Galapagos « Terug naar discussie overzicht

quote:

ANdromeda schreef op 16 november 2023 12:35:

...
Er is een positieve vibe gecreeerd , en er is reeds een opwaartse notering te merken . ...

quote:

Triple A schreef op 24 november 2023 15:11:

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Enkel voor abbonees !

Galapagos speurt in China naar kankerbehandelingen

www.tijd.be/ondernemen/farma-biotech/...

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quote:

KVE83 schreef op 28 november 2023 07:46:

Wat verwachten jullie van de resultaten volgend weekend van Galapagos fase 1/2...

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mercurius-adept schreef op 28 november 2023 20:24:

tjeetje, Gala, Gala...alweer??
Het Stoffels tijdperk is krap begonnen en:

US FDA investigating safety risk of CAR-T cancer therapies

Nov 28 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Tuesday it was investigating cancer therapies made by companies such as Gilead Sciences (GILD.O) and Johnson & Johnson (JNJ.N) over the risk of hospitalizations and death due to a serious safety issue.

The FDA said it had received reports of T-cell malignancies, which refer to a group of blood disorders including lymphomas and leukemias, after treatment with CAR-T therapies or chimeric antigen receptor T-cell therapies.

Approved cancer therapies in this class include Bristol Myers Squibb's (BMY.N) Breyanzi and its partnered therapy, Abecma, with 2seventy bio (TSVT.O).

J&J unit Janssen and Legend Biotech's (LEGN.O) Carvykti, Novartis AG's (NOVN.S) Kymriah, and Gilead's unit Kite's Tecartus and Yescarta are also a part of the investigation.

Shares of Gilead were down marginally, while Legend's stock fell 4.2% in afternoon trading. Autolus Therapeutics (AUTL.O), which is also developing CAR-T therapies, was down nearly 12%.
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RBC analysts said in a note they believed that the concerns could be higher for Novartis' Kymriah, and extremely rare for all the other marketed CAR-Ts.

Gilead said it had cooperated with the FDA on its request for an analysis of the company's data, adding there was no evidence that treatment with either of its two therapies had a causal role in the development of new malignancies.

"We are confident in the overall safety profile of both Tecartus and Yescarta," Gilead told Reuters in an emailed statement.

CAR-T therapies, or chimeric antigen receptor T-cell therapies, generally involve extracting disease-fighting T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.

J&J, Bristol Myers and Novartis did not immediately respond to Reuters' requests for comment.

Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies, the FDA said.

www.reuters.com/business/healthcare-p...

quote:

Endless schreef op 29 november 2023 04:21:

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The therapies involve extraction of a type of white blood cells or T-cells, re-engineering them to attack cancer and infusing them back in the body
It is estimated that about 20,000 patients have likely been treated with CAR-T therapies, so we see the overall risk as low - Brokerage William Blair

quote:

mercurius-adept schreef op 29 november 2023 06:32:

[...]

aha:

"Analysts from William Blair noted the stock market reaction in a Tuesday afternoon note, saying that companies with CAR-T therapies in autoimmune indications have been particularly vulnerable. The firm said that these therapies have shown promise in early data but the risk of cancer might not be acceptable to the overall benefit/risk ratio, as it might be in oncology.

Nkarta, for instance, just announced a move to take its cell therapy work beyond cancer with a green light for a clinical trial of a CAR-NK candidate in lupus.

William Blair said it still sees significant benefit for autoimmune patients if the data continues to show durability and provide treatment-free intervals of multiple years.

For oncology CAR-T companies, William Blair called the stock market reaction “overdone.” These companies will have an opportunity at the upcoming American Society of Hematology meeting in December to prove their case, as well as with data readouts expected in 2024.

“We also believe the news has no read-through to companies that use nonviral approaches for CAR insertion, such as Poseida, and minimal impact on companies developing allogeneic approaches,” William Blair wrote. Allogeneic companies include Allogene, CRISPR Therapeutics, Nkarta, Century Therapeutics and Poseida Therapeutics. The firm said that “the host immune system more readily and rapidly rejects these compared to autologous approaches.”

Allogeneic cell therapies use stem cells from a donor that matches the patients to treat cancers such as leukemia, lymphoma and multiple myeloma. Autologous cell therapy uses a patient’s own cells that are removed, tweaked with the medicine and then reinfused back into the body."
www.fiercebiotech.com/biotech/volatil...

quote:

Endless schreef op 29 november 2023 10:20:

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Galapagos onderzoekt idd met autogene cellen niet van een donor vane to vane van de patiënt zelf.

quote:

mercurius-adept schreef op 29 november 2023 21:59:

eigen samenvatting:

Het eerder nog hypothetische risico op secundaire kanker door CAR-T therapie lijkt nu, langzaam aan, dus een klein maar reëel risico voor de klasse te worden.

De FDA waarschuwing gaat specifiek over CD19 en BCMA
En dat is niet leuk voor Gala, want de huidige pijplijn bestaat nu juist uit:
3x CD19 programma
1x BCMA programma
en de oude JAK-1 en TYK2 programma's

Analyse van mogelijke consequenties bij meer FDA bewijs, door een Leerink analist, van mild tot heel erg:

1. waarschuwingsniveau voor de klasse verhogen tot black box niveau
2. gebruik beperken (bv alleen voor high-risk patients, of later-line treatment)
3. nog strenger toezicht én verandering in de afweging van 'de risico's versus de baten'