Replies to post #249840 on Biotech Values

[DewDiligence]

CABA (-47%), AUTL (-30%), GRCL (-23%) are among the names selling off on today’s FDA press release.

[DewDiligence]

GILD’s Kite subsidiary reduces workforce 7%:

https://www.fiercepharma.com/pharma/gilead-cuts-7-staff-kite-pharma-unit-refreshed-business-strategy-introduced

Kite produces GILD’s two approved CAR-T products, Yescarta and Tecartus (#msg- 173310477). Is the timing of this announcement just a coincidence?

[iwfal]

re:CAR-T lymphoma risk

Comments:

A) CABA, coincidentally, had a cc scheduled the day after that announcement and they spent most of it addressing this FDA warning. They did a fairly good job (clearly an all out prep in preceding 24 hours), including summarizing data from Big Pharma on this topic. The cc is a good summary.

B) a very high percentage of the patients who go on CART have previously had, or subsequently have, secondary cancer inducing treatments. Eg in some (many? all?) Kymriah trials 50% of patients failed a previous Allogeneic stem cell transplant (most involving large doses of radiation). And some of the standard chemo regimens themselves have warnings about secondary cancers, including T Cell.

C) many popular therapies for treating immune diseases have warning about risk of secondary cancers. Yet they sell well despite this and provide substantially less benefit that has been seen in Schett CART data for Lupus etc.

D) one of the providers of existing CART therapies has noted that they have yet to see a T-Cell cancer that was in T-cells loaded with the CAR. (This will be a key metric for CART secondary cancer risk, how many showed CAR). Out of multiple 1000s treated.

My WAG is as long as this is in neighborhood of 1/1000 or less it won’t be much of an impediment to sales. Even at 1 in 500, given the enormous benefit… . And right now VAERS says it’s around 1 in 1000 overall (potentially mostly caused by other treatments?), although undoubtedly VAERS is an undercount.

[Biowatch]

From No Hope to a Potential Cure for a Deadly Blood Cancer
Multiple myeloma is considered incurable, but a third of patients in a Johnson & Johnson clinical trial have lived without detectable cancer for years after facing certain death.

A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year.

They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice.

They all got [CAR-T] immunotherapy, in a study that was a last-ditch effort.

A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease…

… For Anne Stovell of New York, one of the study patients whose cancer disappeared, the result is almost too good to be true.

She says she went through nine drugs to control her cancer after it was diagnosed in 2010, some of which had horrendous side effects. Each eventually failed…

…The drugs are “hideously expensive,” Dr. June said, costing more than $100,000 a year.

The total cost over the years can be millions of dollars, Dr. June said, usually paid by insurers, “and it doesn’t even cure you.”

CAR-T is expensive too. Carvykti’s list price is $555,310. But it is a one-time treatment. And, more important, the hope is that perhaps by giving it earlier in the course of the disease, it could cure patients early on.

Johnson & Johnson is now testing that idea.

https://www.nytimes.com/2025/06/03/health/multiple-myeloma-car-t-immunotherapy.html?unlocked_article_code=1.NE8.IZMn.fE98G03BClji&smid=url-share

See my previos post:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171724103&txt2find=Multiple%20myeloma