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Badger... on a separate note, you had stated previously that there is only one reason to buy a stock... that you think the price is going up. I would expand that to say that there are several reasons why you think a stock may go up. Two of the primary ones I use for individual stocks are 1) that I consider the stock undervalued (these are longer term holdings) and 2) that I expect an upcoming favorable catalyst (these are trades where I usually use options).
For my intrinsic value estimate, once I model that out (either using simple metrics or more complicated methods), I plan to sell (or scale out) once that price is hit, regardless of if it got there because of company specific items, sector strength or some catalyst. I try not to adjust my model unless specific new facts emerge as it is too easy to adjust things in hopes the price will continue to go up.
Regarding catalysts, I split these into 2 camps, the first being ones that are time bound (i.e. earnings reports, FDA PDUFA dates, medical conferences, etc.) and the second are not time-bound (trial read-outs, buyouts, etc). Regarding the second group, those are impossible to trade since you won't know how long you have to hold the position in order to have them play out. This is particularly true if you are holding a stock for a buyout that may never occur. I use my intrinsic value calculation and if it hits that price because of a buyout, fine, but I want to hold my position for reasons other than I buyout because, in my experience, you can hold too long in many cases.
This would only work if you make a new drug combination. The old individual components would still be off-patent and would thus be subject to generics. Gilead is famous for combining their various HIV drugs from 3 pills to 2 pills to a single pill, each time creating a new patent. They still need to sell to physicians why the new brand formulary is superior to the old formulary off patent, but is easier to do, especially if they reduce/cover co-pay.
One could make the argument that if MRK bought IOVA, they could stop the ipi/nivo trials using BMY's ICI, but they already have 90% of the market and an additional 10% of 2,000 patients would not make a difference. BMY could use the same approach but I do not think increasing Opdivo/Yervoy sales would be a driving factor in a buyout decision. Any acquiring company would make a purchasing decision on buying the future revenue stream, not in protecting any current drugs on patent.
Looks like many are anticipating good news next week. PPS has clawed back nicely! New highs possible sooner than later I believe.
That is some good information and not off topic. Almost anything even remotely related is on topic! Keep up the good work!
GMH, a bit off-topic, and I'll try and improve on this discussion and my thoughts in the future, but one point that I keep coming back to is patent expirations and ways of extending those dates. Other companies may full well see value from acquiring Iovance so as to combine it with their products in order to gain patent protection for additional years (Merck, Keytruda).
This is an excerpt from an old article, but it's still relevant on a number of fronts: "Combinations Does one and one make three? That is the question drug companies are asking themselves these days as they face huge threats to their earnings from patent expirations. One novel solution: combining two or more successful drugs into one tablet and marketing it as a whole new product.
Schering-Plough is looking to extend its giant franchise in its allergy drug Claritin by combining it with Singulair, an asthma drug from Merck. Schering-Plough is not alone. Eli Lilly, Pfizer, and Warner-Lambert are all looking to create new combinations of drugs to bolster earnings and sustain growth. Companies are getting a lot more creative in ways to sustain the product lifespan of drugs. The medical community looks at it as a kind of cookbook medicine. They have an aversion to combination drugs. Nonetheless, it is a strategy that has proved successful for some drug makers..."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146086/
Here is another article I cam across that should be of interest. Couple of the highlights I would point out:
https://www.healio.com/news/hematology-oncology/20240418/lifileucel-approval-the-start-of-a-glorious-future-for-cell-therapy-in-solid-tumors
1) Eligibility for treatment (i.e. pulmonary, cardiac or renal issues) was 70%-80% (I had modeled 50%)
2) Significant ("huge") pent up demand for treatment including patients "expressing excitement for TIL" may require prioritization in treatment (wondering if having 12 patients in need but can only accommodate 4 is purely hypothetical). Note even 4/month per ATC is above capacity for the iCTC alone.
3) Ability to reduce IL-2 if toxicity emerges but treatment still effective (lowers the IL-2 revenue but greatly increases eligibility - good for patients and overall revenue)
4) Excitement about ability to extend into other solid tumor types over the next 5 years.
5) Washington University in St. Louis appears to be one of the next ATCs to on-board in 6-8 weeks (from April 21 so around end May target date).
I really do not worry about IP for IOVA. For small molecule drugs, the FDA only requires equivalency testing to then approve a generic so you do get a significant patent cliff. For biologics, it is much more difficult (and costly) to do an equivalency test so I do not see any generic coming into this space.
Regarding the stealing of IP, that is certainly possible, but IOVA would have recourse but would still require a significant investment to create the TIL product and would then require running trials and FDA approval so would be a multi-year theft operation. I feel most competitors want to build a better mousetrap, not copy the existing one, so that is the risk for me. Informal discussions at these biotech conferences where someone lets slip a detail where something worked or didn't work is probably the biggest risk, but not disclosing the entire process.
Thanks to everyone here, I appreciate the discussion and challenges to dig deeper on this investment as well as into this new approach to cancer treatment.
Getting into the weeds a bit, I'm still trying to fully understand another subject, that of patents and licensing. If anyone here has a good take on Iovance's IP portfolio, jump in anytime now or in the future. I see that Iovance has exclusivity on some that they license from others and Iovance also owns some that may be needed by other companies in this arena. Cross licensing will be a subject for a later date, but it will come into play most certainly. My hope is that Iovance has patents that are ultimately part of the standards and deemed essential and thereby have a value for licensing. A few recent patents apply to manufacturing which was thoroughly discussed in the Chardan chat. The ability to manufacture TIL on a large scale may be a big part of the future value of Iovance. Definitely something to watch.
https://patents.justia.com/assignee/iovance-biotherapeutics-inc
Thanks - these articles/videos for lead oncologists at the ATCs are probably the best indication of where this is going.
FYI, TScan uses IL-2 as there reinvigorating agent.
https://stocktwits.com/AuriniaBeach/message/571505436
TIL Therapy for NSCLC:5-1-24
Memorial Sloan Kettering Cancer Center
By Julie Grisham
Great read & Huge Amtagvi potential.
#CureCancer
We discussed this a bit before but good to revisit competition as facts change.
My take based on my research and (limited and self-taught) clinical knowledge:
1) Obsidian data was an early read-out of the P1 trial. That trial is still recruiting and will probably not finalize until 2026. I am guessing the P2 trial would take about 6 years (1 year for design, 3 years recruiting, 1 year for data analysis and 1 year for BLA filing) from that point, so they would not be commercial until 2032.
2) OBX-115 is their revitalization agent is an IL-15. This is the same re-vitalizing agent in Anktiva (N-803) that IBRX uses. It seems that IL-15 revitalizes Natural Killer cells (NK cells) as well as CD4/CD8 cells. TIL replenishes the specific targeting CD4/CD8 cells that have been depleted by fighting the cancer as well as the ICI treatment.
3) IOVA's IL-2 analog seems to be a modified IL-2 to simply remove the toxicity impact from the IL-2.
Given this info, wondering if it wouldn't be good/better to investigate a combo IL-15/TIL to replenish the CD4/CD8 cells and reinvigorate both the CD4/CD and the NK cells. Will be watching this space to see how everything evolves.
Thoughts about OBX-115? How much of a threat is it to Amtagvi over next 3 years? Will it take significant number of patients away from Amtagvi as it advances its clinical trials and seeks accelerated approval? When does IOVA next generation TIL enter the clinic?
https://www.onclive.com/view/obx-115-elicits-responses-in-advanced-or-metastatic-melanoma
I appreciate everyone's input and questions on this site. I always believe that the collective thoughts of a group are always better than I can do on my own. My confirmation bias is probably my own worst enemy.
Also, Google is a good source but sometimes one needs to read beyond the headlines... thanks for any and all insights and corrections.
YW. I may not know the jargon here, but I do know some things.
I am trying to educate myself with this company and the scientific issues.
Form 10-Q calculator. Select the type of filer and the fiscal year end in the form below to obtain the EDGAR filing deadline.
Filer Type: Period End:
Large Accelerated Filer
31
Mar
2024
Due: Friday, May 10, 2024
https://www.securexfilings.com/sec-deadlines/
The Investopedia I'm reading says between 40 and 45 days depending on the size of the company.
GMH, let's make sure we're around for the next 10-K.
Have a great day. Time for me to go do something resembling work.
You are correct. 10-Ks (annual) are 60 days and 10-Qs are 35 days per Investopedia.
"The SEC decided to make information available to the public in a more timely manner in 2002. The new rules tightened these 45- and 90-day requirements to 35 and 60 days respectively."
GMH, is that for 10-Q's or just for the 10-K? I've seen different numbers, so if you have a link with the most current info, I'd appreciate it. I've seen older and newer info, but I honestly don't know what it is currently seeing how it's changed over the decades of my time on this earth (not centuries yet).
Thanks.
Public companies have 60 days to report so last day of May would be the deadline.
Surfkast, here's hoping the company let's us in just a bit on how well things are actually going. I think they'll remain somewhat conservative in what they share, but I do think we're going to get a good amount of very good news.
Still hanging in with the rest of us old timers?
Best wishes for our mutual success on this one.
GMH, I don't know if they could have filed a Q1 that late, but the date is set and I'm happy as well with regards to options. Good luck to you.
Glad they finally set the ER date. My broker had it listed as 5/7 and NASDAQ had it listed at 5/14... was afraid they might move to after the 5/17 options expiration.
I "want" a takeover price of $80-$100, but any CEO that brought that deal to their BoD would be putting their job in serious jeopardy. I just try not to let my optimistic views cloud my judgement of current fair value, which can lead to hanging on too long.
It could be pretty exciting next week!
May 9 - Iovance Biotherapeutics to Host First Quarter 2024 Financial Results Conference Call and Webcast on Thursday, May 9, 2024
"SAN CARLOS, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will report its first quarter 2024 financial results on Thursday, May 9, 2024. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET."
https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-host-first-quarter-2024-financial
GMH, instead of the usual historical takeover premium, I would much prefer a hysterical takeover premium as in crazy high. That way you'll be less disappointed that Iovance didn't go it alone.
Thanks for the reminder on those numbers and reference points. Keep sharing, it's always appreciated.
The Chardan chat is incredibly worthwhile to watch. If you want to see what kind of team we're investing in, you'll get a very good picture of the talent we have at Iovance, Igor Bilinsky, PhD and COO of Iovance. From a manufacturing perspective (and I worked in manufacturing earlier in my life), all of the questions that I had were addressed including a few I had submitted earlier.
Here's one more call giving even more reasons to stay long in my investment and a few intriguing comments that lead me to add more shares.
Good luck to the longs.
This was a manufacturing summit, not a head count of current patients, but what was discussed should give you a picture of just how big this is going to get going forward.
The big take-away - Iovance continues to stay one or more steps ahead of what they need going forward and they continue to be prepared for those potential risks that are outside of their internal control (governmental policies and such).
If you're a good observer of body language, you'll pick up on the bonuses in this chat.
Good luck to the longs.
Great job explaining for me via our conversation earlier today.
Your explained much better then I would have been able to, thank you.
Spot on in your message & if I caused GMH any confusion, my apologies.
We are on track so far & time will tell our story for us & Iovance.
#CureCancer
I had posted an article on historical take-over premiums in the biotech space here earlier, but had not seen any analysis on what happens to the acquiring company after take-over, thus my question.
Regarding take-over premiums, those are generally in the 80-100% range for biotechs the size of IOVA. If there is the expectation of a bidding war, it can go higher, but those are fairly uncommon as acquirers do a pretty good due diligence and get alignment before the offer. Most deals in the biotech space of this size are generally in cash since Big Pharma generally have a lot of cash on the balance sheet.
Generally, I do not plan on, nor want, a take-over as I would rather have the technology as a pure play rather than buried as a subsidiary within another company. Having said that, what I "want" is pretty much irrelevant, since my total share count/vote will not be driving any corporate decisions.
Gopher and GMH, just to add a little clarity (after chatting with Gopher earlier today), the point is that the company acquiring the company being bought does typically see it's share price drop upon acquiring the target company, but it often returns to its previous price and even goes higher if the acquisition proves to be a positive revenue generator for the buyer. To your point GMH, yes, the acquired company no longer exists with its own stock symbol because it is now part of the company that made the purchase (but it still may operate as a wholly owned subsidiary or similar). This is a question and concern that arises if the buying company's stock is part of the deal.
The parent company/purchaser does see a negative impact on its share price initially, but will likely see a gain if the deal was a good one.
In chatting with Gopher, he and I agree we don't always remember the facts as well as we would like, but I remember reading that many target companies stock price will go up to a number just shy of the initial offer as sellers come in to liquidate before the final date of the sale. But one thing I also remember reading is that sometimes the buyout price goes higher as more companies join the fray to acquire the target company and begin bidding up the price. So it's possible that was also part of the memory of which stock goes higher in price and when during that period of time before the deal is finalized.
Gopher, if I missed the finer points of our conversation, jump in when you have time and bail me out (if memory serves, we did have a conversation, right?)
Here's a quick synopsis of what I'm trying to say:
https://www.investopedia.com/ask/answers/203.asp#:~:text=Key%20Takeaways,debt%20to%20finance%20the%20acquisition.
Two new events upcoming: Today - Chardan Annual Genetic Medicines & Cell Therapy Manufacturing Summit Fireside Chat: April 30, 2024 at 2:30 p.m. ET Virtual
In two weeks: The Citizens JMP Life Sciences Conference Fireside Chat: May 13, 2024 at 2:00 p.m. ET New York, NY Virtual
https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-present-upcoming-conferences-13
Are you referring to the acquiring company? The acquired company would no longer be traded.
https://finance.yahoo.com/news/63-ownership-shares-iovance-biotherapeutics-181522845.html
Interesting read on Iovance & Ownership %’s.
We are in a very good place in my opinion
#CureCancer
I read a BioTech Buyout Stat a while back that was quite interesting.
After a Buyout, typically 6 months after BioTech Companies are bought out, they are up 40% on average post sale.
Personally I will sell 20% Apprx of my holdings & retain 80% moving forward onward & upward.
In Wayne I Trust.
#CureCancer
Surkast, if you read the book For Blood and Money, with the focus on Wayne Rothbaum & the journey A to Z with the development of Acerta’s Cancer Drug & BTK Inhibitor.
It took years & its not just a build, pump & dumb kind of thing.
Wayne’s done this over & over & he knows exactly what to do, how to do it, how long it generally takes after FDA Approval.
Then we get now the Operational side of the Biz with the extensive ATC Buildout.
Last I heard we are at 41 or 42.
Wayne let the world know, the goal was 50 by the end of May.
By the end of May, I project IF we continue the ATC buildout, we are looking at 65-70 by end of May.
Wayne knows how to “play” this along.
Under promise & over deliver.
It’s his BioTech MO.
With our overseas pending approvals this & next year, Its my estimate we literally end up with EU, Canada, UK, Australia & possibly other countries hoping on board, literally.
Its really anyones guess here how many patients pr month, pr year our overseas ATC’S can/will generate.
Revenue will be churning & churning come 2025 & 2026
Buyout happens then.
My guess is anywhere from $100 on the low end, to $165.00 on the high end by earlyish 2026. Combined Stock Options & Cash.
Stay Strong Longs & read the book by Nathan Vardi. Like $15 on Amazon.
#Cure Cancer
Surfkast, we're not getting any younger, are we. Fortunately, a lot of things are keeping us alive longer than we deserve.
Good luck to the longs.
I am personally hoping some company gets anxious sooner than later and scoops up this company at a bargain price. Like maybe $50?
Great Buyout read Badger. The business model was in “blast buyout” mode in the 4th Qtr in 2023.
Now we have FDA Approval & there is NO doubt the Mgmt team is building out Iovance & Amtagvi for a future buyout in 2025/2026 in my opinion.
In my opinion, we are waiting on future approvals like Amtagvi & Keytruda together & their nearly 67% effacy together
Looks like a frontline treatment in the making in late 2024, early 2025.
Once this occurs & our report out 5-31-24
On NSCLC will give us a peak into its potential for a Accelerated BLA in 2024/2025.
Wayne in my opinion will not take an offer under $100 a share combining stock options n cash.
Will see…
Stay Strong Longs, are future is so bright, we all gotta wear shades!
#Cure Cancer
Old news and new - I'll leave the speculation for others:
https://www.fiercebiotech.com/special-report/deal-or-no-deal-top-10-takeover-targets-biopharma (check out #5 and #9)
https://www.fiercepharma.com/pharma/merck-still-market-deals-1b-15b-range-ceo-says (Merck is still shopping)
https://www.reuters.com/markets/deals/japans-ono-pharmaceutical-buy-deciphera-24-billion-2024-04-29/ (today's hot news - #5 on the list is now being acquired)
With the Q1 call coming up, and after re-reading the previously posted article from March 1st, I would encourage our analysts and our company's management to address some of those questions that now should have more refined answers. During the three fireside chats, we've been given glimpses of how things are going with the ramp-up, the successes with insurance companies and medicare, the movement toward frontline treatment, the progress with foreign markets, and even the progress on additional TIL therapies. What I hope to hear is an expansion on some of those topics. It's still early in the rollout for Amtagvi, but I suspect guidance will provide some color of what we may expect throughout the remainder of the year. A lot of the targets are still moving, but any color we can get should add support to our investment going forward.
I accept that Iovance has been somewhat conservative in actual statements, but they've also shared information at times that surprised us in very good ways. Here's hoping for that surprise!
I still contend, it's the revenues reported in the Q2, Q3, and Q4 along with the full year guidance for next year that will each drive this stock price higher. Additional bonuses will be the foreign market approvals, successful trial results and movement toward additional licensing of other TIL therapies.
One item that the company has already shared and should not be overlooked is the depth and value of Iovance's patent portfolio.
There's a lot that's building and there's a lot to build on.
Good luck to the longs.
One last reminder, clinical oncologists and medical scientists think in terms of years and decades, it's okay for us to think in terms of a couple of months or a year or two.
An item of note (may have already been posted): Sajeve Samuel Thomas, MD will be presenting at the ASCO
https://meetings.asco.org/meetings/2024-asco-annual-meeting/316/program-guide/search?q=iovance
The following article from March is still a worthwhile read regarding the launch of Amtagvi:
https://www.precisionmedicineonline.com/regulatory-news-fda-approvals/after-iovances-amtagvi-approval-whats-ahead-til-therapy (I've posted the article in full below)
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Here's the part I like (though the numbers discussed are also very exciting):
"March 1, 2024 NEW YORK – Sajeve Thomas, an oncologist at Orlando Health Cancer Institute, had just finished seeing his last patient for the afternoon on Friday, Feb. 16, when he learned that the US Food and Drug Administration had approved Iovance Biotherapeutics' Amtagvi (lifileucel), an autologous tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma.
'It was a beautiful moment because we finally get to move forward with treating patients who have been waiting for this for quite some time," Thomas said. "We were all high-fiving and hugging.' "
Futher in the article: "...At his center, Thomas said he has about 13 or 14 patients on a list to receive Amtagvi as soon as their insurance plans sign off. As of Wednesday, prior authorization requests had already been submitted for five or six of these patients, and the rest were in the works..."
Just a little bonus read for the weekend. Enjoy.
Badgerkid
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Here's the article in full:
After Iovance's Amtagvi Approval, What's Ahead for TIL Therapy?
Mar 01, 2024 | Caroline Hopkins
NEW YORK – Sajeve Thomas, an oncologist at Orlando Health Cancer Institute, had just finished seeing his last patient for the afternoon on Friday, Feb. 16, when he learned that the US Food and Drug Administration had approved Iovance Biotherapeutics' Amtagvi (lifileucel), an autologous tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma.
"It was a beautiful moment because we finally get to move forward with treating patients who have been waiting for this for quite some time," Thomas said. "We were all high-fiving and hugging."
Amtagvi is the first cell therapy to enter the market for a solid tumor indication, and Thomas' cancer center at Orlando Health was one of the sites that participated in the clinical trial that led to the TIL therapy's accelerated approval, which means that the center already has the clinical processes and experience to administer this logistically complex therapy.
"It was a labor of love to participate in these protocols and help develop this, then await this FDA approval as the PDUFA date kept getting pushed out," he said, recalling the many consecutive delays to Amtagvi's approval as regulators ironed out the best way to regulate an altogether new class of bespoke therapies.
Now, Orlando Health is one of the 30 sites Iovance has deemed an authorized treatment center that is ready to begin administering Amtagvi right away, or as soon as advanced melanoma patients secure the necessary prior authorization from their insurance companies.
"We've been giving patients TIL [therapy] for seven years, but one of the key challenges now is trying to get these therapies approved by insurances and go through those motions," he said. "It's a lot easier when it's on a trial."
Amtagvi's list price, $515,000, is too steep to administer without prior authorization from patients' insurance providers. "Everyone's insurance is a bit different, and this is still new," Thomas said.
At his center, Thomas said he has about 13 or 14 patients on a list to receive Amtagvi as soon as their insurance plans sign off. As of Wednesday, prior authorization requests had already been submitted for five or six of these patients, and the rest were in the works, though none had officially gotten the go-ahead from insurers.
The TIL therapy process involves many steps, including an initial surgery to harvest the tumor specimen that is sent to Iovance's manufacturing sites for ex vivo expansion. The patient then must undergo lymphodepleting chemotherapy before ultimately receiving the TIL infusion along with an interleukin-2 infusion. The whole process can take more than a month before accounting for prior authorization, which can tack on several days to several weeks, according to Iovance.
Thomas said he only recently learned that a patient's prior authorization request needs to be cleared before they can even start with the surgical tumor resection. "I'm kind of learning as we go," Thomas said of the reimbursement process for Amtagvi. "I expect there to be a bit more hurdles, now that we have to go through insurance, to actually get these patients treated on a commercial TIL product."
In a call to discuss Iovance's 2023 fourth quarter and full-year financial results on Wednesday afternoon, Executive VP of Commercial Jim Ziegler said the firm is optimistic about payor coverage, both from Medicare and commercial payors. "The payors appreciate the unmet need and understand the clinical value of Amtagvi, and to date, we haven't had any issues," Ziegler said. "But I would provide the disclaimer that we are very, very early on."
Scaling up
During Wednesday's earnings call, Iovance executives said the firm plans to have 50 active treatment sites administering Amtagvi by the end of May.
"The 50 [centers] … are going to pick up the significant portion of the treated patients in the country," Ziegler said. "We will continue to monitor the need to expand from that point."
Similar to how the treatment landscape has played out for autologous CAR T-cell therapy in blood cancer, Iovance expects access to Amtagvi will be concentrated at the top treatment centers. The firm estimates that the top 40 treatment centers it authorizes will provide about 80 percent of treatments.
While the concentration of autologous cell therapies at top cancer centers with specialized personnel and drugmaker-issued stamps of approval can ensure patient safety and provider experience, it can also mean that patients treated at community hospitals and private practices and those living in rural regions will encounter more difficulties in terms of longer travel time and out-of-pocket ancillary costs in accessing Amtagvi.
For all of these reasons, Amtagvi likely won't become a standard-of-care therapy for all melanoma patients right away.
Next up for Iovance
Following Amtagvi's FDA approval, Iovance said on Wednesday that it is planning to file for European approval during the first half of 2024. Then, in the second half of the year, Iovance will file for approval in the UK and Canada. The following year, the firm plans to file for Amtagvi's approval in Australia and in other countries with "significant populations" of advanced melanoma patients. Iovance expects to start seeing revenue gains from the product later this year.
The firm is also focusing on developing the autologous therapy in earlier treatment settings, testing it in combination with other approved therapies, and evaluating its activity in cancer indications other than melanoma. It is also focused on advancing engineered versions of the product.
At his center, even though TIL therapy is now a commercially available option for refractory melanoma patients, Thomas said he is encouraging eligible patients to enroll in clinical trials evaluating the treatment in different settings or testing newer versions of the product.
For his advanced melanoma patients who have not yet received checkpoint inhibitor immunotherapy, for instance, Thomas said Iovance's Phase III TILVANCE-301 study could be an option. Orlando Health is one of the sites involved in this trial of frontline Amtagvi plus Merck's PD-1 checkpoint inhibitor Keytruda (pembrolizumab) against Keytruda alone. This is also the confirmatory trial for converting Amtagvi's accelerated approval to a full approval, and patients will have a chance to cross over to receive TIL therapy if they progress on Keytruda alone, Thomas pointed out.
Thomas has been encouraged by Amtagvi's efficacy in clinical trials and is both thrilled and relieved that his advanced melanoma patients can now access it outside a study. Even so, he highlighted that a 30 percent response rate in advanced melanoma still leaves significant room for improvement. He's hopeful that TIL therapy in earlier lines and some of the newer versions of the treatment can improve on this.
"What we learned from giving TIL in the refractory setting was that folks who had a really low volume of disease did better with their response rates," Thomas said. "There is a real thought that the lower the tumor volume and the earlier in the course of treatment, maybe the more likely we'll be to get long-term responses and potentially long-term remissions."
Beyond Amtagvi, Iovance is studying engineered versions of other autologous TIL therapies, including its investigational product IOV-4001, which involves modifying the TILs to disrupt PDCD1, the gene encoding PD-1. The firm is evaluating this treatment in a Phase I/II trial in both advanced melanoma and non-small cell lung cancer.
Iovance is also evaluating Amtagvi in non-small cell lung cancer, although the FDA late last year paused that trial due to a serious adverse event. During its Wednesday call, Iovance Chief Medical Officer Friedrich Finckenstein said the firm is working closely with the FDA to resume enrolling NSCLC patients in that study "really soon."
Finally, Iovance is preparing to evaluate autologous TIL therapy in advanced endometrial cancer. That trial, which is to begin during the first half of 2024, will include patients whose cancers are both DNA mismatch repair deficient and proficient.
Next wave of TIL approaches
Although Iovance is the first drugmaker to score regulatory approval for an autologous cell therapy in solid tumors, other biotechs and academic centers have been working on their own iterations of the therapy. And now that Amtagvi has proven there's an achievable path to getting these therapies onto the market, these other groups are emboldened to try to bring their own candidates to patients.
"Defining … a regulatory path going forward will help TIL therapies in development and should unleash additional investment," Jason Bock, CEO of the Cell Therapy Manufacturing Center, an MD Anderson Cancer Center and National Resilience joint venture, said.
"TILs will have the challenge of [proving] how sustainable the business model is even once you get to commercialization, but that's something that businesspeople can wrap their minds around and run numbers and calculate return on investment and those kinds of things," Bock had said in an interview just days before Amtagvi's approval. "But it's a lot harder when you have this big black box of regulatory risk that says, 'Hey, there's never been a product commercially approved.'"
Both Bock and Orlando's Thomas pointed to a Cambridge, Massachusetts-based company called Obsidian Therapeutics as one example of a TIL therapy-focused firm that could get a boost from TIL therapy becoming commercially available. Obsidian is developing a genetically modified version of TIL therapy, dubbed OBX-115, so that patients don't need infusions of interleukin-2 alongside their autologous TILs. Obsidian, which is enrolling advanced melanoma patients onto OBX-115 clinical trials and plans to expand into other solid tumors, accomplishes this by engineering the TIL products with membrane-bound, rather than secreted, interleukin.
"We're excited about this one because maybe we'll find the therapy might be better tolerated," said Thomas, whose center is also a clinical trial site for Obsidian. "One of the limiting factors of the whole TIL process is that not everyone can tolerate TIL because of the need for IL-2. Obsidian's product foregoes the need for IL-2."
In December 2023, Obsidian shared early data from its first-in-human OBX-115 trial, in which three out of six patients responded and experienced an "emerging safety profile that appears differentiated from that of unengineered TIL therapy."
Bock highlighted another program from the firm KSQ Therapeutics, which is developing an engineered TIL therapy for solid tumors dubbed KSQ-001EX. That treatment involves autologous TILs that are engineered to inactivate the SOCS1 gene using CRISPR-Cas9. In November 2023, the FDA gave Lexington, Massachusetts-based KSQ the go-ahead to begin studying its TIL therapy in first-in-human trials.
The idea behind KSQ's therapy is that knocking out the SOCS1 gene could enhance the ability of T cells to infiltrate and expand inside the tumor. KSQ is working on another product that knocks out both SOCS1 and another gene, called Regnase-1, which it identified through an unbiased screening process. "There have been so many improvements in our ability to engineer cells, either through viruses or through CRISPR editing, and those are going to be the products that ride on the back of this Iovance approval," Bock said.
Thomas also mentioned selected TIL therapy approaches, where firms harvest patients' TILs, but then also perform apheresis to harvest their dendritic cells and perform whole-exome sequencing of the tumor to identify the top cancer-specific neoantigens. "Then you're co-incubating the dendritic cells, which act like scouts to pick up those antigens and activate and engage the TILs that are most active," he said. "With unselected TILs, you're just expanding out whatever's in the tumor itself, but you don't know if you're actually expanding the TILs that recognize cancer, or whether those TILs are just bystanders that don't really do much."
One such firm developing selected TIL therapy is Turnstone Biologics, which is studying its investigational candidate TIDAL-01 (TBio-4101) in solid tumors including in various melanoma subtypes, breast cancer, and colorectal cancer. Turnstone expects to report initial clinical data on TIDAL-01 in mid-2024.
Whatever the next generation of cell therapies might look like for solid tumors, the field is watching Iovance's early days closely as a roadmap for what's to come.
"Not only was this a new treatment for melanoma, this was the first cellular therapy product approved for solid tumors," Thomas said. "Certainly, that makes it exciting for anyone who's interested in providing cell therapy products for solid tumors."
Going forward, he said it will be important to encourage patients to enroll in these clinical trials so the field can continue improving on the process and achieving even better responses with fewer side effects.
As for the immediate near future, Thomas said that his center is focused on getting patients on Amtagvi who have been waiting for this approval for too long. "Our biggest learning curve now is trying to understand insurance," Thomas said. "And we'll be learning that as we go."
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LOL! I am basically self taught with computers and all. GLTY
Surfkast, thank you. Looks like 40 ATC's at this time. The company stated 50 by the end of May. Looks to be on track.
Looks like I just needed to keep clicking on the "LOAD MORE" button on the search page to add in the rest of the centers after plugging in my zip.
I'm not the sharpest tool (but I am a tool or so I've been told).
I see the following are listed on the website.
Memorial Sloan Kettering Cancer Center
51.0 Miles
1275 York Ave
New York, NY 10065
646-608-2091
Smilow Cancer Hospital-Yale New Haven
80.8 Miles
20 York St
New Haven, CT 06510
203-200-CART
Cooper University Healthcare
83.7 Miles
1 Cooper Plz
Camden, NJ 08103
855-632-2667
Thomas Jefferson University Hospital
84.6 Miles
111 S 11th St
Philadelphia, PA 19107
215-955-8874
University of Maryland Medical Center
172.4 Miles
22 S Greene St
Baltimore, MD 21201
410-328-7609
Dana-Farber Brigham Cancer Center
184.9 Miles
450 Brookline Ave
Boston, MA 02215
877-442-3324
Massachusetts General Cancer Center
187.5 Miles
55 Fruit St
Boston, MA 02114
617-724-4000
MedStar Georgetown University Hospital
207.8 Miles
3800 Reservoir Rd., NW
Washington, DC 20007
202-993-0492
Roswell Park Comprehensive Cancer Center
281.8 Miles
665 Elm St
Buffalo, NY 14203
716-845-2300
West Penn Hospital
307.3 Miles
4800 Friendship Ave
Pittsburgh, PA 15224
412-578-4484
The Cleveland Clinic Foundation
392.9 Miles
9500 Euclid Ave
Cleveland, OH 44195
216-445-5600
Duke University Hospital
425.6 Miles
2400 Pratt Street
Durham, NC 27705
919-684-7115
The Ohio State University Wexner Medical Center, James Cancer Hospital
472.5 Miles
460 W 10th Ave
Columbus, OH 43210
614-293-3153
The University of Tennessee Medical Center
631.8 Miles
1924 Alcoa Hwy
Knoxville, TN 37920
865-305-5003
Brown Cancer Center, University of Louisville
645.3 Miles
529 South Jackson
Louisville, KY 40202
502-562-4673
University of Chicago Medicine
702.4 Miles
5841 S Maryland Ave
Chicago, IL 60637
773-702-1994
Northwestern Memorial Hospital
703.4 Miles
251 E Huron Street
Chicago, IL 60611
312-695-0990
Froedtert & the Medical College of Wisconsin Cancer Network
729.6 Miles
8800 W. Doyne Ave.
Milwaukee, WI 53226
414-805-0505
Northside Hospital
739.4 Miles
1000 Johnson Ferry Rd NE
Atlanta, GA 30342
404-255-1930
Mayo Clinic Florida
840.4 Miles
4500 San Pablo Rd S
Jacksonville, FL 32224
904-953-0863
Barnes-Jewish Hospital
870.8 Miles
One Barnes-Jewish Hospital Plaza
Saint Louis, MO 63110
314-454-8304
UF Health Shands Hospital
904.1 Miles
1535 Gale Lemerand Drive
Gainesville, FL 32610
352-265-0725
University Of Iowa Hospitals And Clinics
905.9 Miles
200 Hawkins Dr
Iowa City, IA 52242
319-356-1616
Orlando Health Cancer Institute
947.1 Miles
1400 S Orange Ave
Orlando, FL 32806
321-841-1893
Mayo Clinic - Rochester
958.8 Miles
200 1st St SW
Rochester, MN 55901
507-538-3270
Moffitt Cancer Center
1002.7 Miles
12902 USF Magnolia Drive
Tampa, FL 33612
888-663-3488
The University of Kansas Cancer Center
1090.5 Miles
4000 Cambridge St
Kansas City, KS 66160
913-588-9187
Nebraska Medicine
1136.7 Miles
505 S 45th Street
Omaha, NE 68105
402-559-5600
Avera Cancer Institute
1167.8 Miles
1000 E 21st Street
Sioux Falls, SD 57105
888-422-1410
Baylor Scott & White Charles A. Sammons Cancer Center
1367.5 Miles
3410 Worth St
Dallas, TX 75246
214-370-1550
Houston Methodist Hospital
1421.2 Miles
6445 Main St
Houston, TX 77030
713-441-9946
MD Anderson
1421.4 Miles
1515 Holcombe Blvd
Houston, TX 77030
713-745-0940
Huntsman Cancer Institute - University of Utah
1957.0 Miles
2000 Circle Of Hope Dr
Salt Lake City, UT 84112
801-587-4652
Honorhealth Research Institute
2121.0 Miles
10510 N 92nd Street
Scottsdale, AZ 85258
480-323-1364
Mayo Clinic Hospital
2122.6 Miles
5777 E Mayo Blvd
Phoenix, AZ 85054
480-301-8484
City of Hope National Medical Center
2423.3 Miles
1500 E Duarte Rd
Duarte, CA 91010
1-800-826-4673
OHSU Hospital
2430.5 Miles
3181 SW Sam Jackson Park Rd
Portland, OR 97239
503-494-5058
Ronald Reagan UCLA Medical Center
2449.8 Miles
757 Westwood Plz
Los Angeles, CA 90095
888-ONC-UCLA
UCLA Santa Monica Medical Center
2453.0 Miles
1250 16th St
Santa Monica, CA 90404
888-ONC-UCLA
Stanford Health Care
2554.1 Miles
300 Pasteur Dr
Stanford, CA 94305
650-498-6000 (promp
Motley article today: "3 Millionaire-Maker Biotech Stocks" "...As veteran investors can attest, however, the time to go shopping is when quality stocks are discounted. With that as the backdrop, here's a rundown on three biotech stocks you may want to consider scooping up while they're still on sale..."
https://finance.yahoo.com/news/3-millionaire-maker-biotech-stocks-143000558.html
It's another MF teaser article to entice a further look at MF. It's click bait if you will, but it's nice to be on the positive side of an article. Let's see if the cycle continues right up to the Q1 call.
Good luck to the longs.
Does anyone have an updated list of the ATC's for Amtagvi? I recently saw that Froedtert in Milwaukee was placed on the list and I believe Iovance has more than 40 approved.
An actual list would be greatly appreciated. Share if you can.
Thanks.
https://www.amtagvi.com/support-and-resources/authorized-treatment-center/
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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