hu3F8 available in Hospital Sant Joan Déu in Spain (and other hospitals)

(Sam Saffron) #1

A note to all European NB community.

Hospital Sant Joan Déu is now treating patients with hu3F8 per the MSK protocol.

hu3F8 is a drug developed by MSK and manufactured by Y-mAbs

There is some discussion about 3F8 here: Immunotherapy: ch14.18 vs antibody-3F8

The promise of hu3F8 is that it can be applied at significantly higher dosages than ch14:18 and 3f8 (2.5x) and is given to children as out-patients with significantly less side effects.

If anyone has any more information please post here.

My understanding is that the drug may be made available in Hong Kong and the UK soon as well.

What after the immunotherapy
(Parker Moss) #2

This is very interesting. Is it available privately or on the Spanish state system? Thanks for letting us know.

(Sam Saffron) #3

I am not certain but according to Wikipedia they are part of the public hospital network.

As far as I understand hu3F8 is available there under compassionate use and they are accepting 2 patients a week the full trial opens in October.

(Mark Shirran) #4

We were at MSK for a vaccine injection today and our RN said there were a couple of nurses from London here this week to train in 3F8 administration. So looks like Madrid isn’t the only European city to be getting access to it…

(Nasos Mwraitis) #5

london nurses probably came from harley street clinic where doctor Stergios Zacharoulis sent them to train . he brought 3f8 to this clinic as i was told by himself. but its 3f8 and not 3huf8 i think. MArk since you do the vaccine in MSK do you have any information about the stats? we hear that 3 years it has like 80% of remaining in remission. is this accurate?

(Mark Shirran) #6

Thanks Nasos

The only data I’ve seen for the vaccine is from the following 2 sources:

  1. The 2014 article published by the MSK group:
  2. Presentations by Brian Kushner and Shakeel Modak at various patient/parent nb conferences.

I did push Brian Kushner for more information but unsurprisingly he wasn’t very forthcoming!

I think the bottom line is no one really knows if it makes a difference and if so, how much of a difference. There are so many other variables at play in the small number of patients that we are talking about, so you have to be very careful how this limited data is interpreted.

For me, the vaccine:

  1. makes sense biologically
  2. seems to have limited significant side effects
  3. the very limited data presented at conferences suggests there might be an improvement in survival (in patients who have previously relapsed) - but as I say there are so many confounding factors and the trials so far haven’t been set up to answer this question - the only published data I’m aware of is linked above and was a phase 1 trial that primarily investigated the maximum tolerated dose
  4. and is something we could personally afford (after a lot of fundraising!)
    … so for us it made sense to give it a shot!

Sorry I can’t be of more help!


(Nasos Mwraitis) #7

Thanks for the response Mark. Of course for a relapse case seems logic to follow the vaccine. As fas as i know in memorial they started doing it also in all first remission patients . that is to be honest the thing that keeps going into my mind. If its a logic step to put a child in remission in this therapy.

(Mark Shirran) #8

Yes Nasos, they have definitely started giving the vaccine to children in first remission at MSK as we are one of them!

All the best, Mark

(Nasos Mwraitis) #9

Wish you all the best

(Sam Saffron) #10

Looks like hu3F8 is going to be far more widely available in a trial very soon:

Locations in California, Florida, Indiana, New York, Ohio, Texas, Denmark, Spain and UK

Top US NB treatment facilities/protocols
(Donna Ludwinski) #11

Yes Sam – the goal is EMA and FDA approval. Trial should be open next month! I had the great pleasure of finally meeting Dr Mora from Barcelona (after years of email) at the AACR pediatric meeting in Dec – he is fantastic! Someone should make a movie out of this whole story some day. :smiley:

(James) #12

oh wow! you’re such a lucky woman Donna! I mean, for meeting Dr. Mora. would really appreciate some more details about that meeting!

(Donna Ludwinski) #13

Trial is now open in Barcelona. For now, unlikely to open in UK at Harley Street.

(Mark Liu) #14

great to hear. do they take patient in first remmsion? i see the trial is for relapse or refractory

(Donna Ludwinski) #15

The trial is open for relapse/refractory (bone and or marrow) but no trial for 1st remission. Best thing is to contact Dr Mora about 1st remission (frontline).

(Shao) #16

Yes. Hospital sant Joan de deu accept international NB patient for Hu3F8. But you should check with them your eligibility before coming

(jindrich daniel) #17

dear donna, I wonder if you could give me some info about your visit in barcelona.
have your child been already treated there?
thank you

(Donna Ludwinski) #18

Hi Jindrich,

I met Dr Mora at a pediatric oncology meeting in the US last Dec, and haven’t been to Barcelona. I can put you in touch with families who have been there if you would like. What is the status of your child?

(jindrich daniel) #19

hi donna
thanks for your answer.
our little finished induction therapy incl. TVD and the coming wednesday she’ll have surgery, HDT is planned for early november.
would be great if you could connect me.
br jindrich

(jindrich daniel) #20

hi donna,
I hope you are fine, can you get back to me please.
we are back from HDT now and we would like to contact parents who went to spain.
thank you