.
The sector was certainly on a tear from Oct to the end of Feb. It has softened a bit since then, Iovance as well. A large number of pharma companies have been having great success with so many new drugs and therapies, I sometimes think that Iovance has gotten lost in the noise just a bit. Great news for many people with many different types of health issues, but it's hard to stand out when so many companies are having success and money is being allocated to a wide segment of that sector. Historically, pharmaceuticals seem to be in another very active phase right now. I suspect M&A will be commonplace over the coming 1-2 years. Iovance could easily be a part of that trend. Right now, we're just another winner amongst the winners.
As we get a handle on the future earnings (both actual and potential), you can bet that IOVA will move up very quickly in price. Patience for me is always a challenge, but patience is what we need for the time being. The hot money is chasing the latest and greatest and Iovance has already demonstrated that they've got the goods. The next big move for IOVA will be based on revenue along with future moves based on new markets, new products, and potentially acquisition.
Q1 with Q2 guidance may move the needle, but I think the best way to look at this right now is 9-12 months out. At that point if all goes as expected (or better IMO vs analysts estimates), we will have 3 Q's of reported earnings and we will then get 2024 guidance. That is when I think IOVA will be at a significantly higher value and on much more solid footing. Many believe that Iovance could easily be in the black sometime next year, myself included.
Good news doesn't always translate immediately to an increase in stock price, but it does compound for future gains.
Good luck to the longs.
Badgerkid
Toms of good things but this is drifting down. Confused.....................
Updated presentation on Iovance patents. Definitely worth a read through:
https://ir.iovance.com/static-files/035fc664-bc5b-4e79-9bed-66bbc7962dbf
https://ir.iovance.com/news-events/events-presentations
GMH, thank you for sharing. Some promising information as expected:
Based on the below excerpt, my question here is: Prior to some of these earlier treatments, would there be a benefit to harvesting some of the tumor tissue and freezing it for later usage prior to using these earlier lines treatment should they not work? The tissue would likely be of better quality for tumor-reactive T cells.
"317 Recent analyses in metastatic melanoma also demonstrated that prior exposure and longer duration of
318 exposure to ICI was associated with worse outcomes with TIL cell therapy (23,24). Prior ICI experience
319 was associated with decreased detection of T cells reactive against neoantigens despite similar
320 predicted neoantigen loads, suggesting that ICI exposure prior to tumor resection could be inversely
321 correlated with expansion of tumor-reactive T cells (24). "
(This makes me think of the book: "The Immortal Life of Henrietta Lacks." It tells the story of an African-American woman who died in 1951, aged just 31, of an aggressive cervical cancer. It also tells the story of her legacy: the HeLa cell line, taken from Henrietta's tumor while she was still alive, cultured in a lab, and discovered to be immortal.
The obvious take-away as discussed below - move TIL up to frontline treatment:
"...To that end, recent data demonstrated the
322 safety of combining pembrolizumab with lifileucel in ICI-naïve patients with advanced (unresectable or
323 metastatic) melanoma; advanced, recurrent, or metastatic head and neck squamous cell carcinoma; and
324 persistent, recurrent, or metastatic cervical cancer (25). Additionally, preliminary activity was recently
325 observed in a phase 1 study of TIL cell therapy plus anti–PD-1 therapy in patients with mNSCLC who
326 underwent tumor resection prior to exposure to anti–PD-1 (9). Given the different mechanisms of action
327 of TIL cell therapy and ICI, the promising signals in earlier settings, and the favorable risk-benefit profile
328 demonstrated in the current study, evaluation of lifileucel with or without the addition of PD-1 pathway
329 blockade earlier in the NSCLC disease course is currently underway (NCT03645928 and NCT04614103)."
Notes on pembro and lifileucel combined:
"330 Recently, in the IOV-COM-202 study with lifileucel plus pembrolizumab, patients with ICI-naïve mNSCLC
331 demonstrated an encouraging ORR of 42.1% for the entire cohort and ORR of 58.3% for patients with
332 EGFR-wild type disease. Durable and deepening responses up to 15.4 months and beyond were
333 observed (21), thus supporting the use of this combination earlier in the disease course."
This should make Merck happy!
And in classic scholarly paper summary fashion:
"339 In summary, TIL cell therapy represents a feasible, individualized, and polyclonal potential treatment
340 option for patients with mNSCLC. This is the first study to demonstrate the efficacy and safety of
341 centrally manufactured autologous TIL cell therapy as a single modality in patients with mNSCLC after
342 treatment with anti–PD-1/PD-L1 therapy. These results are encouraging and warrant further
343 investigation of lifileucel in patients with mNSCLC."
(This is about as good of a summary that you'll get in this type of paper).
A lot to digest in this report, but all shows promise as expected based on comments that came out of the three Healthcare Conferences Fireside Chats.
The sooner patients can receive this treatment in their disease progression, the more likely we'll see much higher positive results, longer survival rates, and actual cancer free patients.
I look forward to the scientists in the room to break this down even further.
IMHO of course.
Was a PDF so apparently cannot access directly. Here is the link where you can download the PDF.
https://aacrjournals.org/cancerdiscovery/article/doi/10.1158/2159-8290.CD-23-1334/742106/Lifileucel-an-Autologous-Tumor-infiltrating
Getting an error message.
Obsidian is still private. This was a private funding round. They are currently in P1 trials. Their advantage is that they are using IL-15 rather than IL-2 since IL-2 is where most of the SAEs come from and also limits the eligibility criteria excluding people with pulmonary, heart or kidney issues. IOVA advantage (beyond approval) is the manufacturing of TIL at commercial levels (not easy). IOVA also has a IL-2 analog trial to eliminate need for IL-2 but that is currently pre-clinical.
jondoeuk, Obsidian is just starting its Phase 1, correct? We should expect a handful of companies that will be looking for ways to advance and improve TIL therapy from around the world. Iovance is also working on improvements in the process and in pre-conditioning. I suspect we may see some of these companies, like Obsidian, get gobbled up by Iovance or some big pharma if their results are promising and should Obsidian make itself available for acquisition (they are currently a private company). They very well may be on the right path, but they are still years away from a BLA and approval. I will also be looking for which of all of these companies will have patents that become part of the acceptable standards for this type of treatment.
Thanks for sharing.
$160.5M Series C https://finance.yahoo.com/news/obsidian-therapeutics-announces-oversubscribed-160-120000318.html
''Proceeds to support clinical development of OBX-115 in ongoing trials, including a multicenter trial for patients with metastatic melanoma and non-small cell lung cancer.''
General McPeak who is now 88 years old and a retired 4 star general, will not run for re-election to the Iovance board of directors. There comes a point where you may want to slow down a bit. I hope he enjoys the heck out of the next 20 years of his life.
Thank you General McPeak for your service to our nation and to this company.
Badgerkid
Updated corporate bylaws just released. Should anyone choose to read the entire document, feel free to summarize here (it won't be me doing the summarizing).
https://ir.iovance.com/sec-filings/sec-filing/8-k/0001104659-24-041200
Item of note:
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On March 26, 2024, General (Ret.) Merrill A. McPeak, a member of the Board of Directors (the “Board”) of Iovance Biotherapeutics, Inc. (the “Company”), provided notice to the Board that he will retire and not be standing for re-election to the Board at the Company’s annual meeting of stockholders (the “Annual Meeting”) currently anticipated to be held in June 2024. General McPeak will serve out his current term as a director of the Company until the Annual Meeting. The decision to retire and not stand for re-election is not due to a disagreement between the Company and General McPeak on any matter regarding the Company’s operations, policies, or practices. The Company thanks General McPeak for his service to the Board.
On March 26, 2024, the Nominating and Corporate Governance Committee of the Board recommended that Frederick G. Vogt, Ph.D., J.D., the Company’s Interim Chief Executive Officer and President, and General Counsel, be nominated to stand for election to the Board at the Annual Meeting, to fill the vacancy created by General McPeak’s retirement. If elected, Dr. Vogt’s term as a director of the Company will be effective as of the date of the Annual Meeting.
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
File Date | Form | Investor | Prev Shares | Latest Shares | Δ Shares (Percent) | Ownership (Percent) | Δ Ownership (Percent) | |
---|---|---|---|---|---|---|---|---|
2024-03-01 | 13G | PERCEPTIVE ADVISORS LLC | 11,979,415 | 19,221,743 | 60.46 | 6.90 | 46.81 | |
2024-02-14 | 13G/A | Point72 Asset Management, L.P. | 8,114,890 | 468,821 | -94.22 | 0.20 | -96.00 | |
2024-02-13 | 13G/A | VANGUARD GROUP INC | 14,463,082 | 22,812,820 | 57.73 | 8.91 | -2.73 | |
2024-02-09 | 13G/A | MHR FUND MANAGEMENT LLC | 12,083,951 | 20,083,951 | 66.20 | 7.80 | 16.42 | |
2024-01-26 | 13G/A | BlackRock Inc. | 12,076,276 | 19,071,756 | 57.93 | 7.50 | -2.60 | |
2024-01-25 | 13G/A | STATE STREET CORP | 14,715,475 | 16,424,388 | 11.61 | 6.42 | -31.12 | |
2023-10-27 | 13D/A | Quogue Capital LLC | 20,000,000 | 25,000,000 | 25.00 | 15.84 | 26.52 | |
2023-02-14 | 13G/A | Avoro Capital Advisors LLC | 8,675,000 | 7,020,000 | -19.08 | 4.40 | -20.00 | |
2023-02-06 | 13G/A | WELLINGTON MANAGEMENT GROUP LLP | 9,584,082 | 421,610 | -95.60 | 0.27 | -95.58 |
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