BMS Announces New EU Manufacturing Site in the Netherlands; AUTO4 (TRBC1 CAR-T) Receives Innovation Passport and ILAP Designation; Allogene’s ALLO-715 Receives RMAT Designation by the FDA; No Major Updates in April’s CHMP Agenda
On Thursday, April 22, BMS announced (press release) that they plan to build a new cell therapy manufacturing site in Europe. Furthermore, Autolus confirmed (press release) that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted AUTO4 an Innovation Passport and entry into the Innovative Licensing and Access Pathway (ILAP) evaluating the TRBC1-targeting CAR-T in a Ph1/2 trial for peripheral T cell lymphoma (PTCL). Allogene announced (press release) that the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 (BCMA CAR-T) for the Ph1 UNIVERSAL trial in r/r MM. Finally, no major regulatory updates were observed for Abecma, Breyanzi, or cilta-cel from this week’s April CHMP Agenda (publication). Below, Celltelligence provides insights into BMS’s potential manufacturing strategy in Europe. Moreover, Celltelligence will provide thoughts on AUTO4’s ILAP designation and how this may accelerate approvals compared to the EMA’s PRIME designation, while discussing ALLO-715’s RMAT designation.
About The Author
The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.
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