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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)
***********************************************************
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
***********************************************************
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/
MN Gopher, as we've discussed many times, the one thing I take comfort in with Iovance is the group of investors that have come together and own a significant portion of this company. Those same investors have a proven track record of making good decisions and ensuring the companies' management teams and key employees can serve the overall needs of those companies, and by extension ensure a good return on their investments.
My belief is they see and know far more than any of us here and yet they've continued to add to their stock positions.
We're in good company with this group of investors and the team at Iovance.
And again, thanks for the recommendation of the book "For Blood and Money" It's a good read and an inside look at one of Iovance's biggest investors - Wayne Rothbaum. More interesting to me is some of the inside looks at the actual scientists and financiers and that whole relationship in setting up some of these biopharm companies.
Badgerkid
Well said Badger, IBRX seems to be alot of
Background “noise” all over message boards filling it with lies & innuendo
Iovance is rock solid and all the major ITC’S opening, IE: Mayo Clinic, MD Anderson(multiple locations)
Duke U, ETC shows just how promising our treatment is for Melanoma & I suspect many other solid tumor applications on the horizon.
Ignore the noise & add shares on these crazy dips, in my opinion.
#CureCancer
Sunman, regarding the nonsense that surrounded the ticker IBRX, it seems a small handful of posters, or one with multiple aliases was running a pump and dump - not very effectively, but that's how it seemed. I don't know if it's a good or mediocre play, but I do know the comparisons that were being made by that small group of noise makers are blatant lies and misinformation. Many of the posters on that board have also grown tired of that incessant nonsense as it didn't help in having a true and detailed conversation about their investment in that company. I use message boards to encourage me to dig a little deeper when I hear something that raises a question or a point of value.
Agreed, it's only noise and nonsense, but I assume it did and does have an effect on some retail investors. Hey, it got me to look if only briefly, but that's what I require of myself to know that I'm doing my due diligence on IOVA.
I've done my due diligence and I have high confidence in my IOVA investment. Amtagvi has the potential to get Iovance into the black by the end of next year (a "blockbuster" therapy of sorts) because of the team at Iovance that's bringing it to market. I do not own any of that other company, but I can't say if it should or should not be considered.
Like I said before, an approved drug or therapy is only part of the equation, even if it has potential of blockbuster status, getting it to market and prescribed by the medical community is "a whole nother thing" (my idiom for today).
Good luck to the Iovance investors, it would seem we have a blockbuster therapy and a winning team running the company.
Yes I do have the time and while waiting, I do fill pot holes here and there. :)
People are getting confused about Anktiva approval and are drawing thoughtless comparisons to Amtagvi.
Lots of nonsense being discussed on Yahoo mb under IBRX ticker.
Post from yahoo;
Lifleucel costs 500 k and response is 31%. Anktiva in melanoma had 68% response , same with pancreatic cancer and solid tumors. Medicare will not pay for 500 k. It will say, keytruda failed? Then it’s chemo and radiation. End of story. Just real world facts.
Not an expert on biopharmaceutical companies by any means but this does look good for IOVA. Maybe they will be getting more attention.
I'm telling you GMH, the Iovance management team seems to have it together. It's one thing to have a workable therapy or successful drug, but there's far more to making it profitable and building the value of a company.
A very good combination indeed.
Another thank you has to go out to my friend who told me to check Iovance out after he had been watching it for several years. I was intrigued by TIL therapy, the approval was awesome, but it's the team at Iovance that has me hanging on to a core position of shares.
Best of luck to you GMH.
Just saw this.... this is why I do not jump in-and-out on biotechs. You never know when an "unexpected" catalyst will happen. Usually these are poster presentations so its good to see they got a spot for an oral presentation... guessing the data from cohort 1A is pretty good to warrant that.
Iovance will be presenting at the ASCO: "Oral Presentation of Updated Results of IOV-COM-202 Cohort 1A of Lifileucel plus Pembrolizumab in Advanced Frontline Melanoma"
https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-present-clinical-and-translational-data
Retired early, it's definitely on the road, but there's still a few pot holes that need to be filled in.
I'm anticipating a very good call at the Q1, but I'm not certain how it will effect share price just yet since actual revenue won't show up until the Q2 report.
Since you retired early, I'm assuming you have some time.
Good luck to you.
Let's get this show on the road. :)
Updates on analysist ratings show this to still be a buy to a strong buy. Looks like the 2024 target is $26.00,
Your welcome Surkast
In my opinion, this is not the time to dump. iThe time was between $15-17. My guidance is to hold on to a core position and accumulate at levels under where we are today. You may always sell some now or wait until it’s above $15 when the time comes in a few months. Long term view in 1-2 years, IOVA gets bought out above $30-40 as sales trajectory confirms $1B trajectory and confirmatory trial is positive. I’m betting on this scenario to take hold. Of course if NSCLC trial is positive, the value improves further.
I believe in this technology and also believe as healthier patients become eligible the it desirable outcomes will only improve.
There are 5 moderator spots open. I will be here.
https://www.cancernetwork.com/view/tumor-infiltrating-lymphocyte-therapy-advances-into-melanoma
Mabye this article will
Help you make an informed decision.
I am an Amateur Self Taught Investor & do not give financial advise who is all in with Iovance. It represents an opportunity in my opinion equivalent buying when Apple One IPhone Arrived.
The rest is history.
We are in our infancy & in the next 10 years, we will rewrite Cancer Treatment Therapies For Use In Humans To Help Cure Cancer & License our Technology to other BP of BioPharm.
As we MN Gophers like to say: Row The Boat
Just wanted to wish you well in your retirement & to encourage you to give it great thought & patience.
In my opinion, it will help fund your retirement one day….
Good Luck
GMH, The link article was enlightening to read exactly what we talk about here.
This is square one of a long marathon in TIL Therapy For Curing Cancer & who knows, mabye other diseases along the way.
This company is for me as an investor, finding the Pot of Gold for lack of a better analogy.
Thank you for sharing. Exceptional confirmation for all to read this must read link.
#CureCancer
GMH, Thanks for finding my error. Confusion on the end of 1st Qtr.
The numbers I posted are for the 2nd & 3rd Qtr’s.
I did post the high end of the spectrum, Im an eternal optimist with Iovance.
I follow the Science & The $ in something like Amtagvi. The top Biotech Investor in our lifetimes is in charge of Iovance & knows EXACTLY what it takes to execute the game plan in real time.
In my opinion, we are blessed beyond comprehension with Wayne leading the charge in helping to Cure Cancer & Find us a Triple Figure Buyout.
Wayne will not make any mistakes in our sale & valuation. He is The Best in the Business.
The Science is what 35-40 years old with Stephen A. Rosenberg being Ground Zero in his steadfast belief Solid Tumor Cancer Tumors could be Cured (Partial Cures too, my addition)
https://ccr.cancer.gov/staff-directory/steven-a-rosenberg
We have to me Apple One equivalent
The beginning of a life transforming Treatment that will be improved upon, Licensed to other BP or BioTech Companies to continue on humanities quest to Cure Cancer.
We will use genetic modifications to possibly improve upon our treatments.
This in theory translate to “Cure” many other Solid Tumor Applications, World Wide. We will in my opinion be FDA Approved one day for many, many solid tumor applications.
We will move to front line in my opinion soon on Melanoma combining Amtagvi with Keytruda.
Our stats show together in Phase 3 study, 66.7% in combo.
This alone crushes our 31.4 Amtagvi FDA accelerated approval for last line of D in use today, alone without Keytruda.
Think Merck: Keytruda Exclusivity ends in 2028. This is their Cash Cow.
Imagine Merck buying Iovance (in 2025/26 in my opinion) n extending Keytruda’s Exclusivity useage piggybacking with Amtagvi Treatments. Iovance with its approved 4 Yr exclusivity extension at the end of their 14 yr exclusivity tagteams them to 2042!
This company is now in say the equivalent
Of a 10 month old kid.
Its the beginning of a world wide expansion for TIL/Amtagvi in Clinical/ Hospital Use in their own ATC’S.
Wayne Rothbaum is a special Biotech investor man. He has long term relationships in Biotech & Buyouts well established prior to Iovance.
His expertise & relationships tell me one thing: Think Acerta & We Are Up Next.
Im adding as many shares at every dip I can.
#CureCancer
Surfkast, I understand your frustration especially given what you've shared with us on this board about your current point in your life. We each have to follow our own path. Good advice that I received from a very successful friend - there's 100's of reasons to sell a stock and only one reason to buy it. No one here can tell you what to do, but I do appreciate your willingness to be board monitor. Timing is not always our friend.
Do you think it would be advisable for one of us to take on the role of monitor? I do think we're going to start seeing a lot more posters on this site in the coming months.
All my best to you no matter what you decide.
Good luck to you throughout your retirement years.
Badgerkid
I may dump Monday.
Always be grateful for what we have as things can get a lot worse. Badgerkid has nicely explained my POV.
I started adding at 11.80 and will
add more as it keeps trending lower. Putin and Iran are in collaboration to stir up trouble in the world to divert attention away from Ukraine and interfere with US elections. They are driving oil prices up so you and I (the average American) get pissed off as our stocks sink lower and uncertainty looms. With inflation not cooling, interest rate cuts will not happen anytime soon. IOVA has only one way to buck the market downtrend. Deliver news about high adoption rate and positive progress with confirmatory phase 3 trial. Any good news with NSCLC study will be icing. I won’t be surprised if SP goes even lower to $10. Not worried though as I’m positive it will buck the trend soon enough and also overall markets likely to rally around September. Enjoying some sunshine and breathing fresh air out in the mountains. Shish kebabs, tszaziki and grilled vegetables for dinner with sips of Old Fashioned Kentucky Bourbon and tipsy cherrries. Stay positive and enjoy the journey no matter what comes at you. Best wishes and Warm Regards.
GMH, thanks for your updates this morning. Enjoyed the articles and the shared info.
Truly appreciate what you've provided to me and to this board.
Badgerkid
Neptune, I'm currently only using the free service to post on iHub, I'm not currently a paid subscriber so I can't respond to private messages except during the one hour free period on Fridays.
To answer your question, I got a tip last year to check out Iovance by a friend who had been paying attention to it for several years. He said it was time to give it a more serious look as they were close to a possible approval. I did some due diligence, took a small position in May of last year, went through a few ups and downs with the various issues and delays, sold a few shares on some ups and bought a few shares again. Then it dropped down into the $3's and I wondered what I had gotten myself into. After that, I did a lot more due diligence and realized the reasons to own this stock were valid and started to build a much bigger position but at prices around $7 or higher, not when it was down in the $3's (dang).
I've now built a nice core position which I will hang onto for what should prove to be a very good ride upwards over the coming months and years if the company continues to execute on its plan. I will try to stay flexible enough in case I see any concerns, but so far the only real issues that we seem to be currently facing are overall market conditions and negative sector sentiment at this time.
Amtagvi approval cemented my reasons to stay long and to further build my position, I continue to stay long because Iovance's management team has proven itself through each of the steps they've taken in being prepared for each contingency and how they hit the ground running with the Amtagvi approval.
Iovance's bigger shareholders are known to be very successful in their investments when they take large positions in companies and I expect Iovance will be one more success on their lists. I don't mind following the leaders, and the individual that shared this lead with me also has a proven track record.
Finally, I tend to get a little impatient, but the advice I've gotten from others who know this arena and have proven themselves, including several posters on this board, remind me that earnings are the driving force for the stock price at this time along with additional TIL therapy approvals and new foreign markets for Iovance's products. I expected a bigger jump on Amtagvi approval, but the market will reward us handsomely on IOVA when revenues start hitting the bottom line. IOVA is still trading at a higher price than the pre-approval price, even following the secondary offering, but the sector has not been our friend over this past month and there's been no news to add to the story.
When Q2, Q3, Q4 and 2025 guidance are available for viewing, we should gain continual price support. If the market doesn't get ahead of the actual numbers, it should be a nice ride. If the biotech sector sentiment makes a turn to the positive again, that should also help the upside during those quiet news periods.
I would like to hear your story if you're willing to share. What brought you over to this board? Invited or did you just stumble onto this motley crew? How long have you been invested in IOVA (assuming you are)?
Good luck to you.
Badgerkid
Another interesting article published yesterday. Should not that Angeles Clinic and Research Institute is currently NOT an ATC.
https://www.cancernetwork.com/view/tumor-infiltrating-lymphocyte-therapy-advances-into-melanoma
Another article from Oncologist at Cooper Health (NJ). They are both a P3 trial site and also recently approved ATC. Comments are interesting in that I was concerned about P3 cannibalizing Commercial patients, but as noted, eligibility requirements probably will limit that. This is unfortunate for patients and hopefully patients will become aware of TIL prior to ICI treatment in the future, but for now, at least there is an L2+ option.
https://www.roi-nj.com/2024/04/18/healthcare/til-then-cooper-doctor-is-excited-to-bring-novel-melanoma-treatment-to-south-jersey-region/
On the Corporate Update deck, they said approximately 50 ATCs 90 days after approval so that would be end of May. They are now at 37 as Duke Medical in NC was added late Friday (4/19). I think 50 will not be too difficult, especially if other Cancer Centers are asking to become ATCs.
I assume you intended to say Q2 and Q3. There will be minimal revenue in Q1 since TIL revenue is only recognized upon infusion which would occur at around day 34 post surgery which puts the first patient into Q2. There will probably be some revenue as ATCs stock IL-2 in preparation, but think that will be minimal... maybe $4-5M.
Your Q2 numbers are aligned with what I have at about 90-120 patient starts. Your Q3 numbers implies a total billings of 360-480 patients. That does seem high to me but would be 2.4-3.2 patients per ATC per month, so not impossible. IOVA indicated an annual total spend of $320M-$340M (which would include manufacturing costs) or $80M-85M per quarter, your numbers would make IOVA extremely profitable at Q3. I hope your numbers are correct, but just wanted to temper expectations a bit.
As an aside, the 12 analysts tracking IOVA do have them as break-even by 2026, which I think is very conservative. Break-even is the holy grail for any biotech as it means limited dilution risk. Break-even should occur at about 160-170 patients per quarter or a little over 1 patient start per ATC (assuming 50 ATCs) per month.
Welcome to the board, neptunesashimi.
Inducement grants awarded. Here's the cool part:
"... today announced that on April 18, 2024 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 79,310 shares of Iovance’s common stock to thirty-seven new, non-executive employees..."
That's 37 new employees. Just saying.
https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-inducement-grants-under-17
Firmly believe in IOVA's fundamentals
GMH, good analysis. To me it should land Q1 between 45 & 60 million.
Q2 between 180 mil & 240 million
Lets see how it plays out in 2024 to have a good idea where 2025 takes us.
GMH, thank you for sharing. I concur.
I do not think the company will give any guidance until the Corporate Update for 2025 (next Feb). I think they will only report out actual starts (thru end-April for Q1, end-July for Q2, etc) which does give some clarity for next quarters' revenue.
In regards to my estimate, since there is no new data, I have revised my starts to about 115 thru April 30. This is based on the following assumptions:
1) Linear ramp based on starts thru Feb (approximately 1.55 patient starts per ATC per month) for the 30 existing ATCs (assuming no adds from the 6 additional ATCs thru April)
2) Fred's comments upon approval and re-iteration during Cowen fireside that the 20 patients were "a tiny fraction of the bolus".
3) Build of of the iCTC for a capacity of 2,000 (165/month) plus a vendor back up because they did not want to end up in a situation similar to the CAR-T roll out where initial demand outstripped capacity.
4) ATCs investment in time and resources (200 hours for the lead physician + support staff training plus infrastructure) is a big commitment from the Cancer Centers so they would expect some demand before committing to becoming an ATC.
The Q2 analyst revenue projections are 5.2M (low), $28.6M (average) and $60.6M (high). This equates to about 10, 58 and 122 starts thru April. We are already way over the 10 thru Feb and only an additional 38 to get to the average. I am confident that we will blow away those 2 and should be closer to the top-end. I was playing that expected pop using some options, but this continued weakness may not hit those strikes even with a substantial beat.
This weakness continues to surprise me. I will probably add some additional lower strike options right before earnings if this weakness/lower level continues.
Surfkast, we're all down from the high. I wish you good luck and a nice run up soon, but this is still all about earnings going forward and the time it'll take to book those earnings IMO. The entire sector has not been our friend ever since we hit the high as did the sector funds. It's all down.
GMH, have you got any updates on your expectations for guidance regarding Q2, 3 and 4?
I think we're at 36 ATC's currently with the goal of 50 by end of May or June? Somewhere around there.
Thanks in advance.
Been retired and still up but down from the high big time here.
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 | |
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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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