jondoeuk
1 week ago
Yes, it is possible now, but identification of neoantigen-reactive TIL for treatment is time- and labour intensive. For example, it takes the US NCI around a month to expand enough TIL just to start screening for reactivity.
Now Dr. Rosenberg's group (at the US NCI) and others are looking at ways to identify neoantigen-reactive TIL from bulk cultures of tumour fragments without requiring patient-specific testing. If successful, this approach has the potential to greatly decrease the time between resection and treatment.
Some years ago, one group published data showing certain tumour-reactive CD8+ T-cells are CD39+CD103+. These cells have been found in many solid tumours, including melanoma, NSCLC (high mutational burden), MSS CRC, and pancreatic (low mutational burden) https://www.nature.com/articles/s41467-018-05072-0
Early data has been presented (from memory, expansion takes around five weeks) https://aacrjournals.org/cancerres/article/84/7_Supplement/LB067/742586/Abstract-LB067-Tumor-reactive-CD8-TIL-with-an
Sunman88
2 weeks ago
$1.70 says it allโฆ.beaten down from $18 to $1.70 in one year after Amtagvi approval. Analyze it please.
Two major dilutions ($400 M+) to raise cash, lies about revenue projection, high cost basis, tough logistics, shrinking demand, etc etc
They are running out of cash. CFO resigned. Will it go to bankruptcy soon to help a few who have shorted big time and facilitate a cheap transfer to the vultures?
Only.a miracle will lift it from $1.70 to $18 again. Q2 will reveal its trajectory and seal its fate. Letโs pray for a miracle here.
Sunman88
4 weeks ago
They analysts are a laughing stock. They are so behind the curve. If you bought based on their recommendation, you are screwed now. Itโs at $2 for many good reasons. Repeated dilutions to ten time of $400M, lies about annual estimates, demand is low, burn rate is through the roof and additional dilutions are now a strong possibility. If they cannot ramp up sales and beat revised estimates hands down in Q2 and Q3, itโs game
over. $1 is more likely.
Sunman88
1 month ago
A year ago, post approval for Amtagvi, share price shot up from $9 to $18. Today it is struggling at $2 mostly due to missed revenue, dilution of shares and loss of trust with current management team. CFO leaving at this juncture is proof positive of chaos. Only hope and prayer is the COO delivers on beating revised forecasts for the next several quarters while burn rate is controlled in a manner to reach breakeven by 2026. This coupled with good news from ongoing studies has the potential to bring the stock back to $9 (market cap $3B) by end of this year or early 2026. However, if they miss revised targets, itโs game over. This is my position and Iโm sticking to it. Good luck to all of us. We need it to get out of this dire state.
badgerkid
1 month ago
From this point forward, what really matters is improving revenues each and every Q for the next several quarters. Despite what's happened in year one, the new CCO Mr. Kirby and his team have to be fully committed to improving the message of the need to have patients start TIL therapy far earlier in their disease progression. The KOL panel said that very same thing in the fireside chat the other day. There's plenty of catalysts for year two, but increasing revenues has to be at the top of the list by far.
Some have speculated that the CFO is leaving (or was asked to leave) due to the botched guidance (or the failure in messaging when it became obvious that guidance wasn't going to be met). It's important to remember that the CFO is only one piece in approving guidance before it goes out to the public. Likely the CEO and some BOD members were also part of that decision. If the CFO is being sacrificed, will there be others?
It's also possible that he's simply moving on as many execs do when they've been in a job for a certain number of years. If they wish to remain relevant, they make those customary job changes multiple times in their careers. Then again, he may simply be going to a job where they understand what he's saying, I always struggled with Jean-Marc's heavy accent on those conference calls.
In the meantime, IOVA is still a victim of the sector and the overall market until such time that they impress with increasing revenues. Q2 is looking like it'll suffice, but I suspect Q3 will finally show those improvements expected with the new CCO at the helm.
Many still want additional new leadership and I can't say that I blame them. Bottom line is the bottom line - revenues need to be increasing. Trusting this company's messaging again will take time.
GL to IOVA longs.
badgerkid
1 month ago
"I was told I'd die from skin cancer - but my tumour disappeared with new therapy": https://inews.co.uk/news/health/skin-cancer-therapy-tumour-disappear-3726365
โThe study demonstrates that for patients with few options left, a single infusion of lifileucel can provide a deep and lasting response and even complete remission in some cases. This marks a major advance in how we think about treating solid tumours.โ
The next step is to help the onc docs to see TIL therapy as an earlier option, as a second line, not end of the line. This has shown to be even far more effective than these good results that we already see when used late in the disease progression.
Moving toward approval in foreign markets, numerous centers that did trials will become the first ATCs, centers that already have the experience necessary to hit the ground running.
GL
badgerkid
1 month ago
Spent a little time digesting the call and the transcript. Dr. Gastman was more conservative and obviously holding back a bit as is necessary when discussing trial data for lung. He can't definitively say without requiring an 8-K, but he most certainly implied that the numbers will be acceptable for the BLA which bodes well for us as shareholders.
Mr. Kirby was as expected, confident and focused. Exactly what I want from a CCO. Sales and marketing needed a lot more than they had previously and Kirby does seem like the real deal. It all depends on how effective they are at communicating with new docs, ATCs, and the entire medical teams necessary to start driving earlier referrals of patients. 3rd line+ is not going to cut it and they know that full well. Iovance needs more patients and earlier line patients to really impress and get that exponential growth that I believe is fully possible.
The big takeaway for me is the one we all know, lung is far bigger than the melanoma market, but melanoma is more than enough to be profitable. The slower start did reveal areas that needed attention but are fully correctible for the future success of Iovance. Melanoma was a great place to start and will make future indications pop much quicker upon their approvals now that many of those early bugs are worked out.
For me, the stock market just doesn't want to reward Iovance's past mistakes until some proof is given over the next couple Q's. Believability is still an issue.
End of the year should be bangin'.
GL to IOVA longs.