surfkast
2 days ago
TILVANCE 301, A Phase III Clinical Trial for Melanoma Patients with Untreated, Unresectable or Metastatic Disease: Actively Enrolling
You may have heard of AMTAGVI, also known by the generic name lifileucel, a new therapy that recently earned FDA approval. AMTAGVI is a type of cellular therapy that uses Tumor Infiltrating Lymphocytes (TILs) to treat patients with advanced melanoma whose melanoma hasn’t responded – or quit responding – to PD-1 based immunotherapies and BRAF/MEK targeted therapy, if their melanoma has the BRAF mutation. TIL therapies involve extracting immune cells called lymphocytes from a patient's tumor, growing them in a laboratory, and then reinfusing them back into the patient's body. TIL therapies aim to harness the patient's own immune system to target and destroy melanoma cells.
PD-1 therapies such as pembrolizumab, a type of immunotherapy called an immune checkpoint inhibitor (ICI), are approved for the treatment of advanced melanoma in the upfront or treatment-naïve setting. Pembrolizumab is an antibody that binds to a protein (PD-1) on the surface of immune T cells, releasing the brakes on T cells so that the immune system can attack and kill cancer cells.
Clinical trials have been investigating the efficacy and safety of combining the cellular therapy, lifileucel, with pembrolizumab in patients with untreated, unresectable, or metastatic melanoma. Results from Phase II clinical trial IOV-COM-202 Cohort 1A, testing this combination in advanced melanoma patients who had not received prior ICI-treatment, demonstrated that two thirds of patients responded with almost a third of the patients having a confirmed complete response (total disappearance of tumor).
These encouraging Phase II results provided the rationale to open TILVANCE-301, a Phase III randomized clinical trial looking at the efficacy and safety of lifileucel in combination with pembrolizumab compared to pembrolizumab alone in untreated, unresectable, or metastatic melanoma patients. Patients meeting the eligibility criteria are randomized to one of the two arms (lifileucel + pembrolizumab or pembrolizumab alone). Participants whose disease progresses when receiving only pembrolizumab will be offered lifileucel monotherapy. This study is actively enrolling participants in the U.S., Canada, Australia, UK and several European countries. The trial also includes mucosal and acral melanoma patients who meet the eligibility criteria.
More information on the TILVANCE 301 trial is available. Please speak with your treating physician to see if this trial is right for you.
MN Gopher
3 days ago
Badger, This WuXi potential sale news is exactly what Iovance needs.
We are seeing very strong demand, we are able to provide 2,000 TIL treatments ourselves & we are not filling 2,000 yet…
To have a Factory next to us makes perfect sense for us to buy & secure another 5,000 TIL treatments next door to meet the demand.
If we move to frontline with Pembro (Keytruda) which in my opinion will
Happen in the next 12 months, we have the facilities to meet the demand up to the 7,000 Max we would now have.
When our own expansion is done, we will be able to produce 5,000 ourselves by 2026/early 2027 Is what I remember reading.
Buying WuXi in Philly gives us a very impressive “Turn Key” business to sell & every $ spent on WuXi comes back to us & then some, selling a Turnkey Business to Cure Cancer…One Day.
G-D Provides opportunity in life & here we stand at the foot of the “Mountain” as Iovance climbs the Mountain one day at a time.
#CureCancer
badgerkid
6 days ago
GMH, agreed, we can't even assume the 15 was anything more than the total so far. It may mean over the past several months, it may mean since approval, it really doesn't say. But even if it's the total since approval, that still goes to the point that Iovance needs less than 2 patients per month per ATC (assuming 50 ATCs) to be profitable. What we've seen from some of the ATCs is that they're at or over that number pushing 3, 4, and 5 patients per month. Iovance has confirmed that they can handle up to 2,000 per year currently with additional space being created, so it's just a matter of time before Iovance surpasses that breakeven number of 1,000 or so patients annually to move into the black. Hopefully sooner for everyone's sake especially the patients.
badgerkid
7 days ago
SB, regarding the article - I scan a lot of sites so credit goes to others who shared initially. If you see something, say something (the old neighborhood watch slogan).
As we've previously discussed, it takes less than 2 patients per month per ATC for Iovance to be profitable. The challenges of slot designation and ensuring patient access in a timely manner are continually improving. As iCTC staffing increases and becomes fully trained, as ATCs work through the early logistical challenges and insurance issues, the patient numbers will certainly increase as less time is wasted and slot management improves. The good news, patients are now getting a chance at life and a potential cure where none existed for many of these patients only 7 months ago. Iovance will continue to have growing pains for a little while longer, but improvements are certainly being made as evidenced in the company's guidance.
This is not the simple game of pill manufacturing, it's far more complex. This is why I'm now of the belief that big pharma will make an offer to acquire after Iovance works out the bugs in this type of treatment. I think the buyer will want a turnkey manufacturing operation when making an offer, and Iovance will certainly be able to ask a bigger price when that time comes. This has not been done before so it's foolish to think that just any big pharma company can step in and do a better job at this stage in the ramp up. I do believe that the time for an offer is getting closer, though.
Good luck to the longs.
badgerkid
1 week ago
15 patients by the end of the month will be treated at the University of Chicago. Read the article.
HEALTH NEWS SUBURBAN CHICAGO
Northwest suburban woman is first in the Midwest to receive 'groundbreaking' skin cancer treatment
Alla Pinzour has lived with melanoma for 15 years. A new therapy offered at University of Chicago Medical Center used her own body’s cells to fight the cancer and shrink her tumors.
By Kaitlin Washburn
Sept 23, 2024, 7:56pm CDT
Alla Pinzour was diagnosed with melanoma in 2009. Earlier this year, she underwent a groundbreaking new treatment for advanced melanoma called TIL therapy. Doctors are pleased with the results.
Provided by University of Chicago Medical Center
Alla Pinzour has lived with skin cancer for 15 years.
She was diagnosed with melanoma in 2009 after finding a small mole on her leg. She’s tried every possible treatment — injections, surgeries, radiation, chemotherapy. But nothing has managed to keep the disease at bay.
Last year, the melanoma spread further. Tumors were found in her stomach, lungs and liver.
“It had advanced more aggressively than it ever had,” Pinzour said.
But her longtime oncologist, Dr. Bruce Brockstein at NorthShore hospital in Highland Park, learned about a new cancer treatment that would become available at University of Chicago Medical Center. It just needed federal approval first.
She waited nearly a year. The treatment, called tumor-infiltrating lymphocyte therapy, was finally approved by the U.S. Food and Drug Administration in February. Weeks later, Pinzour, 50, became the first patient in the Midwest and one of the first in the country to receive the therapy.
“I have always been a trouper. I have always stayed positive,” Pinzour said. “That’s how I believe I handled it for so many years.”
Melanoma is the most aggressive and deadly form of skin cancer. And the options for treating advanced melanoma were limited until 15 years ago, said Dr. Daniel Olson, an oncologist who specializes in melanoma at University of Chicago.
The first therapy to treat metastatic melanoma, called checkpoint inhibitors, was approved in 2008 and changed the landscape for treating the disease, Olson said. That treatment helps about half of patients go into remission or be cancer-free.
TIL therapy is another major breakthrough for treating melanoma, said Olson, who leads the TIL therapy program at the University of Chicago.
“For treating melanoma, it’s really a remarkable therapy. It’s groundbreaking. It’s the best thing out there now,” Olson said.
University of Chicago is one of a handful of medical centers in the U.S. providing the new treatment. The hospital had been running clinical trials for the therapy and knew the approval was coming, Olson said. They lined up Pinzour to receive it as soon as possible.
The therapy relies on the patient’s own T cells, a type of white blood cells in the immune system that can recognize and kill cancer cells, Olson said. These cells are also found in melanoma tumors.
Scientists determined the T cells could be extracted from the tumor, multiplied by the billions in a lab and then returned to the patient’s body to help their immune system fight the tumor, Olson said.
“I describe this to patients, and they think it’s crazy. And it is. It’s a rather remarkable way to treat cancer,” he said.
Not everyone with advanced melanoma is eligible, Olson said. It’s a laborious therapy that can only be used when other treatments have failed, as in Pinzour’s case. The patient also needs to be healthy enough to endure the therapy.
Alla Pinzour has had melanoma for 15 years. Tumors were later found in her lungs, stomach and liver. “I have always been a trouper. I have always stayed positive,” Pinzour said. “That’s how I believe I handled it for so many years.”
Provided by Mark Black/University of Chicago Medical Center
Pinzour, who lives in northwest suburban Hawthorn Woods, said the treatment was brutal. At one point, she had a fever of 105.1 degrees. She felt weak and struggled to get out of bed.
But good news came two months later, during her first scan after getting the therapy. Her tumors had shrunk by half.
“I can’t even describe the emotions. I was yelling, I was screaming. My husband was stunned,” Pinzour said. She goes back for a second scan in November.
Administering the therapy involves a large care team, Olson said. A surgeon first extracts the T cells from the patient’s tumor. Then the patient goes through a week of chemotherapy to tamp down their other white blood cells before getting their T cells put back in. They also receive a drug that helps the T cells continue to grow.
Luckily, it’s a “one-and-done” treatment, Olson said. One-third to half of all patients who receive TIL therapy go into remission or end up cancer-free. Results can take several weeks to months to appear.
Olson said he’s encouraged by how well Pinzour handled the therapy.
“It’s really fortunate she did well and tolerated the treatment. We saw an amazing regression within weeks,” Olson said.
Fifteen patients will be receiving TIL therapy at University of Chicago by the end of the month.
This type of treatment will hopefully soon be available to treat other cancers, Olson said. Ongoing clinical trials are determining if TIL therapy can be used to treat lung, cervical, breast and colon cancers.
The success of the treatment meant Pinzour got to have a normal summer for the first time in years. She spent time with her husband and her two kids, visited with friends and focused on her catering business, Alla’s Yummy Plate Company.
“I am finally able to live my life,” Pinzour said. “I have hope that I will be cancer-free. I’m a believer.”
After several summers spent receiving cancer treatments, Alla Pinzour was finally able to have a normal summer this year with her family. Her doctors have seen a regression in her tumors since she underwent TIL therapy.
Provided by University of Chicago Medical Center
I wasn't able to load the pictures. Here's the link: https://chicago.suntimes.com/health/2024/09/23/northwest-suburban-woman-groundbreaking-skin-cancer-treatment-melanoma-tcell-health-wellness-research
GMH*
1 week ago
I fully agree in that I think most of the short positioning is program level trading. My guess is that there are some HFs that look for any company in the XBI that has a big jump is share price, wait 2-5 days (which is typical peak), then start shorting. For most biotechs, the next catalyst is 2-3 years out so easy short for 9-12 months. If you do this on a portfolio basis, 19 of 20 will be winners (probably 35%-50% draw down). Was actually thinking of shorting SMMT at $30+, but next day was already down to low $20s... and you probably need a portfolio... not sure I could handle the stress and time required.
On the fundamental short side thesis, I do think that the ramp may be a concern (usually slower for biotechs than most people think)... this will go away if they beat/raise on revenue. I think the biggest issue is with the gross margins and COGS. I have heard several comments on different boards that they cannot make money because costs are too high and will take a long time to get to scale. I personally think the issue is patient selection and cycle time. Think the drop rate was really high in Q2 but should be much better in Q3. They guided to revenue but only said they would eventually get to 70% GM, but gave no timeline. The longer that takes, the more dilution that will happen.
Then there is simply the competitive landscape of cancer treatment. Just look at all the ongoing trials. Additionally, TIL treatment is quite onerous, so think that a lot of people would opt for less invasive options prior to TIL, but that may not be the wise choice health wise. Hope oncologists really push early L2 for those reasons alone.
badgerkid
2 weeks ago
Sunman, I think it's less to do with what "they" know, and more to do with sector shorting. Short interest did begin to drop again only to bounce back a bit with the last short interest report:
09/13/2024 60,293,439
08/30/2024 57,686,674
08/15/2024 59,334,386
07/31/2024 61,318,556
07/15/2024 58,941,197
06/28/2024 56,421,027
06/14/2024 54,631,791
If they knew something negative, it would behave much differently and any number of funds would have bailed or reduced significantly - that hasn't happened. If this is tied to an expected slower start, that's a reasonable thought; if expenses are going to be higher with the hiring and build-out, also a reasonable thought. But more likely (and in my opinion), the overall sector has seen incredible and unrelenting shorting. IOVA is just one of many similar stocks where this is observed and I see this tied more to program trading and shorting algos than negative information known only by a limited number of individuals that are shorting but not known by the billion dollar funds that have huge research budgets.
Iovance does not play the game of constantly updating the market or hyping news (for good or for bad, they just don't). Look at Summit's (SMMT) recent rise and fall on the comment that they beat Keytruda - sure looks like a pump and dump now, in hindsight. The Iovance BOD and WR specifically are notorious for not leaking any news - good or bad. So, when there's limited news, fear and doubt can creep in which is a playground for shorting. The company even stated that they were going to offer guidance for that very reason (to combat misinformation), a move that is unprecedented in bios this early in the game.
We've all seen what this company has to offer, most of us think that it's incredible with tremendous upside and profit potential. But if the company is focused on taking Iovance to a profitable and successful company that will likely save a significant number of lives that would have otherwise been lost to cancer, maybe not worrying too much about the share price is a good thing. They haven't lost their institutional investors so my guess is that enough information exists that keeps them around. Who am I to think I know more.
It doesn't change the frustration that many of us feel about the share price, but I see no reason to worry about Iovance's future which has me holding my core position. But maybe I need to trade this stock just a bit more if this is the game that's being played for the time being. The problem with me and trading is I don't have the time to dedicate to doing it well which means it's likely wiser to pick the future winners and just hang on. But even I can see that the current price is a good entry point with the stock likely to rise going into the Q3 report.
Just some random thoughts here.
Good luck to the longs.
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jondoeuk
5 days ago
