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Atlas/Cell therapy/Ryoncil/Species

Ryoncil: which tox species, and why?

remestemcel-L · Allogeneic BM-MSC
Check my plan vs. these
Species
Rat, baboon and pig using species-specific surrogate ceMSC
“The nonclinical program utilized multiple surrogate animal-derived ceMSC manufactured similarly to the clinical product.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
Why that species
Species-matched allogeneic MSC model allogeneic administration and recipient immune interaction
“This approach was taken to model administration of allogeneic ceMSCs in humans and evaluate the interactions between the cell product and recipient immune system.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
Surrogate molecule
Yes: rat, baboon, pig and dog culture-expanded MSC made similarly to remestemcel-L
“Nonclinical studies were conducted using human bone marrow-derived ceMSC and surrogate animal-derived ceMSC produced using an early manufacturing process.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
No relevant species; NSG mouse xenografts and in vitro only

Alofisel

darvadstrocel · Allogeneic adipose MSC
Immunocompromised athymic nude rats (GLP); nude mice for tumourigenicity

Amtagvi

lifileucel · TIL therapy
No animal studies with product; published murine and human TIL literature only

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
No relevant species; no in vivo tox. NSG xenograft (pharmacology) and human tissue cross-reactivity only

Breyanzi

lisocabtagene maraleucel · CD19 CAR-T
No relevant species; in vitro and NSG mouse xenograft only

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
No relevant species; NCG mouse xenografts, non-GLP NHP pilot with autologous NHP CAR-T

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
Nude mouse (ectopic), sheep and goat (orthotopic); non-GLP combined PD/PK/tox

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
SCID mice (EBV+ lymphoma xenograft, literature/PD); no tox species

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
Minipig, pig and rabbit (ocular tox/PK); rcd1 dog for pharmacology; rat and rabbit for rhCNTF DART

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
Athymic (nude) mice for pharmacology; rabbits, guinea pigs, mice for biocompatibility

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
No animal species; abridged programme of in vitro tumorigenicity assays and literature

Kymriah

tisagenlecleucel · CD19 CAR-T
No relevant species; immunodeficient mouse B-ALL xenograft (non-GLP) only

Lantidra

donislecel · Allogeneic pancreatic islets
No studies with product; literature only (diabetic mice, rats, NHP, pigs)

Laviv

azficel-T · Autologous fibroblasts
No preclinical or toxicology studies conducted with the product

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
Rabbit and horse, with analogous MACI (species-matched autologous cells on ACI-Maix)

Omisirge

omidubicel · Expanded cord blood HPC
Immunodeficient irradiated NOD/SCID mouse only (xenogeneic human cells)

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
No conventional tox species; rat and mouse proof-of-concept studies with rodent surrogate products

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
No relevant species; nude rat pharmacology studies only, no tox

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
Immunodeficient (SCID/NSG) mice, Goettingen minipig, Merino sheep; no conventional tox

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Athymic nude mice only (immunodeficient wound model)

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
No relevant species; in vitro and syngeneic mouse surrogate CAR-T only

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
No relevant species; in vitro cross-reactivity/alloreactivity and murine xenograft pharmacology only

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
No tox species; sublethally irradiated immunodeficient mice (xenogeneic GVHD proof-of-concept) plus published murine literature

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
No relevant species; syngeneic mouse lymphoma model with murine surrogate CAR-T (published, non-GLP)

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
Immunodeficient NOD/SCID mice (GvHD xenograft models); no conventional tox species

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
Female sub-lethally irradiated NSG mice (human cells); UM171 compound PK/tox in NSG mouse, rat, cynomolgus monkey

Summary across all 27 cell therapies →