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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 “delay of Type 1 diabetes #T1D”, 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).
Second part: on #ProventionBio #Provention $PRVB #anti-CD3 monoclonal antibody #teplizumab under #FDA consideration for the “delay of clinical #Type1Diabetes #T1D in at-risk individuals”.
Upcoming questions cont’d:
Upcoming questions cont’d:
(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.
Thread on #ProventionBio #Provention $PRVB and their flagship #antiCD3 monoclonal antibody #teplizumab under #FDA consideration for the “delay of clinical #Type1Diabetes #T1D in at-risk individuals”. I have no connection to the company – but I do have COIs. No recommendations
or claims of accuracy, just a summary of the status quo and personal opinion. Assume I’m 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)
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)
