Discover and read the best of Twitter Threads about #Teplizumab

Most recents (6)

Abro 馃Уpara hacer un recuento de lo que el #A帽o2022 nos dej贸:
1. La aprobaci贸n por la @US_FDA en Noviembre del Tzield (#Teplizumab), un anticuerpo monoclonal anti-CD3 que retrasa la aparici贸n de la #diabetes tipo 1.
2. La publicaci贸n en @ScienceMagazine de la fase 1 del ensayo cl铆nico con la #vacuna eOD-GT8-AS01B para prevenir el #VIH, que indujo la sintesis de #anticuerpos neutralizantes vs el virus, en el 97% de los que fueron vacunados.
3. El #Daxxify una nueva forma de toxina botul铆nica tipo A, cuyo efecto tiene una duraci贸n de hasta 6 meses. El efecto del #botox es de alrededor de 3 meses.
Read 27 tweets
馃У#diabetes prevention : are we on the right track?
Here are the players in the development of #T1D 馃憞
-M. Knip

#ISPAD #ISPAD2022 #dedoc掳voices #NothingAboutUsWithoutUs #patientvoice #payitforward @dedocORG @ispad_org 1/n
#diabetes prevention : are we on the right track?
The different stages of #betaCells autoimmunity:
1鈨 Normoglycemia
2鈨 Presymptomatic dysglycemia
3鈨 Symptomatic dysglycemia
Primary prevention shld start during pregnancy.
-M. Knip

#ISPAD2022 #dedoc掳voices @dedocORG @ispad_org 2/n
#diabetes prevention : are we on the right track?
Early life infection may be the initiator of the endotype. There is a step autoantibodies decline among those diagnosed before 7yo.
-M. Knip

#ISPAD2022 #dedoc掳voices #payitforward @dedocORG @ispad_org 3/n
Read 7 tweets
Since people are going gaga over the Vertex Pharma T1D stem-cell announcement yesterday, here's a quick review of where we are, and how we got here: 馃У馃憞
Islet transplants have been happening for more than two decades: pubmed.ncbi.nlm.nih.gov/10911004/
We've been able to make islets and beta cells from stem cells for quite a while, too. Here's a review article from 2012 (yes, almost a decade ago) summarizing progress on stem-cell derived beta cells up to that point: ncbi.nlm.nih.gov/pmc/articles/P鈥
Read 21 tweets
Update #ProventionBio #Provention $PRVB #teplizumab. For a summary of AdCom etc. see thread below. I am not involved with the company but have other conflicts of interest. All is based on public information and personal opinion.
Recap: Company has Breakthrough Therapy Designation and Priority Review, an AdCom vote 10-7 in favour for 鈥渄elay of Type 1 diabetes #T1D鈥, and got a CRL stating CMC problems and failure to demonstrate PK/PD comparability between the studied Lilly-produced
and to-be commercialized ACG-produced teplizumab drug product (DP). A PK/PD substudy in the ongoing phase 3 PROTECT trial of 2 x 12 days of IV teplizumab 6 months apart in new-onset T1D has been completed (AGC Biologics DP ca. 30 patients, Lilly DP ca. 130 patients).
Read 11 tweets
Second part: on #ProventionBio #Provention $PRVB #anti-CD3 monoclonal antibody #teplizumab under #FDA consideration for the 鈥渄elay of clinical #Type1Diabetes #T1D in at-risk individuals鈥.

Upcoming questions cont鈥檇:
(4) If risk/benefit is acceptable, which target population is deemed suitable by the FDA? There were proponents of 3 options in EMDAC: (a) Stage 1 + 2, (b) Stage 2, or (c) Stage 2 + family Hx of T1D (= inclusion criteria of TN-10).
(a) is unlikely, I think, my vote is with (b). With regards to age, I think >8 years (as in TN-10) will be a requirement, given the SEs associated with teplizumab.
Read 26 tweets
Thread on #ProventionBio #Provention $PRVB and their flagship #antiCD3 monoclonal antibody #teplizumab under #FDA consideration for the 鈥渄elay of clinical #Type1Diabetes #T1D in at-risk individuals鈥. I have no connection to the company 鈥 but I do have COIs. No recommendations
or claims of accuracy, just a summary of the status quo and personal opinion. Assume I鈥檓 biased. All public information. Feel free to correct me. For references & links, contact me. Some pictures are copies from public PRVB presentations/FDA briefing docs.
*Summary*

PRVB are seeking approval of 14-day IV teplizumab for the delay of T1D. Teplizumab is a humanised Fc-mutated anti-CD3 monocl Ab that, simply put, turns autoreactive T-cells (regardless of antigen) into exhausted T-cells

(PRVB corporate presentation slide) Image
Read 27 tweets

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